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Monoclonal Antibodies
YH001 + Envafolimab for Sarcoma
Phase 1 & 2
Waitlist Available
Research Sponsored by Tracon Pharmaceuticals Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 25 months
Awards & highlights
Approved for 5 Other Conditions
No Placebo-Only Group
Summary
This trialtests a new treatment for advanced or metastatic sarcoma, combining YH001, envafolimab, & doxorubicin. Results will help decide if it can help certain types of sarcoma.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects include those common to immunotherapy and chemotherapy such as fatigue, nausea, increased risk of infection, allergic reactions to the drugs' components, heart issues especially related to Doxorubicin use.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 25 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~25 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Phase 1: Determine recommended phase 2 dose of YH001 in combination with Envafolimab
Phase 1: Determine recommended phase 2 dose of YH001 in combination with Envafolimab with Doxorubicin
Phase 2: Determine the objective response rate (ORR) of YH001 in combination with Envafolimab
+1 moreSecondary study objectives
Phase 1: Assessment of antitumor activity
Phase 1: Determine the Rate of Envafolimab Immunogenicity
Phase 1: Determine the Rate of YH001 Immunogenicity
+11 moreAwards & Highlights
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
YH001
2020
Completed Phase 1
~50
Doxorubicin
FDA approved
Envafolimab
Not yet FDA approved
Find a Location
Who is running the clinical trial?
Tracon Pharmaceuticals Inc.Lead Sponsor
21 Previous Clinical Trials
1,016 Total Patients Enrolled
2 Trials studying Sarcoma
318 Patients Enrolled for Sarcoma
James Freddo, MDStudy DirectorMedical Monitor
1 Previous Clinical Trials
72 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken steroids or immunosuppressants in the last 14 days.I am willing and able to give my consent to participate in the study.I have not had a heart attack or other serious heart problems in the last 6 months.I am either not able to have children due to surgery or a medical condition, or I can have children but agree to use birth control.I have had radiation therapy to the area around my heart or middle chest.I am not pregnant or breastfeeding.My organs are working well.My heart pumps well, with an ejection fraction over 50%.I have previously received T-cell or NK-cell therapy.I have a GIST or desmoid tumor.My advanced sarcoma has not been treated with immune therapy or doxorubicin.My advanced sarcoma is not responding to standard treatments.I am 18 years old or older.I am sterile or I agree to use a condom with spermicide.I am willing and able to follow the study's schedule and procedures.
Research Study Groups:
This trial has the following groups:- Group 1: P2: Sarcoma Subtype 1 RP2D YH001 + Dose 1 Envafolimab Q3WK
- Group 2: P1 Cohort 2A: Dose 2 YH001 + Dose 1 Envafolimab Q3WK
- Group 3: P1 Cohort 1B: Dose 1 YH001 + Dose 1 Envafolimab + Doxorubicin Q3WK
- Group 4: P2: Sarcoma Subtype 4 RP2D YH001 + Dose 1 Envafolimab + Doxorubicin Q3WK
- Group 5: P1 Cohort 1A: Dose 1 YH001 + Dose 1 Envafolimab Q3WK
- Group 6: P2: Sarcoma Subtype 2 RP2D YH001 + Dose 1 Envafolimab Q3WK
- Group 7: P1 Cohort 2B: Dose 2 YH001 + Dose 1 Envafolimab + Doxorubicin Q3WK
- Group 8: P2: Sarcoma Subtype 3 RP2D YH001 + Dose 1 Envafolimab + Doxorubicin Q3WK
Awards:
This trial has 2 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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