A Single-arm, Phase II Study for Bone Marrow Protection, Safety, and Efficacy of Trilaciclib Combined With Eribulin in Locally Advanced or Metastatic Triple-negative Breast Cancer After at Least Two Prior Chemotherapy Regimens

Triple negative breast cancer (TNBC) has attracted much attention due to its young age of onset, high aggressiveness, lack of clear therapeutic targets and poor clinical prognosis.Eribulin is a novel non-taxane anti-microtubule inhibitor with unique microtubule and non-microtubule anti-tumor mechanism.Myelosuppression is the cause of many cancer chemotherapy-related adverse events, such as infections, sepsis, bleeding, and fatigue, resulting in delayed hospital stays or the need for treatment with hematopoietic growth factors, blood transfusions, and more.In addition, myelosuppression usually leads to a lower dose or longer interval of chemotherapy, which reduces the intensity of chemotherapy and affects the benefit of chemotherapy for patients.Trilaciclib is a highly potent, selective and reversible CDK4/6 inhibitor that protects bone marrow by protecting hematopoietic stem cells and progenitor cells (HSPCs) during systemic chemotherapy.

Start Date04 Nov 2026

Sponsor / Collaborator

Sun Yat-Sen University

NCT07473128

/ Not yet recruitingPhase 3

A Phase III, Randomised, Double-blind, Placebo-controlled, Multicentre Trial Comparing Efficacy and Safety of Trilaciclib Versus Placebo in Participants With Limited-stage Small Cell Lung Cancer

The goal of this clinical trial is to compare the efficacy and safety of trilaciclib versus placebo in subjects with limited stage small cell lung cancer. The main question it aims to answer is:
Does trilaciclib have a myeloprotective effect in subject with limited stage small cell lung cancer?
Participants will be randomised to receive either trilaciclib or placebo.

Start Date31 Mar 2026

Sponsor / Collaborator

Pharmacosmos A/S

ChiCTR2600117016

/ SuspendedNot ApplicableIIT

Evaluating the Efficacy and Safety of Trilaciclib in Patients Receiving First-line Sintilimab Plus Chemotherapy for Advanced Driver Gene-negative Non-squamous Non-Small Cell Lung Cancer

Start Date31 Jan 2026

Sponsor / Collaborator

Sheng Jing Hospital

100 Clinical Results associated with Trilaciclib Dihydrochloride

100 Translational Medicine associated with Trilaciclib Dihydrochloride

100 Patents (Medical) associated with Trilaciclib Dihydrochloride

100

Literatures (Medical) associated with Trilaciclib Dihydrochloride

01 Jun 2026·CLINICAL PHARMACOLOGY & THERAPEUTICS

Comparing the Efficacy of Various Treatment Strategies for Patients With Advanced Triple‐Negative Breast Cancer: An Umbrella Review

Review

Author: Jia, Shubing ; Ma, Xiaolan ; Xin, Tiantian ; Liu, Jirui ; Liu, Zhendong ; Gao, Mingyu ; Yang, Yue ; Gao, Tong ; Xiang, Rongwu ; Zhao, Mingyi

