A Phase IB/II Clinical Study of SHR-9839 for Injection Combined With Other Anti-tumor Therapies in Patients With Advanced Solid Tumors

Hengrui Medicine

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Advanced Solid Tumors

Treatments: Drug: Pemetrexed Disodium for Injection; Drug: SHR-A1921 for Injection; Drug: SHR-A2009 for Injection; Drug: Paclitaxel injection; Drug: Carboplatin for injection; Drug: SHR-9839 for Injection (sc); Drug: Almonertinib Mesilate Tablets; Drug: SHR-1316 Injection; Drug: SHR-9839 for Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT06474455

SHR-9839-201

Details and patient eligibility

About

This study is an open-label, multicenter Phase IB/II clinical trial to evaluate the safety, tolerability and efficacy of SHR-9839 for injection in combination with other antitumor therapies in patients with advanced solid tumors.

Enrollment: 156 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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156 participants in 7 patient groups

SHR-9839 combined with SHR-A2009

Experimental group

Treatment:

Drug: SHR-9839 for Injection

Drug: SHR-A2009 for Injection

SHR-9839 combined with SHR-A1921

Experimental group

Treatment:

Drug: SHR-9839 for Injection

Drug: SHR-A1921 for Injection

SHR-9839 combined with Pemetrexed + Carboplatin

Experimental group

Treatment:

Drug: SHR-9839 for Injection

Drug: Carboplatin for injection

Drug: Pemetrexed Disodium for Injection

SHR-9839 combined with Almonertinib

Experimental group

Treatment:

Drug: SHR-9839 for Injection

Drug: Almonertinib Mesilate Tablets

SHR-9839(sc) + SHR-1316

Experimental group

Treatment:

Drug: SHR-1316 Injection

Drug: SHR-9839 for Injection (sc)

SHR-1316 + Platinum-based chemotherapy ± SHR-9839(sc)

Experimental group

Treatment:

Drug: SHR-1316 Injection

Drug: SHR-9839 for Injection (sc)

Drug: Paclitaxel injection

SHR-9839 (sc) + SHR-1316 + Platinum-based chemotherapy

Experimental group

Treatment:

Drug: SHR-1316 Injection

Drug: SHR-9839 for Injection (sc)

Drug: Paclitaxel injection