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

NCT06827613 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: START-002
• Study Type: interventional
• Target: 50
• Locations: 2 countries
• Sites: 8

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Phase 1 (Safety Run-In): Number of Participants with Dose Limiting Toxicites (DLTs)

  21 days following the first dose of STAR0602 + Sacituzumab Govitecan

• Phase 1 and 2 (Safety Run-In and Cohort Expansion): Number of Participants with Adverse Events and Serious Adverse Events

  Up to 3 years

• Phase 1 and 2 (Safety Run-In and Cohort Expansion): Percentage of participants with Overall Objective Tumor Responses (ORR)

  Proportion of participants who have a complete response (CR) or partial response (PR)

  Up to 3 years

Secondary Outcomes (8)

• Phase 1 and 2 (Safety Run-In and Cohort Expansion): Duration of Response (DOR)

  Up to 3 years

• Phase 1 and 2 (Safety Run-In and Cohort Expansion): Percentage of Participants with Disease Contral (DCR)

  Up to 3 years

• Phase 1 and 2 (Safety Run-In and Cohort Expansion): Progression Free Survival (PFS)

  Up to 3 years

• Phase 1 and 2 (Safety Run-In and Cohort Expansion): Overall Survival (OS)

  Up to 3 years

• Phase 1 and 2 (Safety Run-In and Cohort Expansion): Maximum Observed Concentration (Cmax) for STAR0602

  Cycle 1 and Cycle 3 at predefined intervals (Cycle length = 21 days) up to 3 years

Study Arms (2)

Phase 1 Safety Run-In: Advanced Solid Tumors

EXPERIMENTAL

Interventions: STAR0602 + Sacituzumab Govitecan

Drug: STAR0602; Drug: Sacituzumab Govitecan (SG)

Phase 2 Cohort Expansion: Advanced Solid Tumors

EXPERIMENTAL

Interventions: STAR0602 + Sacituzumab Govitecan at the Recommended Expansion Dose (RED) from Phase 1

Drug: STAR0602; Drug: Sacituzumab Govitecan (SG)

Interventions

STAR0602 DRUG

solution, intravenous infusion

Phase 1 Safety Run-In: Advanced Solid Tumors; Phase 2 Cohort Expansion: Advanced Solid Tumors

Sacituzumab Govitecan (SG) DRUG

intravenous infusion, 10mg/kg

Phase 1 Safety Run-In: Advanced Solid Tumors; Phase 2 Cohort Expansion: Advanced Solid Tumors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have measurable disease as per RECIST v1.1 criteria and documented by CT and/or MRI. Cutaneous or subcutaneous lesions must be measurable by calipers.
• Tumor Type:
• mTNBC (Safety Run-in and Cohort A): Progression or recurrence of locally advanced or metastatic TNBC
• HR+/HER2- mBC (Safety Run-in and Cohort B): Progression or recurrence of locally advanced or metastatic HR+/HER2- breast cancer
• Symptomatic central nervous system (CNS) metastases must have been treated, be asymptomatic for ≥ 14 days, and meet the following at the time of enrollment:
• No concurrent treatment for CNS disease (eg, surgery, radiation, corticosteroids \> 10 mg prednisone/day or equivalent); No concurrent leptomeningeal disease or cord compression.

You may not qualify if:

• History of known autoimmune disease with exceptions of:
• Vitiligo
• Psoriasis
• Atopic dermatitis or other autoimmune skin condition not requiring systemic treatment
• History of Graves' disease, now euthyroid for \> 4 weeks
• Hypothyroidism managed by thyroid replacement
• Alopecia
• Arthritis managed without systemic therapy beyond oral nonsteroidal anti-inflammatory drugs
• Adrenal insufficiency well-controlled on replacement therapy
• Major surgery or traumatic injury within 8 weeks before first dose of study intervention
• Unhealed wounds from surgery or injury
• Clinically significant cardiovascular/vascular disease, gastrointestinal disorders, inflammatory processes, pulmonary compromises
• Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days prior to the initiation of study intervention.
• Vaccination with any live virus vaccine within 4 weeks prior to the initiation of study intervention administration. Inactivated annual influenza vaccination is allowed.
• Participants who are known to be human immunodeficiency virus positive or hepatitis B or C positive and have uncontrolled disease.

Sponsors & Collaborators

• Marengo Therapeutics, Inc.: lead

Study Sites (8)

USC Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

RECRUITING

UCLA Health

Los Angeles, California, 90095, United States

RECRUITING

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

RECRUITING

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43212, United States

RECRUITING

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

RECRUITING

UT Health San Antonio MD Anderson Cancer Center

San Antonio, Texas, 78229, United States

RECRUITING

BC Cancer

Vancouver, British Columbia, V5Z 1K1, Canada

RECRUITING

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2C4, Canada

RECRUITING

MeSH Terms

Interventions

sacituzumab govitecan

Central Study Contacts

Kevin Chin, MD, MS

CONTACT

617-276-5734; kchin@marengotx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2025
• First Posted: February 14, 2025
• Study Start: March 24, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: September 24, 2025

Record last verified: 2025-09

Locations

CA (2); US (6)