JAB-21822 Activity in Adult Patients With Advanced Solid Tumors Harboring KRAS G12C Mutation

Advanced Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05002270
• Other study ID #: JAB-21822-1001
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: September 3, 2021
• Est. completion date: July 2025

Study information

• Verified date: October 2022
• Source: Jacobio Pharmaceuticals Co., Ltd.
• Contact: Huiqiang Wang, PhD
• Phone: 86 10 56315466
• Email: Huiqiang.wang[@]jacobiopharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 2025
• Est. primary completion date: January 2024
• 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 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

Related Conditions & MeSH terms

• Advanced Solid Tumor
• CRC
• Neoplasms
• NSCLC

Intervention

Drug:
• JAB-21822 (KRAS G12C inhibitor)
Administered orally
• JAB-21822 (KRAS G12C inhibitor)
Administered orally
• JAB-21822 (KRAS G12C inhibitor)
Administered orally
• Cetuximab (EGFR inhibitor)
Administered IV

Locations

Country	Name	City	State
United States	Mayo Clinc	Jacksonville	Florida
United States	Mayo Clinc	Phoenix	Arizona
United States	University of Utah	Salt Lake City	Utah
United States	Mayo Clinc	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Jacobio Pharmaceuticals Co., Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose Escalation phase: Number of participants with dose limiting toxicities (DLTs)		At the end of Cycle 1 (each cycle is 21 days)
Primary	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
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
Primary	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 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
Secondary	Dose Escalation and Dose Expansion phase: Area under the plasma concentration versus time curve (AUC)	AUC of JAB-21822 alone or JAB-21822 plus cetuximab will be measured by using plasma PK samples	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 - from baseline to RECIST confirmed Progressive Disease
Secondary	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
Secondary	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
Secondary	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