YH001 + Envafolimab for Sarcoma
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Waitlist Available
Sponsor: Tracon Pharmaceuticals Inc.
No Placebo Group
Trial Summary
What is the purpose of this trial?This is a multicenter, open label, Phase 1/2 study of YH001 initially given in combination with envafolimab, and then given in combination with envafolimab plus doxorubicin in patients with advanced or metastatic sarcoma, followed by Phase 2 cohorts of patients with select histologies of advanced or metastatic sarcoma.
Eligibility Criteria
Adults with advanced or metastatic sarcoma, except for UPS or MFS types, who haven't had immune checkpoint inhibitors or doxorubicin. They should have measurable disease and good organ function. Women must not be pregnant and agree to birth control; men must use a condom if not sterile.Treatment Details
The study is testing YH001 in combination with Envafolimab, and then adding Doxorubicin for certain patients. It's an open-label trial meaning everyone knows what treatment they're getting, starting with Phase 1/2 followed by specific patient groups in Phase 2.
8Treatment groups
Experimental Treatment
Group I: P2: Sarcoma Subtype 4 RP2D YH001 + Dose 1 Envafolimab + Doxorubicin Q3WKExperimental Treatment3 Interventions
Recommended Phase 2 Dose of YH001 in combination with Dose 1 of Envafolimab every 3 weeks and Doxorubicin every 3 weeks for a maximum of 6 doses
Group II: P2: Sarcoma Subtype 3 RP2D YH001 + Dose 1 Envafolimab + Doxorubicin Q3WKExperimental Treatment3 Interventions
Recommended Phase 2 Dose of YH001 in combination with Dose 1 of Envafolimab every 3 weeks and Doxorubicin every 3 weeks for a maximum of 6 doses
Group III: P2: Sarcoma Subtype 2 RP2D YH001 + Dose 1 Envafolimab Q3WKExperimental Treatment2 Interventions
Recommended Phase 2 Dose of YH001 in combination with Dose 1 of Envafolimab every 3 weeks
Group IV: P2: Sarcoma Subtype 1 RP2D YH001 + Dose 1 Envafolimab Q3WKExperimental Treatment2 Interventions
Recommended Phase 2 Dose of YH001 in combination with Dose 1 of Envafolimab every 3 weeks
Group V: P1 Cohort 2B: Dose 2 YH001 + Dose 1 Envafolimab + Doxorubicin Q3WKExperimental Treatment3 Interventions
Dose 1 of YH001 will be dosed in combination with Dose 1 of Envafolimab with Doxorubicin every 3 weeks.
Group VI: P1 Cohort 2A: Dose 2 YH001 + Dose 1 Envafolimab Q3WKExperimental Treatment2 Interventions
Dose 1 of YH001 will be dosed in combination with Dose 1 Envafolimab every 3 weeks.
Group VII: P1 Cohort 1B: Dose 1 YH001 + Dose 1 Envafolimab + Doxorubicin Q3WKExperimental Treatment3 Interventions
Dose 1 of YH001 will be dosed in combination with Dose 1 of Envafolimab with Doxorubicin every 3 weeks.
Group VIII: P1 Cohort 1A: Dose 1 YH001 + Dose 1 Envafolimab Q3WKExperimental Treatment2 Interventions
Dose 1 of YH001 will be dosed in combination with Dose 1 Envafolimab every 3 weeks.
Find a clinic near you
Research locations nearbySelect from list below to view details:
Cleveland ClinicCleveland, OH
Duke UniversityDurham, NC
Memorial Sloan Kettering Cancer CenterNew York, NY
University of Pittsburgh Medical CenterPittsburgh, PA
More Trial Locations
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Who is running the clinical trial?
Tracon Pharmaceuticals Inc.Lead Sponsor