Combining SHR-1802 and Adebrelimab for Advanced Solid Tumors
An Open Label, Multicenter, Phase Ib/II Study of SHR-1802 in Combination With Adebrelimab in Patients With Advanced Solid Tumors
This study is testing a new combination of two treatments, SHR-1802 and adebrelimab, to see if they can help people with advanced solid tumors feel better, and it will also look at how safe they are and the best dose to use.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 132 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Shanghai Hengrui Pharmaceutical Co., Ltd. Industry-sponsored |
| Drugs / interventions | adebrelimab, chemotherapy |
| Locations | 1 site (Changsha, Hunan) |
| Trial ID | NCT05794477 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety, tolerability, pharmacokinetics, and immunogenicity of SHR-1802 when combined with adebrelimab in patients with advanced solid tumors. It aims to determine the recommended phase 2 dose (RP2D) of this combination, with or without chemotherapy agents like carboplatin, cisplatin, or paclitaxel. The study will also assess the efficacy of these treatments in managing advanced solid tumors.
Who should consider this trial
Good fit: Ideal candidates include patients with pathologically confirmed advanced solid tumors who have a good performance status and measurable lesions.
Not a fit: Patients who have received prior anti-PD-1 or PD-L1 therapies or have other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this combination therapy could provide a new treatment option for patients with advanced solid tumors.
How similar studies have performed: While this approach is being explored, similar combinations have shown promise in other studies, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Able and willing to provide a written informed consent； 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; 3. Has a life expectancy≥ 12 weeks； 4. At least one measurable lesion according to RECIST v1.1； 5. Pathologically confirmed advanced solid tumor； 6. Adequate bone marrow reserve and organ function. Exclusion Criteria: 1. Have received anti-PD-1 or PD-L1 antibody therapy; 2. Subjects with other malignant tumors in the past 3 years; 3. Have uncontrolled clinically symptomatic pleural effusion, pericardial effusion, or ascites; 4. Previous or current interstitial pneumonia/interstitial lung disease ; 5. History of autoimmune disease with the possibility of recurrence or active autoimmune disease; 6. Severe infection within 1 month before the first study drug administration; 7. The presence of other serious physical or mental disorders or abnormalities in laboratory tests that may increase the risk of study participation or interfere with study results, as well as patients deemed unsuitable for study participation by the investigator.
Where this trial is running
Changsha, Hunan
- Hunan Cancer Hospital — Changsha, Hunan, China (Recruiting)
Study contacts
- Study coordinator: Shuni Wang, M.M
- Email: shuni.wang@hengrui.com
- Phone: +86 15921207253
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.