Chemotherapy (CT) remains the standard first‐line treatment for advanced triple‐negative breast cancer (aTNBC), despite the emergence of innovative therapies, including targeted therapies (TT) and immune checkpoint inhibitors (ICI). Studies have shown that the treatment strategies for aTNBC vary widely, with inconsistent efficacy across different treatment modalities. A comprehensive search was carried out in electronic databases, such as PubMed and Embase, for systematic reviews and randomized clinical trials (RCTs) that investigated the efficacy of TT, ICI, and CT to treat aTNBC until June 2025. Seventeen published meta‐analyses and 52 RCTs reporting the prognosis of the disease treated with TT, ICI, and CT in aTNBC patients were analyzed. It showed that in terms of prolonging PFS, both the TT group and the ICI group were superior to the CT group [ICI: HR = 0.81 (0.69, 0.94); TT: HR = 0.68 (0.62, 0.74)]. In terms of OS, the TT group was superior to the CT group [HR = 0.77 (0.68, 0.88)]. In the subgroup analysis of TT, compared with CT alone, both sacituzumab govitecan (SG) monotherapy and trilaciclib combined with chemotherapy (TRI_CT) significantly improved the time of PFS [SG: HR = 0.41 (0.30, 0.56); TRI_CT: HR = 0.62 (0.46, 0.86)] and OS [SG: HR = 0.48 (0.33, 0.70); TRI_CT: HR = 0.41 (0.28, 0.59)]. This umbrella review supports SG monotherapy and TRI_CT as the first choice for patients with aTNBC. Additionally, the review was rated as high‐quality evidence using AMSTAR 2, the credibility classification standard, and GRADE rating. The study is reported following the Preferred Reporting Items for Systematic Reviews and Meta‐analyses (PRISMA) guideline and is registered with PROSPERO: CRD420251034666.

28 Mar 2026·Future Oncology

ToPCourT protocol: a phase II trial of Trilaciclib, Pembrolizumab, gemcitabine, and Carboplatin in locally advanced/unresectable or metastatic Triple-negative breast cancer

Article

Author: Symanowski, James T. ; Sears-Smith, Megan B. ; Tan, Antoinette R. ; Matusz-Fisher, Ashley

Triple-negative breast cancer (TNBC) is a clinically aggressive and difficult to treat malignancy. It has a poorer prognosis when compared to the hormone receptor (HR)-positive and human epidermal growth factor receptor type 2 (HER2)-positive subtypes. Due to the lack of targetable receptors, cytotoxic chemotherapy is often the backbone of therapy. Although effective, its use eventually becomes limited due to toxicity and resistance. Trilaciclib is an intravenous cyclin-dependent kinase (CDK) 4/6 inhibitor. Preclinical data showed that transient CDK4/6 inhibition with trilaciclib enhances and lengthens the duration of antitumor responses induced by a combination of chemotherapy and immune checkpoint inhibition. Herein, we describe the design and rationale for ToPCourT, an open label, single-arm, phase II trial. This study will evaluate the efficacy of trilaciclib in combination with pembrolizumab, gemcitabine, and carboplatin in patients with locally advanced unresectable or metastatic TNBC who have received ≤3 lines of therapy in the metastatic setting. The primary endpoint is overall response. Key secondary endpoints include progression-free survival, duration of response, and overall survival.Clinical trial registration: www.clinicaltrials.gov identifier is NCT06027268.

01 Mar 2026·NATURE GENETICS

CDK4/6 inhibition mitigates chemotherapy-induced expansion of TP53-mutant clonal hematopoiesis

Article

Author: Weis, Kenyon ; Tran, Duc ; Chan, Irenaeus C C ; Beeler, J Scott ; Fronick, Catrina ; Abdel-Wahab, Omar ; Mustion, Griffen ; Castro, Cynthia ; Bolton, Kelly L ; Zhang, Pu ; Pan, Xiangyu ; Fox, Nina ; Cuibus, Adriana ; Lewis, Alexander M ; Cruchaga, Carlos ; Stopsack, Konrad H ; Tittley, Steven ; Petrone, Giulia

Therapy-related myeloid neoplasm (tMN) is a fatal consequence of exposure to cytotoxic therapy administered in the treatment of cancer. Individuals with pre-existing TP53 clonal hematopoiesis (CH) are at high risk of tMN, with avoidance of therapy being the only strategy to reduce tMN risk. Here, in four randomized clinical trials, we show that the CDK4/6 inhibitor trilaciclib, given in conjunction with a variety of chemotherapeutic regimens and across diverse populations of patients with cancer, mitigates chemotherapy-related expansion of CH clones with mutations in DNA damage response genes, including TP53. This finding was also observed in a syngeneic mouse model of TP53-mutant CH, demonstrating that CDK4/6 inhibition blocks platinum-induced TP53 competitive repopulation through promoting hematopoietic stem and progenitor quiescence and decreasing the stemness advantage of TP53-mutant clones. This represents a proof of concept for a potential pharmacologic strategy to block chemotherapy-induced expansion of preleukemic TP53-mutant clones.

