Recruiting
Phase 1
Phase 2

Invikafusp Alfa & Sacituzumab Govitecan

Sponsor:

Marengo Therapeutics, Inc.

Code:

NCT06827613

Conditions

Triple Negative Locally Advanced Non-resectable Breast Cancer

HR+, HER2-, Advanced Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

STAR0602

Sacituzumab Govitecan (SG)

Study Details

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

Study ID

NCT06827613

Start date

Mar 24, 2025

Status verified date

Sep, 2025

Completion date

Jan, 2028

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

STAR0602

solution, intravenous infusion

Sacituzumab Govitecan (SG)

intravenous infusion, 10mg/kg

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 ]
  • Phase 1 and 2 (Safety Run-In and Cohort Expansion): Number of Participants with Adverse Events and Serious Adverse Events [ Time Frame: Up to 3 years ]
  • Phase 1 and 2 (Safety Run-In and Cohort Expansion): Percentage of participants with Overall Objective Tumor Responses (ORR) [ Time Frame: Up to 3 years ]

Central Contacts and Locations

Central contacts

Locations

USC Norris Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90033

Contacts

Principal Investigator:

Anastasia Martynova, MD

UCLA Health

Recruiting

Los Angeles, California, United States, 90095

Contacts

Principal Investigator:

Kelly E McCann, MD, PhD

Massachusetts General Hospital Cancer Center

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Steven Isakoff, MD, PhD, MMSC

617-726-6500

Principal Investigator:

Steven Isakoff, MD, PhD, MMSC

Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43212

Contacts

Principal Investigator:

Margaret Gatti-Mays, MD, MPH, FACP

Sarah Cannon Research Institute

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Principal Investigator:

Erika Hamilton, MD

UT Health San Antonio MD Anderson Cancer Center

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Principal Investigator:

Virginia Kaklamani, MD DSc

BC Cancer

Recruiting

Vancouver, British Columbia, Canada, V5Z 1K1

Contacts

Principal Investigator:

Nathalie LeVasseur, MD

Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 2C4

Contacts

Philippe Bedard, MD, FRCPC

philippe.bedard@uhn.ca

Principal Investigator:

Philippe Bedard, MD, FRCPC

More Information

Sponsor

Marengo Therapeutics, Inc.

Last update posted

Sep 24, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Marengo Therapeutics, Inc. on 2025-09-24.