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

Advanced Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06439589
• Other study ID #: HRS2398-201-PD-L1
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: June 2024
• Est. completion date: December 2025

Study information

• Verified date: May 2024
• Source: Shanghai Hengrui Pharmaceutical Co., Ltd.
• Contact: Xin Xu
• Phone: 0518-82342973
• Email: xin.xu[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 88
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Neoplasms

Intervention

Drug:
• HRS2398
HRS2398: Tablets, 40mg/tablet, oral
• Adebrelimab
Adebrelimab (SHR-1316): injection, 600mg(12mL), intravenous infusion

Locations

Country	Name	City	State
China	Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Hengrui Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of subjects with dose-limiting toxicity (DLT)		From first dose of study treatment until the end of Cycle 1(up to 28 days)
Primary	Determination of Recommended Phase II dose (RP2D)		From first dose of study treatment until the end of Cycle 1(up to 28 days)
Primary	Objective Response Rate (ORR)		From time of first dose of HRS2398 or Adebrelimab until the date of objective disease progression or death (up to 6 months)
Secondary	Disease Control Rate (DCR)		From time of first dose of HRS2398 or Adebrelimab until the date of objective disease progression or death (up to 6 months)
Secondary	Duration of Response (DoR)		From time of first dose of objective disease progression until the date of objective disease progression or death (up to 6 months)
Secondary	Progression free Survival (PFS)		From time of first dose of objective disease progression until the date of objective disease progression or death (up to 6 months)
Secondary	Overall Survival (OS)		From time of first dose of objective disease progression until the date of death (up to 24 months)
Secondary	Time To Response(TTR)		From time of first dose of objective disease progression until the date of objective disease progression or death (up to 6 months)