A Randomized Open-Label Phase 1/2 Study of INCB001158 Combined With Subcutaneous (SC) Daratumumab, Compared to Daratumumab SC, in Participants With Relapsed or Refractory Multiple Myeloma

The purpose of this study is to evaluate the safety and antitumor activity of INCB001158 in combination with daratumumab SC, compared with daratumumab SC alone, in participants with relapsed or refractory multiple myeloma.

Start Date25 Sep 2019

Sponsor / Collaborator

Incyte Corp.

EUCTR2018-004076-35-ES

/ Not yet recruitingPhase 2

A Randomized Open-Label Phase 1/2 Study of INCB001158 Combined With Subcutaneous (SC) Daratumumab, Compared to Daratumumab SC, in Participants With Relapsed or Refractory Multiple Myeloma

Start Date19 Aug 2019

Sponsor / Collaborator

Incyte Corp.

NCT03910530

/ CompletedPhase 1

A Phase 1b Study of INCMGA00012 (PD-1 Inhibitor), INCB001158 (Arginase Inhibitor), and the Combination in Japanese Participants With Advanced Solid Tumors

The purpose of this study is to assess the safety and tolerability and the pharmacokinetics (PK) of INCMGA00012 (PD-1 Inhibitor), INCB001158 (Arginase Inhibitor), and the combination in Japanese participants with advanced solid tumor malignancies.

Start Date22 Jul 2019

Sponsor / Collaborator

Incyte Biosciences Japan GK

100 Clinical Results associated with Numidargistat

100 Translational Medicine associated with Numidargistat

100 Patents (Medical) associated with Numidargistat

Literatures (Medical) associated with Numidargistat

01 May 2024·BMJ Oncology

First-in-human phase 1 study of the arginase inhibitor INCB001158 alone or combined with pembrolizumab in patients with advanced or metastatic solid tumours

Article

Author: Naing, Aung ; Garralda, Elena ; Hanna, Glenn J ; Kuriakose, Emil ; Saavedra, Omar ; Papadopoulos, Kyriakos P ; Rahma, Osama ; Chen, Xuejun ; Kallender, Howard ; Gogov, Sven ; Cheng, LuLu ; Bauer, Todd ; Smith, Michael ; Pishvaian, Michael J

Objective:

The arginase inhibitor INCB001158 was evaluated for safety (primary endpoint) in locally advanced or metastatic solid tumours; pharmacokinetics, pharmacodynamics and efficacy were also assessed.

Methods and analysis:

In this non-randomised, open-label, three-part phase 1 study, INCB001158 was orally administered two times per day as monotherapy or in combination with intravenous pembrolizumab 200 mg every 3 weeks. Dose expansion was conducted in tumour-type cohorts (with or without prior anti−PD-1/PD-L1 (programmed death protein 1/programmed death ligand 1) therapy).

Results:

A total of 107 patients received INCB001158 50–150 mg two times per day as monotherapy, and 153 patients, including 6 with moderate renal impairment, received INCB001158 50–100 mg two times per day combined with pembrolizumab. INCB001158 exposure was similar between groups (median, 56 days (monotherapy); 84 days (combination)). 49 patients (45.8%) on monotherapy and 76 (51.7%) on combination therapy experienced grade ≥3 treatment-emergent adverse events (AEs). The most common INCB001158-related AEs were fatigue (n=10/107 (9.3%)) and nausea (n=10/107 (9.3%)) with monotherapy and diarrhoea (n=24/147 (16.3%)) and fatigue (n=22/147 (15.0%)) with combination therapy. The highest response rate was seen in the anti–PD-1/PD-L1–naive combination therapy group with head/neck squamous cell carcinoma (overall response rate, 19.2%; 4/26 partial responses, 1/26 complete response). Consistent with arginase inhibition activity, plasma arginine dose-dependently increased. Arginase 1 expression in the tumour microenvironment did not correlate with response.

Conclusions:

INCB001158 was generally well tolerated. Response rates did not exceed background for given tumour types despite demonstrable pharmacodynamic activity. Overall, the limited antitumour activity of arginase inhibition observed suggests that the role of arginine depletion in cancer is multifaceted.

Trial registration number:

NCT02903914.

