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

Overview

About this study

The purpose of this study is to evaluate the safety and tolerability and determine the recommended Phase 2 dose (RP2D) of YH001 when given with envafolimab dosed at 600 mg SC every 3 weeks in patients with advanced or metastatic sarcoma who are refractory to or intolerant to other available therapies. Also, to evaluate safety and tolerability and determine RP2D of YH001 in combination with envafolimab dosed at 600 mg SC every 3 weeks and doxorubicin dosed at 75 mg/m2 every three weeks in patients with advanced or metastatic sarcoma who have not received doxorubicin or checkpoint inhibitors and are refractory to or intolerant to other available therapies.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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).
  • 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.

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.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 11/28/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Steven Robinson, M.B.B.S.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Steven Attia, D.O.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Mahesh Seetharam, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions