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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
Led by MBrace Therapeutics · Updated on 2026-02-17
150
Participants Needed
7
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating MBRC-201, an antibody-drug conjugate, in patients with advanced metastatic solid tumors that have not responded to standard treatments. This study includes multiple phases: Phase 1a focuses on finding safe dose levels and the maximum tolerated dose, Phase 1b expands to evaluate safety and early clinical activity at chosen doses in specific tumor types including prostate, lung, breast, colorectal, and pancreatic cancers, and Phase 2 further assesses antitumor activity and safety at the recommended dose. The trial is open-label and conducted across multiple centers. The study involves giving MBRC-201 to patients in escalating doses during Phase 1a to identify optimal dosing. Phase 1b enrolls about 80 patients divided into four cohorts based on tumor type to understand safety and clinical effects. Following this, Phase 2 will include around 30 patients in tumor-specific groups to further evaluate the drug at the determined recommended dose. Throughout the phases, pharmacokinetics and immune response to MBRC-201 are monitored, and a Safety Review Committee oversees dosing and patient safety. Participants will undergo regular assessments including safety evaluations, tumor response measurements, and pharmacokinetic studies. The study tracks adverse events, dose-limiting toxicities, and long-term outcomes like progression-free survival and duration of response for up to 24 months. There is also a long-term follow-up period for safety, disease status, and survival that continues until death, loss to follow-up, or withdrawal. The total study duration is estimated to be about 48 months from first enrollment to completion of follow-up data.
CONDITIONS
Brief Title
Phase 1/2 Dose Finding, Safety and PK Study in Advanced Refractory Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent before any study procedures
- Be 18 years of age or older at consent
- Female patients must be at least 2 years postmenopausal, surgically sterile, or agree to use effective contraception with negative pregnancy test
- Male patients with partners of childbearing potential must agree to use effective contraception
- Have histologic or cytologic diagnosis of malignant solid tumor refractory to standard treatments or ineligible/declined standard care
- For Phase 1a: tumor types include mCRPC, breast cancer, CRC, NSCLC, or PDAC
- For Phase 1b: tumor-specific cohorts with mCRPC adenocarcinoma, metastatic NSCLC, metastatic breast cancer, or metastatic CRC/PDAC
- Availability of tumor tissue sample if feasible
- Measurable or evaluable disease per RECIST v1.1 depending on phase
- ECOG performance status of 2 or less
- Life expectancy of at least 3 months
- Adequate organ and marrow function by specified laboratory criteria
You will not qualify if you...
- History of another malignancy within 3 years except certain cured or low-risk cancers
- Known or suspected sensitivity to MBRC-201 ingredients
- Active cerebral or meningeal disease related to cancer unless stable
- Uncontrolled infections within 2 weeks prior to dosing
- Active or symptomatic viral hepatitis or certain recent hepatitis C treatments
- HIV infection with recent opportunistic infections, therapy changes, or low CD4 count
- Recent thromboembolic events or bleeding disorders within 14 days
- Recent serious cardiac events or symptoms within 6 months
- Prolonged QTc interval or risk factors for Torsades de pointes
- Uncontrolled inflammatory bowel disease
- History or active interstitial lung disease or pneumonitis requiring steroids
- Uncontrolled autoimmune disease
- Active significant ocular surface disease
- Recent anticancer therapy or investigational drug use within 14 days
- Prior treatment with camptothecin ADCs in Phase 1b and 2
- Use of prohibited medications
- Major surgery within 28 days before dosing
- Unresolved toxicities from prior anticancer therapy except alopecia
- Medical or psychiatric conditions impairing consent or compliance
- Conditions increasing risk or confounding study participation
- Other serious medical conditions impairing treatment and follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 48 months including all phases
Participants receive MBRC-201 drug treatment through Phase 1a dose escalation, Phase 1b dose expansion, and Phase 2 at the recommended dose. Safety, pharmacokinetics, and preliminary anti-tumor activity are evaluated during this period.
Visits occur regularly during treatment for dosing, safety monitoring, and assessments; visit frequency depends on treatment phase and dosing schedule
Duration - Up to approximately 24 months after treatment
Participants are followed for safety, disease status, and survival assessments until death, withdrawal, lost to follow-up, or study termination.
Periodic visits for long-term safety and survival assessments
Trial Site Locations
Total: 7 locations
1
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94158
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2
START, Midwest
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
3
START, Astera
East Brunswick, New Jersey, United States, 08816
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4
NEXT, Dallas
Irving, Texas, United States, 75039
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5
START San Antonio
San Antonio, Texas, United States, 78229
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6
START, Mountain Region
West Valley City, Utah, United States, 84119
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7
NEXT, Virginia
Fairfax, Virginia, United States, 22031
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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