01 Apr 2024·Cancer medicine

PD‐1 inhibition with retifanlimab and/or arginase inhibition with INCB001158 in Japanese patients with solid tumors: A phase I study

Article

Author: Gu, Yuan ; Doi, Toshihiko ; Yonemori, Kan ; Ueda, Eiji ; Kondo, Shunsuke ; Shimizu, Toshio ; Yamamoto, Noboru ; Koyama, Takafumi ; Chen, Xuejun ; Mita, Tetsuya ; Kuboki, Yasutoshi ; Harano, Kenichi ; Naito, Yoichi ; Yoh, Kiyotaka ; Matsubara, Nobuaki

Abstract:

Background:

Retifanlimab is a humanized monoclonal antibody targeting programmed death protein‐1, and INCB001158 is an oral arginase inhibitor. This phase Ib study investigated retifanlimab, INCB001158, and their combination in Japanese patients with advanced solid tumors.

Methods:

Patients received retifanlimab (500 mg every 4 weeks [Q4W] i.v.) or escalating doses of INCB001158 (75 or 100 mg twice daily [BID]) monotherapy in Part 1 and combination of retifanlimab (500 mg Q4W) and INCB001158 (100 mg BID) in Part 2. Primary endpoints were safety, tolerability, dose‐limiting toxicities (DLTs), and determination of recommended phase II doses in Japanese patients.

Results:

Eighteen patients (retifanlimab or INCB001158 monotherapy and combination; n = 6 each) were enrolled at 2 sites in Japan. There were no DLTs, fatal adverse events (AEs), or discontinuations due to AEs. Rash (all grade 1) was the most common treatment‐emergent AE with retifanlimab (n = 6). Treatment‐related AEs were reported with retifanlimab (n = 4) or INCB001158 (n = 2) monotherapy and with combination (n = 4); an immune‐related AE (thyroid disorder, grade 2) was reported with combination. Two responses were observed with retifanlimab monotherapy (1 complete, 1 partial) and 1 stable disease (SD), for an overall response rate of 33.3% (95% confidence interval [CI], 4.3–77.7) and disease control rate (DCR) of 50% (95% CI, 11.8–88.2). Three patients had SD with INCB001158 monotherapy (DCR 50%; 95% CI, 11.8–88.2). No responses or SD were observed with combination therapy.

Conclusion:

Retifanlimab, INCB001158, and their combination had acceptable safety profiles. Promising retifanlimab antitumor activity warrants further investigation in Japanese patients.

25 Jan 2023·Science translational medicineQ1 · MEDICINE

Radiation-induced circulating myeloid-derived suppressor cells induce systemic lymphopenia after chemoradiotherapy in patients with glioblastoma

Q1 · MEDICINE

Article

Author: Huang, Jiayi ; Tikhonova, Ekaterina ; Thotala, Dinesh ; Frenkel, Felix ; Wang, Xiaowei ; Zhang, Jin ; Inkman, Matthew ; DeNardo, David ; Thotala, Sukrutha ; Miheecheva, Natalia ; Hallahan, Dennis ; Ghosh, Subhajit ; Ataullakhanov, Ravshan

Severe and prolonged lymphopenia frequently occurs in patients with glioblastoma after standard chemoradiotherapy and has been associated with worse survival, but its underlying biological mechanism is not well understood. To address this, we performed a correlative study in which we collected and analyzed peripheral blood of patients with glioblastoma ( n = 20) receiving chemoradiotherapy using genomic and immune monitoring technologies. RNA sequencing analysis of the peripheral blood mononuclear cells (PBMC) showed an elevated concentration of myeloid-derived suppressor cell (MDSC) regulatory genes in patients with lymphopenia when compared with patients without lymphopenia after chemoradiotherapy. Additional analysis including flow cytometry and single-cell RNA sequencing further confirmed increased numbers of circulating MDSC in patients with lymphopenia when compared with patients without lymphopenia after chemoradiotherapy. Preclinical murine models were also established and demonstrated a causal relationship between radiation-induced MDSC and systemic lymphopenia using transfusion and depletion experiments. Pharmacological inhibition of MDSC using an arginase-1 inhibitor (CB1158) or phosphodiesterase-5 inhibitor (tadalafil) during radiation therapy (RT) successfully abrogated radiation-induced lymphopenia and improved survival in the preclinical models. CB1158 and tadalafil are promising drugs in reducing radiation-induced lymphopenia in patients with glioblastoma. These results demonstrate the promise of using these classes of drugs to reduce treatment-related lymphopenia and immunosuppression.

