Clinical trial NCT05276726: A Study of JAB-21822 in Advanced or Metastatic NSCLC With KRAS p.G12C and STK11 Co-mutation and Wild-type KEAP1
Official title: A Phase Ib/II ,Single Arm, Multi-Center, Open Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of JAB-21822 in Advanced or Metastatic Non-small Cell Lung Cancer With a KRAS p.G12C and STK11 Co-mutation and Wild-type KEAP1
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Non-small Cell Lung Cancer
Lead sponsor: Allist Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2022-03-11
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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..

Eligibility criteria: 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

Primary outcomes:
measure: Dose Escalation phase Number of participants with dose limiting toxicities (DLTs)
timeFrame: At the end of Cycle 1 (each cycle is 21 days)
measure: Dose Escalation phase: Number of participants with adverse events
timeFrame: Up to 3 years
measure: Dose Expansion phase: Objective response rate (ORR)
timeFrame: Up to 3 years - from baseline to confirmed Progressive Disease per RECIST.
Secondary outcomes:
measure: Dose Escalation phase: Objective response rate (ORR)
timeFrame: Up to 3 years - from baseline to RECIST confirmed Progressive Disease
measure: Dose Escalation and Dose Expansion phase: Progression-free survival (PFS)
timeFrame: Up to 3 years
measure: Dose Escalation and Dose Expansion phase: Duration of response (DOR)
timeFrame: Up to 3 years
measure: Dose Escalation and Dose Expansion phase: Disease Control Rate (DCR)
timeFrame: Up to 3 years
measure: Dose Escalation and Dose Expansion phase: Overall Survival (OS)
timeFrame: Up to 3 years
measure: Dose Escalation and Dose Expansion phase: Time to response (TTR)
timeFrame: Up to 3 years
measure: Dose Expansion phase: Number of participants with adverse events
timeFrame: Up to 3 years
measure: Dose Escalation and Dose Expansion phase: Plasma concentration (Cmax)
timeFrame: Up to 3 Years
measure: Dose Escalation and Dose Expansion phase: Time to achieve Cmax (Tmax)
timeFrame: Up to 3 Years
measure: Escalation and Dose Expansion phase：Area under the plasma concentration-time curve (AUC)
timeFrame: Up to 3 Years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Research site08
state: Beijing
city: Beijing
country: China
facility: Research site09
state: Beijing
city: Beijing
country: China
facility: Research site021
state: Beijing
city: Beijing
country: China
facility: Research site02
state: Beijing
city: Beijing
country: China
facility: Research site01
state: Beijing
city: Beijing
country: China
facility: Research site013
state: Beijing
city: Chongqing
country: China
facility: Research site010
state: Chongqing
city: Xiamen
country: China
facility: Research site05
state: Fujian
city: Shenzhen
country: China
facility: Research site011
state: Guangdong
city: Nanning
country: China
facility: Research site016
state: Guangxi
city: Shijiazhuang
country: China
facility: Research site017
state: Hebei
city: Ha'erbin
country: China
facility: Research site018
state: Heilongjiang
city: Zhengzhou
country: China
facility: Research site04
state: Henan
city: Changsha
country: China
facility: Research site012
state: Hunan
city: Changchun
country: China
facility: Research site015
state: Jilin
city: Shenyang
country: China
facility: Research site06
state: Liaoning
city: Shenyang
country: China
facility: Research site07
state: Liaoning
city: Hohhot
country: China
facility: Research site014
state: Neimenggu
city: Xi'an
country: China
facility: Research site020
state: Shanxi
city: Hubei
country: China
facility: Research site03
state: Wuhan
city: Hangzhou
country: China
facility: Research site019
state: Zhejiang
Study officials:
References: