The goal of this clinical trial is to test MGC018 in patients with relapsed or refractory Extensive-Stage Small-Cell Lung Cancer (ES-SCLC). The main question it aims to answer is:
• Does the administration of MGC018 achieve a clinically meaningful response rate of 25% in patients with relapsed or refractory ES-SCLC?
Participants enrolled in the trial will receive MGC018 through an intravenous (IV) infusion, every 28 days until disease progression or unacceptable toxicity. Tumor assessment will be done every 2 cycles (28 day cycles). Blood samples will be taken for biomarker analysis before treatment, on cycle 3 day 1, and at progression. A pretreatment biopsies will be done.

Start Date15 Apr 2024

Sponsor / Collaborator

Georgetown University

[+1]

NCT05551117

/ Active, not recruitingPhase 2

A Phase 2, Open-label, Study of Vobramitamab Duocarmazine in Participants With Metastatic Castration-resistant Prostate Cancer and Other Solid Tumors

Study CP-MGC018-03 is an open-label, two-part, Phase 2 study. Part 1 of the study will enroll participants with metastatic castration-resistant prostate cancer (mCRPC) previously treated with one prior androgen receptor axis-targeted therapy (ARAT). ARAT includes abiraterone, enzalutamide, or apalutamide. Participants may have received up to 1 prior docetaxel-containing regimen, but no other chemotherapy agents.
This part of the study will assess the efficacy and tolerability of vobramitamab duocarmazine (MGC018) in two experimental arms (2.0 mg/kg every 4 weeks [Q4W] and 2.7 mg/kg Q4W) . Approximately 100 participants will be randomized 1:1.
Part 2 of the study will enroll participants with locally advanced or metastatic squamous cell carcinoma (SCC) of the anus, melanoma, head and neck squamous cell carcinoma (HNSCC), squamous non-small cell lung carcinoma (NSCLC), and small cell lung carcinoma (SCLC). Participants must have progressive following at least 1 prior line of standard chemotherapy for advanced or metastatic disease. Participants will receive vobramitamab docarmazine at a dose of 2.7 mg/kg every 4 weeks. Up to 200 participants may be enrolled in Part 2.
In both parts, vobramitamab duocarmazine will be administered intravenously (IV) in clinic on Day 1 of each 4-week cycle. Vobramitamab duocarmazine will be administered until criteria for treatment discontinuation are met. Participants will undergo regular testing for signs of disease progression using computed tomography (CT) scans, magnetic resonance imaging (MRI), bone scans, and prostate-specific antigen (PSA) blood tests. Routine examinations and blood tests will be performed and evaluated by the study doctor.

Start Date13 Jun 2023

Sponsor / Collaborator

MacroGenics, Inc.

NCT05293496

/ Active, not recruitingPhase 1

A Phase 1/1b Dose Escalation and Cohort Expansion Study of MGC018 in Combination With Checkpoint Inhibitor in Participants With Advanced Solid Tumors

Study CP-MGC018-02 is a study of vobramitamab duocarmazine (MGC018) in combination with lorigerlimab (MGD019). The study is designed to characterize safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics, and preliminary antitumor activity. Participants with relapsed or refractory, unresectable, locally advanced or metastatic solid tumors including, but not limited to, metastatic castration-resistant prostate cancer (mCRPC), melanoma, pancreatic cancer, hepatocellular carcinoma (HCC), ovarian cancer, and renal cell carcinoma (RCC) will be enrolled.
Vobramitamab duocarmazine and lorigerlimab are administered separately on Day 1 of every 4-week (28-day) cycle at the assigned dose for each cohort. Participants who do not meet criteria for study drug discontinuation may receive study drugs for up to 2 years.
Tumor assessments are performed every 8 weeks (± 7 days) for the initial 6 months on study drugs, then every 12 weeks (± 21 days) until progressive disease (PD).
Participants will be followed for safety throughout the study. .

