JAB-21822 in Combination With Cetuximab in Patients With Advanced CRC and Other Solid Tumors With KRAS G12C Mutation

Browse trials for

• Appendiceal Neoplasms 55

Appendiceal Neoplasms

55 studies on the registry are indexed under Appendiceal Neoplasms; 23 are open to participants now.

This study's enrollment of 48 is close to the median of 50 across 40 interventional studies indexed under Appendiceal Neoplasms.

Lead sponsor

Allist Pharmaceuticals, Inc. is the lead sponsor of 25 studies on the registry; 9 are open to participants now.

Study arms

• Experimental
  Phase 1b Dose Escalation

  Dose escalation of JAB-21822 to determine maximum tolerated dose of JAB-21822 in combination with cetuximab.

  Drug: JAB-21822 · Drug: Cetuximab

• Experimental
  Phase 2 Dose Expansion, Cohort 1

  Enrollment into the dose expansion cohort is for eligible participants with KRAS P.G12C mutant advanced colorectal cancer.

  Drug: JAB-21822 · Drug: Cetuximab

• Experimental
  Phase 2 Dose Expansion, Cohort 2

  Enrollment into the dose expansion cohort is for eligible participants with KRAS P.G12C mutant advanced small intestinal cancer and advanced appendiceal cancer.

  Drug: JAB-21822 · Drug: Cetuximab

Interventions

• DrugJAB-21822

  JAB-21822 administered orally as a tablet.

• DrugCetuximab

  Cetuximab administered as an intravenous (IV) infusion.

Primary outcomes

1. Dose Escalation phase: Number of participants with dose-limiting toxicities (DLTs)

   A DLT is defined as the clinically significant treatment related adverse event (TRAE) or abnormal laboratory values assessment during the first 21 days of (Cycle 1) and excludes events that are deemed clearly related to underlying disease, progression, or intercurrent illness.

   Time frame: At the end of Cycle 1 (each cycle is 21 days)

2. 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.

   Time frame: Up to 4 years - from baseline to RECIST confirmed Progressive Disease

Secondary outcomes

1. 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.

   Time frame: Up to 4 years

2. Dose Escalation and Dose Expansion phase: Peak Plasma Concentration (Cmax)

   Cmax of JAB-21822 will be measured by using plasma PK samples.

   Time frame: Up to 4 years

3. Dose Escalation and Dose Expansion phase: Area under the plasma concentration versus time curve (AUC)

   AUC of JAB-21822 will be measured by using plasma PK samples.

   Time frame: Up to 4 years

4. 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.

   Time frame: Up to 4 years

5. Dose Escalation phase: Overall response rate (ORR)

   The percentage of participants with complete response (CR) or partial response (PR) on RECIST v 1.1.

   Time frame: Up to 4 years

6. 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.

   Time frame: Up to 4 years

7. 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.

   Time frame: Up to 4 years

Publications

• Jiang L, Luo Y, Liang H, Feng X, Huang Y, Li Y, Wang Z, Xu T, Zou H, Li Z, Shen L, Chen Y, Wang W, Li J. The dynamic evolution of circulating tumor cells during glecirasib treatment predicts survival and resistance in gastrointestinal tumors with KRASG12C mutation. Hum Cell. 2026 Jul 1;39(7):95. doi: 10.1007/s13577-026-01405-0. PubMed 42384131 ↗
• Li J, Wang Z, Huang J, Ba Y, Cao B, Luo S, Li W, Bai C, Song Z, Xiong J, Zhu L, An G, Zhang Y, Li Z, Li Y, Gu Y, Hu C, Li X, Huang C, Fu Q, Yin X, Liang X, Zhong D, Shi H, Li X, Li Z, Liu L, Wang F, Liang R, Xia G, Wang Z, Wang-Gillam A, Ding Y, Rao Z, Pan W, Lu S, Sun X, Shen L. Glecirasib with or without cetuximab in previously treated locally advanced or metastatic colorectal cancer with KRASG12C mutation (JAB-21822-1002 and JAB-21822-1007): two open-label, non-randomised phase 1/2 trials. Lancet Gastroenterol Hepatol. 2026 Feb;11(2):110-123. doi: 10.1016/S2468-1253(25)00267-5. Epub 2025 Dec 1. PubMed 41344351 ↗