News (Medical) associated with Numidargistat

06 Jun 2023

·www.pharmaceutical-technology.com

ASCO 2023: Janssen’s Carvykti wins in earlier treatment of multiple myeloma

Adam Zamecnik @a_zamecnik A photo of Janssen’s office in Leiden, Netherlands. Janssen presented data from the Phase III CARTITUDE-4 trial at this year’s ASCO annual meeting. Image Credit: Getty Images / BSR Images Janssen got another fillip in the race for the use of CAR-T therapies in earlier lines of multiple myeloma treatment following a late-breaking abstract presentation of positive data at this year’s annual meeting of the American Society of Clinical Oncology (ASCO). While the company, a subsidiary of Johnson & Johnson , announced that the trial met its primary endpoint in January 2023, the latest data presentation indicates that Carvykti (ciltacabtagene autoleucel), an autologous BCMA-directed CAR-T therapy, reduced the risk of progression/death by 74% in relapsed and refractory myeloma patients who received one to three lines of therapy. Recommended Reports Reports LOA and PTSR Model - GDA-201 in Relapsed Multiple Myeloma GlobalData Reports LOA and PTSR Model - Numidargistat in Relapsed Multiple Myeloma GlobalData View all The ASCO annual meeting is taking place 2–6 June in Chicago, Illinois. In the Phase III CARTITUDE-4 study (NCT04181827), 73% of patients on Carvykti experienced a complete remission, while the overall response rate (ORR) was 85%. The median PFS was not reached in Carvykti-treated patients, while 76% of patients in this cohort reported a 12-month progression-free survival (PFS), as per the abstract (#LBA106), which was presented as part of an ASCO special session on 5 June. The safety profile of Carvykti was roughly comparable to the standard of care, with 97% of patients on Carvykti experiencing grade 3 and grade 4 adverse events (AEs), compared to 94% of subjects in the standard of care cohort. The results from the study were also simultaneously published in The New England Journal of Medicine. Carvykti is marketed for adult patients with refractory multiple myeloma who have received at least four other lines of treatment, following an approval by the US Food and Drug Administration (FDA) in February 2022. On 25 May, Janssen submitted a type II variation application to the European Medicines Agency (EMA) that would expand Carvykti’s use in earlier lines for patients with relapsed and lenalidomide-refractory multiple myeloma based on CARTITUDE-4 data. A major competitor to Carvykti in this space is Celgene’s Abecma, known as idecabtagene vicleucel, which is approved for use in relapsed or refractory multiple myeloma patients after four or more prior lines of therapy. The FDA has already accepted the company’s supplemental biologics license application (sBLA) for Abecma in the earlier setting, with a PDUFA date of 16 December 2023. The EMA has validated the company’s type II variation application, based on an April 2023 company update. These applications are based on data from the Phase III KarMMa-3 trial (NCT03651128), where Abecma reduced the risk of disease/death by 51%. Celgene is a subsidiary of Bristol Myers Squibb . According to a GlobalData Pharma Intelligence Centre consensus forecast, Abecma is estimated to earn global sales of $1.9 billion in 2029, while Carvykti could reach $5.73 billion in the same year. GlobalData is the parent company of Pharmaceutical Technology .

