A Study of JAB-21822 in Patients With KRAS p.G12C Mutated Pancreatic Cancer

Pancreatic Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06008288
• Other study ID #: JAB-21822-2001
• Status: Recruiting
• Phase: Phase 2
• Start date: October 27, 2023
• Est. completion date: November 2025

Study information

• Verified date: March 2024
• 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

This study is to evaluate the efficacy and safety of JAB-21822 monotherapy in adult participants with KRAS G12C mutated pancreatic cancer

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 69
• Est. completion date: November 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• JAB-21822
800mg, orally QD with 21 days each cycle, treatment till disease progression or intolerable toxicity or withdraw for other reasons

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing
China	Beijing Tsinghua Changgung Hospital	Beijing	Beijing
China	Cancer Hospital Chinese Academy of Medical Sciences	Beijing	Beijing
China	Peking Union Medical College Hospital	Beijing	Beijing
China	Hunan Cancer Hospital	Changsha	Hunan
China	Hunan Provincial People's Hospital	Changsha	Hunan
China	West China Hospital of Sichuan University	Chengdu	Sichuan
China	Fujian Cancer Hospital	Fuzhou	Fujian
China	Sun Yat-sen Memorial Hospital, Sun Yat-sen University	Guangzhou	Guangdong
China	Sun Yat-Sen University Cancer Center	Guangzhou	Guangdong
China	The First Affiliated Hospital of Sun, Yat-sen University	Guangzhou	Guangdong
China	The First Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Zhejiang Provincial People's Hospital	Hangzhou	Zhejiang
China	Harbin Medical University Cancer Hospital	Harbin	Heilongjiang
China	Anhui Provincial Cancer Hospital	Hefei	Anhui
China	Shandong Cancer Hospital	Jinan	Shandong
China	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Jiangsu Cancer Hospital	Nanjing	Jiangsu
China	Jiangsu Province Hospital	Nanjing	Jiangsu
China	Guangxi Medical University Cancer Hospital	Nanning	Guangxi
China	Huashan Hospital, Fudan University	Shanghai	Shanghai
China	Shanghai Changhai Hospital	Shanghai	Shanghai
China	The First Hospital of China Medical University	Shenyang	Liaoning
China	Tianjin Medical University Cancer Institute&Hospital	Tianjin	Tianjin
China	Hubei Cancer Hospital	Wuhan	Hubei
China	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei
China	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shanxi
China	Henan Cancer Hospital	Zhengzhou	Henan
China	The First Affiliated Hospital of Zhengzhou University	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	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.	Approximately 1.5 years
Secondary	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.	Approximately 1.5 years
Secondary	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.	Approximately 1.5 years
Secondary	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.	Approximately 1.5 years
Secondary	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)	Approximately 1.5 years
Secondary	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).	Approximately 1.5 years
Secondary	Overall survival (OS)	OS is defined as time from date of the first dose to date of death due to any cause.	Approximately 2.0 years
Secondary	Number of participants with adverse events	Participants will be assessed for incidence and severity of AEs according to NCI-CTCAE 5.0 criteria	Approximately 1.5 years