SHR-9839 combined with other anti-cancer treatments for advanced solid tumors

A Phase IB/II, Open-Label, Multicentre Clinical Study to Evaluate the Safety, Tolerability and Efficacy of SHR-9839 for Injection in Combination With Other Therapies in Patients With Advanced Solid Tumors

This trial will test whether adding the experimental drug SHR-9839 to other cancer treatments helps adults with advanced solid tumors tolerate therapy and shrink tumors.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 156 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 2 sites (Zhengzhou, Henan and 1 other locations)
• Trial ID: NCT06474455 on ClinicalTrials.gov

What this trial studies

This open-label, multicenter Phase IB/II trial combines the investigational injectable SHR-9839 with other anti-tumor agents (including SHR-A1921, SHR-A2009, almonertinib, and pemetrexed) to characterize safety and preliminary activity in patients with advanced solid tumors. Phase IB focuses on dose-finding and tolerability, while Phase II expands selected combinations to measure tumor responses by RECIST v1.1. Eligible adults (18–75) must have measurable disease, ECOG performance status 0–1, adequate organ function, and life expectancy of at least 12 weeks. The trial is conducted at cancer centers in Zhengzhou and Hangzhou, China, and is open-label without placebo control.

Who should consider this trial

Good fit: Adults aged 18–75 with histologically or cytologically confirmed locally advanced or metastatic solid tumors (Part A) or squamous non-small cell lung cancer (Part B), at least one measurable lesion, ECOG 0–1, adequate organ and marrow function, and life expectancy ≥12 weeks who can consent and comply with study visits.

Not a fit: Patients with active central nervous system metastases, unresolved spinal cord compression, uncontrolled tumor-related pain, clinically significant ascites or pleural/pericardial effusions, or other contraindications by lab or performance status are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, these combinations could provide better tumor control or extend survival for some patients with advanced solid tumors.

How similar studies have performed: Combining novel targeted or immune agents with standard therapies has shown benefit in some cancers, but SHR-9839 itself is investigational and prior clinical data are limited.

Eligibility criteria

Inclusion Criteria:

1. Aged 18-75 years old (inclusive), regardless of gender.
2. Part A: Patients with locally advanced or metastatic solid tumors confirmed by histology or cytology; Part B: Squamous non-small cell lung cancer.
3. At least one measurable tumor lesion according to RECIST v1.1.
4. ECOG performance score of 0-1.
5. Life expectancy ≥ 12 weeks.
6. Adequate bone marrow and organ function.
7. Have the ability to informed consent, have signed the IRB / EC approved informed consent and dated, willing and able to comply with the treatment plan to visit the inspection and other procedural requirements.

Exclusion Criteria:

1. Patients with active central nervous system ( CNS ) metastases.
2. Spinal cord compression not be cured by surgery or radiotherapy.
3. Subjects with uncontrollable tumor-related pain.
4. Moderate and severe ascites with clinical symptoms; Uncontrollable or moderate and above pleural effusion, pericardial effusion.
5. Anti-tumor treatments such as chemotherapy within 4 weeks prior to the first dose of study drug.
6. Received \> 30 Gy chest radiotherapy within 24 weeks prior to the first dose of study drug.
7. Major organ surgery or significant trauma within 4 weeks prior to the first dose of study drug.
8. Concomitant other malignancies ≤ 3 years prior to the first dose of study drug.
9. History of interstitial pneumonitis or imaging at screening suggestive of suspected interstitial pneumonitis or inability to exclude interstitial pneumonitis; or other moderate-to-severe lung disease that severely affects lung function.
10. Serious cardiovascular and cerebrovascular diseases.
11. Patients with clinically significant bleeding symptoms within 3 months prior to the first dose of study drug.
12. History of immunodeficiency, including HIV test positive.
13. Active hepatitis B or hepatitis C infection.
14. History of severe allergic reactions to any component of any study drug to be accepted.
15. Known history of alcohol or drug dependence.
16. Mental disorders or poor compliance.
17. Pregnant or lactating women.
18. Patients with any active, known or suspected autoimmune disease.
19. Patients received systemic immunostimulatory therapy within 4 weeks before starting the study, or received systemic immunosuppressive therapy within 2 weeks before starting the first study.
20. Patients who had previously used immune checkpoint inhibitors were not allowed to be enrolled in this study if they had a CTCAE grade 3 immune-related adverse event that lasted for 4 weeks or more, or a CTCAE grade 4 immune-related adverse event.

Where this trial is running

Zhengzhou, Henan and 1 other locations

• Henan Cancer Hospital — Zhengzhou, Henan, China (Recruiting)
• Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Qingkai Zhou

Conditions Advanced Solid Tumors