Non-small Cell Lung Cancer
Conditions
Brief summary
Evaluate the safety and tolerability, drug levels, and clinical activity of JAB-21822 in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors with KRAS p.G12C mutation and a serine/threonine kinase 11 (STK11) co-mutation.
Detailed description
The primary objective of this study is to evaluate the safety and tolerability of JAB-21822 during Dose Escalation phase and preliminary antitumor activity in patients with NSCLC with concurrent KRAS G12C mutant and STK11 mutant and KEAP wild type either treatment naïve or at least one line prior therapy for advance disease during the expansion phase..
Interventions
DRUGJAB 21822
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. Pathologically documented, locally-advanced or metastatic NSCLC with KRAS p.G12C mutation identified through molecular testing. 2. STK11 co-mutation and KEAP1 Wild-Type (local confirmation) 3. Treatment naïve or have received at least 1 prior standard therapy for advanced NSCLC 4. ECOG 0-1
Exclusion criteria
1. Has CNS metastases or carcinomatous meningitis, except treated CNS metastases with no evidence of radiographic progression or hemorrhage for at least 28 days 2. Any severe and/or uncontrolled medical conditions 3. Active infection requiring systemic treatment within 7 days 4. Therapeutic radiation therapy within 3 weeks of study day 1
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose Escalation phase Number of participants with dose limiting toxicities (DLTs) | At the end of Cycle 1 (each cycle is 21 days) | A DLT is defined as the clinically significant treatment-related adverse event or abnormal laboratory values assessment during the first 21 days of Cycle 1. It excludes adverse events (AEs) that are deemed clearly related to underlying disease, progression, or intercurrent illness. |
| Dose Escalation phase: Number of participants with adverse events | Up to 3 years | Patients will be assessed for incidence and severity of AEs according to NCI-CTCAE 5.0 criteria |
| Dose Expansion phase: Objective response rate (ORR) | Up to 3 years - from baseline to confirmed Progressive Disease per RECIST. | ORR is defined as the percentage of participants with complete response (CR) or partial response (PR) per RECIST v 1.1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dose Escalation and Dose Expansion phase: 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 disease progression per RECIST v1.1 or death due to any cause, whichever occurs first. |
| Dose Escalation and Dose Expansion phase: Disease Control Rate (DCR) | Up to 3 years | DCR is defined as percentage of participants with complete response (CR), partial response (PR), or stable disease (SD) per RECIST v1.1 |
| Dose Escalation and Dose Expansion phase: Overall Survival (OS) | Up to 3 years | Defined as time from first treatment to death by any cause |
| Dose Escalation and Dose Expansion phase: Time to response (TTR) | Up to 3 years | Defined as time from first treatment to first evidence of PR or CR |
| Dose Expansion phase: 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 |
| Dose Escalation and Dose Expansion phase: Plasma concentration (Cmax) | Up to 3 Years | Cmax of JAB-21822 will be measured by using plasma PK samples |
| Escalation and Dose Expansion phase：Area under the plasma concentration-time curve (AUC) | Up to 3 Years | AUC of JAB-21822 will be measured by using plasma PK samples |
| Dose Escalation and Dose Expansion phase: Time to achieve Cmax (Tmax) | Up to 3 Years | Tmax of JAB-21822 will be measured by using plasma PK samples |
| Dose Escalation phase: Objective response rate (ORR) | Up to 3 years - from baseline to RECIST confirmed Progressive Disease | ORR is defined as the percentage of participants with complete response (CR) or partial response (PR) per RECIST v 1.1 |
| Dose Escalation and Dose Expansion phase: 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 per RECIST1.1 or death whichever occurs first |
Countries
China
Contacts
CONTACTShanghai Allist Pharmaceuticals Co., Ltd Shanghai Allist Pharmaceuticals Co., Ltd
CONTACTWang Jie Wang Jie M.D.
Outcome results
None listed