Safety, PK, and Preliminary Efficacy of MBRC-101 in Advanced Refractory Solid Tumors

Part of paid clinical trials in San Francisco, California.

Sponsor
MBrace Therapeutics
Study ID
NCT06014658
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Antibody-Drug Conjugate — DRUG
    MBRC-101: AN ANTI-EPHA5 MONOMETHYL AURISTATIN E (MMAE) ANTIBODY DRUG CONJUGATE

Study Details

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.

Key Dates

Start date
Nov 7, 2023
Status verified
Mar 2025
Primary completion
Jul 31, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
130 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1 Dose Escalation
  • Experimental: Phase 1b Expansion
  • Experimental: Phase 2

Primary Outcome Measure

Occurrence of treatment-emergent adverse events (TEAEs) [ Time Frame: Up to 24 Months ]

Central Contacts

Locations (17)

FacilityCityStateZIPSite coordinators
UCSF Helen Diller Family Comprehensive Cancer CenterSan FranciscoCalifornia94158
Pam Munster, MD (PRINCIPAL_INVESTIGATOR)
University of Colorado, Anschutz Cancer Pavilion (ACP(AuroraColorado80045
Jennifer R Diamond, MD
Winship Cancer Institute, Emory UniversityAtlantaGeorgia30322
Ticiana Leal, MD
University of Chicago Medical CenterChicagoIllinois60637
Nan Chen, MD
Horizon Oncology ResearchLafayetteIndiana47905-
Karmanos Cancer InstituteDetroitMichigan48201
Khalil Choucair, MD
Comprehensive Cancer Center of NevadaLas VegasNevada89169
Kyaw Z Thein, MD
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08903
Sanjay Goel, MD
Sanjay Goel, MD (PRINCIPAL_INVESTIGATOR)
Columbia University Irving Medical CenterNew YorkNew York10032
Linda Wu, MD
Carolina BioOncology InstituteHuntersvilleNorth Carolina28078-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111
Martin Edelman, MD
University of Pennsylvania, Abramson Cancer CenterPhiladelphiaPennsylvania19014
Kim Reiss-Binder, MD
Medical University of South Carolina (MUSC)CharlestonSouth Carolina29425
Mariam Alexander, MD
PRISMA Health, Institute for Translational OncologyGreenvilleSouth Carolina29605
William J Edenfield, MD
NEXT OncologyAustinTexas78758
Andrae Vandross, MD
NEXT OncologyIrvingTexas75039
Shiraj Sen, MD
NEXT OncologyFairfaxVirginia22031
Adham Salkeni, MD

Find similar trials in San Francisco, CA

By research site
UCSF Helen Diller Family Comprehensive Cancer Center· San Francisco, CAUniversity of Colorado, Anschutz Cancer Pavilion (ACP(· Aurora, COWinship Cancer Institute, Emory University· Atlanta, GAUniversity of Chicago Medical Center· Chicago, ILHorizon Oncology Research· Lafayette, INKarmanos Cancer Institute· Detroit, MI

Related Studies