NSCLC, Solid Tumor
Conditions
Keywords
KRAS p.G12C Mutant Advanced Solid Tumor; NSCLC
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.
Interventions
DRUGJAB-21822
JAB-21822 will be administered orally
Sponsors
Allist Pharmaceuticals, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Written informed consent 2. Advanced (metastatic or unresectable) KRAS p.G12C mutant solid tumors, with failure or absence of standard treatment 3. Subject must be ≥18 years 4. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1. 5. Subjects with life expectancy ≥3 months. 6. Subjects must have at least one measurable lesion as defined by RECIST v1.1. 7. There was no serious organ dysfunction in the screening stage 8. Male or female subjects of reproductive age agree to use adequate contraception
Exclusion criteria
1. History of intestinal disease or major gastric surgery or inability to swallow oral medications 2. Other active cancer 3. Previously treated with KRAS G12C inhibitor 4. Active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV) 5. Impaired heart function or clinically significant heart disease 6. Pregnant or breast-feeding 7. Previous allogeneic bone marrow transplant or organ transplant 8. Intended study subjects who were unable to abstain from alcohol during medication 9. Other unqualified conditions judged by the investigators
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of dose limiting toxicities (DLTs) in the dose escalation phase | first 21 days | Number of participants with dose limiting toxicities |
| 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 |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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 |
| 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 |
| Peak Plasma Concentration (Cmax) | up to 3 years | Cmax of JAB-21822 will be measured by using plasma PK samples |
Countries
China
Outcome results
None listed