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STAR0602

DRUG3 trials

Sponsors

Marengo Therapeutics, Inc., National Cancer Institute (NCI)

Conditions

Abdominal NeoplasmAdvanced Solid TumorsCarcinomaColorectal CancerEpstein-Barr Virus InfectionsGenital Neoplasm, FemaleHR+, HER2-, Advanced Breast CancerLung Cancer

Phase 1

A Study of a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule STAR0602 in Participants With Advanced Solid Tumors
RecruitingNCT05592626
Marengo Therapeutics, Inc.Abdominal Neoplasm, Advanced Solid Tumors, Carcinoma +11
Start: 2023-01-04End: 2027-09-01Target: 366Updated: 2026-08-11
A Study of Invikafusp Alfa (STAR0602), a Selective T Cell Receptor (TCR)-Targeting, Bifunctional Antibody-fusion Molecule, in Combination With Sacituzumab Govitecan in Participants With Advanced Solid Tumors
RecruitingNCT06827613
Marengo Therapeutics, Inc.HR+, HER2-, Advanced Breast Cancer, Triple Negative Locally Advanced Non-resectable Breast Cancer
Start: 2025-03-24End: 2028-01-31Target: 50Updated: 2025-09-24
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
Not yet recruitingNCT07902921
National Cancer Institute (NCI)Lung Cancer, mCRPC, Metastatic Castrate-resistant Prostate Cancer +7
Start: 2026-11-03End: 2030-06-30Target: 67Updated: 2026-10-29

Related Papers

Bispecific dual T cell agonist invikafusp alfa in solid tumors: the phase 1/2 START-001 trial.
2026-10-23
PARP inhibition combined with a T-cell receptor β chain-directed antibody fusion molecule drives polyclonal antitumor immunity and tumor regression
Journal for ImmunoTherapy of Cancer2026-07-01
PS5-09-16: A phase 1b/2 clinical investigation of invikafusp alfa (STAR0602), a first-in-class dual T-cell agonist, in combination with sacituzumab govitecan in patients with metastatic TNBC or HR+/HER2- MBC (START-002 trial)
Clinical Cancer Research2026-02-17
Phase 2 dose expansion of START-001: A phase 1/2 study of invikafusp alfa (STAR0602), a first-in-class, selective T cell receptor (TCR)-targeting, bifunctional antibody-fusion molecule, as monotherapy in patients with antigen-rich tumors resistant to anti-PD(L)-1.
Journal of Clinical Oncology2025-05-28
Trial START-001: A phase 1/2 study of STAR0602, a first-in-class, selective T cell receptor (TCR)-targeting, bifunctional antibody-fusion molecule, as monotherapy in patients with antigen-rich tumors post checkpoint inhibitor (CPI) treatment.
Journal of Clinical Oncology2023-06-011 citations