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 (START-002)

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 (START-002)

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.

Study Overview

• Status: Recruiting
• Conditions: HR+, HER2-, Advanced Breast Cancer; Triple Negative Locally Advanced Non-resectable Breast Cancer
• Intervention / Treatment: Drug: STAR0602; Drug: Sacituzumab Govitecan (SG)

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Kevin Chin, MD, MS; Phone Number: 617-276-5734; Email: kchin@marengotx.com

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1K1
      • Recruiting
      • BC Cancer
      • Contact: Rahma Osman; Phone Number: 2825 604-877-6000; Email: rahma.osman@bccancer.bc.ca
      • Principal Investigator: Nathalie LeVasseur, MD
  • Ontario
    • Toronto, Ontario, Canada, M5G 2C4
      • Recruiting
      • Princess Margaret Cancer Centre
      • Contact: Philippe Bedard, MD, FRCPC; Email: philippe.bedard@uhn.ca
      • Principal Investigator: Philippe Bedard, MD, FRCPC
• United States
  • California
    • Los Angeles, California, United States, 90033
      • Recruiting
      • USC Norris Comprehensive Cancer Center
      • Principal Investigator: Anastasia Martynova, MD
      • Contact: Stephanie Kim, MSN, RN; Phone Number: 323-865-0240; Email: stephanie.kim2@med.usc.edu
    • Los Angeles, California, United States, 90095
      • Recruiting
      • UCLA Health
      • Principal Investigator: Kelly E McCann, Md, PhD
      • Contact: Bhavisha Tailor; Phone Number: 16907 310-998-4747; Email: BTailor@mednet.ucla.edu
      • Sub-Investigator: Aditya Bardia, MD, MPH
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital Cancer Center
      • Contact: Steven Isakoff, MD, PhD, MMSC; Phone Number: 617-726-6500
      • Principal Investigator: Steven Isakoff, MD, PhD, MMSC
  • Ohio
    • Columbus, Ohio, United States, 43212
      • Recruiting
      • Ohio State University Comprehensive Cancer Center
      • Contact: Paige A Hayes; Phone Number: 614-688-6355; Email: paige.hayes@osumc.edu
      • Principal Investigator: Margaret Gatti-Mays, MD, MPH, FACP
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Recruiting
      • Sarah Cannon Research Institute
      • Principal Investigator: Erika Hamilton, MD
      • Contact: Kate Hall; Phone Number: 629-250-9081; Email: kate.schiesser@scri.com
  • Texas
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • UT Health San Antonio MD Anderson Cancer Center
      • Contact: Jonah Crayton; Phone Number: 210-450-1000; Email: craytonj@uthscsa.edu
      • Principal Investigator: Virginia Kaklamani, MD DSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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.

2. 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
3. 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.

Exclusion Criteria:

1. 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
2. Major surgery or traumatic injury within 8 weeks before first dose of study intervention
3. Unhealed wounds from surgery or injury
4. Clinically significant cardiovascular/vascular disease, gastrointestinal disorders, inflammatory processes, pulmonary compromises
5. Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days prior to the initiation of study intervention.
6. Vaccination with any live virus vaccine within 4 weeks prior to the initiation of study intervention administration. Inactivated annual influenza vaccination is allowed.
7. Participants who are known to be human immunodeficiency virus positive or hepatitis B or C positive and have uncontrolled disease.
8. Second primary invasive malignancy not in remission for ≥ 1 year. Exceptions include non-melanoma locally advanced skin cancer, cervical carcinoma in situ, localized prostate cancer (Gleason score ≤ 7), resected melanoma in situ, or any malignancy considered to be indolent and never required systemic therapy, with the exception of indolent lymphomas.
9. Pregnant, likely to become pregnant, or lactating women (where pregnancy is defined as the state of a female after conception and until the termination of gestation)
10. Treatment with >10 mg per day of prednisone (or equivalent) or other immune-suppressive drugs within 7 days prior to the initiation of study intervention. Exceptions may be made for participants who have had allergic reactions to iodinated contrast media. Steroids for topical, ophthalmic, inhaled, or nasal administration are allowed

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phase 1 Safety Run-In: Advanced Solid Tumors; Interventions: STAR0602 + Sacituzumab Govitecan	Drug: STAR0602; solution, intravenous infusion; Drug: Sacituzumab Govitecan (SG); intravenous infusion, 10mg/kg
Experimental: Phase 2 Cohort Expansion: Advanced Solid Tumors; Interventions: STAR0602 + Sacituzumab Govitecan at the Recommended Expansion Dose (RED) from Phase 1	Drug: STAR0602; solution, intravenous infusion; Drug: Sacituzumab Govitecan (SG); intravenous infusion, 10mg/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Proportion of participants who have a complete response (CR) or partial response (PR) or stable disease (SD)	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
Phase 1 and 2 (Safety Run-In and Cohort Expansion): Area Under the Concentration Curve (AUC) for STAR0602		Cycle 1 and Cycle 3 at predefined intervals (Cycle length = 21 days) up to 3 years
Phase 1 and 2 (Safety Run-In and Cohort Expansion): Apparent Total Body Clearance (CL) for STAR0602		Cycle 1 and Cycle 3 at predefined intervals (Cycle length = 21 days) up to 3 years
Phase 1 and 2 (Safety Run-In and Cohort Expansion): Apparent Volume of Distribution (Vd) for STAR0602		Cycle 1 and Cycle 3 at predefined intervals (Cycle length = 21 days) up to 3 years

Collaborators and Investigators

• Sponsor: Marengo Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: January 28, 2025
• First Submitted That Met QC Criteria: February 10, 2025
• First Posted (Actual): February 14, 2025

Study Record Updates

• Last Update Posted (Estimated): September 24, 2025
• Last Update Submitted That Met QC Criteria: September 19, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms; Immunologic Factors; Physiological Effects of Drugs; Immunoconjugates; sacituzumab govitecan
• Other Study ID Numbers: START-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No