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

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Drug: Pemetrexed Disodium for Injection; Drug: SHR-1316 Injection; Drug: Paclitaxel injection; Drug: SHR-9839 for Injection; Drug: SHR-A2009 for Injection; Drug: SHR-A1921 for Injection; Drug: Carboplatin for injection; Drug: Almonertinib Mesilate Tablets; Drug: SHR-9839 for Injection (sc)

• Study Type: Interventional
• Enrollment (Estimated): 156
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Qingkai Zhou; Phone Number: +8618205139261; Email: Qingkai.zhou@hengrui.com

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450003
      • Recruiting
      • Henan Cancer Hospital
      • Principal Investigator: Qiming Wang
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310005
      • Recruiting
      • Zhejiang Cancer Hospital
      • Principal Investigator: Zhengbo Song

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SHR-9839 combined with SHR-A2009	Drug: SHR-9839 for Injection; SHR-9839 for injection.; Drug: SHR-A2009 for Injection; SHR-A2009 for injection.
Experimental: SHR-9839 combined with SHR-A1921	Drug: SHR-9839 for Injection; SHR-9839 for injection.; Drug: SHR-A1921 for Injection; SHR-A1921 for injection.
Experimental: SHR-9839 combined with Almonertinib	Drug: SHR-9839 for Injection; SHR-9839 for injection.; Drug: Almonertinib Mesilate Tablets; Almonertinib Mesilate Tablets.
Experimental: SHR-9839 combined with Pemetrexed + Carboplatin	Drug: Pemetrexed Disodium for Injection; Pemetrexed Disodium for Injection.; Drug: SHR-9839 for Injection; SHR-9839 for injection.; Drug: Carboplatin for injection; Carboplatin for injection.
Experimental: SHR-9839(sc) + SHR-1316	Drug: SHR-1316 Injection; SHR-1316 injection.; Drug: SHR-9839 for Injection (sc); SHR-9839 for Injection (sc).
Experimental: SHR-1316 + Platinum-based chemotherapy ± SHR-9839(sc)	Drug: SHR-1316 Injection; SHR-1316 injection.; Drug: Paclitaxel injection; Paclitaxel injection.; Drug: SHR-9839 for Injection (sc); SHR-9839 for Injection (sc).
Experimental: SHR-9839 (sc) + SHR-1316 + Platinum-based chemotherapy	Drug: SHR-1316 Injection; SHR-1316 injection.; Drug: Paclitaxel injection; Paclitaxel injection.; Drug: SHR-9839 for Injection (sc); SHR-9839 for Injection (sc).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 (AEs) and serious adverse events (SAEs) and laboratory abnormalities (phase IB)	Assess safety and tolerability of SHR-A2009 by way of adverse events (CTCAE v5.0).	Begin from sign the ICF until the end of the safety follow-up period, up to approximately 24 months.
Objective Response Rate (ORR) (phase II).	Evaluated using RECIST 1.1.	The first treatment lasted until disease progression, up to approximately 24 months.

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2024
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: June 2, 2024
• First Submitted That Met QC Criteria: June 19, 2024
• First Posted (Actual): June 25, 2024

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Amino Acids, Peptides, and Proteins; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Therapeutics; Drug Administration Routes; Drug Therapy; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Coordination Complexes; Guanine; Hypoxanthines; Purinones; Purines; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic; Taxoids; Cyclodecanes; Diterpenes; Pemetrexed; Carboplatin; Paclitaxel; Injections
• Other Study ID Numbers: SHR-9839-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No