Actively Recruiting
Phase 1/2 Dose Finding, Safety and PK Study in Advanced Refractory Solid Tumors
Led by MBrace Therapeutics · Updated on 2026-02-17
150
Participants Needed
7
Research Sites
225 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 evaluations
- Be 18 years of age or older
- Females must be at least 2 years postmenopausal, surgically sterile, or willing to use effective contraception
- Males with partners of childbearing potential must agree to use effective contraception
- Have a confirmed diagnosis of malignant solid tumor with no standard treatment options or ineligible/declined standard treatments
- For Phase 1a: have mCRPC, breast cancer, colorectal cancer, NSCLC, or PDAC
- For Phase 1b: have specific tumor types including mCRPC with adenocarcinoma histology, advanced metastatic NSCLC, breast cancer subtypes, or advanced metastatic CRC or PDAC
- Availability of tumor tissue sample if feasible
- Have evaluable or measurable disease per RECIST v1.1
- ECOG performance status of 2 or less
- Life expectancy of at least 3 months
- Adequate organ and marrow function as defined by laboratory values
You will not qualify if you...
- History of another malignancy within 3 years except certain cured or low-risk cancers
- Known sensitivity to MBRC-201 ingredients
- Active cerebral/meningeal disease related to cancer unless clinically stable
- Uncontrolled infections within 2 weeks prior to dosing
- Active or symptomatic viral hepatitis
- HIV infection with specific immune or viral load criteria
- Recent thromboembolic or bleeding events within 14 days
- Recent serious cardiac events within 6 months
- Prolonged QT 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 ocular surface disease at screening
- Recent anticancer therapy within 14 days prior to dosing
- Use of investigational drugs within 14 days prior to dosing
- Prior treatment with ADCs containing camptothecin payloads for Phase 1b and 2
- Use of prohibited concomitant medications
- Major surgery within 28 days prior to dosing
- Unresolved toxicities from prior cancer therapy greater than Grade 1 except alopecia
- Medical or psychiatric conditions affecting consent or compliance
- Conditions posing significant risk or interfering with participation
- Other serious underlying medical conditions impairing treatment or follow-up
AI-Screening
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Trial Site Locations
Total: 7 locations
1
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94158
Actively Recruiting
2
START, Midwest
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
3
START, Astera
East Brunswick, New Jersey, United States, 08816
Actively Recruiting
4
NEXT, Dallas
Irving, Texas, United States, 75039
Actively Recruiting
5
START San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
6
START, Mountain Region
West Valley City, Utah, United States, 84119
Actively Recruiting
7
NEXT, Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
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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