Actively Recruiting
Safety, PK, and Preliminary Efficacy of MBRC-101 in Advanced Refractory Solid Tumors
Led by MBrace Therapeutics · Updated on 2026-03-02
130
Participants Needed
17
Research Sites
155 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a first-in-human (FIH), open label Phase 1/1b / Phase 2 study in patients with advanced metastatic solid tumors refractory to standard treatment. Phase 1 will identify potential optimal biologically relevant doses (OBRD) and the maximum tolerated dose (MTD) of MBRC-101 at one 1 or more dosing regimens. Phase 1b will evaluate the safety and preliminary clinical activity of MBRC-101 at potential OBRDs. Phase 1 and Phase 1b will both characterize single and multiple-dose PK profiles and evaluate incidence and persistence of anti-MBRC-101 Ab. Phase 2 will evaluate the efficacy of MBRC-101 at the RP2D from Phase1b.
CONDITIONS
Official Title
Safety, PK, and Preliminary Efficacy of MBRC-101 in Advanced Refractory Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent and ability to comply with study procedures
- At least 18 years old at consent
- Female patients must be at least 2 years postmenopausal, surgically sterile, or using effective contraception; males must use effective contraception
- Histologic or cytologic diagnosis of malignant solid tumor with no effective standard treatment or ineligibility for such treatment
- For Phase 1b cohorts, specific tumor types: NSCLC, TNBC or HR positive HER2 negative breast cancer, or other specified advanced metastatic solid tumors
- Availability of tumor tissue sample for EphA5 expression analysis (retrospective assessment)
- Measurable disease per RECIST v1.1 for Phase 1b and Phase 2; evaluable or measurable disease for Phase 1
- ECOG performance status 0 to 2
- Life expectancy of at least 3 months
- Adequate hematologic function without recent RBC or platelet transfusions
- Estimated glomerular filtration rate (eGFR) of at least 30 mL/min
- Total bilirubin no more than 1.5 times upper limit normal
- AST and ALT no more than 3 times upper limit normal
- INR less than 1.5 or up to 3.0 if on anticoagulation
- Discontinued other cancer treatments at least 2 weeks before first dose
- Prior antibody-drug conjugate therapy allowed in Phase 1 only
You will not qualify if you...
- Sensory or motor neuropathy Grade 2 or higher
- Uncontrolled central nervous system metastases
- Use of investigational drugs within 14 days prior to first dose
- Any anticancer therapy within 14 days prior to first dose (with some exceptions for hormonal therapy)
- Use of strong CYP3A inhibitors or inducers within 14 days prior to first dose
- Recent thromboembolic events or bleeding disorders within 14 days
- Recent major cardiovascular events within 6 months
- QTc interval greater than 470 msec
- HIV infection with active or unstable disease criteria
- Active or symptomatic viral hepatitis
- Known allergy to MBRC-101 ingredients
- Major surgery within 28 days prior to first dose
- History of another malignancy within 3 years, with specified exceptions
- Active systemic infections requiring treatment
- Conditions that may increase risk or interfere with participation
- Medical or psychiatric disorders compromising consent or compliance
- Active ocular surface disease or related ophthalmologic conditions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 17 locations
1
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94158
Actively Recruiting
2
University of Colorado, Anschutz Cancer Pavilion (ACP(
Aurora, Colorado, United States, 80045
Actively Recruiting
3
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
4
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Actively Recruiting
5
Horizon Oncology Research
Lafayette, Indiana, United States, 47905
Completed
6
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Actively Recruiting
7
Comprehensive Cancer Center of Nevada
Las Vegas, Nevada, United States, 89169
Actively Recruiting
8
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
Actively Recruiting
9
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
10
Carolina BioOncology Institute
Huntersville, North Carolina, United States, 28078
Active, Not Recruiting
11
University of Pennsylvania, Abramson Cancer Center
Philadelphia, Pennsylvania, United States, 19014
Actively Recruiting
12
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Actively Recruiting
13
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States, 29425
Actively Recruiting
14
PRISMA Health, Institute for Translational Oncology
Greenville, South Carolina, United States, 29605
Actively Recruiting
15
NEXT Oncology
Austin, Texas, United States, 78758
Actively Recruiting
16
NEXT Oncology
Irving, Texas, United States, 75039
Actively Recruiting
17
NEXT Oncology
Fairfax, Virginia, United States, 22031
Actively Recruiting
Research Team
K
Kellogg Parsons, MD, M.H.S.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here