Phase 3Clinical ResultDrug ApprovalNDAASCO

05 Aug 2021

·www.globenewswire.com

Calithera Biosciences Reports Second Quarter 2021 Financial

-- Cash, Cash Equivalents and Investments Totaled $92.2 million as of June 30, 2021 -- -- Conference Call and Webcast Scheduled for 2:00 p.m. PT on August 5, 2021-- SOUTH SAN FRANCISCO, Calif., Aug. 05, 2021 (GLOBE NEWSWIRE) -- Calithera Biosciences, Inc. (Nasdaq: CALA), a fully-integrated clinical stage biotechnology company focused on discovering and developing novel, small molecule drugs for the treatment of cancer and other life-threatening diseases, announced today its financial results for the second quarter ended June 30, 2021. “In the second quarter, we announced a license agreement with Antengene for the development of CB-708, a potential first-in-class oral small molecule CD73 inhibitor developed internally via our drug discovery engine,” said Susan Molineaux, PhD, president and chief executive officer of Calithera. “We continued to advance our two lead programs, telaglenastat in non-small cell lung cancer patients with KEAP1/NRF2 genetic mutations and CB-280 for the treatment of cystic fibrosis. In addition, interim data from the Phase 1b study of CB-280 has been accepted for presentation at the upcoming North American Cystic Fibrosis Conference. Further, in June, we became members of the Broad Institute’s Cancer Dependency Map (DepMap) Consortium. The goal of the DepMap initiative is to discover new targets and biomarkers for precision cancer medicines. Our membership in the Consortium will provide an opportunity for us to generate novel data for discovery programs and forge deeper collaborations with Broad’s data and computational scientists in order to enable translational decisions for our programs. We are pleased with our continued progress and believe the Company is poised to reach multiple important milestones in the coming quarters. We look forward to sharing our progress.” Second Quarter 2021 and Recent Highlights Selected Second Quarter 2021 Financial Results Cash, cash equivalents and investments totaled $92.2 million at June 30, 2021. Revenue was $3.0 million for the three months ended June 30, 2021 and represents revenue recognized in the second quarter from the company’s license agreement with Antengene. Research and development expenses for the second quarter 2021 were $12.8 million, compared to $15.6 million in the same period prior year. The decrease of $2.8 million was primarily due to a $2.1 million decrease in the telaglenastat program and a $1.2 million decrease in the INCB001158 program, partially offset by increases in our CB-280 program and investments in early stage research. General and administrative expenses for the second quarter 2021 were $4.5 million, compared to $5.1 million in the same period prior year. The decrease of $0.6 million was primarily related to decreases in professional services costs and in rent expense related to our facility lease amendment in March 2021. Net loss for the three months ended June 30, 2021 was $14.3 million. Conference Call Information Calithera will host an update conference call today, Thursday, August 5, at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time. The call may be accessed by dialing (855) 783-2599 (domestic) or (631) 485-4877 (international) and referring to conference ID 4536305. To access the live audio webcast or the subsequent archived recording, visit the Investors section of the Calithera website at . The webcast will be recorded and available for replay on Calithera’s website for 30 days. About Calithera Calithera Biosciences is a clinical-stage biopharmaceutical company pioneering the discovery and development of targeted therapies that disrupt cellular metabolic pathways to preferentially block tumor cells and enhance immune-cell activity. Driven by a commitment to rigorous science and a passion for improving the lives of people impacted by cancer and other life-threatening diseases, Calithera is advancing a pipeline of first-in-clinic, oral therapeutics to meaningfully expand treatment options available to patients. Calithera is headquartered in South San Francisco, California. For more information about Calithera, please visit . Forward Looking Statements Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "anticipate," "estimate," "intend," "poised" and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. These statements include those related to Calithera’s clinical trials, the timing of enrollment of the KEAPSAKE and CB-280 Ph1b clinical trials, Antengene’s ability to continue the development and future commercialization of CB-708, the receipt by Calithera of future development, regulatory and sales milestones, as well as tiered royalties on sales of CB-708 if successfully commercialized and the overall advancement of Calithera’s product candidates in clinical trials. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. The potential product candidates that Calithera develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all. In addition, clinical trials may not confirm any safety, potency or other product characteristics described or assumed in this press release. Such product candidates may not be beneficial to patients or be successfully commercialized. The failure to meet expectations with respect to any of the foregoing matters may have a negative effect on Calithera's stock price. Additional information concerning these and other risk factors affecting Calithera's business can be found in Calithera's periodic filings with the Securities and Exchange Commission at . These forward-looking statements are not guarantees of future performance and speak only as of the date hereof, and, except as required by law, Calithera disclaims any obligation to update these forward-looking statements to reflect future events or circumstances. CONTACTS:Stephanie Wong ir@Calithera.com 650.870.1063 INVESTORS:Burns McClellanLee Roth212.213.0006lroth@burnsmc.com MEDIA:Sam Brown, Inc.Hannah Hurdle805.338.4752hannahhurdle@sambrown.com

CollaborateFinancial StatementFirst in ClassSmall molecular drug

19 May 2021

·www.globenewswire.com

Multiple Myeloma Pipeline Analysis Demonstrates Stunning Growth With A Gamut of Pharma Companies Involved Worldwide

