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Phase 1/2 Study of MBRC-201 ADC for Advanced Solid Tumors

This study is testing a new drug called MBRC-201 ADC for people with advanced solid tumors that haven't responded to standard treatments. These tumors include prostate, breast, colorectal, non-small cell lung, and pancreatic cancers. The study aims to find the safest and most effective dose of MBRC-201 ADC, and to see how well it works. Researchers will be looking at side effects and how long the treatment's effects last. You may be eligible if you are 18 or older and have one of these advanced cancers. The study is currently recruiting about 150 participants.

Study design
This is an open-label study, meaning you and your doctors will know which treatment you are receiving. It involves different phases to find the right dose and then further evaluate the drug's effects.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety and treatment effects for approximately 24 months after enrollment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07145255

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
MBrace Therapeutics
~150 participants
Updated 2026-02-17 on ClinicalTrials.gov
What's tested:ADC

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Type, incidence, severity, seriousness, and relatedness of adverse events (AEs)
Measured over From Enrollment through treatment and long term follow-up (approximately 24 months)
+4 more outcomes measured

Conditions

Prostate Cancer Castration-resistant Prostate Cancer
Breast Cancer
Colo-rectal Cancer
Lung Cancer (Non-Small Cell)
Pancreas Cancer, Duct Cell Adenocarcinoma

Explore related trials

Breast CarcinomaColorectal CarcinomaLung Non-Small Cell CarcinomaPancreatic CarcinomaProstate CarcinomaSolid Neoplasm

Where it's being run

7 sites across 6 states
Texas2
California1
Michigan1
New Jersey1
Utah1
Virginia1

Who to contact

Lam Phu
[email protected]
415-613-2945
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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).
Absolute neutrophil count (ANC) ≥ 1500/uL
Hemoglobin (Hgb) ≥ 9 g/dL
Platelet count ≥ 100,000/uL
International normalized ratio (INR) \< 1.5 (or ≤ 3.0 if on therapeutic anticoagulation)
Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min by the CKD-EPI or similar equation or as measured by 24-hour urine collection
Total bilirubin ≤ 1.5 × ULN \[or ≤ 3-times ULN for patients with Gilbert's disease or documented hepatic tumor involvement\]
ALT and AST ≤ 3 × ULN \[or ≤ 5-times ULN for patients with documented hepatic tumor involvement\]

Exclusion

Acquired immunodeficiency syndrome (AIDs)-defining opportunistic infection within 6 months of the start of screening
A change in antiretroviral therapy within 3 months of the start of screening and viral load \> 500 copies/mL
Receiving antiretroviral therapy that may interfere with study drug
CD4 count \< 350 at screening 7. Thromboembolic events and/or bleeding disorders ≤ 14 days (e.g., venous thromboembolism \[VTE\] or pulmonary embolism \[or PE\]) prior to the first dose of study drug 8. Documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms (including congestive heart failure) consistent with New York Heart Association Class III-IV within 6 months prior to the first dose of study drug 9. A baseline QT (time from the beginning of the Q wave to the end of the T wave) interval as corrected by Fridericia's formula (QTcF) \> 470 msec or patients with risk factors for Torsades de pointes 10. Uncontrolled Inflammatory Bowel Disease (IBD) 11. A history of (non-infectious) ILD/pneumonitis requiring steroid therapy, or active ILD/pneumonitis, or clinically suspected ILD/pneumonitis that cannot be ruled out by imaging at screening 12. Uncontrolled autoimmune disease or syndrome 13. Active ocular surface disease at screening, including confluent superficial keratitis, cornea epithelial defect, corneal ulcer or stromal opacity or any components of the ophthalmologic history which, in the investigator's opinion, may place the patient at significant risk. Cataracts alone are not an exclusion criterion. 14. Any anticancer therapy within 14 days prior to the first dose of study drug, including: small molecules, immunotherapy, chemotherapy, monoclonal antibody therapy, radiotherapy, or any other agents to treat cancer (anti-hormonal therapy given for advanced prostate cancer or as adjuvant therapy for early stage, HR positive breast cancer is not considered cancer therapy for the purpose of this protocol). 15. Use of any investigational drug within 14 days prior to the first dose of study drug. 16. For Phase 1b and Phase 2: prior treatment with an ADC with a camptothecin (CPT) payload, such as Enhertu (trastuzumab deruxtecan), Datroway (datopotamab deruxtecan), or Trodelvy (sacituzumab govitecan). Prior treatment with irinotecan and other non-ADC topoisomerase inhibitors is allowed in all phases of the study. 17. Current use of any prohibited concomitant medication(s). 18. Major surgery within 28 days prior to first dose of study drug. 19. Patients who have not recovered from AEs due to prior anticancer therapy (i.e., have residual toxicities \> Grade 1) with the exception of alopecia 20. Any medical, psychiatric, addictive, or other kind of disorder which compromises the ability of the patient to give written informed consent and/or to comply with procedures. 21. Condition or situation which, based on Investigator or Sponsor assessment, may put the patient at significant risk, may confound the study results, or may interfere significantly with patient's participation in the study. 22. Other serious underlying medical condition that would impair the patient's ability to receive or tolerate the planned treatment and follow-up

What this trial measures

  • Type, incidence, severity, seriousness, and relatedness of adverse events (AEs)From Enrollment through treatment and long term follow-up (approximately 24 months)

    • TEAEs will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v.5.0.

  • • Incidence and prevalence of Dose-limiting Toxicities (DLTs) and cumulative safety by dose level21 days

    The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, hematologic toxicity, and Non-hematologic (laboratory) toxicities

  • Duration of Response (DOR)Approximately 24 months

    will be defined as the time from the first documentation of an objective tumor response (CR or PR) to the first documentation of tumor progression or to death due to any cause, whichever comes first, whichever comes first as defined by RECIST version 1.1.

  • Disease Control Rate (DCR)Approximately 24 months

    DCR will be defined as the proportion of patients with best overall response of CR, PR, or stable disease (SD), whichever comes first as defined by RECIST version 1.1.

  • Progression Free Survival (PFS)Approximately 24 months

    PFS will be defined as the time from the start of any study treatment to first documentation of disease progression or to death due to any cause, whichever comes first as defined by RECIST version 1.1.