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

Primary Purpose

Non-small Cell Lung Cancer

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
JAB 21822
Sponsored by
Jacobio Pharmaceuticals Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Research site08
  • Research site09
  • Research site021
  • Research site02
  • Research site01Recruiting
  • Research site013
  • Research site010
  • Research site05
  • Research site011
  • Research site016
  • Research site017
  • Research site018
  • Research site04
  • Research site012
  • Research site015
  • Research site06
  • Research site07
  • Research site014
  • Research site020
  • Research site03
  • Research site019

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Phase 1 ,Dose Exploration ,monotherapy

Phase 2, Dose Expansion, Part1 monotherapy

Phase 2 Dose Expansion, Part 2 monotherapy

Arm Description

Dose escalation of JAB21822 will be administered as monotherapy to determine the MTD and RP2D

Part 1 dose expansion is to evaluate the safety and clinical activity of JAB-21822 at RP2D in subjects with previously untreated advanced non-small cell lung cancer (NSCLC)

Part 2 dose expansion is to evaluate the safety and clinical activity of JAB-21822 at RP2D in subjects who had received at least one previous line of systemic therapy for NSCLC

Outcomes

Primary Outcome Measures

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.
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
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

Secondary Outcome Measures

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
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
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.
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
Dose Escalation and Dose Expansion phase: Overall Survival (OS)
Defined as time from first treatment to death by any cause
Dose Escalation and Dose Expansion phase: Time to response (TTR)
Defined as time from first treatment to first evidence of PR or CR
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
Dose Escalation and Dose Expansion phase: Plasma concentration (Cmax)
Cmax of JAB-21822 will be measured by using plasma PK samples
Dose Escalation and Dose Expansion phase: Time to achieve Cmax (Tmax)
Tmax of JAB-21822 will be measured by using plasma PK samples
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

Full Information

First Posted
March 3, 2022
Last Updated
September 26, 2022
Sponsor
Jacobio Pharmaceuticals Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05276726
Brief Title
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

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 17, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
February 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jacobio Pharmaceuticals Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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..

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
104 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Phase 1 ,Dose Exploration ,monotherapy
Arm Type
Experimental
Arm Description
Dose escalation of JAB21822 will be administered as monotherapy to determine the MTD and RP2D
Arm Title
Phase 2, Dose Expansion, Part1 monotherapy
Arm Type
Experimental
Arm Description
Part 1 dose expansion is to evaluate the safety and clinical activity of JAB-21822 at RP2D in subjects with previously untreated advanced non-small cell lung cancer (NSCLC)
Arm Title
Phase 2 Dose Expansion, Part 2 monotherapy
Arm Type
Experimental
Arm Description
Part 2 dose expansion is to evaluate the safety and clinical activity of JAB-21822 at RP2D in subjects who had received at least one previous line of systemic therapy for NSCLC
Intervention Type
Drug
Intervention Name(s)
JAB 21822
Intervention Description
Administered orally
Primary Outcome Measure Information:
Title
Dose Escalation phase Number of participants with dose limiting toxicities (DLTs)
Description
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.
Time Frame
At the end of Cycle 1 (each cycle is 21 days)
Title
Dose Escalation phase: Number of participants with adverse events
Description
Patients will be assessed for incidence and severity of AEs according to NCI-CTCAE 5.0 criteria
Time Frame
Up to 3 years
Title
Dose Expansion phase: Objective response rate (ORR)
Description
ORR is defined as the percentage of participants with complete response (CR) or partial response (PR) per RECIST v 1.1
Time Frame
Up to 3 years - from baseline to confirmed Progressive Disease per RECIST.
Secondary Outcome Measure Information:
Title
Dose Escalation phase: Objective response rate (ORR)
Description
ORR is defined as the percentage of participants with complete response (CR) or partial response (PR) per RECIST v 1.1
Time Frame
Up to 3 years - from baseline to RECIST confirmed Progressive Disease
Title
Dose Escalation and Dose Expansion phase: Progression-free survival (PFS)
Description
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
Time Frame
Up to 3 years
Title
Dose Escalation and Dose Expansion phase: Duration of response (DOR)
Description
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.
Time Frame
Up to 3 years
Title
Dose Escalation and Dose Expansion phase: Disease Control Rate (DCR)
Description
DCR is defined as percentage of participants with complete response (CR), partial response (PR), or stable disease (SD) per RECIST v1.1
Time Frame
Up to 3 years
Title
Dose Escalation and Dose Expansion phase: Overall Survival (OS)
Description
Defined as time from first treatment to death by any cause
Time Frame
Up to 3 years
Title
Dose Escalation and Dose Expansion phase: Time to response (TTR)
Description
Defined as time from first treatment to first evidence of PR or CR
Time Frame
Up to 3 years
Title
Dose Expansion phase: Number of participants with adverse events
Description
Patients will be assessed for incidence and severity of adverse events (AEs) according to NCI-CTCAE criteria
Time Frame
Up to 3 years
Title
Dose Escalation and Dose Expansion phase: Plasma concentration (Cmax)
Description
Cmax of JAB-21822 will be measured by using plasma PK samples
Time Frame
Up to 3 Years
Title
Dose Escalation and Dose Expansion phase: Time to achieve Cmax (Tmax)
Description
Tmax of JAB-21822 will be measured by using plasma PK samples
Time Frame
Up to 3 Years
Title
Escalation and Dose Expansion phase：Area under the plasma concentration-time curve (AUC)
Description
AUC of JAB-21822 will be measured by using plasma PK samples
Time Frame
Up to 3 Years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pathologically documented, locally-advanced or metastatic NSCLC with KRAS p.G12C mutation identified through molecular testing. STK11 co-mutation and KEAP1 Wild-Type (local confirmation) Treatment naïve or have received at least 1 prior standard therapy for advanced NSCLC ECOG 0-1 Exclusion Criteria: Has CNS metastases or carcinomatous meningitis, except treated CNS metastases with no evidence of radiographic progression or hemorrhage for at least 28 days Any severe and/or uncontrolled medical conditions Active infection requiring systemic treatment within 7 days Therapeutic radiation therapy within 3 weeks of study day 1
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jacobio Pharmaceuticals
Phone
86 10 56315466
Email
clinicaltrials@jacobiopharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacobio Pharmaceuticals
Organizational Affiliation
Jacobio Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Research site08
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100010
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research site09
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100010
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research site021
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100032
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research site02
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100089
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research site01
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100101
Country
China
Individual Site Status
Recruiting
Facility Name
Research site013
City
Beijing
State/Province
Beijing
ZIP/Postal Code
101100
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research site010
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400000
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research site05
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361000
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research site011
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518000
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research site016
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530000
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research site017
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research site018
City
Ha'erbin
State/Province
Heilongjiang
ZIP/Postal Code
150000
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research site04
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450000
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research site012
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410000
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research site015
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130000
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research site06
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110000
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research site07
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110000
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research site014
City
Hohhot
State/Province
Neimenggu
ZIP/Postal Code
010000
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research site020
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710000
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research site03
City
Hubei
State/Province
Wuhan
ZIP/Postal Code
430060
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research site019
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Not yet recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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