Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT05288205

Phase 1/2a Study of JAB-21822 Plus JAB-3312 in Patients With Advanced Solid Tumors Harboring KRAS p.G12C Mutation

Led by Allist Pharmaceuticals, Inc. · Updated on 2025-04-04

240

Participants Needed

27

Research Sites

202 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a multicenter, open-label phase 1/2a study consisting of two parts: dose escalation phase and dose expansion phase. The objective of the dose escalation phase is to evaluate the safety, tolerability and pharmacokinetics of JAB-21822 in combination with JAB-3312 in patients with advanced solid tumors harboring KRAS p.G12C mutation and to determine the RP2D for the combination therapy. In the dose expansion phase, preliminary efficacy and safety of the combination therapy at the RP2D will be further explored in patients with specific cancer harboring KRAS p.G12C mutation.

CONDITIONS

Official Title

Phase 1/2a Study of JAB-21822 Plus JAB-3312 in Patients With Advanced Solid Tumors Harboring KRAS p.G12C Mutation

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent before any study procedures
  • Diagnosed with locally advanced or metastatic solid tumors with KRAS p.G12C mutation
  • Failed, lack, unwilling to undergo, or intolerant to standard-of-care treatments
  • Expected survival of at least 3 months
  • Have at least one measurable lesion by RECIST v1.1 criteria
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Meet required organ function laboratory criteria at screening
  • Able to swallow oral medications without significant gastrointestinal issues affecting absorption
Not Eligible

You will not qualify if you...

  • Previous or current tumors of other types within 3 years except certain cured or low-risk cancers
  • Serious allergy to the study drugs or their excipients
  • Severe autoimmune diseases or requiring long-term immunosuppressive hormone therapy within 6 months
  • Positive for HIV, hepatitis B, or hepatitis C viruses
  • Acute myocardial infarction, unstable angina, or cerebrovascular accident within 6 months before treatment
  • Impaired cardiac function or significant cardiac diseases
  • Pregnant or lactating women

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 27 locations

1

The First Affiliated Hospital of USTC Anhui Provincial Hospital

Hefei, Anhui, China, 230001

Not Yet Recruiting

2

Pecking Union Medical College Hospital

Beijing, Beijing Municipality, China, 100005

Not Yet Recruiting

3

Cancer Hospital Chinese Academy Of Medical Sciences

Beijing, Beijing Municipality, China, 100021

Actively Recruiting

4

Beijing Tiantan Hospital, Captal Medical University

Beijing, Beijing Municipality, China, 100070

Not Yet Recruiting

5

Beijing Cancer Hospital

Beijing, Beijing Municipality, China, 100142

Actively Recruiting

6

Peking University Third Hospital

Beijing, Beijing Municipality, China, 100191

Actively Recruiting

7

Beijing Chest Hospital, Capital Medical University

Beijing, Beijing Municipality, China, 101125

Not Yet Recruiting

8

Fujian cancer Hospital

Fuzhou, Fujian, China, 350014

Not Yet Recruiting

9

The First Affiliated Hospital Xiamen University

Xiamen, Fujian, China, 361003

Not Yet Recruiting

10

The first Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China, 510080

Not Yet Recruiting

11

Zhujiang Hospital of Southem Medical University

Guangzhou, Guangdong, China, 510280

Not Yet Recruiting

12

Cancer Hospital Chinese Academy Of medical Sciences Shenzhen Center

Shenzhen, Guangdong, China, 518116

Not Yet Recruiting

13

Harbin Medical University Cancer Hospital-Mammary gland of internal

Harbin, Heilongjiang, China, 150081

Not Yet Recruiting

14

Henan Cancer Hospital

Zhengzhou, Henan, China, 450003

Not Yet Recruiting

15

The First Affiliated Hosipital Of Zhengzhou University

Zhengzhou, Henan, China, 450052

Not Yet Recruiting

16

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China, 430022

Not Yet Recruiting

17

Tongji Hospital Tongji Medical College of Hust

Wuhan, Hubei, China, 430030

Not Yet Recruiting

18

Renmin Hospital Of Wuhan University

Wuhan, Hubei, China, 430060

Not Yet Recruiting

19

Xiangya Hospital Central South Univesity

Changsha, Hunan, China, 410008

Not Yet Recruiting

20

Hunan Cancer Hospital

Changsha, Hunan, China, 410031

Not Yet Recruiting

21

The First Hospital Of China Medical University

Shenyang, Liaoning, China, 110001

Not Yet Recruiting

22

The Affilated Hospital of Inner Mongolia Medical University

Hohhot, Neimenggu, China, 750306

Not Yet Recruiting

23

Qilu Hospital of Shandong University

Jinan, Shandong, China, 250012

Not Yet Recruiting

24

Shandong Cancer Hospital

Jinan, Shandong, China, 250117

Not Yet Recruiting

25

LinYi Cancer Hospital

Linyi, Shandong, China, 276002

Not Yet Recruiting

26

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China, 200032

Not Yet Recruiting

27

The Second Affiliated Hospital Zhejiang School of Medicine

Hangzhou, Zhejiang, China, 310009

Not Yet Recruiting

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Research Team

S

Shanghai Allist Pharmaceuticals Co., Ltd Shanghai Allist Pharmaceuticals Co., Ltd

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

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