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Advanced SarcomaPhase 1/2NCT05448820

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

A Phase 1/2 study testing YH001, Envafolimab and Doxorubicin in people with Advanced Sarcoma and Metastatic Sarcoma, run by Tracon Pharmaceuticals Inc. at 6 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
YH001, Envafolimab and Doxorubicin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
6 sitesUnited States
Study dates
14 Nov 2022to Sep 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 10Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Northwestern University

    Chicago, Illinois, 60611

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Duke University

    Durham, North Carolina, 27710

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15232

  • Sarcoma Oncology Center

    Santa Monica, California, 90403

Other trials in United States

About this study

Official title: 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.

Being tested
YH001, Envafolimab, Doxorubicin
Keywords
Tracon, STS, LMS, DDLS, ASPS, envafolimab, YH001, CTLA-4, PD-L1, chondrosarcoma
Medical subject headings
Sarcoma, Diabetes Mellitus, Insulin-Dependent, 12, Chondrosarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • YH001Drug

    Anti-CTLA4 antibody

  • EnvafolimabDrug

    Also called KN035

    Anti-PD-L1 antibody

  • DoxorubicinDrug

    Anthracycline

Study groups in NCT05448820
Study groupRoleWhat they receive
P1 Cohort 1A: Dose 1 YH001 + Dose 1 Envafolimab Q3WKExperimentalDose 1 of YH001 will be dosed in combination with Dose 1 Envafolimab every 3 weeks.
Receives: Drug: YH001; Drug: Envafolimab
P1 Cohort 2A: Dose 2 YH001 + Dose 1 Envafolimab Q3WKExperimentalDose 1 of YH001 will be dosed in combination with Dose 1 Envafolimab every 3 weeks.
Receives: Drug: YH001; Drug: Envafolimab
P1 Cohort 1B: Dose 1 YH001 + Dose 1 Envafolimab + Doxorubicin Q3WKExperimentalDose 1 of YH001 will be dosed in combination with Dose 1 of Envafolimab with Doxorubicin every 3 weeks.
Receives: Drug: YH001; Drug: Envafolimab; Drug: Doxorubicin
P1 Cohort 2B: Dose 2 YH001 + Dose 1 Envafolimab + Doxorubicin Q3WKExperimentalDose 1 of YH001 will be dosed in combination with Dose 1 of Envafolimab with Doxorubicin every 3 weeks.
Receives: Drug: YH001; Drug: Envafolimab; Drug: Doxorubicin
P2: Sarcoma Subtype 1 RP2D YH001 + Dose 1 Envafolimab Q3WKExperimentalRecommended Phase 2 Dose of YH001 in combination with Dose 1 of Envafolimab every 3 weeks
Receives: Drug: YH001; Drug: Envafolimab
P2: Sarcoma Subtype 2 RP2D YH001 + Dose 1 Envafolimab Q3WKExperimentalRecommended Phase 2 Dose of YH001 in combination with Dose 1 of Envafolimab every 3 weeks
Receives: Drug: YH001; Drug: Envafolimab
P2: Sarcoma Subtype 3 RP2D YH001 + Dose 1 Envafolimab + Doxorubicin Q3WKExperimentalRecommended 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
Receives: Drug: YH001; Drug: Envafolimab; Drug: Doxorubicin
P2: Sarcoma Subtype 4 RP2D YH001 + Dose 1 Envafolimab + Doxorubicin Q3WKExperimentalRecommended 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
Receives: Drug: YH001; Drug: Envafolimab; Drug: Doxorubicin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 8 months

  2. 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.

    Measured: 8 months

  3. 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.

    Measured: 18 months

  4. 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.

    Measured: 22 months

Secondary outcomes (14)

  1. Phase 1: YH001 concentrations

    Determine YH001 trough concentration when given with envafolimab with or without doxorubicin.

    Measured: 8 months

  2. Phase 1: Envafolimab concentrations

    Determine envafolimab trough concentration when given with YH001 with or without doxorubicin.

    Measured: 8 months

  3. Phase 1: Determine the Rate of YH001 Immunogenicity

    Evaluate the formation of YH001 anti-drug antibodies (ADA).

    Measured: 8 months

  4. Phase 1: Determine the Rate of Envafolimab Immunogenicity

    Evaluate the formation of envafolimab anti-drug antibodies (ADA).

    Measured: 8 months

  5. Phase 1: Assessment of antitumor activity

    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.

    Measured: 8 months

  6. Phase 2: Determine the disease control rate (DCR)

    Determine the Disease Control Rate of envafolimab, YH001 and doxorubicin or envafolimab and YH001 in patients with advanced or metastatic sarcoma.

    Measured: 22 months

  7. Phase 2: Determine duration of response (DOR)

    Determine the Duration of Response of envafolimab, YH001 and doxorubicin or envafolimab and YH001 in patients with advanced or metastatic sarcoma.

    Measured: 22 months

  8. Phase 2: Determine Progression Free Survival (PFS)

    Determine Progression Free Survival of envafolimab, YH001 and doxorubicin or envafolimab and YH001 in patients with advanced or metastatic sarcoma.

    Measured: 22 months

  9. Phase 2: Determine Overall Survival (OS)

    Determine Overall Survival of envafolimab, YH001 and doxorubicin or envafolimab and YH001 in patients with advanced or metastatic sarcoma.

    Measured: 22 months

  10. Phase 2: YH001 concentration

    Determine YH001 trough concentration when given with envafolimab with or without doxorubicin.

    Measured: 22 months

  11. Phase 2: Envafolimab concentration

    Determine envafolimab trough concentration when given with YH001 with or without doxorubicin.

    Measured: 22 months

  12. Phase 2: Determine the Rate of YH001 Immunogenicity

    Evaluate the formation of YH001 anti-drug antibodies (ADA).

    Measured: 22 months

  13. Phase 2: Determine the Rate of Envafolimab Immunogenicity

    Evaluate the formation of envafolimab anti-drug antibodies (ADA).

    Measured: 22 months

  14. Phase 2: Type Incidence and Severity of Adverse Events

    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.

    Measured: 25 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2022
  2. Study start14 Nov 2022
  3. Primary completionNov 2023 (estimated)
  4. Study completionSep 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05448820
Sponsor's protocol ID
YH001/KN035SAR101
Status last verified
Sep 2023
First submitted
28 Jun 2022
Last updated
21 Sep 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing YH001, Envafolimab and Doxorubicin in people with Advanced Sarcoma and Metastatic Sarcoma, run by Tracon Pharmaceuticals Inc. at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1: Determine recommended phase 2 dose of YH001 in combination with Envafolimab (time frame: 8 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05448820.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.

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