This is a multicenter, open-label phase 1/2a study consisting of two parts: dose escalation phase and dose expansion phase. The objective of the dose escalation phase is to evaluate the safety, tolerability and pharmacokinetics of JAB-21822 in combination with JAB-3312 in patients with advanced solid tumors harboring KRAS p.G12C mutation and to determine the RP2D for the combination therapy. In the dose expansion phase, preliminary efficacy and safety of the combination therapy at the RP2D will be further explored in patients with specific cancer harboring KRAS p.G12C mutation.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
240
The First Affiliated Hospital of USTC Anhui Provincial Hospital
Hefei, Anhui, China
NOT_YET_RECRUITINGPecking Union Medical College Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGCancer Hospital Chinese Academy Of Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGBeijing Tiantan Hospital, Captal Medical University
Beijing, Beijing Municipality, China
recommended phase-2 dose (RP2D).
RP2D should be selected based on a comprehensive assessment of maximum tolerated dose(MTD), toxicity, pharmacokinetic(PK) profile, and efficacy data.
Time frame: Approximately 2 years
Number of participants with dose limiting toxicities
Dose-limiting toxicity (DLT) is defined as an adverse event (AE) or clinically significant abnormal laboratory value occurring in Cycle 1 (DLT assessment period), which is unrelated to progressive disease, concurrent disease, or concomitant medication but related to JAB-21822 and/or JAB-3312, and meets the criteria for DLT.
Time frame: Approximately 2 years
Number of participants with AEs
All patients participating in this study will be assessed for incidence and severity of AEs and serious AEs, including changes in laboratory values, vital signs, electrocardiograms, cardiac imagings and ophthalmological assessments
Time frame: Approximately 2 years
Objective response rate (ORR)
ORR is defined as the proportion of participants with confirmed complete response or partial response
Time frame: Approximately 2 years
Progression-free survival (PFS)
Period of time from the start of treatment to tumor progression or death from any cause (whichever occurs first) based on RECIST v1.1
Time frame: Approximately 2 years
Shanghai Allist Pharmaceuticals Co., Ltd Shanghai Allist Pharmaceuticals Co., Ltd
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Beijing Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGPeking University Third Hospital
Beijing, Beijing Municipality, China
RECRUITINGBeijing Chest Hospital, Capital Medical University
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGFujian cancer Hospital
Fuzhou, Fujian, China
NOT_YET_RECRUITINGThe First Affiliated Hospital Xiamen University
Xiamen, Fujian, China
NOT_YET_RECRUITINGThe first Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
NOT_YET_RECRUITING...and 17 more locations