Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 75Years
All Genders
NCT06439589

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

Led by Shanghai Hengrui Pharmaceutical Co., Ltd. · Updated on 2024-07-05

88

Participants Needed

2

Research Sites

76 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Able to give voluntary informed consent and willing to complete all study procedures
  • Age between 18 and 75 years old
  • For dose escalation: advanced solid tumors confirmed clinically or pathologically, with failed standard therapy or no effective treatment
  • For dose expansion and efficacy phases: advanced solid tumors with prior systemic immunotherapy and platinum-containing chemotherapy
  • At least one measurable tumor lesion as per RECIST v1.1 criteria
  • ECOG performance status score of 0 or 1
Not Eligible

You will not qualify if you...

  • Presence of meningeal metastases or untreated brain metastases
  • Cancerous ascites or pleural effusion with symptoms requiring drainage, or drainage received within 14 days before first dose
  • Any active, known autoimmune disease

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

Henan Cancer Hospital

Zhengzhou, Henan, China, 450003

Actively Recruiting

2

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China, 200030

Not Yet Recruiting

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Research Team

X

Xin Xu

CONTACT

Y

Yuting Wang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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