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
Overview
- Phase
- Phase 1
- Intervention
- SHR-9839 ； pemetrexed ；carboplatin
- Conditions
- Advanced Solid Tumors
- Sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.
- Enrollment
- 156
- Locations
- 2
- Primary Endpoint
- Incidence of dose-limiting toxicity (DLT) (phase IB)
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Aged 18-75 years old (inclusive), regardless of gender.
- •Patients with locally advanced or metastatic solid tumors confirmed by histology or cytology,.
- •At least one measurable tumor lesion according to RECIST v1.
- •ECOG performance score of 0-
- •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.
Exclusion Criteria
- •Patients with active central nervous system ( CNS ) metastases.
- •Spinal cord compression not be cured by surgery or radiotherapy.
- •Subjects with uncontrollable tumor-related pain.
- •Clinically uncontrollable the third space effusion.
- •Anti-tumor treatments such as chemotherapy within 4 weeks prior to the first dose of study drug.
- •Received \> 30Gy 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.
Arms & Interventions
SHR-9839 combined with pemetrexed + carboplatin
Intervention: SHR-9839 ； pemetrexed ；carboplatin
SHR-9839 combined with Almonertinib
Intervention: SHR-9839 ； Almonertinib
SHR-9839 combined with SHR-A1921
Intervention: SHR-9839 ； SHR-A1921
SHR-9839 combined with SHR-A2009
Intervention: SHR-9839 ；SHR-A2009
Outcomes
Primary Outcomes
Incidence of dose-limiting toxicity (DLT) (phase IB)
Time Frame: 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)
Time Frame: 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).
Time Frame: The first treatment lasted until disease progression，Up to approximately 24 months.
Evaluated using RECIST 1.1
Secondary Outcomes
- 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.)