Trials / Recruiting
RecruitingNCT05592626
A Study of a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule STAR0602 in Participants With Advanced Solid Tumors
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)
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 365 (estimated)
- Sponsor
- Marengo Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
This Phase 1/2 study consists of two parts: Phase 1 Dose Escalation and Phase 2 Dose Expansion. In Phase 1 Dose Escalation, STAR0602 will be administered intravenously in participants with advanced solid tumors to assess safety/tolerability profile of STAR0602 and to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of STAR0602. In Phase 2 Dose Expansion, STAR0602 at RP2D will be administered to participants with advanced, antigen-rich solid tumors to further evaluate safety and assess preliminary clinical activity of STAR0602. Clinical activity will be evaluated by objective tumor response rate (ORR), duration of response (DOR), disease control rate (DCR), and progression free survival (PFS).
Conditions
- Advanced Solid Tumors
- Genital Neoplasm, Female
- Urogenital Neoplasms
- Lung Neoplasm
- Neoplasms by Site
- Papillomavirus Infection
- Epstein-Barr Virus Infections
- Carcinoma
- Neoplasms
- Vulvar Neoplasms
- Vulvar Diseases
- Abdominal Neoplasm
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | STAR0602 | solution, intravenous infusion |
Timeline
- Start date
- 2023-01-04
- Primary completion
- 2026-10-01
- Completion
- 2026-10-01
- First posted
- 2022-10-24
- Last updated
- 2025-07-09
Locations
32 sites across 4 countries: United States, Canada, France, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05592626. Inclusion in this directory is not an endorsement.