182

News (Medical) associated with Trilaciclib Dihydrochloride

04 May 2026

·www.biospace.com

NextCure and Simcere Zaiming Initiate Dose Optimization for SIM0505 (CDH6 ADC) in Gynecologic Cancers

Dose optimization will initially be focused on evaluating SIM0505 in patients with platinum-resistant ovarian cancer (PROC) Phase 1 data readout to be presented at ASCO 2026 BELTSVILLE, Md., May 04, 2026 (GLOBE NEWSWIRE) -- NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class, and best-in-class therapies to treat cancer and Simcere Zaiming Pharmaceutical Co., Ltd., (Simcere) an oncology-focused biopharmaceutical company and a subsidiary of Simcere Pharmaceutical Group Ltd (HKEX: 2096), today announced initiation of the dose optimization portion of the Phase 1 study of SIM0505, focusing on patients with platinum-resistant ovarian cancer. SIM0505 is an investigational antibody drug conjugate (ADC) comprised of an antibody that targets Cadherin-6 (CDH6) and a proprietary topoisomerase 1 inhibitor (TOPOi) payload. “Initiation of dose optimization highlights the promise of our novel CDH6-directed ADC and our focus on bringing SIM0505 to patients as quickly as possible. The dose optimization study is intended to help finalize dose selection and further de-risk advancement toward registrational studies. Additionally, we are accelerating development of the program by increasing the number of U.S. and China trial sites and expanding our clinical site footprint into Canada and Europe,” said Michael Richman, President and CEO of NextCure. “We look forward to presenting Phase 1 data at the upcoming 2026 American Society of Clinical Oncology (ASCO) conference as we continue to build momentum in the program.” About SIM0505 SIM0505 is a novel antibody drug conjugate (ADC) directed to cadherin-6 (CDH6 ADC), featuring a proprietary topoisomerase 1 inhibitor (TOPOi) payload. The ADC is designed for broad anti-tumor activity, fast systemic clearance and an improved potential therapeutic window. SIM0505 is being evaluated in an open-label, Phase 1 study ( NCT06792552 ) for the potential treatment of advanced solid tumors, including ovarian cancer with an emphasis on platinum resistant ovarian cancer. The Food and Drug Administration granted Fast Track to SIM0505 for platinum-resistant ovarian cancer. NextCure holds exclusive global rights for SIM0505, excluding China, Hong Kong, Macau, and Taiwan which are retained by Simcere Zaiming Pharmaceutical Co., Ltd. About NextCure, Inc. NextCure is a clinical-stage biopharmaceutical company focused on advancing innovative medicines to treat cancer patients through the use of targeted therapies including antibody-drug conjugates. We focus on advancing therapies that leverage our core strengths in understanding biological pathways and biomarkers, the interactions of cells within and beyond the tumor microenvironment, and the role each interaction plays in a biologic response. About Simcere Zaiming Simcere Zaiming is an oncology-focused biopharmaceutical company and a subsidiary of Simcere Pharmaceutical Group Limited (HKEX: 2096, "Simcere"). Founded in 2023, Simcere Zaiming is dedicated to developing groundbreaking therapies to meet the unmet clinical needs of cancer patients globally. With a robust and innovative R&D pipeline featuring distinct clinical assets, Simcere Zaiming has successfully launched several innovative products in China, including Enzeshu ® , COSELA ® , Enweida ® , Endostar ® , and Enlituo ® . The Company is determined to deliver potentially transformative treatment options to cancer patients worldwide through its internal R&D, manufacturing, and commercialization capabilities, complemented by strategic collaborations with leading partners. Forward-Looking Statements Some of the statements contained in this press release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including with respect to funding for our operations, objectives and expectations for our business, operations and financial performance and condition, including the progress and results of clinical trials, development plans and upcoming milestones regarding our therapies. Any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim”, “anticipate”, “assume”, “believe”, “continue”, “could”, “should”, “due”, “estimate”, “expect”, “intend”, “hope”, “may”, “objective”, “plan”, “predict”, “potential”, “positioned”, “seek”, “target”, “towards”, “forward”, “later”, “will”, “would”, and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or similar language. Forward-looking statements involve substantial risks and uncertainties that could cause actual results to differ materially from those projected in any forward-looking statement. Such risks and uncertainties include, among others: market and other conditions; positive results in preclinical studies which may not be predictive of the results of clinical trials; NextCure’s limited operating history and not having any products approved for commercial sale; NextCure’s history of significant losses; NextCure’s need and ability to obtain additional financing on acceptable terms or at all; risks related to clinical development, marketing approval and commercialization; NextCure’s reliance upon collaborators and international vendors for advancing clinical programs; and NextCure’s dependence on key personnel. More detailed information on these and additional factors that could affect NextCure’s actual results are described under the heading “Risk Factors” in NextCure’s most recent Annual Report on Form 10-K and in NextCure’s other filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. Forward-looking statements speak only as of the date of this press release, and NextCure assumes no obligation to update any forward-looking statements, even if expectations change. Investor Inquiries Timothy Mayer, Ph.D. NextCure, Inc. Chief Operating Officer (240) 762-6486 IR@nextcure.com Mike Moyer Managing Director, LifeSci Advisors, LLC Phone: (617) 308-4306 mmoyer@lifesciadvisors.com

