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Protocol # 22-577

Status

Recruiting

Description

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.

Condition

  • Advanced Solid Tumor

Interventions

  • STAR0602

Phase

Phase 1/Phase 2

Study Type

Interventional

Further Study Details

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

Enrollment

365

Study Start Date

January 4, 2023

Eligibility

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

Sponsors

Marengo Therapeutics, Inc.

Source

Marengo Therapeutics, Inc.

Official title

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)

Clinicaltrials.gov Identifier

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.