Search Cancer Clinical Trials

Recruiting

This is an open label, multicenter, phase 1/2 study to assess the safety/tolerability and preliminary clinical activity of STAR0602 as a single agent administered intravenously in participants with advanced solid tumors that are antigen-rich.

• Advanced Solid Tumor

• STAR0602

Phase 1/Phase 2

Interventional

Primary Outcome:

• Phase 1 (Dose Escalation):Number of Participants with Dose-limiting Toxicities (DLTs) in Cycle 1
• Phase 1 and 2 (Dose Escalation and Expansion): Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
• Phase 2 (Dose Expansion): Percentage of Participants with Overall Objective Tumor Responses (ORR)

Secondary Outcome:

• Phase 1 and 2 (Dose Escalation and Expansion): Percentage of Participants with ORR
• Phase 1 and 2 (Dose Escalation and Expansion): Duration of Responses (DOR)
• Phase 1 and 2 (Dose Escalation and Expansion): Percentage of Participants with Disease Control (CR, PR, and Stable Disease)
• Phase 2 (Dose Expansion): Progression Free Survival (PFS)
• Phase 2 (Dose Expansion): Overall Survival (OS)
• Phase 1 and 2 (Dose Escalation and Expansion): Maximum Observed Plasma Concentration (Cmax) for STAR0602
• Phase 1 and 2 (Dose Escalation and Expansion): Time (Tmax) to Reach the Maximum Plasma Concentration (Cmax) for STAR0602
• Phase 1 and 2 (Dose Escalation and Expansion): Area Under the Plasma Concentration (AUC) Versus Time Curve for STAR0602
• Phase 1 and 2 (Dose Escalation and Expansion): Terminal Elimination Half-life (t1/2) for STAR0602
• Phase 1 and 2 (Dose Escalation and Expansion): Apparent Total Body Clearance (CL) for STAR0602
• Phase 1 and 2 (Dose Escalation and Expansion): Apparent Volume of Distribution (Vd) for STAR0602
• Phase 1 and 2 (Dose Escalation and Expansion): Anti-drug Antibody (ADA) formation

365

January 4, 2023

• Gender:     All
• Minimum age:     18 Years
• Maximum age:     N/A
• Healthy volunteers:     No

Marengo Therapeutics, Inc.

Marengo Therapeutics, Inc.

A Phase 1/2, First-in-Human, Open-Label, Dose Escalation and Expansion Study of STAR0602, a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule, in Subjects With Unresectable, Locally Advanced, or Metastatic Solid Tumors That Are Antigen-rich (START-001)

NCT05592626

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.