Los Angeles, USA, May 18, 2021 (GLOBE NEWSWIRE) -- Multiple Myeloma Pipeline Analysis Demonstrates Stunning Growth with a Gamut of Pharma Companies Involved Worldwide The Multiple Myeloma pipeline is majorly thriving owing to the several different companies developing novel and sophisticated blockbuster drugs, increasing R&D, increasing global prevalence, better awareness and appropriate diagnosis in patients. DelveInsight’s ‘Multiple Myeloma Pipeline Insights’ report provides a holistic view of the pipeline therapies that are under development in preclinical as well as clinical stages of development, and growth prospects across the Multiple Myeloma domain. Some of the key takeaways from the Multiple Myeloma Pipeline report: Got queries? Want to know more? Request for Sample @ Multiple Myeloma Pipeline Insights Multiple Myeloma is a malignant disorder characterized by uncontrolled proliferation of clonal plasma cells causing a wide variety of complications leading to organ dysfunction and eventually death. It is the second most prevalent hematological malignancy worldwide, with a median onset of 60 years. This incurable malignancy develops from an accumulation of terminally differentiated monoclonal plasma cells (PC) in the bone marrow. Reach out @ Multiple Myeloma Pipeline: Novel therapies and emerging technologies The Multiple Myeloma pipeline report proffers a holistic view of the business opportunities, threats, prospective collaborations and agreements, strong competitors, growth strategies, failed as well as discontinued drugs. Multiple Myeloma Pipeline: Drug Portfolio The report lays down a complete coverage of the therapeutics by development stage, product type, route of administration, molecule type, and MOA type for Multiple Myeloma across the complete product development cycle, including all clinical and non-clinical stages. Multiple Myeloma Therapeutic Assessment By Product Type By Stage By Molecule Type By Route of Administration By Mechanism of Action By Targets By Stage and Route of AdministrationBy Stage and Product Type Scope of the Report Coverage: GlobalKey Players: Kiadis Pharma, CASI Pharmaceuticals, NOXXON Pharma, MorphoSys), Sana Biotechnology, Ayala Pharmaceuticals, Cellectar Biosciences, Bristol-Myers Squibb, Poseida Therapeutics, AbbVie/Genentech, Janssen Research and Development, Nanjing Legend Biotech, Genenta Science, Biotest AG, Teneobio, iCell Gene Therapeutics, Juno Therapeutics, Arch Oncology, Regeneron Pharmaceuticals, Incyte Corporation, NexImmune Inc., Chongqing Precision Biotech, Novartis, CASI Pharmaceuticals, Ionis Pharmaceuticals, AgenTus Therapeutics, Biohaven Pharmaceuticals, CRISPR Therapeutics, Pfizer, GlaxoSmithKline, Seagen Inc., Heidelberg Pharma, Bluebird Bio, C4 Therapeutics, Inc., Hoffmann-La Roche, Phosplatin Therapeutics, Arcellx, Inc., HitGen Inc., Boehringer Ingelheim, I-Mab Biopharma, Celyad Oncology, Amgen and othersKey Multiple Myeloma Pipeline Therapies: TNB-383B, ONC201, AO-176, JCARH125, REGN5458, INCB001158, TAK-573, NEXI-002 T Cells, PHE885, CID-103, ION251, EMB-06, agenT-797, CTX120, PF-06863135, SEA-BCMA, AEVI-007, HDP-101, bb21217, CFT7455, RO7425781, PT-112, HG146, CYAD-211, AMG 701, Nivolumab, ventoclax, RAPA-201 autologous T cells, K NK004, CID 103, NOX-A12, TJ202, APG-2575, AL 102, CLR 131 and others. Reach out @ Multiple Myeloma Pipeline: Novel therapies and emerging technologies Table of Contents Visit to know more of what’s covered @ Multiple Myeloma Emerging Therapies Related Reports Multiple Myeloma MarketDelveInsight’s ‘Multiple Myeloma (MM)-Market Insights, Epidemiology and Market Forecast—2030’ report. Multiple Myeloma Epidemiology ForecastDelveInsight’s ‘Multiple Myeloma (MM)- Epidemiology Forecast to 2030’ report. Car T Cell Therapy For Multiple Myeloma MarketDelveInsight’s ‘CAR T-Cell Therapy for Multiple Myeloma-Market Insights and Market Forecast-2030’ report. Refractory Multiple Myeloma MarketDelveInsight's "Refractory Multiple Myeloma - Market Insights, Epidemiology, and Market Forecast-2030" report. Relapsed Refractory Multiple Myeloma MarketDelveInsight's "Relapsed/Refractory Multiple Myeloma (RRMM) - Market Insights, Epidemiology, and Market Forecast-2030" report. Triple Refractory Multiple Myeloma MarketDelveInsight's "Triple-refractory Multiple Myeloma - Market Insights, Epidemiology, and Market Forecast-2030" report. Higher Risk Chronic Myelomonocytic Leukemia MarketDelveInsight's "Higher-Risk Chronic Myelomonocytic Leukemia Market Insights, Epidemiology, and Market Forecast-2030" report. Related Posts Multiple Myeloma Market Insights Multiple Myeloma Therapies MarketRare Cancer Market Outlook About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing end-to-end comprehensive solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve. For more insights, visit Pharma, Healthcare, and Biotech News

