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OncoMatch/Clinical Trials/NCT06723236

A Study of MGC028 in Participants With Advanced Solid Tumors

Is NCT06723236 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies MGC028 for advanced solid tumors.

Phase 1RecruitingMacroGenicsNCT06723236Data as of May 2026

Treatment: MGC028The 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.

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Extracted eligibility criteria

Cancer type

Tumor Agnostic

Non-Small Cell Lung Carcinoma

Cholangiocarcinoma

Pancreatic Cancer

Colorectal Cancer

Biomarker criteria

Allowed: EGFR actionable mutation

progression on or following therapy for actionable mutations (e.g. EGFR or ALK mutations), if present

Allowed: ALK actionable mutation

progression on or following therapy for actionable mutations (e.g. EGFR or ALK mutations), if present

Allowed: KRAS actionable mutation

Progression after prior targeted treatment for CRC with actionable mutations such as EGFR, KRAS, BRAF and MSI-H/dMMR, if present.

Allowed: BRAF actionable mutation

Progression after prior targeted treatment for CRC with actionable mutations such as EGFR, KRAS, BRAF and MSI-H/dMMR, if present.

Allowed: EGFR actionable mutation

Progression after prior targeted treatment for CRC with actionable mutations such as EGFR, KRAS, BRAF and MSI-H/dMMR, if present.

Prior therapy

Must have received: anti-PD-1/PD-L1 therapy — NSCLC adenocarcinoma

progression on or following anti-PD-1/PD-L1 inhibitor, unless contraindicated

Must have received: EGFR tyrosine kinase inhibitor — NSCLC adenocarcinoma with actionable EGFR mutation

progression on or following therapy for actionable mutations (e.g. EGFR or ALK mutations), if present

Must have received: ALK inhibitor — NSCLC adenocarcinoma with actionable ALK mutation

progression on or following therapy for actionable mutations (e.g. EGFR or ALK mutations), if present

Must have received: cytotoxic chemotherapy — NSCLC adenocarcinoma

no more than 2 prior lines of cytotoxic chemotherapy for advanced or metastatic disease

Must have received: systemic therapy — pancreatic cancer

following at least 1 systemic therapy

Must have received: cytotoxic chemotherapy — pancreatic cancer

no more than 2 prior lines of cytotoxic therapy for advanced or metastatic disease

Must have received: fluoropyrimidine-based chemotherapy — colorectal adenocarcinoma

Progression during or following standard therapy with a fluoropyrimidine-based chemotherapy, oxaliplatin and irinotecan unless contraindicated, refused or unavailable

Must have received: oxaliplatin — colorectal adenocarcinoma

Progression during or following standard therapy with a fluoropyrimidine-based chemotherapy, oxaliplatin and irinotecan unless contraindicated, refused or unavailable

Must have received: irinotecan — colorectal adenocarcinoma

Progression during or following standard therapy with a fluoropyrimidine-based chemotherapy, oxaliplatin and irinotecan unless contraindicated, refused or unavailable

Must have received: targeted therapy — colorectal adenocarcinoma with actionable mutations such as EGFR, KRAS, BRAF and MSI-H/dMMR

Progression after prior targeted treatment for CRC with actionable mutations such as EGFR, KRAS, BRAF and MSI-H/dMMR, if present.

Must have received: cytotoxic chemotherapy — colorectal adenocarcinoma

No more that 2 lines of cytotoxic chemotherapy for advanced or metastatic disease

Must have received: systemic therapy — colorectal adenocarcinoma

No more than 4 lines of systemic regimens for advanced or metastatic disease

Cannot have received: ADAM9 targeted agent

Prior treatment with ADAM9 targeted agent for cancer.

Cannot have received: stem cell transplant

Prior stem cell, tissue, or solid organ transplant.

Cannot have received: tissue transplant

Prior stem cell, tissue, or solid organ transplant.

Cannot have received: solid organ transplant

Prior stem cell, tissue, or solid organ transplant.

Cannot have received: CAR-T cell therapy

Prior treatment with ... chimeric antigen receptor (CAR)-T cell therapy ... within 4 weeks of the start of study treatment.

Cannot have received: systemic cancer treatment

Prior treatment with ... systemic cancer treatment ... within 4 weeks of the start of study treatment.

Cannot have received: experimental treatment

Prior treatment with ... experimental treatment within 4 weeks of the start of study treatment.

Cannot have received: major surgery

Prior treatment with major surgery ... within 4 weeks of the start of study treatment.

Cannot have received: mediastinal or lung radiation

Prior treatment with ... mediastinal or lung radiation ... within 4 weeks of the start of study treatment.

Cannot have received: vaccination with live virus vaccines

Prior treatment with ... vaccination with live virus vaccines ... within 4 weeks of the start of study treatment.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • UCSF - Helen Diller Family Cancer Center · San Francisco, California
  • Dana Farber/Harvard Cancer Center · Boston, Massachusetts
  • South Texas Accelerated Research Therapeutics (START) Midwest · Grand Rapids, Michigan
  • Icahn School of Medicine at Mt. Sinai · New York, New York
  • South Texas Accelerated Research Therapeutics (START) San Antonio · San Antonio, Texas

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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