YH001 Plus Envafolimab With or Without Doxorubicin in Patients With Advanced or Metastatic Sarcoma

Tracon Pharmaceuticals Inc.15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Advanced Sarcoma Metastatic Sarcoma Soft Tissue Sarcoma

Interventions

YH001DRUG

Anti-CTLA4 antibody

EnvafolimabDRUG

Anti-PD-L1 antibody

DoxorubicinDRUG

Anthracycline

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Histologically confirmed advanced or metastatic sarcoma patients without UPS or MFS who are refractory to or intolerant to standard treatments for their disease. 2. Histologically confirmed advanced or metastatic sarcoma patients without UPS or MFS who have not received any immune checkpoint inhibitors or doxorubicin, and with histology for which doxorubicin is considered a reasonable treatment option (for Cohort 1B, 2B and Expanded Cohort 1B and/or 2B) 3. Measurable disease by RECIST 1.1 4. Age ≥ 18 years 5. Adequate organ function 6. Left ventricular ejection fraction (LVEF) as measured by echo or multigated acquisition scan of \> 50% (for patients to receive doxorubicin) 7. Willingness and ability to consent for self to participate in study 8. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures 9. Men who are sterile or agree to use a condom with spermicide . 10. Women of non-child bearing potential due to surgical sterilization or medically-documented ovarian failure confirmed by medical history, or women of child bearing potential who test negative for pregnancy at time of enrollment and agree to use at least 2 acceptable methods of birth control Exclusion Criteria: 1. Gastrointestinal stromal tumor (GIST) or desmoid tumors 2. Condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days prior to enrollment 3. Known allergy to any component of any study drug that the patient would receive if enrolled into this study 4. Prior T-cell or NK-cell therapy 5. Prior pericardial or mediastinal radiation (for patients to receive doxorubicin) 6. Acute coronary syndromes within 6 months of enrollment 7. Women who are pregnant or breast feeding 8. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for this study

Locations (6)

Sarcoma Oncology Center

Santa Monica, California, United States

Northwestern University

Chicago, Illinois, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Duke University

Durham, North Carolina, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 22 months

Secondary Outcomes

Phase 1: YH001 concentrations

Determine YH001 trough concentration when given with envafolimab with or without doxorubicin.

Time frame: 8 months

Phase 1: Envafolimab concentrations

Data from ClinicalTrials.gov

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