Clinical Trial: NCT05592626
A Study of a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule STAR0602 in Participants With Advanced Solid Tumors
Status:
RECRUITINGPhase:
Phase 1| Lead Sponsor: | Marengo Therapeutics, Inc. |
| Information Provided By: | Marengo Therapeutics, Inc. |
| Last Update Posted: | 2026-08-11 |
Study Overview
Brief 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 and in combination with chemotherapy administered intravenously in participants with advanced solid tumors that are antigen-rich.
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)
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, NSCLC (Non-small Cell Lung Cancer), Colorectal Cancer
Intervention / Treatment
- Drug: STAR0602
- Combination Product: Irinotecan (Camptosar)
- Combination Product: Docetaxel (Taxotere)
Other Study ID Numbers
- CP-START-001
- 2023-505334-10-01
- 2023
Start Date (Actual)
2023-01-04
Primary Completion Date (Estimated)
2027-09
Study Completion Date (Estimated)
2027-09
Enrollment (Estimated)
366
Study Type
Interventional
Phase
Phase 1, Phase 2
| Lead Sponsor: | Marengo Therapeutics, Inc. |
| Information Provided By: | Marengo Therapeutics, Inc. |
| Last Update Posted: | 2026-08-11 |
Study Overview
Brief 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 and in combination with chemotherapy administered intravenously in participants with advanced solid tumors that are antigen-rich.
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)
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, NSCLC (Non-small Cell Lung Cancer), Colorectal Cancer
Intervention / Treatment
- Drug: STAR0602
- Combination Product: Irinotecan (Camptosar)
- Combination Product: Docetaxel (Taxotere)
Other Study ID Numbers
- CP-START-001
- 2023-505334-10-01
- 2023
Start Date (Actual)
2023-01-04
Primary Completion Date (Estimated)
2027-09
Study Completion Date (Estimated)
2027-09
Enrollment (Estimated)
366
Study Type
Interventional
Phase
Phase 1, Phase 2