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

NCT06439589 | Recruiting Phase 1

• 1 other identifier: HRS2398-201-PD-L1
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 2

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.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (3)

• 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）

• 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)

Secondary Outcomes (5)

• 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)

• 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)

• Overall Survival (OS)

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

Study Arms (1)

HRS2398 given in combination with adebrelimab

EXPERIMENTAL

Drug: HRS2398; Drug: Adebrelimab

Interventions

HRS2398 DRUG

HRS2398: Tablets, 40mg/tablet, oral

HRS2398 given in combination with adebrelimab

Adebrelimab DRUG

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

HRS2398 given in combination with adebrelimab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Hengrui Pharmaceutical Co., Ltd.: lead

Study Sites (2)

Henan Cancer Hospital

Zhengzhou, Henan, 450003, China

RECRUITING

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

NOT YET RECRUITING

Central Study Contacts

Xin Xu

CONTACT

0518-82342973; xin.xu@hengrui.com

Yuting Wang

CONTACT

0518-82342973; yuting.wang@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: June 3, 2024
• Study Start: June 12, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 5, 2024

Record last verified: 2024-07

Locations

CN (2)