A Phase 1/2a Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of JAB-21822 in Combination With JAB-3312 in Patients With Advanced Solid Tumors Harboring KRAS p.G12C Mutation

Status: Recruiting
Location: See all (27) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• A written informed consent should be signed by a subject or his/her legal representative before any study-related procedures are performed;

• Subjects with histologically or cytologically confirmed locally advanced or metastatic advanced solid tumors harboring KRAS p.G12C mutation who have failed or lack standard-of-care (SOC) or are unwilling to undergo or intolerant to SOC;

• Expected survival ≥ 3 months;

• Subjects must have at least one measurable lesion as defined by RECIST v1.1. If no measurable lesion untreated with radiation is selected as the target lesion, a lesion treated with radiation ≥ 4 weeks before the first dose and with progression confirmed by radiography may be selected as the target lesion;

• Eastern Cooperative Oncology Group(ECOG) performance status 0-1;

• The organ functions of subjects meet the criteria for the following laboratory parameters at screening;

• Subjects must be able to swallow oral medications without gastrointestinal abnormalities that significantly affect drug absorption

Locations
Other Locations
China
Beijing Cancer Hospital
RECRUITING
Beijing
Beijing Chest Hospital, Capital Medical University
NOT_YET_RECRUITING
Beijing
Beijing Tiantan Hospital, Captal Medical University
NOT_YET_RECRUITING
Beijing
Cancer Hospital Chinese Academy Of Medical Sciences
RECRUITING
Beijing
Pecking Union Medical College Hospital
NOT_YET_RECRUITING
Beijing
Peking University Third Hospital
RECRUITING
Beijing
Hunan Cancer Hospital
NOT_YET_RECRUITING
Changsha
Xiangya Hospital Central South Univesity
NOT_YET_RECRUITING
Changsha
Fujian cancer Hospital
NOT_YET_RECRUITING
Fuzhou
The first Affiliated Hospital, Sun Yat-sen University
NOT_YET_RECRUITING
Guangzhou
Zhujiang Hospital of Southem Medical University
NOT_YET_RECRUITING
Guangzhou
The Second Affiliated Hospital Zhejiang School of Medicine
NOT_YET_RECRUITING
Hangzhou
Harbin Medical University Cancer Hospital-Mammary gland of internal
NOT_YET_RECRUITING
Harbin
The First Affiliated Hospital of USTC Anhui Provincial Hospital
NOT_YET_RECRUITING
Hefei
The Affilated Hospital of Inner Mongolia Medical University
NOT_YET_RECRUITING
Hohhot
Qilu Hospital of Shandong University
NOT_YET_RECRUITING
Jinan
Shandong Cancer Hospital
NOT_YET_RECRUITING
Jinan
LinYi Cancer Hospital
NOT_YET_RECRUITING
Linyi
Fudan University Shanghai Cancer Center
NOT_YET_RECRUITING
Shanghai
The First Hospital Of China Medical University
NOT_YET_RECRUITING
Shenyang
Cancer Hospital Chinese Academy Of medical Sciences Shenzhen Center
NOT_YET_RECRUITING
Shenzhen
Renmin Hospital Of Wuhan University
NOT_YET_RECRUITING
Wuhan
Tongji Hospital Tongji Medical College of Hust
NOT_YET_RECRUITING
Wuhan
Union Hospital Tongji Medical College Huazhong University of Science and Technology
NOT_YET_RECRUITING
Wuhan
The First Affiliated Hospital Xiamen University
NOT_YET_RECRUITING
Xiamen
Henan Cancer Hospital
NOT_YET_RECRUITING
Zhengzhou
The First Affiliated Hosipital Of Zhengzhou University
NOT_YET_RECRUITING
Zhengzhou
Contact Information
Primary
Shanghai Allist Pharmaceuticals Co., Ltd Shanghai Allist Pharmaceuticals Co., Ltd
zhenhua.gong@allist.com.cn
021-80423288
Time Frame
Start Date: 2022-04-14
Estimated Completion Date: 2026-03
Participants
Target number of participants: 240
Treatments
Experimental: Dose escalation
Experimental: Dose expansion
Sponsors
Leads: Allist Pharmaceuticals, Inc.

This content was sourced from clinicaltrials.gov

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