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NCT05293496

A Study of MGC018 in Combination With MGD019 in Participants With Advanced Solid Tumors

Completed Phase 1 Last updated 14 October 2025
What this trial tests

Phase 1 trial testing vobramitamab duocarmazine in Advanced Solid Tumor in 31 participants. Completed in 26 August 2025.

Timeline
19 April 2022
Primary endpoint
24 June 2025
26 August 2025

Quick facts

Lead sponsorMacroGenics
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designsequential
Maskingnone
Primary purposetreatment
Enrollment31
Start date19 April 2022
Primary completion24 June 2025
Estimated completion26 August 2025
Sites10 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

MacroGenics — full company profile →

Who can join

18 and older, any sex, with Advanced Solid Tumor or Castration-Resistant Prostatic Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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. .

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Tumor biomarkers for diagnosis, prognosis and targeted therapy.
    Zhou Y, Tao L, Qiu J, Xu J, et al · · 2024 · cited 379× · PMID 38763973 · DOI 10.1038/s41392-024-01823-2
  2. Dual blockade immunotherapy targeting PD-1/PD-L1 and CTLA-4 in lung cancer.
    Cheng W, Kang K, Zhao A, Wu Y. · · 2024 · cited 110× · PMID 39068460 · DOI 10.1186/s13045-024-01581-2
  3. Single cell analysis of cribriform prostate cancer reveals cell intrinsic and tumor microenvironmental pathways of aggressive disease.
    Wong HY, Sheng Q, Hesterberg AB, Croessmann S, et al · · 2022 · cited 104× · PMID 36229464 · DOI 10.1038/s41467-022-33780-1
  4. The promise and challenges of combination therapies with antibody-drug conjugates in solid tumors.
    Wei Q, Li P, Yang T, Zhu J, et al · · 2024 · cited 102× · PMID 38178200 · DOI 10.1186/s13045-023-01509-2
  5. Beyond CTLA-4 and PD-1 Inhibition: Novel Immune Checkpoint Molecules for Melanoma Treatment.
    Ziogas DC, Theocharopoulos C, Lialios PP, Foteinou D, et al · · 2023 · cited 58× · PMID 37345056 · DOI 10.3390/cancers15102718
  6. The Immunotherapy and Immunosuppressive Signaling in Therapy-Resistant Prostate Cancer.
    Xu P, Wasielewski LJ, Yang JC, Cai D, et al · · 2022 · cited 29× · PMID 35892678 · DOI 10.3390/biomedicines10081778
  7. Drug conjugates for the treatment of lung cancer: from drug discovery to clinical practice.
    Zhou L, Lu Y, Liu W, Wang S, et al · · 2024 · cited 27× · PMID 38429828 · DOI 10.1186/s40164-024-00493-8
  8. New Emerging Targets in Cancer Immunotherapy: The Role of B7-H3.
    Koumprentziotis IA, Theocharopoulos C, Foteinou D, Angeli E, et al · · 2024 · cited 26× · PMID 38250867 · DOI 10.3390/vaccines12010054

Verify or expand the search:

Other trials of vobramitamab duocarmazine

Trials testing the same drug.

Other recruiting trials for Advanced Solid Tumor

Currently open trials in the same condition.

Other MacroGenics trials

Trials by the same sponsor.

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