Clinical trial · Interventional
JAB-21822 Activity in Adult Patients With Advanced Solid Tumors Harboring KRAS G12C Mutation
A Phase 1/2, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-21822 Monotherapy and Combination Therapy in Adult Patients With Advanced Solid Tumors Harboring KRAS G12C Mutation
NCT05002270CI-TRIAL-00100724completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is to evaluate the safety and tolerability of JAB-21822 monotherapy and combination therapy in adult participants with advanced solid tumors harboring KRAS G12C mutation.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
| CRC | Colorectal Carcinoma | ALIAS | 0.90 |
| NSCLC | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cetuximab (EGFR inhibitor) | Drug | Cetuximab | ALIAS |
| JAB-21822 (KRAS G12C inhibitor) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm A0, JAB-21822 monotherapy, Phase 1, Dose Escalation
- description
- Dose escalation of JAB-21822 will be administered alone to determine the MTD and RP2D
- interventionNames
- Drug: JAB-21822 (KRAS G12C inhibitor)
- type
- EXPERIMENTAL
- label
- Arm A1, JAB-21822 monotherapy, Phare 2, Dose Expansion
- description
- JAB-21822 will be administered alone at RP2D in selected cancer type patients to evaluate the preliminary antitumor activity.
- interventionNames
- Drug: JAB-21822 (KRAS G12C inhibitor)
- type
- EXPERIMENTAL
- label
- Experimental: Arm B, JAB-21822 combination with Cetuximab, Phase 2, Dose Expansion
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participants must be able to provide an archived tumor sample * Histologically or cytologically confirmed solid tumors with KRAS G12C mutation * Must have received at least 1 prior standard therapy * Must have at least 1 measurable lesion per RECIST v1.1 * Must have adequate organ function * Must be able to swallow and retain orally administered medication Exclusion Criteria: * Has brain or spinal metastases, except if treated and no evidence of radiographic progression or hemorrhage for at least 28 days * Active infection requiring systemic treatment within 7 days * Active HBV or HCV * Any severe and/or uncontrolled medical conditions * LVEF ≤50% assessed by ECHO or QTcF * QT interval \>470 msec * Experiencing unresolved CTCAE 5.0 Grade \>1 toxicities
References
Publications (1)
- DERIVEDLi J, Deng T, Gu Y, Calles Blanco A, Li Z, Bai C, Wu L, Huang J, Li X, Yao Y, Song Z, Li Y, Liu L, Xing L, Wu W, Martinez-Perez J, Hubert A, Zugazagoitia J, Zhang J, Wang Y, Zhao Y, Wen G, Xia G, Zhong D, Chen X, Jiang K, Wang-Gillam A, Ding Y, Liu S, Rao Z, Liu X, Shen L. Efficacy and safety of glecirasib in solid tumors with KRAS G12C mutation: A pooled analysis of two phase I/II trials. Cancer Commun (Lond). 2025 Nov;45(11):1500-1512. doi: 10.1002/cac2.70056. Epub 2025 Oct 2. PMID 41037823