Status:
RECRUITING
Phase 1/2a Study of JAB-21822 Plus JAB-3312 in Patients With Advanced Solid Tumors Harboring KRAS p.G12C Mutation
Lead Sponsor:
Allist Pharmaceuticals, Inc.
Conditions:
KRAS P.G12C
Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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, tolera...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT05288205
Start Date
April 14 2022
End Date
March 1 2026
Last Update
April 4 2025
Active Locations (27)
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1
The First Affiliated Hospital of USTC Anhui Provincial Hospital
Hefei, Anhui, China, 230001
2
Pecking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100005
3
Cancer Hospital Chinese Academy Of Medical Sciences
Beijing, Beijing Municipality, China, 100021
4
Beijing Tiantan Hospital, Captal Medical University
Beijing, Beijing Municipality, China, 100070