YH001 Plus Envafolimab With or Without Doxorubicin in Patients With Advanced or Metastatic Sarcoma
A Phase 1/2 Study of YH001 in Combination With Envafolimab With or Without Doxorubicin in Patients With Advanced or Metastatic Sarcoma
1 other identifier
interventional
15
1 country
6
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Nov 2022
Typical duration for phase_1
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 28, 2022
CompletedFirst Posted
Study publicly available on registry
July 7, 2022
CompletedStudy Start
First participant enrolled
November 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2025
CompletedSeptember 21, 2023
September 1, 2023
12 months
June 28, 2022
September 19, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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
Secondary Outcomes (14)
Phase 1: YH001 concentrations
8 months
Phase 1: Envafolimab concentrations
8 months
Phase 1: Determine the Rate of YH001 Immunogenicity
8 months
Phase 1: Determine the Rate of Envafolimab Immunogenicity
8 months
Phase 1: Assessment of antitumor activity
8 months
- +9 more secondary outcomes
Study Arms (8)
P1 Cohort 1A: Dose 1 YH001 + Dose 1 Envafolimab Q3WK
EXPERIMENTALDose 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
EXPERIMENTALDose 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
EXPERIMENTALDose 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
EXPERIMENTALDose 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
EXPERIMENTALRecommended Phase 2 Dose of YH001 in combination with Dose 1 of Envafolimab every 3 weeks
P2: Sarcoma Subtype 2 RP2D YH001 + Dose 1 Envafolimab Q3WK
EXPERIMENTALRecommended 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
EXPERIMENTALRecommended 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
EXPERIMENTALRecommended 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
Interventions
Anti-CTLA4 antibody
Anti-PD-L1 antibody
Anthracycline
Eligibility Criteria
You may qualify if:
- Histologically confirmed advanced or metastatic sarcoma patients without UPS or MFS who are refractory to or intolerant to standard treatments for their disease.
- 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)
- Measurable disease by RECIST 1.1
- Age ≥ 18 years
- Adequate organ function
- Left ventricular ejection fraction (LVEF) as measured by echo or multigated acquisition scan of \> 50% (for patients to receive doxorubicin)
- Willingness and ability to consent for self to participate in study
- Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
- Men who are sterile or agree to use a condom with spermicide .
- 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
You may not qualify if:
- Gastrointestinal stromal tumor (GIST) or desmoid tumors
- Condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days prior to enrollment
- Known allergy to any component of any study drug that the patient would receive if enrolled into this study
- Prior T-cell or NK-cell therapy
- Prior pericardial or mediastinal radiation (for patients to receive doxorubicin)
- Acute coronary syndromes within 6 months of enrollment
- Women who are pregnant or breast feeding
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Sarcoma Oncology Center
Santa Monica, California, 90403, United States
Northwestern University
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
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
James Freddo, MD
Medical Monitor
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2022
First Posted
July 7, 2022
Study Start
November 14, 2022
Primary Completion
November 1, 2023
Study Completion
September 1, 2025
Last Updated
September 21, 2023
Record last verified: 2023-09