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

NCT05293496 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2025-10-14

No results posted yet for this study

Summary

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. .

Conditions

  • Advanced Solid Tumor
  • Castration-Resistant Prostatic Cancer
  • Malignant Melanoma
  • Pancreatic Ductal Carcinoma
  • Hepatocellular Cancer
  • Epithelial Ovarian Cancer
  • Renal Cell Carcinoma

Interventions

BIOLOGICAL

vobramitamab duocarmazine

Vobramitamab duocarmazine is an antibody drug conjugate (ADC) targeted against B7-H3.

BIOLOGICAL

lorigerlimab

Lorigerlimab is a bispecific DART® molecule that binds PD-1 and CTLA-4.

Sponsors & Collaborators

Principal Investigators

  • Denise Casey, M.D. · MacroGenics

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-19
Primary Completion
2025-06-24
Completion
2025-08-26
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05293496 on ClinicalTrials.gov