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

Phase 1

Recruiting

• Conditions: Advanced Solid Tumors
• Interventions: Drug: HRS2398; Drug: Adebrelimab

• Registration Number: NCT06439589
• Lead Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-28
• Study First Submitted QC: 2024-05-28
• Study First Posted: 2024-06-03
• Study Start: 2024-06-12
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-03
• Last Update Posted: 2024-07-05
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 88

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HRS2398 given in combination with adebrelimab	HRS2398	-
HRS2398 given in combination with adebrelimab	Adebrelimab	-

Primary Outcome Measures

Name	Time	Method
Determination of Recommended Phase II dose (RP2D)	From first dose of study treatment until the end of Cycle 1（up to 28 days）
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)
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）

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	From time of first dose of objective disease progression until the date of death (up to 24 months)
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)
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)
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)
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)

Trial Locations

Locations (2)

Henan Cancer Hospital; 🇨🇳 Zhengzhou, Henan, China

Shanghai Chest Hospital; 🇨🇳 Shanghai, Shanghai, China