Phase 1Fast TrackASCOADC

21 Apr 2026

·www.globenewswire.com

NextCure and Simcere’s SIM0505 (CDH6 ADC) Phase 1 Data to be Presented at ASCO 2026

Poster to be presented at the American Society for Clinical Oncology on Monday, June 1, 2026BELTSVILLE, Md., April 21, 2026 (GLOBE NEWSWIRE) -- NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class, and best-in-class therapies to treat cancer and Simcere Zaiming Pharmaceutical Co., Ltd., (Simcere) an oncology-focused biopharmaceutical company and a subsidiary of Simcere Pharmaceutical Group Ltd (HKEX: 2096), today announced a poster will be presented at ASCO 2026 highlighting Phase 1 data for SIM0505 in the treatment of solid tumors. ASCO 2026 is being held May 29 – June 2 in Chicago, Illinois. SIM0505 is an investigational antibody drug conjugate (ADC) targeting Cadherin-6 (CDH6) with a proprietary topoisomerase 1 inhibitor (TOPOi) payload. “We are very pleased to announce that the Phase 1 results for SIM0505 have been accepted as a poster presentation at ASCO 2026. This important milestone validates our collaborative clinical approach and highlights our mission of advancing innovative medicines to treat cancer patients,” said Michael Richman, President and CEO of NextCure. Presentation Details: Title: Phase 1, multicenter, first-in-human (FIH) global study of SIM0505, an anti-CDH6 (CDH6) antibody-drug-conjugate (ADC) in patients with advanced solid tumorsPoster Abstract #: 5580Poster Board: 246Presenter: Xiaohua Wu, MD, PhD, Chief Physician and Chairman of the Multidisciplinary Team in Gynecologic Oncology at Fudan University Shanghai Cancer Center, Shanghai, ChinaSession: Gynecologic CancerSession Date: Monday June 1, 2026Session Time: 9:00 AM CST to 12:00 PM CDT A full copy of the poster will be available on the NextCure website under the Investor Relations “Events & Presentations” tab following the presentation. About SIM0505 SIM0505 is a novel antibody drug conjugate (ADC) directed to cadherin-6 (CDH6 ADC), featuring a proprietary topoisomerase 1 inhibitor (TOPOi) payload. The ADC is designed for broad anti-tumor activity, fast systemic clearance and an improved potential therapeutic window. SIM0505 is being evaluated in an open-label, Phase 1 study (NCT06792552) for the potential treatment of advanced solid tumors, including ovarian cancer, with an emphasis on platinum resistant ovarian cancer. NextCure holds exclusive global rights for SIM0505, excluding China, Hong Kong, Macau, and Taiwan which are retained by Simcere Zaiming Pharmaceutical Co., Ltd. About NextCure, Inc. NextCure is a clinical-stage biopharmaceutical company focused on advancing innovative medicines to treat cancer patients through the use of targeted therapies including antibody-drug conjugates. We focus on advancing therapies that leverage our core strengths in understanding biological pathways and biomarkers, the interactions of cells within and beyond the tumor microenvironment, and the role each interaction plays in a biologic response. About Simcere ZaimingSimcere Zaiming is an oncology-focused