STAR0602 for Advanced Solid Tumors
This study is testing a drug called STAR0602 in people with advanced solid tumors that are unresectable (cannot be removed by surgery), locally advanced, or metastatic (have spread). These are cancers for which standard treatments are no longer working or have too many side effects. STAR0602 is a special type of antibody-fusion molecule designed to target specific T cells (a type of immune cell) to fight cancer. The study is looking at the safety and side effects of STAR0602, as well as how well it shrinks tumors. You may be able to join if you have certain types of solid tumors and have not received more than three prior treatments for your advanced cancer. The study is currently unclear on its recruitment status.
- Study design
- This is an open-label (meaning you and your doctors will know what treatment you are receiving) Phase 1/2 study, planning to enroll 365 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be monitored for adverse events for up to 3 years, and tumor responses will be measured for up to 3 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05592626
A Study of a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule STAR0602 in Participants With Advanced Solid Tumors
Recruiting
PHASE1Ages 18+InterventionalTreatmentMarengo Therapeutics, Inc.
~366 participants
Updated 2026-08-11 on ClinicalTrials.gov
What's tested:STAR0602Irinotecan (Camptosar)Docetaxel (Taxotere)
At a glance
Recruiting sites
16 of 19 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 1 (Dose Escalation):Number of Participants with Dose-limiting Toxicities (DLTs) in Cycle 1
Measured over Cycle 1 (Cycle length= 28 days)
+2 more outcomes measured
Conditions
Where it's being run
19 sites across 15 statesSpain3
Florida2
Texas2
California1
Kansas1
Maryland1
Massachusetts1
Michigan1
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
No concurrent treatment for CNS disease (e.g., surgery, radiation, corticosteroids \> 10 mg prednisone/day or equivalent);
No concurrent leptomeningeal disease or cord compression. 5. Subjects who have previously received a CPI (e.g., anti-PD-L1, anti-PD-1, anti CTLA 4) prior to enrollment must have CPI immune-related toxicity resolved to either Grade ≤ 1 or baseline (prior to the CPI) to be eligible for enrollment.
Subjects who experienced previous CPI-related endocrine abnormalities are eligible for the study regardless of CTCAE grade if well controlled on replacement therapy.
Subjects who have had previous CPI-related Grade 3 to 4 pneumonitis, peri/myocarditis, colitis and bowel perforation, myositis, encephalitis, or peripheral neuropathy will need Sponsor approval.
Exclusion
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. Prior therapy within the following timeframe before planned infusion of STAR0602 as follows:
Cytotoxic chemotherapy, small molecule inhibitors, radiation, interventional radiology procedure, or similar investigational therapies within ≤ 2 weeks or participants who have not recovered (i.e., ≤ Grade 1 or to baseline) from AEs due to a previously administered agent;
Monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, or similar investigational therapies within 6 weeks prior to the initiation of study drug or participants who have not recovered (i.e., ≤ Grade 1 or to baseline) from AEs due to agents administered more than 4 weeks earlier. Note: Participants with ≤ Grade 2 neuropathy or ≤ Grade 2 alopecia are an exception to this criterion and may qualify for the study. 6. Clinically significant cardiovascular/vascular disease, gastrointestinal disorders, inflammatory processes, pulmonary compromises 7. Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days prior to the initiation of study drug. 8. Vaccination with any live virus vaccine within 4 weeks prior to the initiation of study drug administration. Inactivated annual influenza vaccination is allowed. 9. Participants who are known to be human immunodeficiency virus positive or hepatitis B or C positive and have uncontrolled disease. 10. 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. 11. 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). 12. Hepatic metastases unless adequately treated, either locally (e.g., by surgery, radiofrequency ablation, or chemoembolization) or systemically or both, and stable for 3 months. 13. Bulky disease defined as any lesion ≥ 5 cm in greatest dimension unless approved by the Sponsor.
What this trial measures
- Phase 1 (Dose Escalation):Number of Participants with Dose-limiting Toxicities (DLTs) in Cycle 1Cycle 1 (Cycle length= 28 days)
- Phase 1 and 2 (Dose Escalation and Expansion): Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)Up to 3 years
- Phase 2 (Dose Expansion): Percentage of Participants with Overall Objective Tumor Responses (ORR)Up to 3 years
Complete response (CR) and partial response (PR)