A Study of MGC028 in Participants With Advanced Solid Tumors
NCT06723236 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 124
Last updated 2026-04-27
Summary
The goal of this clinical trial is to characterize the safety, tolerability, dose-limiting toxicities (DLT), and maximum tolerated dose (MTD) or maximum administered dose of MGC028 (if no MTD is defined). The study will enroll adult participants with relapsed or refractory, unresectable, locally advanced of metastatic solid tumors known to express ADAM9.
The main question the study aims to answer is:
* What types of side effects will participants experience when receiving MGC028?
* Can MGC028 cause cancer to shrink, remain stable, or able to control disease progression of participants with advanced solid tumors?
Participants will
* Undergo screening procedures to determine eligibility
* Receive study treatments initially every 3 weeks.
* Have blood samples taken for routine and research tests
* Have other examinations to check heart and lung function, and general health status
* Be asked about any side effects that may be happening or other medications you are taking. The study doctor will provide treatment for side effects, if necessary.
* Have the study doctor assess your tumor status at regular intervals to determine how you are responding to treatment.
Conditions
- Advanced Solid Tumors
- NSCLC Adenocarcinoma
- Cholangiocarcinoma
- Pancreatic Carcinoma
- Colorectal Carcinoma
Interventions
- BIOLOGICAL
-
MGC028
MGC028 is an antibody-drug conjugate targeted against ADAM9.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Pepi Pencheva, 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
- 2025-02-13
- Primary Completion
- 2026-11-30
- Completion
- 2027-04-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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