Back to resultsA Study of JAB-21822 in Patients With KRAS p.G12C Mutated Pancreatic Cancer
Primary Purpose
KRAS P.G12C, Pancreatic Cancer
Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
JAB-21822
Sponsored by
About this trial
This is an interventional treatment trial for KRAS P.G12C
Eligibility Criteria
Inclusion Criteria: Histopathologically or cytologically confirmed pancreatic cancer with KRAS p.G12C mutation identified through molecular testing. Previously progressed on or after gemcitabine-based and/or FOFIRINOX/mFOFIRINOX chemotherapy, no more than 3 lines of prior systemic therapies. Participants with disease recurrence during or within 6 months after adjuvant therapy can be included. Participants with MSI-H/dMMR must experience anti-PD-1 therapy. Exclusion Criteria: Previously received a KRAS G12C inhibitor. History of interstitial lung disease, non-infectious pneumonia, or uncontrolled lung disease (including pulmonary fibrosis, acute lung disease, etc.). Uncontrolled pleural effusion, pericardial effusion, or ascites. Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms calculated from 3 electrocardiograms. Use of a drug with known risk of torsades de points (TdP) within 14 days prior to the first dose. Cannot discontinue a proton pump inhibitor (PPI) or H2 receptor blocker within 3 days or 5 half-lives (whichever is longer) prior to the first dose.
Sites / Locations
- Beijing Cancer Hospital
- Peking Union Medical College Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
JAB-21822
Arm Description
Monotherapy
Outcomes
Primary Outcome Measures
Objective response rate (ORR) by independent central radiological review (IRC) according to RECIST 1.1.
ORR is defined as the proportion of participants with confirmed complete response or partial response by IRC according to RECIST 1.1.
Secondary Outcome Measures
Duration of response (DOR)
DOR is defined as the time from date of the first objective tumor response (CR or PR) to the first documentation of either Progression of Disease (PD) or death due to any cause, whichever occurs first.
Time to response (TTR) by IRC according to RECIST 1.1
TTR is defined as the duration of time between the date of the first dose and the date of first documented response of either CR or PR.
Progression-free survival (PFS) by IRC according to RECIST 1.1
PFS is defined as time from the first dose until disease progression or death from any cause, whichever occurs first.
Disease control rate (DCR) by IRC according to RECIST 1.1
DCR is defined as the proportion of participants with BOR of CR or PR or stable disease (SD)
CA19-9 response rate
CA19-9 response rate is defined as the proportion of participants with CA19-9 response (achieving ≥50% decrease in CA19-9 serum levels).
Overall survival (OS)
OS is defined as time from date of the first dose to date of death due to any cause.
Number of participants with adverse events
Participants will be assessed for incidence and severity of AEs according to NCI-CTCAE 5.0 criteria
Full Information
NCT ID
NCT06008288
First Posted
August 18, 2023
Last Updated
August 18, 2023
Sponsor
Jacobio Pharmaceuticals Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT06008288
Brief Title
A Study of JAB-21822 in Patients With KRAS p.G12C Mutated Pancreatic Cancer
Official Title
A Phase 2, Multi-Center, Open-Label, Single-arm Study to Evaluate the Efficacy and Safety of JAB-21822 Monotherapy in Patients With Locally Advanced or Metastatic KRAS p.G12C Mutated Pancreatic Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
November 2025 (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
This study is to evaluate the efficacy and safety of JAB-21822 monotherapy in adult participants with KRAS G12C mutated pancreatic cancer
Detailed Description
This is a single-arm, open-label, multicenter phase 2 study to evaluate the efficacy and safety of JAB-21822 monotherapy in adult participants with advanced KRAS p.G12C mutated pancreatic cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
KRAS P.G12C, Pancreatic Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
69 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
JAB-21822
Arm Type
Experimental
Arm Description
Monotherapy
Intervention Type
Drug
Intervention Name(s)
JAB-21822
Other Intervention Name(s)
Glecirasib
Intervention Description
800mg, orally QD with 21 days each cycle, treatment till disease progression or intolerable toxicity or withdraw for other reasons
Primary Outcome Measure Information:
Title
Objective response rate (ORR) by independent central radiological review (IRC) according to RECIST 1.1.
Description
ORR is defined as the proportion of participants with confirmed complete response or partial response by IRC according to RECIST 1.1.
Time Frame
Approximately 1.5 years
Secondary Outcome Measure Information:
Title
Duration of response (DOR)
Description
DOR is defined as the time from date of the first objective tumor response (CR or PR) to the first documentation of either Progression of Disease (PD) or death due to any cause, whichever occurs first.
Time Frame
Approximately 1.5 years
Title
Time to response (TTR) by IRC according to RECIST 1.1
Description
TTR is defined as the duration of time between the date of the first dose and the date of first documented response of either CR or PR.
Time Frame
Approximately 1.5 years
Title
Progression-free survival (PFS) by IRC according to RECIST 1.1
Description
PFS is defined as time from the first dose until disease progression or death from any cause, whichever occurs first.
Time Frame
Approximately 1.5 years
Title
Disease control rate (DCR) by IRC according to RECIST 1.1
Description
DCR is defined as the proportion of participants with BOR of CR or PR or stable disease (SD)
Time Frame
Approximately 1.5 years
Title
CA19-9 response rate
Description
CA19-9 response rate is defined as the proportion of participants with CA19-9 response (achieving ≥50% decrease in CA19-9 serum levels).
Time Frame
Approximately 1.5 years
Title
Overall survival (OS)
Description
OS is defined as time from date of the first dose to date of death due to any cause.
Time Frame
Approximately 2.0 years
Title
Number of participants with adverse events
Description
Participants will be assessed for incidence and severity of AEs according to NCI-CTCAE 5.0 criteria
Time Frame
Approximately 1.5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histopathologically or cytologically confirmed pancreatic cancer with KRAS p.G12C mutation identified through molecular testing.
Previously progressed on or after gemcitabine-based and/or FOFIRINOX/mFOFIRINOX chemotherapy, no more than 3 lines of prior systemic therapies. Participants with disease recurrence during or within 6 months after adjuvant therapy can be included.
Participants with MSI-H/dMMR must experience anti-PD-1 therapy.
Exclusion Criteria:
Previously received a KRAS G12C inhibitor.
History of interstitial lung disease, non-infectious pneumonia, or uncontrolled lung disease (including pulmonary fibrosis, acute lung disease, etc.).
Uncontrolled pleural effusion, pericardial effusion, or ascites.
Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms calculated from 3 electrocardiograms.
Use of a drug with known risk of torsades de points (TdP) within 14 days prior to the first dose.
Cannot discontinue a proton pump inhibitor (PPI) or H2 receptor blocker within 3 days or 5 half-lives (whichever is longer) prior to the first dose.
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
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
12. IPD Sharing Statement
Learn more about this trial
A Study of JAB-21822 in Patients With KRAS p.G12C Mutated Pancreatic Cancer
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