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
1 other identifier
interventional
156
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 2024
Longer than P75 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 2, 2024
CompletedFirst Posted
Study publicly available on registry
June 25, 2024
CompletedStudy Start
First participant enrolled
July 2, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2029
May 11, 2026
May 1, 2026
4.9 years
June 2, 2024
May 5, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (1)
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.
Study Arms (7)
SHR-9839 combined with SHR-A2009
EXPERIMENTALSHR-9839 combined with SHR-A1921
EXPERIMENTALSHR-9839 combined with Pemetrexed + Carboplatin
EXPERIMENTALSHR-9839 combined with Almonertinib
EXPERIMENTALSHR-9839(sc) + SHR-1316
EXPERIMENTALSHR-1316 + Platinum-based chemotherapy ± SHR-9839(sc)
EXPERIMENTALSHR-9839 (sc) + SHR-1316 + Platinum-based chemotherapy
EXPERIMENTALInterventions
SHR-1316 injection.
SHR-9839 for injection.
Pemetrexed Disodium for Injection.
Carboplatin for injection.
Paclitaxel injection.
SHR-9839 for Injection (sc).
Eligibility Criteria
You may qualify if:
- Aged 18-75 years old (inclusive), regardless of gender.
- Part A: Patients with locally advanced or metastatic solid tumors confirmed by histology or cytology; Part B: Squamous non-small cell lung cancer.
- At least one measurable tumor lesion according to RECIST v1.1.
- ECOG performance score of 0-1.
- Life expectancy ≥ 12 weeks.
- Adequate bone marrow and organ function.
- 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.
You may not qualify if:
- Patients with active central nervous system ( CNS ) metastases.
- Spinal cord compression not be cured by surgery or radiotherapy.
- Subjects with uncontrollable tumor-related pain.
- Moderate and severe ascites with clinical symptoms; Uncontrollable or moderate and above pleural effusion, pericardial effusion.
- Anti-tumor treatments such as chemotherapy within 4 weeks prior to the first dose of study drug.
- Received \> 30 Gy chest radiotherapy within 24 weeks prior to the first dose of study drug.
- Major organ surgery or significant trauma within 4 weeks prior to the first dose of study drug.
- Concomitant other malignancies ≤ 3 years prior to the first dose of study drug.
- 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.
- Serious cardiovascular and cerebrovascular diseases.
- Patients with clinically significant bleeding symptoms within 3 months prior to the first dose of study drug.
- History of immunodeficiency, including HIV test positive.
- Active hepatitis B or hepatitis C infection.
- History of severe allergic reactions to any component of any study drug to be accepted.
- Known history of alcohol or drug dependence.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Henan Cancer Hospital
Zhengzhou, Henan, 450003, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310005, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2024
First Posted
June 25, 2024
Study Start
July 2, 2024
Primary Completion (Estimated)
June 1, 2029
Study Completion (Estimated)
December 1, 2029
Last Updated
May 11, 2026
Record last verified: 2026-05