RECRUITING

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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)

Quick Facts

Study Start:2025-03-24

Study Completion:2028-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06827613

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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:	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

Inclusion Criteria

Exclusion 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:

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

Contacts and Locations

Study Contact

Kevin Chin, MD, MS

CONTACT

617-276-5734

kchin@marengotx.com

Study Locations (Sites)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114

United States

Collaborators and Investigators

Sponsor: Marengo Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-24

Study Completion Date2028-01

Study Record Updates

Study Start Date2025-03-24

Study Completion Date2028-01

Terms related to this study

Additional Relevant MeSH Terms

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