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

NCT05448820 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2023-09-21

No results posted yet for this study

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.

Conditions

  • Advanced Sarcoma
  • Metastatic Sarcoma
  • Soft Tissue Sarcoma

Interventions

DRUG

YH001

Anti-CTLA4 antibody

DRUG

Envafolimab

Anti-PD-L1 antibody

DRUG

Doxorubicin

Anthracycline

Sponsors & Collaborators

  • Tracon Pharmaceuticals Inc.

    lead INDUSTRY

Principal Investigators

  • James Freddo, MD · Medical Monitor

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-14
Primary Completion
2023-11-30
Completion
2025-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05448820 on ClinicalTrials.gov