Start Date19 Apr 2022

Sponsor / Collaborator

MacroGenics, Inc.

100 Clinical Results associated with vobramitamab duocarmazine

100 Translational Medicine associated with vobramitamab duocarmazine

100 Patents (Medical) associated with vobramitamab duocarmazine

Literatures (Medical) associated with vobramitamab duocarmazine

01 Sep 2023·Journal for immunotherapy of cancer

Antitumor activity of the investigational B7-H3 antibody-drug conjugate, vobramitamab duocarmazine, in preclinical models of neuroblastoma

Article

Author: Bonvini, Ezio ; Bensa, Veronica ; Giusto, Elena ; Cilli, Michele ; Corrias, Maria Valeria ; Ciampi, Eleonora ; Calarco, Enzo ; Loo, Derik ; Brignole, Chiara ; Perri, Patrizia ; Pastorino, Fabio ; Ponzoni, Mirco ; Astigiano, Simonetta

Introduction:

B7-H3 is a potential target for pediatric cancers, including neuroblastoma (NB). Vobramitamab duocarmazine (also referred to as MGC018 and herein referred to as vobra duo) is an investigational duocarmycin-based antibody-drug conjugate (ADC) directed against the B7-H3 antigen. It is composed of an anti-B7-H3 humanized IgG1/kappa monoclonal antibody chemically conjugated through a cleavable valine-citrulline linker to aduocarmycin-hydroxybenzamideazaindole (vc-seco-DUBA). Vobra duo has shown preliminary clinical activity in B7-H3-expressing tumors.

Methods:

B7-H3 expression was evaluated by flow-cytometry in a panel of human NB cell lines. Cytotoxicity was evaluated in monolayer and in multicellular tumor spheroid (MCTS) models by the water-soluble tetrazolium salt,MTS, proliferation assay and Cell Titer Glo 3D cell viability assay, respectively. Apoptotic cell death was investigated by annexin V staining. Orthotopic, pseudometastatic, and resected mouse NB models were developed to mimic disease conditions related to primary tumor growth, metastases, and circulating tumor cells with minimal residual disease, respectively.

Results:

All human NB cell lines expressed cell surface B7-H3 in a unimodal fashion. Vobra duo was cytotoxic in a dose-dependent and time-dependent manner against all cell lines (IC50 range 5.1–53.9 ng/mL) and NB MCTS (IC50 range 17.8–364 ng/mL). Vobra duo was inactive against a murine NB cell line (NX-S2) that did not express human B7-H3; however, NX-S2 cells were killed in the presence of vobra duo when co-cultured with human B7-H3-expressing cells, demonstrating bystander activity. In orthotopic and pseudometastatic mouse models, weekly intravenous treatments with 1 mg/kg vobra duo for 3 weeks delayed tumor growth compared with animals treated with an irrelevant (anti-CD20) duocarmycin-ADC. Vobra duo treatment for 4 weeks further increased survival in both orthotopic and resected NB models. Vobra duo compared favorably to TOpotecan-TEMozolomide (TOTEM), the standard-of-care therapy for NB relapsed disease, with tumor relapse delayed or arrested by two or three repeated 4-week vobra duo treatments, respectively. Further increased survival was observed in mice treated with vobra duo in combination with TOTEM. Vobra duo treatment was not associated with body weight loss, hematological toxicity, or clinical chemistry abnormalities.

Conclusion:

Vobra duo exerts relevant antitumor activity in preclinical B7-H3-expressing NB models and represents a potential candidate for clinical translation.

