Combining HRS2398 and Adebrelimab for advanced solid tumors

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

This study is testing a new combination of two cancer treatments, HRS2398 and Adebrelimab, to see if they can help people with advanced solid tumors who haven't had success with other therapies.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 88 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. (industry)
• Drugs / interventions: chemotherapy, immunotherapy, Adebrelimab
• Locations: 2 sites (Zhengzhou, Henan and 1 other locations)
• Trial ID: NCT06439589 on ClinicalTrials.gov

What this trial studies

This multicenter, open-label clinical trial evaluates the safety, tolerability, and efficacy of HRS2398 in combination with Adebrelimab in patients with advanced solid tumors. The study is designed in two phases: a dose-finding phase and an efficacy-expanding phase, focusing on patients who have either failed standard therapies or have no effective treatment options available. Participants will be monitored for pharmacokinetic characteristics and immunogenicity of the treatment combination, with the aim of determining the recommended phase 2 dose (RP2D).

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with advanced solid tumors that have progressed after standard therapy or for whom no effective treatment exists.

Not a fit: Patients with untreated brain metastases or those requiring drainage for symptomatic ascites or pleural effusion may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment combination could provide a new therapeutic option for patients with advanced solid tumors who have limited treatment alternatives.

How similar studies have performed: While the combination of immunotherapy agents is a growing area of research, the specific combination of HRS2398 and Adebrelimab is novel and has not been extensively tested in prior studies.

Eligibility criteria

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.

Where this trial is running

Zhengzhou, Henan and 1 other locations

• Henan Cancer Hospital — Zhengzhou, Henan, China (RECRUITING)
• Shanghai Chest Hospital — Shanghai, Shanghai Municipality, China (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: Xin Xu

Conditions: Advanced Solid Tumors