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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.
The primary objective of this study is to evaluate the safety and tolerability of JAB-21822 monotherapy to determine the MTD and PR2D during Dose Escalation phase; then to evaluate preliminary antitumor activity when JAB-21822 administered alone and combination with cetuximab during Dose Expansion phase in adult participants with advanced solid tumors harboring KRAS G12C mutation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A0, JAB-21822 monotherapy, Phase 1, Dose Escalation | Experimental | Dose escalation of JAB-21822 will be administered alone to determine the MTD and RP2D |
|
| Arm A1, JAB-21822 monotherapy, Phare 2, Dose Expansion | Experimental | JAB-21822 will be administered alone at RP2D in selected cancer type patients to evaluate the preliminary antitumor activity. |
|
| Experimental: Arm B, JAB-21822 combination with Cetuximab, Phase 2, Dose Expansion | Experimental | JAB-21822 will be administered together with Cetuximab in mCRC patients to evaluate the preliminary antitumor activity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JAB-21822 (KRAS G12C inhibitor) | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose Escalation phase: Number of participants with dose limiting toxicities (DLTs) | At the end of Cycle 1 (each cycle is 21 days) | |
| Dose Escalation and Dose Expansion phase: Number of participants with adverse events | Patients will be assessed for incidence and severity of adverse events (AEs) according to NCI-CTCAE criteria | Up to 4 years |
| Dose Expansion phase: Overall response rate (ORR) | ORR is defined as the percentage of participants with complete response (CR) or partial response (PR) per RECIST v 1.1 | Up to 4 years - from baseline to RECIST confirmed Progressive Disease |
| Dose Expansion phase: Duration of response ( DOR ) | DOR is defined as the time from the participant's initial objective response (CR or PR) to disease progression per CTCAE v1.1 or death due to any cause, whichever occurs first. | Up to 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Dose Escalation and Dose Expansion phase: Peak Plasma Concentration (Cmax) | Cmax of JAB-21822 alone or JAB-21822 plus cetuximabn will be measured by using plasma PK samples | Up to 4 years |
| Dose Escalation and Dose Expansion phase: Area under the plasma concentration versus time curve (AUC) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinc | Phoenix | Arizona | 85054 | United States | ||
| Mayo Clinc |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41037823 | Derived | Li 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. |
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| JAB-21822 (KRAS G12C inhibitor) | Drug | Administered orally |
|
| JAB-21822 (KRAS G12C inhibitor) | Drug | Administered orally |
|
| Cetuximab (EGFR inhibitor) | Drug | Administered IV |
|
AUC of JAB-21822 alone or JAB-21822 plus cetuximab will be measured by using plasma PK samples |
| Up to 4 years |
| Dose Escalation phase: Overall response rate (ORR) | The percentage of participants with complete response (CR) or partial response (PR) on RECIST v 1.1. | Up to 4 years - from baseline to RECIST confirmed Progressive Disease |
| Dose Escalation phase: Duration of response ( DOR ) | DOR is defined as the time from the participant's initial objective response (CR or PR) to disease progression per CTCAE v1.1 or death due to any cause, whichever occurs first. | Up to 4 years |
| Dose Escalation and Dose Expansion phase: Disease Control Rate ( DCR ) | DCR is defined as percentage of participants with complete response (CR), partial response (PR), or stable disease(SD) per CTCAE v1.1 | Up to 4 years |
| Dose Escalation and Dose Expansion phase: Progression-free survival (PFS) | PFS is defined as the interval of time between the date of first treatment to the earliest date of disease progression per CTCAE v1.1 or death which occurs first | Up to 4 years |
| Scottsdale |
| Arizona |
| 85259 |
| United States |
| Mayo Clinc | Jacksonville | Florida | 32224 | United States |
| University of Utah | Salt Lake City | Utah | 84112 | United States |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000068818 | Cetuximab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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