01 Mar 2023·EUROPEAN UROLOGY

B7-H3 as a Therapeutic Target in Advanced Prostate Cancer

Article

Author: Calì, Bianca ; Fenor de la Maza, Maria D ; Baker, Chloe ; Obradovic, Aleksandar ; Rekowski, Jan ; Sharp, Adam ; Nguyen, Alana H T ; de Bono, Johann S ; Buroni, Lorenzo ; Figueiredo, Ines ; Riisnaes, Ruth ; Seed, George ; Westaby, Daniel ; Bertan, Claudia ; Gallagher, Lewis ; Welti, Jon ; Miranda, Susana ; Neeb, Antje ; Tunariu, Nina ; Drake, Charles G ; Hawley, Jessica E ; Bressan, Silvia ; Crespo, Mateus ; Yuan, Wei ; Guo, Christina ; Rescigno, Pasquale ; Bogdan, Denisa ; Alimonti, Andrea ; Ferreira, Ana ; Carreira, Suzanne ; Gurel, Bora ; Shen, Michael M ; Chandran, Khobe

BACKGROUND:

B7-H3 is a cell surface immunomodulatory glycoprotein overexpressed in prostate cancers (PCs). Understanding its longitudinal expression at emergence of castration resistance and association with tumour genomics are critical to the development of and patient selection for B7-H3 targeted therapies.

OBJECTIVE:

To characterise B7-H3 expression in same-patient hormone-sensitive (HSPC) and castration-resistant (CRPC) PC biopsies, associating this with PC genomics, and to evaluate the antitumour activity of an anti-B7-H3 antibody-drug conjugate (ADC) in human CRPC in vitro and in vivo.

DESIGN, SETTING, AND PARTICIPANTS:

We performed immunohistochemistry and next-generation sequencing on a cohort of 98 clinically annotated CRPC biopsies, including 72 patients who also had HSPC biopsies for analyses. We analysed two CRPC transcriptome and exome datasets, and PC scRNASeq datasets. PC organoids (patient-derived xenograft [PDX]-derived organoids [PDX-Os]) were derived from PDXs generated from human CRPC biopsies.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS:

We evaluated B7-H3 mRNA expression in relation to a panel of 770 immune-related genes, compared B7-H3 protein expression between same-patient HSPC and CRPC biopsies, determined associations with PC genomic alterations, and evaluated the antitumour activity of DS-7300a, a topoisomerase-1 inhibitor payload anti-B7-H3 ADC, in human PC cell lines, organoids (PDX-Os), and xenografts (PDXs) of different histologies, B7-H3 expressions, and genomics.

RESULTS AND LIMITATIONS:

B7-H3 was among the most highly expressed immunomodulatory genes in CRPCs. Most CRPCs (93%) expressed B7-H3, and in patients who developed CRPC, B7-H3 expression was frequently expressed at the time of HSPC diagnosis (97%). Conversion from B7-H3 positive to negative, or vice versa, during progression from HSPC to CRPC was uncommon. CRPC with neuroendocrine features were more likely to be B7-H3 negative (28%) than adenocarcinomas. B7-H3 is overexpressed in tumours with defective DNA repair gene (ATM and BRCA2) alterations and is associated with ERG expression, androgen receptor (AR) expression, and AR activity signature. DS7300a had antitumour activity against B7-H3 expressing human PC models including cell lines, PDX-Os, and PDXs of adenocarcinoma and neuroendocrine histology.

CONCLUSIONS:

The frequent overexpression of B7-H3 in CRPC compared with normal tissue and other B7 family members implicates it as a highly relevant therapeutic target in these diseases. Mechanisms driving differences in B7-H3 expression across genomic subsets warrant investigation for understanding the role of B7-H3 in cancer growth and for the clinical development of B7-H3 targeted therapies.

PATIENT SUMMARY:

B7-H3, a protein expressed on the surface of the most lethal prostate cancers, in particular those with specific mutations, can be targeted using drugs that bind B7-H3. These findings are relevant for the development of such drugs and for deciding which patients to treat with these new drugs.

