Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around
Principal Investigator
by Pamela Munster
Headshot of Pamela Munster
Pamela Munster

Description

Summary

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.

Official Title

A Multicenter, Open-label, Phase 1/1b / Phase 2 Dose Finding, Safety, and Pharmacokinetic Study of MBRC-101, an Anti-EphA5 Monomethyl Auristatin E (MMAE) Antibody Drug Conjugate, in Advanced Refractory Solid Tumors

Details

Keywords

Cancer, Antibodies, Immunoconjugates, Antibody-Drug Conjugate

Eligibility

Locations

  • UCSF Helen Diller Family Comprehensive Cancer Center accepting new patients
    San Francisco California 94158 United States
  • Comprehensive Cancer Center of Nevada accepting new patients
    Las Vegas Nevada 89169 United States

Lead Scientist at UCSF

  • Pamela Munster
    Professor, Medicine, School of Medicine. Authored (or co-authored) 161 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
MBrace Therapeutics
ID
NCT06014658
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 130 study participants
Last Updated