A Study of JAB-21822 in Advanced or Metastatic NSCLC With KRAS p.G12C and STK11 Co-mutation and Wild-type KEAP1

Non-small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05276726
• Other study ID #: JAB-21822-1003
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: August 17, 2022
• Est. completion date: February 2026

Study information

• Verified date: September 2022
• Source: Jacobio Pharmaceuticals Co., Ltd.
• Contact: Jacobio Pharmaceuticals
• Phone: 86 10 56315466
• Email: clinicaltrials[@]jacobiopharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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..

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 104
• Est. completion date: February 2026
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• JAB 21822
Administered orally

Locations

Country	Name	City	State
China	Research site01	Beijing	Beijing
China	Research site013	Beijing	Beijing
China	Research site02	Beijing	Beijing
China	Research site021	Beijing	Beijing
China	Research site08	Beijing	Beijing
China	Research site09	Beijing	Beijing
China	Research site015	Changchun	Jilin
China	Research site012	Changsha	Hunan
China	Research site010	Chongqing	Chongqing
China	Research site018	Ha'erbin	Heilongjiang
China	Research site019	Hangzhou	Zhejiang
China	Research site014	Hohhot	Neimenggu
China	Research site03	Hubei	Wuhan
China	Research site016	Nanning	Guangxi
China	Research site06	Shenyang	Liaoning
China	Research site07	Shenyang	Liaoning
China	Research site011	Shenzhen	Guangdong
China	Research site017	Shijiazhuang	Hebei
China	Research site020	Xi'an	Shanxi
China	Research site05	Xiamen	Fujian
China	Research site04	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Jacobio Pharmaceuticals Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose Escalation phase Number of participants with dose limiting toxicities (DLTs)	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.	At the end of Cycle 1 (each cycle is 21 days)
Primary	Dose Escalation phase: Number of participants with adverse events	Patients will be assessed for incidence and severity of AEs according to NCI-CTCAE 5.0 criteria	Up to 3 years
Primary	Dose Expansion phase: Objective response rate (ORR)	ORR is defined as the percentage of participants with complete response (CR) or partial response (PR) per RECIST v 1.1	Up to 3 years - from baseline to confirmed Progressive Disease per RECIST.
Secondary	Dose Escalation phase: Objective response rate (ORR)	ORR is defined as the percentage of participants with complete response (CR) or partial response (PR) per RECIST v 1.1	Up to 3 years - from baseline to RECIST confirmed Progressive Disease
Secondary	Dose Escalation and Dose Expansion phase: Progression-free survival (PFS)	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	Up to 3 years
Secondary	Dose Escalation and Dose Expansion phase: Duration of response (DOR)	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.	Up to 3 years
Secondary	Dose Escalation and Dose Expansion phase: Disease Control Rate (DCR)	DCR is defined as percentage of participants with complete response (CR), partial response (PR), or stable disease (SD) per RECIST v1.1	Up to 3 years
Secondary	Dose Escalation and Dose Expansion phase: Overall Survival (OS)	Defined as time from first treatment to death by any cause	Up to 3 years
Secondary	Dose Escalation and Dose Expansion phase: Time to response (TTR)	Defined as time from first treatment to first evidence of PR or CR	Up to 3 years
Secondary	Dose Expansion phase: Number of participants with adverse events	Patients will be assessed for incidence and severity of adverse events (AEs) according to NCI-CTCAE criteria	Up to 3 years
Secondary	Dose Escalation and Dose Expansion phase: Plasma concentration (Cmax)	Cmax of JAB-21822 will be measured by using plasma PK samples	Up to 3 Years
Secondary	Dose Escalation and Dose Expansion phase: Time to achieve Cmax (Tmax)	Tmax of JAB-21822 will be measured by using plasma PK samples	Up to 3 Years
Secondary	Escalation and Dose Expansion phase:Area under the plasma concentration-time curve (AUC)	AUC of JAB-21822 will be measured by using plasma PK samples	Up to 3 Years