RecruitingPhase 1Phase 2NCT07145255

Phase 1/2 Dose Finding, Safety and PK Study in Advanced Refractory Solid Tumors

A Multicenter, Open-label Phase 1/2 Dose Finding, Safety, and Pharmacokinetic Study of MBRC-201, an Antibody-drug Conjugate, in Advanced Refractory Solid Tumors


Sponsor

MBrace Therapeutics

Enrollment

150 participants

Start Date

Sep 3, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a multicenter, open-label FIH, Phase 1a (dose escalation), Phase 1b (dose expansion) and Phase 2 study in patients with advanced metastatic solid tumors refractory to standard treatment.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is a Phase 1/2 trial testing a new experimental drug called MBRC-201 in people with advanced solid tumors that have not responded to standard treatments. The study will first find the right dose (Phase 1) and then test it in specific cancer types (Phase 2), including prostate cancer, lung cancer, breast cancer, colorectal cancer, and pancreatic cancer. **You may be eligible if...** - You are 18 years or older - You have a confirmed advanced solid tumor (specific types depending on the study phase) that has not responded to or has no remaining standard treatment options - Your general health status (ECOG) is 0–2 and expected survival is at least 3 months - Your blood counts, kidney, and liver function meet required levels **You may NOT be eligible if...** - You have had another cancer within the past 3 years (some exceptions apply) - You have active or uncontrolled brain or spinal fluid cancer involvement - You have active viral, bacterial, or fungal infections within 2 weeks before starting the drug - You have active hepatitis C, uncontrolled HIV, or active hepatitis B - You had a heart attack, stroke, or serious heart condition within the past 6 months - You have a prolonged heart rhythm (QTcF above 470 ms) - You have previously received an antibody-drug conjugate (ADC) with a specific payload type (for Phase 1b/2) - You received cancer treatment within 14 days before starting the study drug Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGADC

MBRC-201 ADC


Locations(7)

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States

START, Midwest

Grand Rapids, Michigan, United States

START, Astera

East Brunswick, New Jersey, United States

NEXT, Dallas

Irving, Texas, United States

START San Antonio

San Antonio, Texas, United States

START, Mountain Region

West Valley City, Utah, United States

NEXT, Virginia

Fairfax, Virginia, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07145255


Related Trials