01 Jan 2021·Biochemical pharmacologyQ2 · MEDICINE

B7-H3 augments the pro-angiogenic function of tumor-associated macrophages and acts as a novel adjuvant target for triple-negative breast cancer therapy

Q2 · MEDICINE

Article

Author: Bei, Yuncheng ; Yang, Nanfei ; Song, Yue ; Cheng, Nan ; Zhang, Wenlong ; Zhang, Weijie ; Shen, Pingping ; Xu, Lizhi ; Shu, Yuxin ; Bai, Xuexia

B7-H3 is an immune checkpoint molecule from the B7 superfamily. It has been widely studied in tumor immune evasion in certain types of cancer. In our preliminary study, we found that B7-H3 is specifically enriched in tumor-associated macrophages (TAMs) in triple-negative breast cancer (TNBC) patients and strongly correlated with poor clinical prognosis. However, the role of B7-H3 in breast cancer remains elusive. Our current study aims to explore the potential of B7-H3 as a novel target in TNBC therapy. Here, we demonstrated that B7-H3 enriched on TAMs is tightly correlated with TNBC clinical progression. B7-H3^high TAMs exhibit great pro-metastatic and immunosuppressive functions by intriguing extracellular matrix (ECM) reconstruction and tumor angiogenesis, therefore helping tumor cell dissemination and dampening T-cell infiltration in tumor microenvironment (TME). Importantly, targeting blockade of B7-H3 by anti-B7-H3 antibody improves the tumor vasculature disorder, thereby enhancing chemotherapy and PD-1 therapy efficacy. In conclusion, our study establishes the correlation between B7-H3^high TAMs and TNBC progression for the first time. By exploring the possibility of targeting B7-H3 expressed in both tumor cells and TAMs, we suggest that B7-H3 could be a promising target in clinical TNBC treatment.

News (Medical) associated with vobramitamab duocarmazine

06 Nov 2024

·firstwordpharma.com

MacroGenics' ADC moves one step closer to the drug development graveyard

MacroGenics is pulling back even further on the reins of lead antibody-drug conjugate (ADC) vobramitamab duocarmazine (vobra duo). The biotech said in its quarterly earnings report Tuesday that development of the B7-H3-targeting ADC is officially paused until it has complete safety and efficacy data from the Phase II TAMARACK study in-hand.Whether those results will support continued work on vobra duo, formerly MGC018, remains to be seen. Patient dosing in TAMARACK, which had been enrolling individuals with metastatic castration-resistant prostate cancer (mCRPC), was paused in July shortly after the company reported five patient deaths in the trial. MacroGenics expects to have mature median progression-free survival data from TAMARACK in early 2025.Stopped studiesThe development pause affects a Phase I/II trial of the ADC in solid tumours other than mCRPC, including non–small-cell lung cancer, triple-negative breast cancer, squamous cell carcinoma of the head and neck, and melanoma.A Phase I combination study of vobra duo plus MacroGenics' experimental PD-1/CTLA-4 bispecific lorigerlimab will also remain on hold. That trial was enrolling patients with relapsed or refractory, unresectable, locally advanced or metastatic solid tumours.MacroGenics said that, in addition to the TAMARACK safety and efficacy data, its development decision on vobra duo will be based on the competitive landscape for mCRPC, clinical resource availability, and potential partnering opportunities for the ADC.

