Phase 1/2a Study of JAB-21822 Plus JAB-3312 in Patients With Advanced Solid Tumors Harboring KRAS p.G12C Mutation
NCT05288205 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 240
Last updated 2025-04-04
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.
Conditions
- KRAS P.G12C
- Non-small Cell Lung Cancer
- Colorectal Cancer
- Pancreatic Ductal Carcinoma
Interventions
- DRUG
-
JAB-21822
KRAS G12C inhibitor
- DRUG
-
JAB-3312
SHP2 inhibitor
Sponsors & Collaborators
-
Allist Pharmaceuticals, Inc.
lead INDUSTRY
Principal Investigators
-
Wang Wang Jie M.D. · Peking University Cancer Hospital & Institute
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-04-14
- Primary Completion
- 2026-03-31
- Completion
- 2026-03-31
Countries
- China
Study Locations
More Related Trials
-
JAB-30355 in Patients With Advanced Solid Tumors Harboring TP53 Y220C Mutation
NCT06386146 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Phase I Clinical Study of YL-15293 in Patients With Advanced Solid Tumor With KRAS Mutation
NCT05173805 ·Status: UNKNOWN ·Phase: PHASE1/PHASE2
-
Study of ZG005 Combined With Gecacitinib in Patients With Advanced Non-Small Cell Lung Cancer
NCT06903377 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
JSKN022 in Subjects With Advanced Malignant Solid Tumors
NCT07292402 ·Status: RECRUITING ·Phase: PHASE1
-
Efficacy and Safety of IBI351 in Combination With Chemotherapy in Advanced Non-squamous Non-small Cell Lung Cancer Subjects With KRAS G12C Mutation
NCT05504278 ·Status: RECRUITING ·Phase: PHASE1
-
A Phase Ib/II Study Of JS015 Combination Therapy in Advanced Solid Tumors
NCT06139211 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
A Phase Ib Study of JMKX001899 in Combination With Other Therapies in Advanced NSCLC Harboring KRAS G12C Mutation
NCT06946927 ·Status: RECRUITING ·Phase: PHASE1
-
A Phase 3 Study of IN10018 in Combination With D-1553 Versus Standard Therapy for First Line Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation
NCT07174908 ·Status: RECRUITING ·Phase: PHASE3
-
The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of JS207 in Patients With Advanced Malignant Tumor
NCT06022250 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
SHR-1210 in Recurrent/Metastatic Nasopharyngeal Carcinoma Who Have Received Previous At Least Two Lines of Chemotherapy.
NCT03558191 ·Status: COMPLETED ·Phase: PHASE2
-
A Real-World Study of IBI351 for KRAS G12C+ NSCLC in China
NCT07198620 ·Status: NOT_YET_RECRUITING
-
JSKN033 in Chinese Subjects with Advanced Malignant Tumors
NCT06770881 ·Status: NOT_YET_RECRUITING ·Phase: PHASE1/PHASE2
-
A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Initial Efficacy of JS212 in Subjects With Advanced Malignant Solid Tumour
NCT06888830 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
A 1/2 Phase Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ASKB589 in Patients With Locally Advanced or Metastatic Solid Tumors
NCT04632108 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
IBI351 Plus Cetuximab β in Untreated Advanced Non-small Cell Lung Cancer With KRAS G12C Mutation
NCT07198841 ·Status: RECRUITING ·Phase: PHASE2
-
A Study of Anlotinib Combined With AK105 Injection in Subjects With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Advanced Solid Tumor
NCT04291248 ·Status: UNKNOWN ·Phase: PHASE2
-
Phase II Study of SHR-1210(Anti-PD-1 Antibody) Combination With Apatinib Versus Pemetrexed and Carboplatin in Subjects With KRAS Mutant Stage IV Non-squamous Non-small Cell Lung Cancer
NCT03777124 ·Status: TERMINATED ·Phase: PHASE2
-
Phase I/Ib Multiple Ascending Dose Study in China
NCT03523390 ·Status: COMPLETED ·Phase: PHASE1
-
Concurrent Nab-paclitaxel with Intensity-modulated Radiation Therapy in Patients with Stage III-IVa Nasopharyngeal Carcinoma
NCT06611150 ·Status: RECRUITING ·Phase: PHASE1
-
Study of GV20-0251 in Participants With Solid Tumor Malignancies
NCT07070518 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
A Phase II Study of TPF With PD-1 Inhibitor Induction Therapy for Locally Advanced Nasopharyngeal Carcinoma
NCT06781112 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
A Trial of SHR-A2102 With Adebrelimab With or Without Other Antitumor Therapy in Advanced or Metastatic Non-small Cell Lung Cancer
NCT06512051 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
A Phase I/II Study of WJB001 Combination Therapy on Safety and Efficacy for Advanced Solid Tumors
NCT06953323 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Single-agent Capecitabine as Adjuvant Chemotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma
NCT02958111 ·Status: UNKNOWN ·Phase: PHASE3
-
A Study to Evaluate the Safety and Efficacy of SHR-1210, Gemcitabine and Cis-platinum by R/M NPC Subjects
NCT03121716 ·Status: COMPLETED ·Phase: PHASE1