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

Advanced Colorectal Cancer Clinical Trial

Official title:

A Phase Ib/II Trial of JAB-21822 in Combination With Cetuximab in Patients With Advanced Colorectal Cancer, Small Intestine Cancer and Appendiceal Cancer With KRAS G12C Mutation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05194995
• Other study ID #: JAB-21822-1007
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: February 17, 2022
• Est. completion date: January 2026

Study information

• Verified date: March 2023
• Source: Jacobio Pharmaceuticals Co., Ltd.
• Contact: Jacobio Pharmaceuticals
• Phone: 86-10-56315466
• Email: clinicaltrials[@]jacobiopharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is to evaluate the safety, tolerability, pharmacokinetics and antitumor activity of JAB-21822 in combination with cetuximab in patients with advanced colorectal cancer，advanced small intestine cancer and advanced appendiceal cancer with KRAS p.G12C mutation.

Description:

The primary objective of this study is to evaluate the safety and tolerability of JAB-21822 in combination with cetuximab to determine the MTD and RP2D during Dose Escalation phase; then to evaluate preliminary antitumor activity when JAB-21822 is administered in combination with cetuximab during Dose Expansion phase in patients with advanced colorectal cancer，advanced small intestine cancer and advanced appendiceal cancer with KRAS p.G12C mutation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: January 2026
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participants must be able to provide an archived tumor sample
• Histologically or cytologically confirmed advanced colorectal cancer, advanced small intestinal cancer and advanced appendiceal cancer with KRAS p.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 metastases, except if treated and no evidence of radiographic progression or hemorrhage for at least 28 days
• Active infection requiring systemic treatment within 14 days
• Active HIV, HBV or HCV
• Any severe and/or uncontrolled medical conditions
• LVEF<50% assessed by ECHO
• QT interval >470 msec

Related Conditions & MeSH terms

• Advanced Colorectal Cancer
• Appendiceal Cancer
• Appendiceal Neoplasms
• Colorectal Neoplasms
• Intestinal Neoplasms

Intervention

Drug:
• JAB-21822
JAB-21822 administered orally as a tablet.
• Cetuximab
Cetuximab administered as an intravenous (IV) infusion.

Locations

Country	Name	City	State
China	Research site01	Beijing	Beijing
China	Research site02	Beijing	Beijing
China	Research site12	Beijing	Beijing
China	Research site31	Beijing	Beijing
China	Research site04	Changchun	Jilin
China	Research site11	Changsha	Hunan
China	Research site29	Changsha	Hunan
China	Research site17	Chengdu	Sichuan
China	Research site26	Foshan	Guangdong
China	Research site03	Guangzhou	Guangdong
China	Research site19	Hangzhou	Zhejiang
China	Research site21	Hangzhou	Zhejiang
China	Research site06	Harbin	Heilongjiang
China	Research site15	Jinan	Shandong
China	Research site16	Linyi	Shandong
China	Research site08	Nanchang	Jiangxi
China	Research site09	Nanjing	Jiangsu
China	Research site24	Nanjing	Jiangsu
China	Research site32	Nanjing	Jiangsu
China	Research site13	Nanning	Guangxi
China	Research site28	Shanghai	Shanghai
China	Research site10	Shenyang	Liaoning
China	Research site18	Wuhan	Hubei
China	Research site22	Xi'an	Shanxi
China	Research site23	Xi'an	Shanxi
China	Research site20	Xiamen	Fujian
China	Research site14	Yinchuan	Ningxia
China	Research site05	Zhengzhou	Henan
China	Research site07	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Jacobio Pharmaceuticals Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At the end of Cycle 1 (each cycle is 21 days)
Primary	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
Secondary	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
Secondary	Dose Escalation and Dose Expansion phase: Peak Plasma Concentration (Cmax)	Cmax of JAB-21822 will be measured by using plasma PK samples.	Up to 4 years
Secondary	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.	Up to 4 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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