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NCT Number: NCT06439589

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.

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Key information

Conditions

Advanced Solid Tumors

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Henan Cancer Hospital, Zhengzhou, Henan, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects are able to give voluntary informed consent, understand the study and are willing to follow and complete all the test procedures.
  • Age 18~75 years old.
  • 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.
  • 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.
  • At least one measurable lesion per RECIST v1.1 criteria.
  • ECOG PS score: 0-1.

Exclusion criteria

  • Patients with meningeal metastases; or with brain metastases that have not been treated with surgery or radiotherapy.
  • 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.
  • Presence of any active, known autoimmune disease.

Treatment and study plan

HRS2398

Drug

HRS2398: Tablets, 40mg/tablet, oral

Adebrelimab

Drug

Adebrelimab (SHR-1316): injection, 600mg(12mL), intravenous infusion

Primary outcomes

  1. 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）

  2. 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）

  3. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. Overall Survival (OS)

    Time frame: From time of first dose of objective disease progression until the date of death (up to 24 months)

  5. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Xin Xu

CONTACT

[email protected]

0518-82342973

Yuting Wang

CONTACT

[email protected]

0518-82342973

Sponsors and collaborators

Lead sponsor

Shanghai Hengrui Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 3, 2024
Registry last updated
Jul 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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