ADCPhase 1Phase 2Clinical Trial Termination

30 Oct 2024

·www.globenewswire.com

MacroGenics Announces Leadership Transition

Scott Koenig, M.D., Ph.D., to step down as President and CEOBoard to initiate search process to identify new CEO ROCKVILLE, MD, Oct. 30, 2024 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing innovative antibody-based therapeutics for the treatment of cancer, today announced that Scott Koenig, M.D., Ph.D., intends to step down as President and Chief Executive Officer early next year. The Company’s Board of Directors has retained Heidrick & Struggles to lead a search process to identify its next Chief Executive Officer and has established a special committee of the Board to oversee the transition process. William Heiden, Chairman of the Board of Directors said, “Scott was a co-founder of MacroGenics twenty-four years ago and the Company has achieved many milestones under his leadership – including several partnered or company-owned FDA approved monoclonal antibody therapeutics developed by the company. On behalf of the Board, I want to thank Scott for his incredible dedication to the Company’s mission of discovering and developing novel therapeutics to improve patient care.” Mr. Heiden continued, “Today, MacroGenics has several innovative antibody-based therapeutics in development for the treatment of cancer, as well as significant alliances with leading pharmaceutical and biotechnology companies to develop and commercialize novel therapeutics. The Company today has a broad portfolio of promising assets and a strong balance sheet, and the Board and Scott agreed that this is the right time to transition to our next phase of leadership. We look forward to continuing to benefit from his perspectives as an advisor and shareholder.” “I am proud of our many achievements since our founding in 2000, in which we built a fully integrated, science-focused biotechnology company and have been successful in discovering, developing, manufacturing, and commercializing novel immunotherapeutics derived from our proprietary Fc-engineered antibody, bi-specific DART molecule, and antibody drug conjugate (ADC) technologies,” said Dr. Koenig. “Since the company’s IPO in 2013, we were able to fund a significant part of the development portfolio through the achievement of over $1 billion of non-dilutive capital via partnerships. Thanks to the incredible passion and dedication of the people at MacroGenics, three novel therapeutics from our pipeline advanced to approval, including MARGENZA® and ZYNYZ® to treat patients with cancer, and TZIELD® for individuals with early-stage Type 1 diabetes, and we have advanced a rich portfolio of clinical and preclinical molecules in development. I am confident that MacroGenics is well positioned in its current mission to address the significant unmet medical needs of patients with cancer. I look forward to continuing to support the Company in its work to achieve its key strategic objectives and create value for all our stakeholders.” About MacroGenics, Inc. MacroGenics is a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics' technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company's website at www.macrogenics.com. MacroGenics, the MacroGenics logo and MARGENZA are trademarks or registered trademarks of MacroGenics, Inc. Cautionary Note on Forward-Looking Statements Any statements in this press release about future expectations, plans and prospects for MacroGenics (“Company”), including statements about the Company’s strategy, future operations, clinical development of and regulatory plans for the Company’s therapeutic candidates, expected timing of the release of final safety and efficacy data, including mature median rPFS and other statements containing the words “subject to”, "believe", “anticipate”, “plan”, “expect”, “intend”, “estimate”, “potential,” “project”, “may”, “will”, “should”, “would”, “could”, “can”, the negatives thereof, variations thereon and similar expressions, or by discussions of strategy constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: risks that TZIELD, vobramitamab duocarmazine, lorigerlimab, ZYNYZ, MARGENZA or any other product candidate’s revenue, expenses and costs may not be as expected, risks relating to TZIELD, vobramitamab duocarmazine, lorigerlimab, ZYNYZ, MARGENZA or any other product candidate’s market acceptance, competition, reimbursement and regulatory actions; future data updates, especially timing and results of mature median radiographic progression-free survival, other efficacy and safety data with respect to vobramitamab duocarmazine; our ability to provide manufacturing services to our customers; the uncertainties inherent in the initiation and enrollment of future clinical trials; the availability of financing to fund the internal development of our product candidates; expectations of expanding ongoing clinical trials; availability and timing of data from ongoing clinical trials; expectations for the timing and steps required in the regulatory review process; expectations for regulatory approvals; expectations of future milestone payments; the impact of competitive products; our ability to enter into agreements with strategic partners and other matters that could affect the availability or commercial potential of the Company's product candidates; business, economic or political disruptions due to catastrophes or other events, including natural disasters, terrorist attacks, civil unrest and actual or threatened armed conflict, or public health crises; costs of litigation and the failure to successfully defend lawsuits and other claims against us; and other risks described in the Company's filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof. ###

