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Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

Massachusetts General Hospital Cancer Center
Boston, Massachusetts 02114
Contact:
Steven Isakoff, MD, PhD, MMSC
617-726-6500

More Details

Status
Recruiting
Sponsor
Marengo Therapeutics, Inc.

Study Contact

Kevin Chin, MD, MS
617-276-5734
kchin@marengotx.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.