Clinical trial NCT06827613: 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
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Triple Negative Locally Advanced Non-resectable Breast Cancer
HR+, HER2-, Advanced Breast Cancer
Lead sponsor: Marengo Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2025-02-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Phase 1 (Safety Run-In): Number of Participants with Dose Limiting Toxicites (DLTs)
timeFrame: 21 days following the first dose of STAR0602 + Sacituzumab Govitecan
measure: Phase 1 and 2 (Safety Run-In and Cohort Expansion): Number of Participants with Adverse Events and Serious Adverse Events
timeFrame: Up to 3 years
measure: Phase 1 and 2 (Safety Run-In and Cohort Expansion): Percentage of participants with Overall Objective Tumor Responses (ORR)
timeFrame: Up to 3 years
Secondary outcomes:
measure: Phase 1 and 2 (Safety Run-In and Cohort Expansion): Duration of Response (DOR)
timeFrame: Up to 3 years
measure: Phase 1 and 2 (Safety Run-In and Cohort Expansion): Percentage of Participants with Disease Contral (DCR)
timeFrame: Up to 3 years
measure: Phase 1 and 2 (Safety Run-In and Cohort Expansion): Progression Free Survival (PFS)
timeFrame: Up to 3 years
measure: Phase 1 and 2 (Safety Run-In and Cohort Expansion): Overall Survival (OS)
timeFrame: Up to 3 years
measure: Phase 1 and 2 (Safety Run-In and Cohort Expansion): Maximum Observed Concentration (Cmax) for STAR0602
timeFrame: Cycle 1 and Cycle 3 at predefined intervals (Cycle length = 21 days) up to 3 years
measure: Phase 1 and 2 (Safety Run-In and Cohort Expansion): Area Under the Concentration Curve (AUC) for STAR0602
timeFrame: Cycle 1 and Cycle 3 at predefined intervals (Cycle length = 21 days) up to 3 years
measure: Phase 1 and 2 (Safety Run-In and Cohort Expansion): Apparent Total Body Clearance (CL) for STAR0602
timeFrame: Cycle 1 and Cycle 3 at predefined intervals (Cycle length = 21 days) up to 3 years
measure: Phase 1 and 2 (Safety Run-In and Cohort Expansion): Apparent Volume of Distribution (Vd) for STAR0602
timeFrame: Cycle 1 and Cycle 3 at predefined intervals (Cycle length = 21 days) up to 3 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
Study officials:
References: