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
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Jacobio Pharmaceuticals Co., Ltd. |
United States,
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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