Actively Recruiting

Phase 2
Age: 18Years +
All Genders
ID06008288

Study of JAB-21822 Monotherapy in Advanced Pancreatic Cancer and Other Solid Tumors with KRAS p.G12C Mutation An Open-label Phase II Clinical Trial

Led by Allist Pharmaceuticals, Inc. · Updated on 2026-03-13

88

Participants Needed

31

Research Sites

218 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research investigates the use of JAB-21822 (Glecirasib) as a treatment for adult patients with locally advanced or metastatic solid tumors that have the KRAS p.G12C mutation. The trial focuses on patients with pancreatic cancer who have not responded to or cannot tolerate specific chemotherapy regimens, as well as patients with other advanced solid tumors excluding non-small cell lung cancer and colorectal cancer. The study aims to evaluate the effectiveness and safety of this drug in these groups. Participants receive JAB-21822 orally at a dose of 800 mg once daily in 21-day cycles. Treatment continues until the disease progresses, intolerable side effects occur, or participants choose to withdraw. This is a single-arm, open-label phase II trial conducted at multiple centers, meaning all participants receive the same experimental treatment without a comparison group. Throughout the trial, researchers monitor participants for their response to treatment using imaging reviewed by an independent radiology committee over approximately 1.5 years. They track the objective response rate, safety, and tolerability. The study includes regular assessments and follows patients until disease progression or other reasons for stopping treatment, aiming to gather detailed information on how well the drug works and its side effects.

CONDITIONS

Official Title

A Phase II Study Evaluating JAB-21822 Monotherapy in Adult Patients With Pancreatic Cancer and Other Solid Tumors Harboring the KRAS p.G12C Mutation.

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Confirmed KRAS p.G12C mutation using validated diagnostic tests
  • Locally advanced, unresectable, or metastatic solid tumors excluding NSCLC and CRC
  • For pancreatic cancer, prior progression or intolerance to gemcitabine-based chemotherapy or FOLFIRINOX/mFOLFIRINOX/NALIRIFOX
  • For other solid tumors, progression or intolerance to prior systemic therapies with no satisfactory alternatives
Not Eligible

You will not qualify if you...

  • Previous treatment with any KRAS G12C inhibitor
  • History of interstitial lung disease, non-infectious pneumonia, or uncontrolled lung disease with symptoms
  • Uncontrolled pleural effusion, pericardial effusion, or ascites
  • QTcF interval of 470 ms or longer based on three electrocardiograms
  • Use of drugs with known risk of torsades de points within 14 days before first dose

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 31 locations

1

Anhui Provincial Cancer Hospital

Hefei, Anhui, China

Actively Recruiting

2

Beijing Cancer Hospital

Beijing, Beijing Municipality, China, 100142

Actively Recruiting

3

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China, 100730

Actively Recruiting

4

Beijing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, China

Actively Recruiting

5

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Actively Recruiting

6

Fujian Cancer Hospital

Fuzhou, Fujian, China

Actively Recruiting

7

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Actively Recruiting

8

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, China

Actively Recruiting

9

The First Affiliated Hospital of Sun, Yat-sen University

Guangzhou, Guangdong, China

Actively Recruiting

10

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, China

Actively Recruiting

11

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Actively Recruiting

12

Henan Cancer Hospital

Zhengzhou, Henan, China

Actively Recruiting

13

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Actively Recruiting

14

Hubei Cancer Hospital

Wuhan, Hubei, China

Actively Recruiting

15

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Actively Recruiting

16

Hunan Cancer Hospital

Changsha, Hunan, China

Actively Recruiting

17

Hunan Provincial People's Hospital

Changsha, Hunan, China

Actively Recruiting

18

Jiangsu Cancer Hospital

Nanjing, Jiangsu, China

Actively Recruiting

19

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Actively Recruiting

20

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Actively Recruiting

21

The First Hospital of China Medical University

Shenyang, Liaoning, China

Actively Recruiting

22

Shandong Cancer Hospital

Jinan, Shandong, China

Actively Recruiting

23

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Not Yet Recruiting

24

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Actively Recruiting

25

Shanghai Changhai Hospital

Shanghai, Shanghai Municipality, China

Actively Recruiting

26

The First Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, China

Actively Recruiting

27

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Actively Recruiting

28

Tianjin Medical University Cancer Institute&Hospital

Tianjin, Tianjin Municipality, China

Actively Recruiting

29

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Not Yet Recruiting

30

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Actively Recruiting

31

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

Actively Recruiting

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Research Team

S

Shanghai Allist Pharmaceuticals Co., Ltd

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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