Executive ChangeIPOADC

15 Sep 2024

·pipelinereview.com

MacroGenics Announces Updated Efficacy & Safety Data from TAMARACK Phase 2 Study of Vobra Duo in mCRPC Patients at ESMO Congress 2024

ROCKVILLE, MD, USA I September 15, 2024 I MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing innovative antibody-based therapeutics for the treatment of cancer, today presented updated efficacy and safety results from the TAMARACK Phase 2 study of vobramitamab duocarmazine (vobra duo), an antibody-drug conjugate (ADC) that targets B7-H3, for patients with metastatic castration-resistant prostate cancer (mCRPC). The data were featured in a poster presentation at the European Society for Medical Oncology (ESMO) Congress, taking place in Barcelona, Spain from September 13-17, 2024. “A key reason for conducting the TAMARACK study was to test the hypothesis that we could improve upon the duration of vobra duo treatment observed in the Phase 1 study by reducing the starting dose from 3.0 mg/kg to either 2.0 or 2.7 mg/kg and increasing the dosing interval from every three weeks to every four weeks. In doing so, our aim was to improve safety and tolerability, extend the treatment duration and achieve improved rPFS as compared to the result in our Phase 1 mCRPC dose expansion cohort,” said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. “We believe that these latest results from TAMARACK continue to demonstrate that vobra duo is an active drug in prostate cancer. Ultimately, our path forward for the molecule will depend on the final safety and efficacy data, including mature median rPFS, which we expect to have in hand no later than early 2025. We expect to make decisions about potential future development in the context of a competitive treatment landscape assessment, resource allocation across our clinical portfolio and potential partnering opportunities for vobra duo.” TAMARACK Study Demographics The abstract submitted to ESMO was based on a data cut-off as of April 12, 2024; updated data based on a cut-off date of July 9, 2024, are included below and are reported in the Company’s poster presentation at ESMO. The TAMARACK trial enrolled a total of 181 participants, with 176 participants receiving at least one dose of vobra duo at either 2.0 mg/kg q4W (n=90) or 2.7 mg/kg q4W (n=86). As of the data cut-off date, 23 and 16 participants remained on treatment in the 2.0 mg/kg and 2.7 mg/kg cohorts, respectively. While mCRPC study participants are no longer being dosed in the study, participants continue to be monitored for adverse events, disease progression, and survival. Baseline Characteristics: TAMARACK Efficacy Results as of July 9, 2024 Cut-off Date Overall, the Company believes that the results to date from the TAMARACK study indicate antitumor activity associated with vobra duo in mCRPC as demonstrated by the protocol-specified primary endpoint of landmark 6-month radiographic progression-free survival (rPFS) rate, as well as other measures of tumor response. Tumor response rates TAMARACK Safety Results as of July 9, 2024 Cut-off Date Overall summary of adverse events (AEs) Tolerability findings ESMO Poster Presentation Title: TAMARACK: Randomized Phase 2 trial of the B7-H3 targeting antibody drug conjugate (ADC) vobramitamab duocarmazine (vobra duo) in metastatic castration-resistant prostate cancer (mCRPC) Presenter / Lead Author: Johann de Bono, M.D., M.Sc., Ph.D., FRCP, FMedSci, Division of Clinical Studies, Royal Marsden Hospital Institute of Cancer Research, Sutton, UK Presentation ID: 1654P Session Date: Sunday, September 15, 2024 Poster Display Time: 9:00 a.m. – 5:00 p.m. CEST The poster presentation is available for download under “Events & Presentations” in the Investor Relations section of MacroGenics’ website at http://ir.macrogenics.com/events.cfm . About Vobra Duo and the TAMARACK Study Vobra duo is an antibody-drug conjugate (ADC) that targets B7-H3, an antigen with broad expression across multiple solid tumors and a member of the B7 family of molecules involved in immune regulation. The TAMARACK Phase 2 study of vobra duo is being conducted in participants with mCRPC who were previously treated with one prior androgen receptor axis-targeted therapy (ARAT). Participants may have received up to one prior taxane-containing regimen, but no other chemotherapy agents. The TAMARACK study is designed to evaluate vobra duo at two different doses: 2.0 mg/kg or 2.7 mg/kg every four weeks (q4W). About MacroGenics, Inc. MacroGenics (the Company) is a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics’ technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company’s website at www.macrogenics.com . MacroGenics and the MacroGenics logo are trademarks or registered trademarks of MacroGenics, Inc. SOURCE: MacroGenics

