Status:
RECRUITING
A Study of a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule STAR0602 in Participants With Advanced Solid Tumors
Lead Sponsor:
Marengo Therapeutics, Inc.
Conditions:
Advanced Solid Tumors
Genital Neoplasm, Female
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is an open label, multicenter, phase 1/2 study to assess the safety/tolerability and preliminary clinical activity of STAR0602 as a single agent administered intravenously in participants with ad...
Detailed Description
This Phase 1/2 study consists of two parts: Phase 1 Dose Escalation and Phase 2 Dose Expansion. In Phase 1 Dose Escalation, STAR0602 will be administered intravenously in participants with advanced so...
Eligibility Criteria
Inclusion
- Participants must have histologically confirmed solid tumors that are unresectable, locally advanced, or metastatic and for which standard curative therapies do not exist or are no longer effective or have intolerable toxicities. Subjects should not have received more than three lines of prior therapies for their advanced or metastatic diseases.
- For Phase 1, participants must have one of the following solid tumors:
- High mutational burden (TMB-H)
- Microsatellite Instability (MSI-H)/DNA mismatch repair (dMMR)
- Virally associated tumors
- For Phase 2, participants must have one of the following solid tumors:
- TMB-H
- MSI-H/dMMR
- CRC (both Ras wild type and mutant)
- Virally associated tumors
- Metastatic triple negative breast cancer
- Platinum-resistant epithelial ovarian cancer
- Metastatic castration-resistance prostate cancer
- Primary stage IV or recurrent non-small cell lung cancer
- Immunogenic solid tumors
- (Other tumor histologies may also be included in Phase 2 as additional data emerge to support their inclusion.)
- 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 (e.g., surgery, radiation, corticosteroids \> 10 mg prednisone/day or equivalent);
- No concurrent leptomeningeal disease or cord compression.
Exclusion
- Participants with a 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.
- Major surgery or traumatic injury within 8 weeks before first dose of study drug.
- Unhealed wounds from surgery or injury.
- Treatment with \>10 mg per day of prednisone (or equivalent) or other immune-suppressive drugs within 7 days prior to the initiation of study drug. Exceptions may be made for patients who have had allergic reaction to iodinated contrast media. Steroids for topical, ophthalmic, inhaled, or nasal administration are allowed.
- Clinically significant cardiovascular/vascular disease, gastrointestinal disorders, inflammatory processes, pulmonary compromises
- Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days prior to the initiation of study drug.
- Vaccination with any live virus vaccine within 4 weeks prior to the initiation of study drug administration. Inactivated annual influenza vaccination is allowed.
- Participants who are known to be human immunodeficiency virus positive or hepatitis B or C positive and have uncontrolled disease.
- 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.
- 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).
- Hepatic metastases unless adequately treated, either locally (e.g., by surgery, radiofrequency ablation, or chemoembolization) or systemically or both, and stable for 3 months.
Key Trial Info
Start Date :
January 4 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
365 Patients enrolled
Trial Details
Trial ID
NCT05592626
Start Date
January 4 2023
End Date
October 1 2026
Last Update
July 9 2025
Active Locations (32)
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1
Loma Linda University Cancer Center
Loma Linda, California, United States, 92354
2
UC Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
3
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, United States, 80218
4
AdventHealth Celebration
Celebration, Florida, United States, 34747