biopharmaceutical company and a subsidiary of Simcere Pharmaceutical Group Limited (HKEX: 2096, "Simcere"). Founded in 2023, Simcere Zaiming is dedicated to developing groundbreaking therapies to meet the unmet clinical needs of cancer patients globally. With a robust and innovative R&D pipeline featuring distinct clinical assets, Simcere Zaiming has successfully launched several innovative products in China, including Enzeshu®, COSELA®, Enweida®, Endostar®, and Enlituo®. The Company is determined to deliver potentially transformative treatment options to cancer patients worldwide through its internal R&D, manufacturing, and commercialization capabilities, complemented by strategic collaborations with leading partners. Forward-Looking Statements Some of the statements contained in this press release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including with respect to funding for our operations, objectives and expectations for our business, operations and financial performance and condition, including the progress and results of clinical trials, development plans and upcoming milestones regarding our therapies. Any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim”, “anticipate”, “assume”, “believe”, “continue”, “could”, “should”, “due”, “estimate”, “expect”, “intend”, “hope”, “may”, “objective”, “plan”, “predict”, “potential”, “positioned”, “seek”, “target”, “towards”, “forward”, “later”, “will”, “would”, and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or similar language. Forward-looking statements involve substantial risks and uncertainties that could cause actual results to differ materially from those projected in any forward-looking statement. Such risks and uncertainties include, among others: market and other conditions; positive results in preclinical studies may not be predictive of the results of clinical trials; NextCure’s limited operating history and not having any products approved for commercial sale; NextCure’s history of significant losses; NextCure’s need and ability to obtain additional financing on acceptable terms or at all; risks related to clinical development, marketing approval and commercialization; NextCure’s reliance upon collaborators and international vendors for advancing clinical programs; NextCure’s ability to maintain listing of its common stock on the Nasdaq Global Select Market; and NextCure’s dependence on key personnel. More detailed information on these and additional factors that could affect NextCure’s actual results are described under the heading “Risk Factors” in NextCure’s most recent Annual Report on Form 10-K and in NextCure’s other filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. Forward-looking statements speak only as of the date of this press release, and NextCure assumes no obligation to update any forward-looking statements, even if expectations change. Investor Inquiries Timothy Mayer, Ph.D.NextCure, Inc.Chief Operating Officer(240) 762-6486IR@nextcure.com Mike MoyerManaging Director,LifeSci Advisors, LLCPhone: (617) 308-4306mmoyer@lifesciadvisors.com

Phase 1ASCOADC

31 Mar 2026

·ir.nextcure.com

NextCure and Simcere’s SIM0505 (CDH6 ADC) Abstract Accepted for ASCO 2026

The American Society for Clinical Oncology to be held in Chicago May 29 – June 2, 2026 BELTSVILLE, Md., March 31, 2026 (GLOBE NEWSWIRE) -- NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class, and best-in-class therapies to treat cancer and Simcere Zaiming Pharmaceutical Co., Ltd., (Simcere) an oncology-focused biopharmaceutical company, today announced that an abstract for SIM0505 has been accepted for the American Society for Clinical Oncology (ASCO 2026) meeting being held May 29 – June 2 in Chicago, Illinois. SIM0505 is an investigational antibody drug conjugate (ADC) targeting Cadherin-6 (CDH6) with a proprietary topoisomerase 1 inhibitor (TOPOi) payload. The ongoing open-label, Phase 1 study (NCT06792552) is evaluating SIM0505 in advanced solid tumors, including ovarian cancer, with an emphasis on platinum resistant ovarian cancer. About SIM0505 SIM0505 is a novel antibody drug conjugate (ADC) directed to cadherin-6 (CDH6 ADC), featuring a proprietary topoisomerase 1 inhibitor (TOPOi) payload. The ADC is designed for broad anti-tumor activity, fast systemic clearance and an improved potential therapeutic window. SIM0505 is being evaluated in an open-label, Phase 1 study (NCT06792552) for the potential treatment of advanced solid tumors, including ovarian cancer, with an emphasis on platinum resistant ovarian cancer. NextCure holds exclusive global rights for SIM0505, excluding China, Hong Kong, Macau, and Taiwan which are retained by Simcere Zaiming Pharmaceutical Co., Ltd. About NextCure, Inc. NextCure is a clinical-stage biopharmaceutical company focused on advancing innovative medicines to treat cancer patients through the use of targeted therapies including antibody-drug conjugates. We focus on advancing therapies that leverage our core strengths in understanding biological pathways and biomarkers, the interactions of cells within and beyond the tumor microenvironment, and the role each interaction plays in a biologic response. About Simcere Zaiming Simcere Zaiming is an oncology-focused biopharmaceutical company and a subsidiary of Simcere Pharmaceutical Group Limited (HKEX: 2096, "Simcere"). Founded in 2023, Simcere Zaiming is dedicated to developing groundbreaking therapies to meet the unmet clinical needs of cancer patients globally. With a robust and innovative R&D pipeline featuring distinct clinical assets, Simcere Zaiming has successfully launched several innovative products in China, including Enzeshu®, COSELA®, Enweida®, Endostar®, and Enlituo®. The Company is determined to deliver potentially transformative treatment options to cancer patients worldwide through its internal R&D, manufacturing, and commercialization capabilities, complemented by strategic collaborations with leading partners. Forward-Looking Statements Some of the statements contained in this press release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including with respect to funding for our operations, objectives and expectations for our business, operations and financial performance and condition, including the progress and results of clinical trials, development plans and upcoming milestones regarding our therapies. Any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim”, “anticipate”, “assume”, “believe”, “continue”, “could”, “should”, “due”, “estimate”, “expect”, “intend”, “hope”, “may”, “objective”, “plan”, “predict”, “potential”, “positioned”, “seek”, “target”, “towards”, “forward”, “later”, “will”, “would”, and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or similar language. Forward-looking statements involve substantial risks and uncertainties that could cause actual results to differ materially from those projected in any forward-looking statement. Such risks and uncertainties include, among others: market and other conditions; positive results in preclinical studies may not be predictive of the results of clinical trials; NextCure’s limited operating history and not having any products approved for commercial sale; NextCure’s history of significant losses; NextCure’s need and ability to obtain additional financing on acceptable terms or at all; risks related to clinical development, marketing approval and commercialization; NextCure’s reliance upon collaborators and international vendors for advancing clinical programs; NextCure’s ability to maintain listing of its common stock on the Nasdaq Global Select Market; and NextCure’s dependence on key personnel. More detailed information on these and additional factors that could affect NextCure’s actual results are described under the heading “Risk Factors” in NextCure’s most recent Annual Report on Form 10-K and in NextCure’s other filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. Forward-looking statements speak only as of the date of this press release, and NextCure assumes no obligation to update any forward-looking statements, even if expectations change. Investor Inquiries Timothy Mayer, Ph.D. NextCure, Inc. Chief Operating Officer (240) 762-6486 IR@nextcure.com Mike Moyer Managing Director, LifeSci Advisors, LLC Phone: (617) 308-4306 mmoyer@lifesciadvisors.com Source: NextCure

