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

Launched by SHANGHAI HENGRUI PHARMACEUTICAL CO., LTD. · May 28, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment combination of HRS2398 and Adebrelimab for patients with advanced solid tumors, which are types of cancer that have spread beyond their original site. The main goals of the study are to see how well these drugs work together, how safe they are, and to find the right dose for future treatment. The trial is currently recruiting participants aged 18 to 75 who have advanced solid tumors that have not responded to standard therapies or for whom no effective treatments are available.

To participate, individuals must be able to provide informed consent and have at least one measurable tumor. Patients with certain brain conditions or active autoimmune diseases are not eligible. If you join this study, you can expect to receive the new treatment and undergo regular check-ups to monitor your health and the effects of the drugs. This trial aims to gather important information that could help improve treatment options for people with advanced solid tumors in the future.

Gender

ALL

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.