YH001 Plus Envafolimab With or Without Doxorubicin in Patients With Advanced or Metastatic Sarcoma (NCT05448820) | Clinical Trial Compass
UnknownPhase 1/2
YH001 Plus Envafolimab With or Without Doxorubicin in Patients With Advanced or Metastatic Sarcoma
United States15 participantsStarted 2022-11-14
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Phase 1: Determine recommended phase 2 dose of YH001 in combination with Envafolimab
Timeframe: 8 months
2
Phase 1: Determine recommended phase 2 dose of YH001 in combination with Envafolimab with Doxorubicin
Timeframe: 8 months
3
Phase 2: Determine the objective response rate (ORR) of YH001 in combination with Envafolimab and Doxorubicin
Timeframe: 18 months
4
Phase 2: Determine the objective response rate (ORR) of YH001 in combination with Envafolimab
. 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
Exclusion criteria
. 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