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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
156
SHR-9839 for injection.
SHR-A1921 for injection.
SHR-A2009 for injection.
Henan Cancer Hospital
Zhengzhou, Henan, China
RECRUITINGZhejiang Cancer Hospital
Hangzhou, Zhejiang, China
RECRUITINGIncidence 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 (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).
Time frame: 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.
Time frame: The first treatment lasted until disease progression, up to approximately 24 months.
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).
Time frame: Begin from sign the ICF until the end of the safety follow-up period, up to approximately 24 months.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Almonertinib Mesilate Tablets.
Pemetrexed Disodium for Injection.
Carboplatin for injection.
Paclitaxel injection.
SHR-1316 injection.
SHR-9839 for Injection (sc).