RecruitingProstate Cancer Castration-resistant Prostate CancerBreast CancerColo-rectal Cancer
Phase 1/2 Dose Finding, Safety and PK Study in Advanced Refractory Solid Tumors
Eligible age
18+ yrs
Accepts
All genders
Locations
6 states
Healthy volunteers
No
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About this study
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.
Sponsor: MBrace Therapeutics
You may qualify if…
- ✓ 1. Provide written consent on an informed consent form (ICF), approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), prior to any study-specific evaluation. Patients should have the ability to read and understand the ICF, ask for any clarifications from the study staff, and be able to comply with all planned study procedures.
- ✓ 2. 18 years of age or older at the time of informed consent.
- ✓ 3. Female patients must be at least 2 years postmenopausal (defined as 2 years without menses), surgically sterile (at least 6 months prior to dosing; must be documented) or patients of childbearing potential under the following conditions:
- ✓ Must be nonlactating and have a negative serum (preferred) or urine pregnancy test results within 72 hours prior to the first dose of MBRC-201.
- ✓ Must agree not to try to become pregnant during the study and for at least 6 months after the final dose of MBRC-201
- ✓ Must agree to practice effective contraception (must agree to use 2 forms of contraception, 1 of which must be a barrier method) and willing to continue to use effective contraception for the duration of study participation and for 6 months after the final dose of study drug.
- ✓ 4. Male patients whose partners are of childbearing potential must agree to use effective contraception (must agree to use 2 forms of contraception, 1 of which must be a barrier method) (Section 10.4) for the duration of study participation and for 6 months after the final dose of study drug.
- ✓ 5. Have a histologic or cytologic diagnosis of malignant solid tumor for which there are no standard-of-care treatment options known to confer a clinical benefit or for which the patient is ineligible or declines (except for Phase 1b-Cohort A).
You may not qualify if…
- ✕ 1. History of another malignancy within 3 years before the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. Allowed exceptions are patients with:
- ✕ 1. Non-melanoma skin cancer considered completely cured;
- ✕ 2. Localized prostate cancer treated with curative intent with no evidence of progression;
- ✕ 3. Low-risk or very low-risk (per standard clinical guidelines) localized prostate cancer under active surveillance without immediate intent to treat;
- ✕ 4. Malignancy that is otherwise considered cured with minimal risk of recurrence.
- ✕ 2. Known or suspected sensitivity to any of the ingredients of the investigational product MBRC-201.
- ✕ 3. Active cerebral/meningeal disease related to the underlying malignancy. Patients with a history of cerebral/meningeal disease related to the underlying malignancy are allowed if prior central nervous system disease has been treated and the patient is clinically stable. (defined as not having received steroid treatment for symptoms related to cerebral/meningeal disease for at least 2 weeks prior to the first dose of study drug and with no ongoing related AEs).
- ✕ 4. Any uncontrolled viral, bacterial, or fungal infection within 2 weeks prior to the first dose of study drug, unless deemed not clinically significant by the investigator (e.g., onychomycosis). Routine antimicrobial prophylaxis is permitted.
Where it's recruiting
California
San Francisco
Michigan
Grand Rapids
New Jersey
East Brunswick
Texas
Irving · San Antonio
Utah
West Valley City
Virginia
Fairfax
Source: ClinicalTrials.gov · NCT07145255 · last updated 2026-02-17