NCT06008288
Recruiting
Phase 2
A Single-arm, Multicenter, Open-label Phase II Clinical Study Evaluating the Efficacy and Safety of JAB-21822 Monotherapy in Patients With Locally Advanced or Metastatic Pancreatic Cancer and Other Solid Tumors Harboring the KRAS p.G12C Mutation.
Allist Pharmaceuticals, Inc.31 sites in 1 country88 target enrollmentStarted: October 27, 2023Last updated:
Overview
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Allist Pharmaceuticals, Inc.
- Enrollment
- 88
- Locations
- 31
- Primary Endpoint
- Objective response rate (ORR) by independent central radiological review (IRC) according to RECIST 1.1.
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
JAB-21822
Experimental
Monotherapy
Intervention: JAB-21822 (Drug)
Outcomes
Primary Outcomes
Objective response rate (ORR) by independent central radiological review (IRC) according to RECIST 1.1.
Time Frame: 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 Outcomes
- Duration of response (DOR)(Approximately 1.5 years)
- Time to response (TTR) by IRC according to RECIST 1.1(Approximately 1.5 years)
- Progression-free survival (PFS) by IRC according to RECIST 1.1(Approximately 1.5 years)
- Disease control rate (DCR) by IRC according to RECIST 1.1(Approximately 1.5 years)
- CA19-9 response rate (Applicable only to pancreatic cancer)(Approximately 1.5 years)
- Overall survival (OS)(Approximately 2.0 years)
- Number of participants with adverse events(Approximately 1.5 years)
Investigators
Study Sites (31)
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Related News
Glecirasib Receives Orphan Drug Designation from EMA for Pancreatic Cancer- Jacobio Pharma's glecirasib, a KRAS G12C inhibitor, has been granted orphan drug designation by the European Medicines Agency (EMA) for pancreatic cancer.
- Glecirasib previously received orphan drug designation from the FDA in the United States and breakthrough therapy designation from the CDE in China for pancreatic cancer.
- Clinical trial data presented at ASCO GI 2024 showed a cORR of 41.9% and a DCR of 93.5% in second-line and above KRAS G12C mutated pancreatic cancer patients.
- Ongoing pivotal trial (NCT06008288) is evaluating glecirasib in advanced KRAS G12C mutated pancreatic ductal adenocarcinoma (PDAC) and other solid tumors across 30 sites in China.Glecirasib Shows Promise as Novel KRAS G12C Inhibitor in Solid Tumors- Glecirasib, a selective KRAS G12C inhibitor by Jacobio Pharmaceuticals, demonstrates promising clinical activity in advanced solid tumors with KRAS G12C mutations.
- In NSCLC patients who progressed on prior therapies, glecirasib achieved an objective response rate of 47.9% and a median progression-free survival of 8.2 months.
- Glecirasib also showed encouraging results in pancreatic cancer, with a 41.9% objective response rate and a median overall survival of 10.7 months.
- The drug exhibits a favorable safety profile with low rates of gastrointestinal toxicities, potentially improving patient tolerability and treatment adherence.