Safety & PK of MBRC-101 in Advanced Refractory Solid Tumors

Active:	Yes
Cancer Type:	Lung Cancer Solid Tumor	NCT ID:	NCT06014658
Trial Phases:	Phase I	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 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.

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).

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

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

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