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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05002270
Other study ID # JAB-21822-1001
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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