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

Active:	Yes
Cancer Type:	Lung Cancer Solid Tumor	NCT ID:	NCT06014658
Trial Phases:	Phase I Phase II	Protocol IDs:	MBRC-101-001 (primary) NCI-2024-00437
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	mBrace Therapeutics
NCI Full Details:	http://clinicaltrials.gov/show/NCT06014658

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.

Objectives

Phase 1, dose escalation, will enroll approximately 30 patients with advanced or
metastatic solid tumors refractory to standard therapy. EphA5 expression will not be
required for enrollment into Phase 1 but will be assessed retrospectively.

Phase1b, the dose expansion phase will evaluate the safety and preliminary clinical
activity of MBRC-101 at potential OBRDs and dosing regimens in patients with advanced or
metastatic solid tumors refractory to standard therapy. Phase 1b will enroll 3 expansion
cohorts of ˜ 20 patients per cohort (n ˜ 60 total).

The Phase 2 portion will begin when the RP2D has been determined from Phase 1b and all
Phase 1b patients have completed at least two cycles of treatment or have discontinued
from the study prior to completing two cycles of treatment. Phase 2 will evaluate
anti-tumor activity and safety of the RP2D determined during Phase 1b. Phase 2 will focus
on a specific tumor type identified during Phase 1/1b and will enroll approximately 30
patients.

Safety will be monitored by the Safety Review Committee (SRC) at each dose escalation in
Phase 1 and at regular intervals throughout Phase 1b and Phase 2.

Overall Response Rate (ORR), Progression Free Survival (PFS), Response Rate (RR), Overall
Survival (OS), Disease Control Rate (DCR), and Complete and Partial response (CR and PR)
will be used to evaluate efficacy per RECIST v1.1 criteria based on the results of
positron emission tomography and computed tomography (PET-CT), computerized tomography
(CT), and magnetic resonance imaging (MRI) scans.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.