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

Phase 1

Not yet recruiting

• Conditions: Advanced Solid Tumors
• Interventions: Drug: SHR-9839 ；SHR-A2009; Drug: SHR-9839 ； pemetrexed ；carboplatin; Drug: SHR-9839 ； Almonertinib; Drug: SHR-9839 ； SHR-A1921

• Registration Number: NCT06474455
• Lead Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-05
• Study Start: 2024-06
• Study First Submitted: 2024-06-02
• Study First Submitted QC: 2024-06-19
• Last Update Submitted: 2024-06-19
• Study First Posted: 2024-06-25
• Last Update Posted: 2024-06-25
• Primary Completion: 2026-06
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 156

Inclusion Criteria

1. Aged 18-75 years old (inclusive), regardless of gender.
2. Patients with locally advanced or metastatic solid tumors confirmed by histology or cytology,.
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. Clinically uncontrollable the third space effusion.
5. Anti-tumor treatments such as chemotherapy within 4 weeks prior to the first dose of study drug.
6. Received > 30Gy 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SHR-9839 combined with SHR-A2009	SHR-9839 ；SHR-A2009	-
SHR-9839 combined with pemetrexed + carboplatin	SHR-9839 ； pemetrexed ；carboplatin	-
SHR-9839 combined with Almonertinib	SHR-9839 ； Almonertinib	-
SHR-9839 combined with SHR-A1921	SHR-9839 ； SHR-A1921	-

Primary Outcome Measures

Name	Time	Method
Incidence of dose-limiting toxicity (DLT) (phase IB)	21 days after the first dose was administered to each subject，Up to approximately 24 months.
Incidence and severity of adverse events (AE) and serious adverse events (SAE) and laboratory abnormalities (phase IB)	Begin from sign the ICF until the end of the safety follow-up period，Up to approximately 24 months.	Assess safety and tolerability of SHR-A2009 by way of adverse events (CTCAE v5.0)
Objective Response Rate (ORR) (phase II).	The first treatment lasted until disease progression，Up to approximately 24 months.	Evaluated using RECIST 1.1

Secondary Outcome Measures

Name	Time	Method
Incidence and severity of adverse events (AE) and serious adverse events (SAE) and laboratory abnormalities (phase II)	Begin from sign the ICF until the end of the safety follow-up period，Up to approximately 24 months.	Assess safety and tolerability of SHR-A2009 by way of adverse events (CTCAE v5.0)

Trial Locations

Locations (2)

HeNan CANCER HOSPITAL; 🇨🇳 Zhenzhou, Henan, China

Zhejiang Cancer Hospital; 🇨🇳 Zhejiang, HangZhou, China