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

September 19, 2023 updated by: Tracon Pharmaceuticals Inc.

A Phase 1/2 Study of YH001 in Combination With Envafolimab With or Without Doxorubicin in Patients With Advanced or Metastatic Sarcoma

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • California
      • Santa Monica, California, United States, 90403
        • Sarcoma Oncology Center
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • University of Pittsburgh Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: P1 Cohort 1A: Dose 1 YH001 + Dose 1 Envafolimab Q3WK
Dose 1 of YH001 will be dosed in combination with Dose 1 Envafolimab every 3 weeks.
Drug: YH001
Anti-CTLA4 antibody
Drug: Envafolimab
Anti-PD-L1 antibody
Other Names:
  • KN035
Experimental: P1 Cohort 2A: Dose 2 YH001 + Dose 1 Envafolimab Q3WK
Dose 1 of YH001 will be dosed in combination with Dose 1 Envafolimab every 3 weeks.
Drug: YH001
Anti-CTLA4 antibody
Drug: Envafolimab
Anti-PD-L1 antibody
Other Names:
  • KN035
Experimental: P1 Cohort 1B: Dose 1 YH001 + Dose 1 Envafolimab + Doxorubicin Q3WK
Dose 1 of YH001 will be dosed in combination with Dose 1 of Envafolimab with Doxorubicin every 3 weeks.
Drug: YH001
Anti-CTLA4 antibody
Drug: Envafolimab
Anti-PD-L1 antibody
Other Names:
  • KN035
Drug: Doxorubicin
Anthracycline
Experimental: P1 Cohort 2B: Dose 2 YH001 + Dose 1 Envafolimab + Doxorubicin Q3WK
Dose 1 of YH001 will be dosed in combination with Dose 1 of Envafolimab with Doxorubicin every 3 weeks.
Drug: YH001
Anti-CTLA4 antibody
Drug: Envafolimab
Anti-PD-L1 antibody
Other Names:
  • KN035
Drug: Doxorubicin
Anthracycline
Experimental: P2: Sarcoma Subtype 1 RP2D YH001 + Dose 1 Envafolimab Q3WK
Recommended Phase 2 Dose of YH001 in combination with Dose 1 of Envafolimab every 3 weeks
Drug: YH001
Anti-CTLA4 antibody
Drug: Envafolimab
Anti-PD-L1 antibody
Other Names:
  • KN035
Experimental: P2: Sarcoma Subtype 2 RP2D YH001 + Dose 1 Envafolimab Q3WK
Recommended Phase 2 Dose of YH001 in combination with Dose 1 of Envafolimab every 3 weeks
Drug: YH001
Anti-CTLA4 antibody
Drug: Envafolimab
Anti-PD-L1 antibody
Other Names:
  • KN035
Experimental: P2: Sarcoma Subtype 3 RP2D YH001 + Dose 1 Envafolimab + Doxorubicin Q3WK
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
Drug: YH001
Anti-CTLA4 antibody
Drug: Envafolimab
Anti-PD-L1 antibody
Other Names:
  • KN035
Drug: Doxorubicin
Anthracycline
Experimental: P2: Sarcoma Subtype 4 RP2D YH001 + Dose 1 Envafolimab + Doxorubicin Q3WK
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
Drug: YH001
Anti-CTLA4 antibody
Drug: Envafolimab
Anti-PD-L1 antibody
Other Names:
  • KN035
Drug: Doxorubicin
Anthracycline

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Phase 1: Determine recommended phase 2 dose of YH001 in combination with Envafolimab
Time Frame: 8 months
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
Time Frame: 8 months
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
Time Frame: 18 months
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
Time Frame: 22 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Phase 1: YH001 concentrations
Time Frame: 8 months
Determine YH001 trough concentration when given with envafolimab with or without doxorubicin.
8 months
Phase 1: Envafolimab concentrations
Time Frame: 8 months
Determine envafolimab trough concentration when given with YH001 with or without doxorubicin.
8 months
Phase 1: Determine the Rate of YH001 Immunogenicity
Time Frame: 8 months
Evaluate the formation of YH001 anti-drug antibodies (ADA).
8 months
Phase 1: Determine the Rate of Envafolimab Immunogenicity
Time Frame: 8 months
Evaluate the formation of envafolimab anti-drug antibodies (ADA).
8 months
Phase 1: Assessment of antitumor activity
Time Frame: 8 months
Assess objective response rate (ORR) of YH001 by investigator using RECIST 1.1 when combined with envafolimab or envafolimab/doxorubicin combination in patients with advanced or metastatic sarcoma.
8 months
Phase 2: Determine the disease control rate (DCR)
Time Frame: 22 months
Determine the Disease Control Rate of envafolimab, YH001 and doxorubicin or envafolimab and YH001 in patients with advanced or metastatic sarcoma.
22 months
Phase 2: Determine duration of response (DOR)
Time Frame: 22 months
Determine the Duration of Response of envafolimab, YH001 and doxorubicin or envafolimab and YH001 in patients with advanced or metastatic sarcoma.
22 months
Phase 2: Determine Progression Free Survival (PFS)
Time Frame: 22 months
Determine Progression Free Survival of envafolimab, YH001 and doxorubicin or envafolimab and YH001 in patients with advanced or metastatic sarcoma.
22 months
Phase 2: Determine Overall Survival (OS)
Time Frame: 22 months
Determine Overall Survival of envafolimab, YH001 and doxorubicin or envafolimab and YH001 in patients with advanced or metastatic sarcoma.
22 months
Phase 2: YH001 concentration
Time Frame: 22 months
Determine YH001 trough concentration when given with envafolimab with or without doxorubicin.
22 months
Phase 2: Envafolimab concentration
Time Frame: 22 months
Determine envafolimab trough concentration when given with YH001 with or without doxorubicin.
22 months
Phase 2: Determine the Rate of YH001 Immunogenicity
Time Frame: 22 months
Evaluate the formation of YH001 anti-drug antibodies (ADA).
22 months
Phase 2: Determine the Rate of Envafolimab Immunogenicity
Time Frame: 22 months
Evaluate the formation of envafolimab anti-drug antibodies (ADA).
22 months
Phase 2: Type Incidence and Severity of Adverse Events
Time Frame: 25 months
Type, incidence, severity (graded by National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] Version 5.0), timing, seriousness, and relatedness of AEs and laboratory abnormalities.
25 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tracon Pharmaceuticals Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: James Freddo, MD, Medical Monitor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 14, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 28, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 3, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 7, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 21, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 19, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • YH001/KN035SAR101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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