A Study of MGC030 in Participants With Advanced Solid Tumors

NCT07822399 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: CP-MGC030-01
• Study Type: interventional
• Target: 314
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study is designed to characterize safety, tolerability, pharmacokinetics (PK), immunogenicity, and preliminary anti-tumor activity of MGC030. Participants with relapsed or refractory, unresectable, locally advanced or metastatic solid tumors of select types. The main question the study aims to answer is:

• What types of side effects will participants experience when receiving MGC030?
• Can MGC030 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

GastroEsophageal Cancer; Colorectal Cancer; Esophageal Cancer; Pancreatic Cancer; Urothelial Cancer; Gastric Cancer (GC)

Outcome Measures

Primary Outcomes (1)

• Number of participants with adverse events (AEs), serious AEs (SAEs), AEs leading to dose interruption, AEs leading to dose reduction or treatment discontinuation, does limiting toxicities and AEs of special interest.

  Throughout the study, estimated duration 2 years.

Secondary Outcomes (4)

• Mean concentrations MGC030 antibody-drug conjugate, total antibody and unconjugated payload.

  Throughout the study treatment period, up to 2 years

• Number of Participants Who Develop Anti-Drug Antibodies to MGC030

  Throughout the study treatment period, up to 2 years

• Objective response rate

  Throughout the study treatment period, up to 2 years

• Duration of Response

  Throughout the study treatment period, up to 2 years.

Study Arms (13)

Dose escalation Cohort 1

EXPERIMENTAL

MGC030 Dose Level 1

Biological: MGC030

Dose escalation Cohort 2

EXPERIMENTAL

MGC030 Dose Level 2

Biological: MGC030

Dose escalation Cohort 3

EXPERIMENTAL

MGC030 Dose Level 3

Biological: MGC030

Dose escalation Cohort 4

EXPERIMENTAL

MGC030 Dose Level 4

Biological: MGC030

Dose escalation Cohort 5

EXPERIMENTAL

MGC030 Dose Level 5

Biological: MGC030

Dose escalation Cohort 6

EXPERIMENTAL

MGC030 Dose Level 6

Biological: MGC030

Dose Optimization Cohort 1

EXPERIMENTAL

Dose Optimization Dose Level 1

Biological: MGC030

Dose Optimization Cohort 2

EXPERIMENTAL

Dose Optimization Dose Level 2

Biological: MGC030

Expansion Cohort 1

EXPERIMENTAL

Recommended dose for expansion

Biological: MGC030

Expansion Cohort 2

EXPERIMENTAL

Recommended dose for expansion

Biological: MGC030

Expansion Cohort 3

EXPERIMENTAL

Recommended dose for expansion

Biological: MGC030

Expansion Cohort 4

EXPERIMENTAL

Recommended dose for expansion

Biological: MGC030

Expansion Cohort 5

EXPERIMENTAL

Recommended dose for expansion

Biological: MGC030

Interventions

MGC030 BIOLOGICAL

Antibody-drug conjugate

Dose Optimization Cohort 1; Dose Optimization Cohort 2; Dose escalation Cohort 1; Dose escalation Cohort 2; Dose escalation Cohort 3; Dose escalation Cohort 4; Dose escalation Cohort 5; Dose escalation Cohort 6; Expansion Cohort 1; Expansion Cohort 2; Expansion Cohort 3; Expansion Cohort 4; Expansion Cohort 5

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants in dose escalation cohorts must have histologically proven unresectable, locally advanced or metastatic solid tumor limited to one of the following types: urothelial cancer, colorectal cancer (CRC), gastric or gastroesophageal junction (GEJ) cancer, esophageal cancer, or pancreatic carcinoma that is refractory to standard therapy, or for which standard therapy does not exist, has proven to be intolerable, or has been refused by the participant.
• Participants in expansion cohorts must have histologically proven, unresectable, locally advanced or metastatic solid tumors
• Urothelial cancer with progression following platinum-containing chemotherapy for metastatic or locally advanced/unresectable cancer, or within 12 months from completion of neo-adjuvant or adjuvant platinum-containing chemotherapy for localized muscle-invasive cancer.
• Gastric/GEJ carcinoma with progression during or following at least 1 systemic therapy.
• Esophageal cancer with progression during or following at least 1 systemic therapy.
• CRC with progression during or following treatment with at least 2 prior lines of systemic therapy (containing a fluoropyrimidine plus a platinum analogue and/or irinotecan) for metastatic disease.
• CRC harboring an activating EGFR mutation must have progressed during or following at least one EGFR targeted therapy, if available.
• Participants should have received no more than 4 prior lines of systemic therapy for advanced or metastatic disease.
• Pancreatic cancer with progression during or following at least 1 systemic therapy. Participants should have received no more than 2 prior lines of cytotoxic chemotherapy for advanced or metastatic disease.
• Participants must have at least one lesion that meets the definition of measurable disease by RECIST v1.1.
• Participants must have an available archival or formalin-fixed paraffin-embedded tumor tissue or be willing to undergo a biopsy procedure to obtain a fresh tumor sample.
• Participants have acceptable physical condition and laboratory values.
• Participants of childbearing potential must agree to use highly effective methods of birth control.
• Participants must not be pregnant, planning to be pregnant, or breastfeeding.

You may not qualify if:

• Any underlying medical or psychiatric condition impairing participant's ability to receive, tolerate, or comply with the planned treatment or study procedures.
• Active brain metastases or leptomeningeal metastases.
• Prior stem cell, tissue, or solid organ transplant.
• Another malignancy that required treatment within the past 2 years, with the exception of those with a negligible risk of metastasis or death such as adequately treated non-melanomatous skin cancer, localized prostate cancer (Gleason Score \< 6), or carcinoma in situ.
• History of primary immunodeficiency.
• Active viral, bacterial, or fungal infection
• Prior treatment with Topoisomerase 1-based ADCs for cancer.
• Prior treatment with major surgery, mediastinal or lung radiation, vaccination with live virus vaccines, systemic cancer treatment, chimeric antigen receptor (CAR)-T cell therapy, or experimental treatment within 4 weeks of the start of study treatment.

Sponsors & Collaborators

• MacroGenics: lead

MeSH Terms

Conditions

Colorectal Neoplasms; Esophageal Neoplasms; Stomach Neoplasms; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Stomach Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Frank Perabo, MD, PhD

  MacroGenics

  STUDY DIRECTOR

Central Study Contacts

Global Trial Manager

CONTACT

301-251-5172; info@macrogenics.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2026
• First Posted: September 16, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: September 16, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share