This study is a multicenter,open-label,randomized, phase II clinical study conducted in China. The purpose of this study is to evaluate the efficacy of SKB315 plus PD-1 inhibitor ±capecitabine in patients with Unresectable Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
This study is a multicenter,open-label,randomized, phase II clinical study conducted in China. The purpose of this study is to evaluate the efficacy of SKB315 plus PD-1 inhibitor ±capecitabine in patients with Unresectable Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma This study will also evaluate efficacy, physical function, safety, and tolerability of SKB315 combination, as well as Pharmacokinetics (PK) of SKB315 and the immunogenicity profile of SKB315 will be evaluated as well.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Tislelizumab will be administered as the protocol described
Tislelizumab will be administered as the protocol described
Capecitabine will be taken orally as the protocol described
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Objective Response Rate (ORR)
The sum of the number of cases with Complete Response (CR) and Partial Response (PR) in all treated tumor patients (CR + PR) divided by the total number of cases.
Time frame: up to 2 years
Duration of Response (DOR)
Time from the start of the first assessment of CR or PR in tumor patients to PD or death due to any reason.
Time frame: up to 2 years
Progression Free Survival (PFS)
Time from start of treatment to progression of disease (PD) or death, whichever occurs first, in patients with tumors.
Time frame: up to 2 years
Overall Survival (OS)
Time from start of treatment to death due to any reason.
Time frame: up to 2 years
Safety and tolerability assessed by adverse events (AEs)
An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Time frame: Until 90 days after the end of treatment
Time to Response (TTR)
Time from the start of treatment to the first assessment of CR or PR in tumor patients.
Time frame: up to 2 years
Disease Control Rate (DCR)
Proportion of patients with best overall response of CR, PR, or SD and without PD or death due to any reason at the time of assessment in tumor patients.
Time frame: up to 2 years
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