KRAS P.G12C, Pancreatic Cancer, Solid Tumor
Conditions
Brief summary
Patients with other advanced solid tumors (excluding NSCLC and CRC) who have progressed after prior systemic therapy or are intolerant and lack satisfactory alternative treatment options, aiming to evaluate the efficacy and safety of Glecirasib in these patients.
Detailed description
This study is a single-arm, multicenter, open-label, basket-design, pivotal phase II trial targeting adult patients with locally advanced or metastatic solid tumors harboring the KRAS p.G12C mutation. The included populations are: * Patients with advanced pancreatic cancer who have progressed or are intolerant to prior gemcitabine-based chemotherapy regimens or FOLFIRINOX/mFOLFIRINOX/NALIRIFOX treatments. * Patients with other advanced solid tumors (excluding NSCLC and CRC) who have progressed after prior systemic therapies or are intolerant and lack satisfactory alternative treatment options. The study aims to evaluate the efficacy and safety of Glecirasib in these patient populations.
Interventions
DRUGJAB-21822
800mg, orally QD with 21 days each cycle, treatment till disease progression or intolerable toxicity or withdraw for other reasons
Sponsors
Allist Pharmaceuticals, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with the KRAS p.G12C mutation confirmed through testing using prospectively validated companion diagnostic reagents or clinical trial assay (CTA) methods. * Histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumors (excluding NSCLC and CRC). * Patients with pancreatic cancer must have progressed or been intolerant to prior gemcitabine-based chemotherapy regimens or FOLFIRINOX/mFOLFIRINOX/NALIRIFOX treatment. Patients with other types of solid tumors must have progressed or been intolerant to prior systemic therapies and lack satisfactory alternative treatment options.
Exclusion criteria
* Previously received a KRAS G12C inhibitor. * History of interstitial lung disease, non-infectious pneumonia, or uncontrolled lung disease (including pulmonary fibrosis, acute lung disease, etc.) with clinical symptoms. * Uncontrolled pleural effusion, pericardial effusion, or ascites. * Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms calculated from 3 electrocardiograms. * Use of a drug with known risk of torsades de points (TdP) within 14 days prior to the first dose.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) by independent central radiological review (IRC) according to RECIST 1.1. | Approximately 1.5 years | ORR is defined as the proportion of participants with confirmed complete response or partial response by IRC according to RECIST 1.1. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of response (DOR) | Approximately 1.5 years | DOR is defined as the time from date of the first objective tumor response (CR or PR) to the first documentation of either Progression of Disease (PD) or death due to any cause, whichever occurs first. |
| Time to response (TTR) by IRC according to RECIST 1.1 | Approximately 1.5 years | TTR is defined as the duration of time between the date of the first dose and the date of first documented response of either CR or PR. |
| Progression-free survival (PFS) by IRC according to RECIST 1.1 | Approximately 1.5 years | PFS is defined as time from the first dose until disease progression or death from any cause, whichever occurs first. |
| Disease control rate (DCR) by IRC according to RECIST 1.1 | Approximately 1.5 years | DCR is defined as the proportion of participants with BOR of CR or PR or stable disease (SD) |
| CA19-9 response rate (Applicable only to pancreatic cancer) | Approximately 1.5 years | CA19-9 response rate is defined as the proportion of participants with CA19-9 response (achieving ≥50% decrease in CA19-9 serum levels). |
| Overall survival (OS) | Approximately 2.0 years | OS is defined as time from date of the first dose to date of death due to any cause. |
| Number of participants with adverse events | Approximately 1.5 years | Participants will be assessed for incidence and severity of AEs according to NCI-CTCAE 5.0 criteria |
Countries
China
Contacts
CONTACTShanghai Allist Pharmaceuticals Co., Ltd
STUDY_DIRECTORShanghai Allist Pharmaceuticals
Shanghai Allist Pharmaceuticals Co.,Ltd.
Outcome results
None listed