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

NCT07145255 | Recruiting Phase 1 FDA Drug

• 1 other identifier: MBRC-201-001
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 7

Brief Summary

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

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

Keywords

ADC; prostate cancer; breast cancer; colorectal cancer; non-small cell lung cancer; MBrace

Outcome Measures

Primary Outcomes (5)

• Type, incidence, severity, seriousness, and relatedness of adverse events (AEs)

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

  From Enrollment through treatment and long term follow-up (approximately 24 months)

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

  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

  21 days

• Duration of Response (DOR)

  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.

  Approximately 24 months

• Disease Control Rate (DCR)

  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.

  Approximately 24 months

• Progression Free Survival (PFS)

  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.

  Approximately 24 months

Secondary Outcomes (2)

• To evaluate the antitumor activity of MBRC-201 at the RP2D

  Approximately 24 months

• To evaluate preliminary antitumor activity of MBRC-201 at potential RP2D, OBRDs, and dosing regimens

  approximately 24 months

Study Arms (3)

Phase 1a

EXPERIMENTAL

Dose Escalation

Drug: ADC

Phase 1b

EXPERIMENTAL

Dose Expansion

Drug: ADC

Phase 2

EXPERIMENTAL

Recommended Phase 2 Dose

Drug: ADC

Interventions

ADC DRUG

MBRC-201 ADC

Phase 1a; Phase 1b; Phase 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• years of age or older at the time of informed consent.
• 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.
• 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.
• 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).
• A. For Phase 1a dose escalation: Patients must have one of the following tumor types:
• i. mCRPC, breast cancer (TNBC, HR+/HER2-negative or HER2-low, HR-/HER2+), CRC, NSCLC, or PDAC
• B. For Phase 1b: Patients must have one of the following tumor types:
• i. Cohort A: Histologic or cytologic diagnosis of mCRPC (with confirmed adenocarcinoma histology) refractory to standard treatment.
• Patients must have had prior exposure to at least one novel AR-targeted therapy (e.g., abiraterone acetate, enzalutamide, apalutamide, darolutamide). Prior taxane or lutetium Lu 177 vipivotide tetraxetan is acceptable but not required.
• ii. Cohort B: Histologic or cytologic diagnosis of advanced metastatic NSCLC refractory to standard treatment.
• iii. Cohort C: Histologic or cytologic diagnosis of advanced metastatic breast cancer (TNBC, HR+/HER2-negative or HER2-low, HR-/HER2+) refractory to standard treatment.

You may not qualify if:

• 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:
• Non-melanoma skin cancer considered completely cured;
• Localized prostate cancer treated with curative intent with no evidence of progression;
• Low-risk or very low-risk (per standard clinical guidelines) localized prostate cancer under active surveillance without immediate intent to treat;
• Malignancy that is otherwise considered cured with minimal risk of recurrence.
• Known or suspected sensitivity to any of the ingredients of the investigational product MBRC-201.
• 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).
• 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.
• Active or symptomatic viral hepatitis, including patients with active hepatitis C infection (positive by polymerase chain reaction or on antiviral therapy for hepatitis C within the last 6 months). Patients who have been treated for hepatitis C infection or who have spontaneously recovered are permitted.
• Patients with HIV infection with 1 or more of the following:
• 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
• 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

Sponsors & Collaborators

• MBrace Therapeutics: lead

Study Sites (7)

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94158, United States

RECRUITING

START, Midwest

Grand Rapids, Michigan, 49546, United States

RECRUITING

START, Astera

East Brunswick, New Jersey, 08816, United States

RECRUITING

NEXT, Dallas

Irving, Texas, 75039, United States

RECRUITING

START San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

START, Mountain Region

West Valley City, Utah, 84119, United States

RECRUITING

NEXT, Virginia

Fairfax, Virginia, 22031, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Colonic Neoplasms; Carcinoma, Non-Small-Cell Lung; Pancreatic Neoplasms; Prostatic Neoplasms; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: August 28, 2025
• Study Start: September 3, 2025
• Primary Completion (Estimated): September 30, 2029
• Study Completion (Estimated): December 30, 2029
• Last Updated: February 17, 2026

Record last verified: 2026-01

Locations

US (7)