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RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - A written willing to sign a consent form should be signed by a subject or his/her legal representative before any study-related procedures are performed; - Subjects with diagnosed by tissue sample (biopsy-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 Who Should NOT Join This Trial: - Patients with previous (≤ 3 years) or current tumors of other pathological types, except for cured cervical carcinoma in situ, ductal carcinoma in situ of the breast, prostatic intraepithelial neoplasia, superficial non-invasive bladder cancer, stage I skin cancer (except melanoma); subjects without recurrence or metastasis for \> 3 years after treatment, without current evidence of tumor, and without significant risk of recurrence of previous malignant diseases in the opinion of the study doctor may also be enrolled; - Serious allergy to the investigational drug or excipients (such as microcrystalline cellulose, etc.); ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 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 Exclusion Criteria: * Patients with previous (≤ 3 years) or current tumors of other pathological types, except for cured cervical carcinoma in situ, ductal carcinoma in situ of the breast, prostatic intraepithelial neoplasia, superficial non-invasive bladder cancer, stage I skin cancer (except melanoma); subjects without recurrence or metastasis for \> 3 years after treatment, without current evidence of tumor, and without significant risk of recurrence of previous malignant diseases in the opinion of the study doctor may also be enrolled; * Serious allergy to the investigational drug or excipients (such as microcrystalline cellulose, etc.); * Patients with previous (≤ 6 months before the initiation of treatment) or current severe autoimmune diseases (including adverse reactions caused by previous anti- tumor immunotherapies), or autoimmune diseases requiring long-term systemic hormone therapy at immunosuppressive dose levels (prednisone \> 10 mg/day or equivalent drugs); * HIV, hepatitis B virus(HBV), or hepatitis C virus(HCV) positive; * Previous (≤ 6 months prior to the first dose) or current evidence of the following diseases: acute myocardial infarction, unstable angina and cerebrovascular accident; * Subjects who have impaired cardiac functions or clinically significant cardiac diseases; * Pregnant or lactating women

Treatments Being Tested

DRUG

JAB-21822

KRAS G12C inhibitor

DRUG

JAB-3312

SHP2 inhibitor

Locations (20)

The First Affiliated Hospital of USTC Anhui Provincial Hospital
Hefei, Anhui, China
Pecking Union Medical College Hospital
Beijing, Beijing Municipality, China
Cancer Hospital Chinese Academy Of Medical Sciences
Beijing, Beijing Municipality, China
Beijing Tiantan Hospital, Captal Medical University
Beijing, Beijing Municipality, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Beijing Chest Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Fujian cancer Hospital
Fuzhou, Fujian, China
The First Affiliated Hospital Xiamen University
Xiamen, Fujian, China
The first Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Zhujiang Hospital of Southem Medical University
Guangzhou, Guangdong, China
Cancer Hospital Chinese Academy Of medical Sciences Shenzhen Center
Shenzhen, Guangdong, China
Harbin Medical University Cancer Hospital-Mammary gland of internal
Harbin, Heilongjiang, China
Henan Cancer Hospital
Zhengzhou, Henan, China
The First Affiliated Hosipital Of Zhengzhou University
Zhengzhou, Henan, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
Tongji Hospital Tongji Medical College of Hust
Wuhan, Hubei, China
Renmin Hospital Of Wuhan University
Wuhan, Hubei, China
Xiangya Hospital Central South Univesity
Changsha, Hunan, China
Hunan Cancer Hospital
Changsha, Hunan, China