A Study of a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule STAR0602 in Participants With Advanced Solid Tumors

Launched by MARENGO THERAPEUTICS, INC. · Oct 17, 2022

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment called STAR0602, which is a special type of antibody designed to target certain solid tumors in patients whose cancer has advanced and cannot be treated with standard therapies. The trial aims to see how safe STAR0602 is and whether it helps patients with various types of tumors, including those linked to certain viruses or with specific genetic features. The study is open to both men and women aged 65 and older who have been diagnosed with solid tumors that are either inoperable or have not responded to previous treatments.

To be eligible for the trial, participants must have confirmed advanced solid tumors and should not have received more than three prior treatment lines. The study is looking for individuals with specific tumor characteristics, like high genetic changes or certain viral associations. If someone chooses to join the trial, they can expect to receive STAR0602 through an intravenous infusion, and they will be closely monitored for any side effects or signs of effectiveness. It's important to note that there are certain medical conditions and treatments that may exclude someone from participating, so a thorough medical evaluation will be conducted before enrollment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 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.
• 2. For Phase 1, participants must have one of the following solid tumors:
• • 1. High mutational burden (TMB-H)
• • 2. Microsatellite Instability (MSI-H)/DNA mismatch repair (dMMR)
• • 3. Virally associated tumors
• 3. For Phase 2, participants must have one of the following solid tumors:
• • 1. TMB-H
• • 2. MSI-H/dMMR
• • 3. CRC (both Ras wild type and mutant)
• • 4. Virally associated tumors
• • 5. Metastatic triple negative breast cancer
• • 6. Platinum-resistant epithelial ovarian cancer
• • 7. Metastatic castration-resistance prostate cancer
• • 8. Primary stage IV or recurrent non-small cell lung cancer
• • 9. Immunogenic solid tumors
• • (Other tumor histologies may also be included in Phase 2 as additional data emerge to support their inclusion.)
• 4. 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 Criteria:
• 1. 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.
• • 2. Major surgery or traumatic injury within 8 weeks before first dose of study drug.
• • 3. Unhealed wounds from surgery or injury.
• • 4. 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.
• • 5. Clinically significant cardiovascular/vascular disease, gastrointestinal disorders, inflammatory processes, pulmonary compromises
• • 6. Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days prior to the initiation of study drug.
• • 7. Vaccination with any live virus vaccine within 4 weeks prior to the initiation of study drug administration. Inactivated annual influenza vaccination is allowed.
• • 8. Participants who are known to be human immunodeficiency virus positive or hepatitis B or C positive and have uncontrolled disease.
• • 9. 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.
• • 10. 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).
• • 11. Hepatic metastases unless adequately treated, either locally (e.g., by surgery, radiofrequency ablation, or chemoembolization) or systemically or both, and stable for 3 months.