Phase 1ASCOADC

100 Deals associated with Trilaciclib Dihydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D11987	Trilaciclib Dihydrochloride	L01XE	DB15442

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Extensive stage Small Cell Lung Cancer	China	G1 Therapeutics, Inc.	12 Jul 2022
Chemotherapy-induced myelosuppression	United States	Pharmacosmos A/S	12 Feb 2021

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Small cell lung cancer limited stage	Phase 3	-	Pharmacosmos A/S	31 Mar 2026
Triple Negative Breast Cancer	Phase 3	China	G1 Therapeutics, Inc.	07 Dec 2021
Metastatic Triple-Negative Breast Carcinoma	Phase 3	United States	G1 Therapeutics, Inc.	14 May 2021
Metastatic Triple-Negative Breast Carcinoma	Phase 3	China	G1 Therapeutics, Inc.	14 May 2021
Metastatic Triple-Negative Breast Carcinoma	Phase 3	Australia	G1 Therapeutics, Inc.	14 May 2021
Metastatic Triple-Negative Breast Carcinoma	Phase 3	Bulgaria	G1 Therapeutics, Inc.	14 May 2021
Metastatic Triple-Negative Breast Carcinoma	Phase 3	France	G1 Therapeutics, Inc.	14 May 2021
Metastatic Triple-Negative Breast Carcinoma	Phase 3	Moldova	G1 Therapeutics, Inc.	14 May 2021
Metastatic Triple-Negative Breast Carcinoma	Phase 3	Poland	G1 Therapeutics, Inc.	14 May 2021
Metastatic Triple-Negative Breast Carcinoma	Phase 3	Russia	G1 Therapeutics, Inc.	14 May 2021