Clinical ResultADCPhase 2Phase 1ASCO

100 Deals associated with vobramitamab duocarmazine

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Indication	Highest Phase	Country/Location	Organization	Date
Castration-Resistant Prostatic Cancer	Phase 3	US	MacroGenics, Inc.	11 Jul 2022
Melanoma	Phase 3	US	MacroGenics, Inc.	11 Jul 2022
Non-Small Cell Lung Cancer	Phase 3	US	MacroGenics, Inc.	11 Jul 2022
Extensive stage Small Cell Lung Cancer	Phase 2	US	MacroGenics, Inc.	15 Apr 2024
Anus Neoplasms	Phase 2	US	MacroGenics, Inc.	13 Jun 2023
Anus Neoplasms	Phase 2	AU	MacroGenics, Inc.	13 Jun 2023
Anus Neoplasms	Phase 2	BE	MacroGenics, Inc.	13 Jun 2023
Anus Neoplasms	Phase 2	FR	MacroGenics, Inc.	13 Jun 2023
Anus Neoplasms	Phase 2	IT	MacroGenics, Inc.	13 Jun 2023
Anus Neoplasms	Phase 2	PL	MacroGenics, Inc.	13 Jun 2023

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05551117 (TAMARACK, ESMO2024) Manual	Phase 2	Metastatic castration-resistant prostate cancer	176	Vobra duo 2.0 mg/kg	ypjhspzrzj(duzknpofya) = lzlekjcnae csxzvkylcr (tmitseyyyp ) View more	Positive	15 Sep 2024
				Vobra duo 2.7 mg/kg	ypjhspzrzj(duzknpofya) = veqknhebjf csxzvkylcr (tmitseyyyp ) View more
NCT05551117 (Tamarack, GlobeNewswire) Manual	Phase 2	Metastatic castration-resistant prostate cancer	176	Vobramitamab duocarmazine (vobra duo) 2.0 mg/kg q4W	nethahtxox(lqzcdxpdtx) = ytvekcvqan czuaakhkij (wvqkhpgsxr ) View more	Positive	09 May 2024
				Vobramitamab duocarmazine (vobra duo) 2.7 mg/kg q4W	nethahtxox(lqzcdxpdtx) = usapxarrhs czuaakhkij (wvqkhpgsxr ) View more
NCT05551117 (TAMARACK, Corporate Publications) Manual	Phase 2	Metastatic castration-resistant prostate cancer	177	Vobra duo 2.0 mg/kg	ihbplejipa(slmvdarbjp) = xeerccmtfr rpmglxddyw (wycamchgpc ) View more	Positive	03 Apr 2024
				Vobra duo 2.7 mg/kg	ihbplejipa(slmvdarbjp) = xxbhysqopm rpmglxddyw (wycamchgpc ) View more
NCT03729596 (MGC018, ESMO2021)	Phase 1	HR-positive/HER2-low Solid Tumors	49	MGC018 3 mg/kg IV	uxxccbkiwy(wmasqryarq) = ftnsnhvhcn xmcthzewgb (ksdvbgbmzg )	-	16 Sep 2021
NCT03729596 (ASCO 12021 \| ASCO 22021) Manual	Phase 1	HR-positive/HER2-low Solid Tumors	29	MGC018	kncjiamqfb(fbbtdpttrk) = bhxkyaocpk hkadeoweqc (bidxdgrgle ) View more	Positive	28 May 2021

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