Small molecular drugCell TherapyCollaborate

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Refractory Multiple Myeloma	Phase 2	United States	Incyte Corp.	25 Sep 2019
Refractory Multiple Myeloma	Phase 2	Germany	Incyte Corp.	25 Sep 2019
Refractory Multiple Myeloma	Phase 2	Spain	Incyte Corp.	25 Sep 2019
Relapse multiple myeloma	Phase 2	United States	Incyte Corp.	25 Sep 2019
Relapse multiple myeloma	Phase 2	Germany	Incyte Corp.	25 Sep 2019
Relapse multiple myeloma	Phase 2	Spain	Incyte Corp.	25 Sep 2019
Advanced Malignant Solid Neoplasm	Phase 2	United States	Incyte Corp.	21 Nov 2017
Advanced Malignant Solid Neoplasm	Phase 2	Belgium	Incyte Corp.	21 Nov 2017
Advanced Malignant Solid Neoplasm	Phase 2	United Kingdom	Incyte Corp.	21 Nov 2017
Biliary Tract Neoplasms	Phase 2	United States	Incyte Corp.	21 Nov 2017

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02903914 (First-in-human phase 1 study, Pubmed)	Phase 1	Neoplasm Metastasis \| Squamous Cell Carcinoma of Head and Neck \| Mesothelioma ... View more	-	INCB001158 50-150 mg monotherapy	zmeagkidkd(hjizxwbfjm) = n=24/147 (16.3%) with combination therapy pnhzbgmazr (ukqrbreexa ) View more	Negative	01 May 2024
				INCB001158 50-100 mg + Pembrolizumab
NCT03837509 (CTgov)	Phase 1/2	Relapse multiple myeloma \| Refractory Multiple Myeloma	15	Daratumumab+INCB001158 (Phase 1: INCB001158 75 mg BID + Daratumumab)	llnknhnynp = aonxfqoaxr feqazviqca (bkichemnrr, pfjwgtpyah - aikzitudbx) View more	-	20 Mar 2023
				Daratumumab+INCB001158 (Phase 1: INCB001158 100 mg BID + Daratumumab)	llnknhnynp = aepjbhrkti feqazviqca (bkichemnrr, fiujgjrmyt - tfnxxiagna) View more
NCT03314935 (ASCO_GI 12021 \| ASCO_GI 22021) Manual	Phase 1/2	Advanced Bile Duct Carcinoma	33	gemcitabine + Cisplatin + INCB001158 100 mg (phase II)	grzrdthepw(ksoyhugafc) = ejkasoyxca ghmxbmfwuw (bmvnofmvrg, 11.1 - 42.3) View more	Positive	20 Jan 2021
NCT03361228 (CTgov)	Phase 1/2	Advanced Malignant Solid Neoplasm	5	Pembrolizumab+Epacadostat+INCB001158 (INCB001158 50mg BID+ Epacadostat + Pembrolizumab)	rbpppohgro(wfwkxtwpzx) = rgjyzcdssa embjlatcnf (syymszxdpa, gzulhbpxvr - zhtrtkyygf) View more	-	21 May 2020
				Pembrolizumab+Epacadostat+INCB001158 (INCB001158 75 mg BID + Epacadostat + Pembrolizumab)	rbpppohgro(wfwkxtwpzx) = fjupujoweh embjlatcnf (syymszxdpa, qodbsnacir - mrasqqpthx) View more
NCT02903914 (ESMO2019) Manual	Phase 1	Solid tumor	73	INCB001158+Pembrolizumab (combination)	fuodhdbiak(lfotfndkst) = 100 mg BID fqwpgtjijh (dvidejnpxe ) View more	Positive	29 Sep 2019
				INCB001158 (monotherapy)
SITC2016	Not Applicable	Immunosuppression \| Neoplasms	-	CB-1158	eryaduovxo(sibywhccpa) = etqujkhtah lilnwjmcnd (gkndjcwdmm )	-	16 Nov 2016

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