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06698965 (ESMO_ELCC2026)	Phase 2	Extensive stage Small Cell Lung Cancer First line	52	Trilaciclib 240 mg/m + Envafolimab + EC	revxexgmom(ndwrwilsdx) = rtebhfziay xcubnxyykf (ptkzmetweg ) View more	Positive	25 Mar 2026
				Envafolimab + EC	revxexgmom(ndwrwilsdx) = tgfkeowczw xcubnxyykf (ptkzmetweg ) View more
ASCO_GI2026	Phase 2	Oesophageal squamous cell carcinoma recurrent First line	10	Carboplatin (AUC=4-6, IV, Q3W)Paclitaxel (175 mg/m2, IV, Q3W)Trilaciclib (240 mg/m2, IV, Q3W) + Carboplatin (AUC=4-6, IV, Q3W)Paclitaxel (175 mg/m2, IV, Q3W)Trilaciclib (240 mg/m2, IV, Q3W) + Carboplatin (AUC=4-6, IV, Q3W)Paclitaxel (175 mg/m2, IV, Q3W)Trilaciclib (240 mg/m2, IV, Q3W) + Carboplatin (AUC=4-6, IV, Q3W)Paclitaxel (175 mg/m2, IV, Q3W)Trilaciclib (240 mg/m2, IV, Q3W) (Metastatic/recurrent esophageal squamous cell carcinoma)	pnajusabmv(giinvancny) = Other AEs were mainly grade 1-2, including decreased appetite (50%), fatigue (40%), headache (40%), and alopecia (10%). ypckpqdkvz (lxgezdqaok ) View more	Positive	08 Jan 2026
NCT05978648 (ESMO2025)	Phase 2	Early Stage Breast Carcinoma Adjuvant HR-negative \| HER2- positive	89	Epirubicin/cyclophosphamide followed by weekly paclitaxel+Trilaciclib (Triple-negative breast cancer (TNBC))	xgjaokissi(mtklsrkqxm) = shhszgfyof xjupuaiegs (hfmptkvtyw ) View more	Positive	17 Oct 2025
				Docetaxel/carboplatin/trastuzumab ± pertuzumab+Trilaciclib (HER2-positive breast cancer)	xgjaokissi(mtklsrkqxm) = fnurtmwfha xjupuaiegs (hfmptkvtyw ) View more
NCT06955156 (ESMO2025)	Phase 2	Advanced Triple-Negative Breast Carcinoma Neoadjuvant	28	Trilaciclib (240mg/m) + anti-PD-1-antibody + nab-paclitaxel + carboplatin	fkszfzgpul(btwdhywavg) = fhcjlwhzix qyvjuinemc (wqdkufwhdv ) View more	Positive	17 Oct 2025
ChiCTR2500097520 (ESMO2025)	Phase 2	stomach adenocarcinoma \| Gastroesophageal junction adenocarcinoma Adjuvant \| First line	115	Trilaciclib (Cohort 1)	hqvnpgqhjh(qctonwijnp) = Trilaciclib-related adverse events were limited to 2 cases of phlebitis, with no new safety signals irvhwzfxjx (mguaxlcscj )	Positive	17 Oct 2025
				Trilaciclib (Cohort 2)
NCT06698965 (ESMO2025)	Phase 2	Small Cell Lung Cancer	19	Trilaciclib + Etoposide + Carboplatin + Envafolimab	sjmatfhqel(tbsbdiplkr) = wxecjwggia oymbijsjbr (uqntvnpslh ) View more	Positive	17 Oct 2025
				Etoposide + Carboplatin + Envafolimab	sjmatfhqel(tbsbdiplkr) = khwnshrlyf oymbijsjbr (uqntvnpslh ) View more
ASTRO2025	Phase 2	Small cell lung cancer limited stage	18	Trilaciclib	xayfrvuurv(trvvrukfec) = ihxoabeuwa yoexfliepv (myxtnttbkj ) View more	Positive	27 Sep 2025
NCT04887831 (PRESERVE3, CTgov)	Phase 2	Bone Marrow Diseases \| Neutropenia \| Urothelial Carcinoma of the Urinary Bladder ... View more	92	Avelumab+Carboplatin+Gemcitabine+cisplatin (Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy)	rxuokciqzv = yxpzbrcvhe mdtykbjnzu (cuzxfxdtel, noqztplywr - fsoshghflv) View more	-	17 Aug 2025
				Avelumab+Carboplatin+Trilaciclib+Gemcitabine+cisplatin (Trilaciclib Plus Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy)	rxuokciqzv = srnyxvifqp mdtykbjnzu (cuzxfxdtel, wnfisrcvow - bmkriomrec) View more
NCT05910034 (ASCO2025)	Phase 2	Non-Small Cell Lung Cancer Second line PD-1 inhibitors	25	Trilaciclib+Envafolimab+Docetaxel	ddsnqzczwn(etddnitxbr) = Hematological toxicity occurred in 17/25 (68%) pts during the first cycle, with a lower incidence in cohort A compared to cohorts B and C ctjcvdjmtf (ncinueaqfw ) View more	Positive	30 May 2025
				Docetaxel+Envafolimab
AACR2025	Not Applicable	Extensive stage Small Cell Lung Cancer	201	Trilaciclib 240 mg/m^2 + Chemotherapy	hoptzqyqsm(nwiziswxtu) = yizemnfqyh teelfxdnue (pekhaqpaoe ) View more	Positive	30 Apr 2025

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Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis