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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Marengo Therapeutics, Inc.
Study ID
NCT06827613
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • HR+, HER2-, Advanced Breast Cancer
  • Triple Negative Locally Advanced Non-resectable Breast Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • STAR0602 — DRUG
    solution, intravenous infusion
  • Sacituzumab Govitecan (SG) — DRUG
    intravenous infusion, 10mg/kg

Study Details

This is a Phase 1b/2, Open-label Study to Investigate the Safety and Efficacy of Invikafusp alfa (STAR0602), a Selective T Cell Receptor (TCR)-targeting, Bifunctional Antibody-fusion Molecule, in Combination with Sacituzumab Govitecan in Participants with Unresectable, Locally Advanced, or Metastatic Solid Tumors.

Key Dates

Start date
Mar 24, 2025
Status verified
Sep 2025
Primary completion
Jan 31, 2027
Completion
Jan 31, 2028

Study Design

Enrollment
50 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1 Safety Run-In: Advanced Solid Tumors
    Interventions: STAR0602 + Sacituzumab Govitecan
  • Experimental: Phase 2 Cohort Expansion: Advanced Solid Tumors
    Interventions: STAR0602 + Sacituzumab Govitecan at the Recommended Expansion Dose (RED) from Phase 1

Primary Outcome Measure

Phase 1 (Safety Run-In): Number of Participants with Dose Limiting Toxicites (DLTs) [ Time Frame: 21 days following the first dose of STAR0602 + Sacituzumab Govitecan ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
UCLA HealthLos AngelesCalifornia90095
Bhavisha Tailor
[email protected]
310-998-4747
Kelly E McCann, MD, PhD (PRINCIPAL_INVESTIGATOR)
Aditya Bardia, MD, MPH (SUB_INVESTIGATOR)
USC Norris Comprehensive Cancer CenterLos AngelesCalifornia90033
Stephanie Kim, MSN, RN
[email protected]
323-865-0240
Anastasia Martynova, MD (PRINCIPAL_INVESTIGATOR)
Massachusetts General Hospital Cancer CenterBostonMassachusetts02114
Steven Isakoff, MD, PhD, MMSC
617-726-6500
Steven Isakoff, MD, PhD, MMSC (PRINCIPAL_INVESTIGATOR)
Ohio State University Comprehensive Cancer CenterColumbusOhio43212
Paige A Hayes
[email protected]
614-688-6355
Margaret Gatti-Mays, MD, MPH, FACP (PRINCIPAL_INVESTIGATOR)
Sarah Cannon Research InstituteNashvilleTennessee37203
Kate Hall
[email protected]
629-250-9081
Erika Hamilton, MD (PRINCIPAL_INVESTIGATOR)
UT Health San Antonio MD Anderson Cancer CenterSan AntonioTexas78229
Jonah Crayton
[email protected]
210-450-1000
Virginia Kaklamani, MD DSc (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By research site
UCLA Health· Los Angeles, CAUSC Norris Comprehensive Cancer Center· Los Angeles, CAMassachusetts General Hospital Cancer Center· Boston, MAOhio State University Comprehensive Cancer Center· Columbus, OHSarah Cannon Research Institute· Nashville, TNUT Health San Antonio MD Anderson Cancer Center· San Antonio, TX

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