A Study of JAB-21822 in Adult Patients With Advanced Solid Tumors Harboring KRAS p.G12C Mutation in China
- Registration Number
- NCT05009329
- Lead Sponsor
- Jacobio Pharmaceuticals Co., Ltd.
- Brief Summary
To assess safety, tolerability, PK, efficacy and determine recommended phase 2 dose (RP2D) of JAB-21822 (glecirasib) administered in adult participants with KRAS p.G12C-mutant advanced solid tumors.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 311
- Written informed consent
- Advanced (metastatic or unresectable) KRAS p.G12C mutant solid tumors, with failure or absence of standard treatment
- Subject must be ≥18 years
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
- Subjects with life expectancy ≥3 months.
- Subjects must have at least one measurable lesion as defined by RECIST v1.1.
- There was no serious organ dysfunction in the screening stage
- Male or female subjects of reproductive age agree to use adequate contraception
- History of intestinal disease or major gastric surgery or inability to swallow oral medications
- Other active cancer
- Previously treated with KRAS G12C inhibitor
- Active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV)
- Impaired heart function or clinically significant heart disease
- Pregnant or breast-feeding
- Previous allogeneic bone marrow transplant or organ transplant
- Intended study subjects who were unable to abstain from alcohol during medication
- Other unqualified conditions judged by the investigators
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Phase 1 Dose Exploration JAB-21822 Dose escalation of JAB-21822 to determine maximum tolerated dose. Phase IIa Dose Expansion JAB-21822 Patients with KRAS p.G12C mutant advanced non small cell lung cancer or other solid tumors will be enrolled and treated at the monotherapy RP2D to evaluate the safety and preliminary efficacy. Phase IIb JAB-21822 Patients with KRAS p.G12C mutant advanced non small cell lung cancer will be enrolled and treated at the monotherapy RP2D to evaluate the safety and efficacy.
- Primary Outcome Measures
Name Time Method Number of participants with adverse events up to 3 years Patients will be assessed for incidence and severity of adverse events (AEs) according to NCI-CTCAE criteria
Incidence of dose limiting toxicities (DLTs) in the dose escalation phase first 21 days Number of participants with dose limiting toxicities
Overall response rate (ORR) by IRC (independent review committee) up to 3 years ORR is defined as the proportion of participants with complete response and partial response (CR+PR) per RECIST v 1.1
- Secondary Outcome Measures
Name Time Method Overall response rate (ORR) by investigator up to 3 years ORR is defined as the proportion of participants with complete response and partial response (CR+PR) per RECIST v 1.1
Disease Control Rate ( DCR ) up to 3 years DCR is defined as percentage of participants with complete response (CR), partial response (PR), and stable disease(SD) per RECIST v1.1
Peak Plasma Concentration (Cmax) up to 3 years Cmax of JAB-21822 will be measured by using plasma PK samples
Duration of response ( DOR ) up to 3 years DOR is defined as the time from the participant's initial objective response (CR or PR) to study drug therapy, to disease progression or death due to any cause, whichever occurs first.
Progression-free survival (PFS) up to 3 years PFS is defined as the interval of time between the date of first treatment to the earliest date of disease progression or death per RECIST v1.1, which occurs first
Time to response (TTR) up to 3 years Time from patient randomization (first treatment) to first response per RECIST 1.1 criteria
Trial Locations
- Locations (1)
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, China
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