Phase Ib/II Study of HRS2398 in Combination With Adebrelimab in Patients With Advanced Solid Tumors

July 3, 2024 updated by: Shanghai Hengrui Pharmaceutical Co., Ltd.

An Open-label, Multi-center Phase Ib/II Study of HRS2398 in Combination With Adebrelimab in Patients With Advanced Solid Tumors

This study is a multicenter, open-label, dose-finding/efficacy-expanding phase Ib/II clinical trial, which aims to observe and evaluate the tolerability, safety, pharmacokinetic characteristics and immunogenicity of HRS2398 combined with Adebrelimab injection in patients with advanced solid tumors, determine the RP2D, and preliminarily evaluate the efficacy of HRS2398 combined with Adebrelimab in patients with advanced solid tumors.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

88

Phase

  • 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 Backup

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China, 450003
        • Recruiting
        • Henan Cancer Hospital
        • Principal Investigator:
          • Yanyan Liu
    • Shanghai
      • Shanghai, Shanghai, China, 200030
        • Not yet recruiting
        • Shanghai Chest Hospital
        • Contact:
          • Hua Zhong

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Subjects are able to give voluntary informed consent, understand the study and are willing to follow and complete all the test procedures.
  2. Age 18~75 years old.
  3. Dose escalation phase: patients with clinically diagnosed or pathologically confirmed advanced solid tumors who have failed standard therapy (disease progression during or after treatment) or for whom no effective standard treatment regimen exists.
  4. Dose Expansion and Efficacy Expansion Phase: Patients with advanced solid tumors who have received systemic immunotherapy and platinum-containing chemotherapy in the recurrent/metastatic settings.
  5. At least one measurable lesion per RECIST v1.1 criteria.
  6. ECOG PS score: 0-1.

Exclusion Criteria:

  1. Patients with meningeal metastases; or with brain metastases that have not been treated with surgery or radiotherapy.
  2. Cancerous ascites and pleural effusion with clinical symptoms, requiring puncture and drainage; or those who have received ascites, pleural effusion drainage within 14 days before the first dose.
  3. Presence of any active, known autoimmune disease.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HRS2398 given in combination with adebrelimab
Drug: HRS2398
HRS2398: Tablets, 40mg/tablet, oral
Drug: Adebrelimab
Adebrelimab (SHR-1316): injection, 600mg(12mL), intravenous infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The number of subjects with dose-limiting toxicity (DLT)
Time Frame: From first dose of study treatment until the end of Cycle 1（up to 28 days）
From first dose of study treatment until the end of Cycle 1（up to 28 days）
Determination of Recommended Phase II dose (RP2D)
Time Frame: From first dose of study treatment until the end of Cycle 1（up to 28 days）
From first dose of study treatment until the end of Cycle 1（up to 28 days）
Objective Response Rate (ORR)
Time Frame: From time of first dose of HRS2398 or Adebrelimab until the date of objective disease progression or death (up to 6 months)
From time of first dose of HRS2398 or Adebrelimab until the date of objective disease progression or death (up to 6 months)

Secondary Outcome Measures

Outcome Measure
Time Frame
Disease Control Rate (DCR)
Time Frame: From time of first dose of HRS2398 or Adebrelimab until the date of objective disease progression or death (up to 6 months)
From time of first dose of HRS2398 or Adebrelimab until the date of objective disease progression or death (up to 6 months)
Duration of Response (DoR)
Time Frame: From time of first dose of objective disease progression until the date of objective disease progression or death (up to 6 months)
From time of first dose of objective disease progression until the date of objective disease progression or death (up to 6 months)
Progression free Survival (PFS)
Time Frame: From time of first dose of objective disease progression until the date of objective disease progression or death (up to 6 months)
From time of first dose of objective disease progression until the date of objective disease progression or death (up to 6 months)
Overall Survival (OS)
Time Frame: From time of first dose of objective disease progression until the date of death (up to 24 months)
From time of first dose of objective disease progression until the date of death (up to 24 months)
Time To Response(TTR)
Time Frame: From time of first dose of objective disease progression until the date of objective disease progression or death (up to 6 months)
From time of first dose of objective disease progression until the date of objective disease progression or death (up to 6 months)

Collaborators and Investigators

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

Sponsor

Shanghai Hengrui Pharmaceutical Co., Ltd.

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)

June 12, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

May 28, 2024

First Submitted That Met QC Criteria

May 28, 2024

First Posted (Actual)

June 3, 2024

Study Record Updates

Last Update Posted (Actual)

July 5, 2024

Last Update Submitted That Met QC Criteria

July 3, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HRS2398-201-PD-L1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

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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