Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| P1 Cohort 1A: Dose 1 YH001 + Dose 1 Envafolimab Q3WK | Experimental | Dose 1 of YH001 will be dosed in combination with Dose 1 Envafolimab every 3 weeks. |
|
| P1 Cohort 2A: Dose 2 YH001 + Dose 1 Envafolimab Q3WK | Experimental | Dose 1 of YH001 will be dosed in combination with Dose 1 Envafolimab every 3 weeks. |
|
| P1 Cohort 1B: Dose 1 YH001 + Dose 1 Envafolimab + Doxorubicin Q3WK | Experimental | Dose 1 of YH001 will be dosed in combination with Dose 1 of Envafolimab with Doxorubicin every 3 weeks. |
|
| P1 Cohort 2B: Dose 2 YH001 + Dose 1 Envafolimab + Doxorubicin Q3WK | Experimental | Dose 1 of YH001 will be dosed in combination with Dose 1 of Envafolimab with Doxorubicin every 3 weeks. |
|
| P2: Sarcoma Subtype 1 RP2D YH001 + Dose 1 Envafolimab Q3WK | Experimental | Recommended Phase 2 Dose of YH001 in combination with Dose 1 of Envafolimab every 3 weeks |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YH001 | Drug | Anti-CTLA4 antibody |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1: Determine recommended phase 2 dose of YH001 in combination with Envafolimab | Evaluate safety and tolerability and determine the recommended Phase 2 dose (RP2D) of YH001 when given with envafolimab dosed SC every 3 weeks in patients with advanced or metastatic sarcoma who are refractory to or intolerant to other available therapies. | 8 months |
| Phase 1: Determine recommended phase 2 dose of YH001 in combination with Envafolimab with Doxorubicin | Evaluate safety and tolerability and determine RP2D of YH001 in combination with envafolimab dosed SC every 3 weeks and doxorubicin dosed every three weeks in patients with advanced or metastatic sarcoma who have not received doxorubicin and are refractory to or intolerant to other available therapies. | 8 months |
| Phase 2: Determine the objective response rate (ORR) of YH001 in combination with Envafolimab and Doxorubicin | Determine the ORR of envafolimab, YH001 and doxorubicin by RECIST 1.1 by investigator assessment in patients who have not received immune checkpoint inhibitors or doxorubicin with subtypes of advanced or metastatic soft tissue sarcoma. | 18 months |
| Phase 2: Determine the objective response rate (ORR) of YH001 in combination with Envafolimab | Determine the ORR of envafolimab and YH001 by RECIST 1.1 by investigator in patients with subtypes of advanced or metastatic soft tissue sarcoma who have not received immune checkpoint inhibitors. | 22 months |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1: YH001 concentrations | Determine YH001 trough concentration when given with envafolimab with or without doxorubicin. | 8 months |
| Phase 1: Envafolimab concentrations | Determine envafolimab trough concentration when given with YH001 with or without doxorubicin. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| James Freddo, MD | Medical Monitor | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sarcoma Oncology Center | Santa Monica | California | 90403 | United States | ||
| Northwestern University |
Not provided
| Label | URL |
|---|---|
| TRACON Pharmaceuticals | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| P2: Sarcoma Subtype 2 RP2D YH001 + Dose 1 Envafolimab Q3WK | Experimental | Recommended Phase 2 Dose of YH001 in combination with Dose 1 of Envafolimab every 3 weeks |
|
| P2: Sarcoma Subtype 3 RP2D YH001 + Dose 1 Envafolimab + Doxorubicin Q3WK | Experimental | 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 |
|
| P2: Sarcoma Subtype 4 RP2D YH001 + Dose 1 Envafolimab + Doxorubicin Q3WK | Experimental | 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 |
|
| Envafolimab | Drug | Anti-PD-L1 antibody |
|
|
| Doxorubicin | Drug | Anthracycline |
|
| 8 months |
| Phase 1: Determine the Rate of YH001 Immunogenicity | Evaluate the formation of YH001 anti-drug antibodies (ADA). | 8 months |
| Phase 1: Determine the Rate of Envafolimab Immunogenicity | Evaluate the formation of envafolimab anti-drug antibodies (ADA). | 8 months |
| Phase 1: Assessment of antitumor activity | Assess objective response rate (ORR) of YH001 by investigator using RECIST 1.1 when combined with envafolimab or envafolimab/doxorubicin combination in patients with advanced or metastatic sarcoma. | 8 months |
| Phase 2: Determine the disease control rate (DCR) | Determine the Disease Control Rate of envafolimab, YH001 and doxorubicin or envafolimab and YH001 in patients with advanced or metastatic sarcoma. | 22 months |
| Phase 2: Determine duration of response (DOR) | Determine the Duration of Response of envafolimab, YH001 and doxorubicin or envafolimab and YH001 in patients with advanced or metastatic sarcoma. | 22 months |
| Phase 2: Determine Progression Free Survival (PFS) | Determine Progression Free Survival of envafolimab, YH001 and doxorubicin or envafolimab and YH001 in patients with advanced or metastatic sarcoma. | 22 months |
| Phase 2: Determine Overall Survival (OS) | Determine Overall Survival of envafolimab, YH001 and doxorubicin or envafolimab and YH001 in patients with advanced or metastatic sarcoma. | 22 months |
| Phase 2: YH001 concentration | Determine YH001 trough concentration when given with envafolimab with or without doxorubicin. | 22 months |
| Phase 2: Envafolimab concentration | Determine envafolimab trough concentration when given with YH001 with or without doxorubicin. | 22 months |
| Phase 2: Determine the Rate of YH001 Immunogenicity | Evaluate the formation of YH001 anti-drug antibodies (ADA). | 22 months |
| Phase 2: Determine the Rate of Envafolimab Immunogenicity | Evaluate the formation of envafolimab anti-drug antibodies (ADA). | 22 months |
| Phase 2: Type Incidence and Severity of Adverse Events | Type, incidence, severity (graded by National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] Version 5.0), timing, seriousness, and relatedness of AEs and laboratory abnormalities. | 25 months |
| Chicago |
| Illinois |
| 60611 |
| United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Duke University | Durham | North Carolina | 27710 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15232 | United States |
| ID | Term |
|---|---|
| D012509 | Sarcoma |
| C563326 | Diabetes Mellitus, Insulin-Dependent, 12 |
| D002813 | Chondrosarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009372 | Neoplasms, Connective Tissue |
Not provided
Not provided
| ID | Term |
|---|---|
| C000718749 | envafolimab |
| D004317 | Doxorubicin |
| ID | Term |
|---|---|
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
Not provided
Not provided