A Study of a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule STA… (NCT05592626) | Clinical Trial Compass
RecruitingPhase 1/2
A Study of a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule STAR0602 in Participants With Advanced Solid Tumors
United States365 participantsStarted 2023-01-04
Plain-language 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 advanced solid tumors that are antigen-rich.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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:
✓. For Phase 2, participants must have one of the following solid tumors:
✓. TMB-H
✓. MSI-H/dMMR
Exclusion criteria
✕. Participants with a history of known autoimmune disease with exceptions of:
✕. 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.
What they're measuring
1
Phase 1 (Dose Escalation):Number of Participants with Dose-limiting Toxicities (DLTs) in Cycle 1
Timeframe: Cycle 1 (Cycle length= 28 days)
2
Phase 1 and 2 (Dose Escalation and Expansion): Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timeframe: Up to 3 years
3
Phase 2 (Dose Expansion): Percentage of Participants with Overall Objective Tumor Responses (ORR)
✕. 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.