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NOT YET RECRUITING
NCT07909356
PHASE1

A Study of MC001 in Patients With Advanced or Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) and Other Folate Receptor Alpha (FRα)-Expressing Solid Tumors

Sponsor: Medicovestor, Inc

View on ClinicalTrials.gov

Summary

The purpose of this First-in-Human, Phase 1 study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary antitumor activity of MC001 in adults with advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) and other solid tumors that have relapsed or are refractory to standard therapies. MC001 is an investigational dimeric antibody-drug conjugate (ADC) that targets folate receptor alpha (FRα) and delivers a microtubule-disrupting cytotoxic payload, monomethyl auristatin E (MMAE). The study will be conducted in two sequential parts: Part A (Dose Escalation): Evaluates ascending intravenous (IV) dose levels of MC001 administered once every 3 weeks (Q3W) using a standard 3+3 design in patients with advanced solid tumors to identify dose-limiting toxicities (DLTs), the maximum tolerated dose (MTD), and the recommended dose for expansion (RDE). Part B (Dose Expansion): Evaluates MC001 at the selected RDE in patients with advanced or metastatic PDAC whose tumors express FRα on at least 30% of tumor cells to further characterize safety and preliminary efficacy.

Official title: A First-in-Human, Open-Label, Multicenter, Phase 1, Dose Escalation Study With Cohort Expansion to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of MC001, a Dimeric Antibody-Drug Conjugate (ADC), in Patients With Advanced or Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) and Other Solid Tumors Expressing Folate Receptor Alpha (FRα)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-12

Completion Date

2029-01

Last Updated

2026-11-03

Healthy Volunteers

No

Interventions

BIOLOGICAL

MC001

Dimeric fully human IgG1 monoclonal antibody targeting Folate Receptor alpha (FRα) conjugated to Monomethyl Auristatin E (MMAE) via a protease-cleavable linker. Administered as an IV infusion once every 21 days (Q3W) following premedication with dexamethasone, diphenhydramine, acetaminophen, and a 5-HT3 antagonist.

Locations (4)

SUNY Upstate Medical University

Syracuse, New York, United States

Carolina BioOncology Institute, PLLC

Huntersville, North Carolina, United States

NEXT Oncology

San Antonio, Texas, United States

NEXT Oncology

Fairfax, Virginia, United States