Clinical trial NCT05002270: JAB-21822 Activity in Adult Patients With Advanced Solid Tumors Harboring KRAS G12C Mutation
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Advanced Solid Tumor
NSCLC
CRC
Keywords: KRAS G12C Mutant Advanced Solid Tumor; NSCLC; CRC
Lead sponsor: Jacobio Pharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-08-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Dose Escalation phase: Number of participants with dose limiting toxicities (DLTs)
timeFrame: At the end of Cycle 1 (each cycle is 21 days)
measure: Dose Escalation and Dose Expansion phase: Number of participants with adverse events
timeFrame: Up to 4 years
measure: Dose Expansion phase: Overall response rate (ORR)
timeFrame: Up to 4 years - from baseline to RECIST confirmed Progressive Disease
measure: Dose Expansion phase: Duration of response ( DOR )
timeFrame: Up to 4 years
Secondary outcomes:
measure: Dose Escalation and Dose Expansion phase: Peak Plasma Concentration (Cmax)
timeFrame: Up to 4 years
measure: Dose Escalation and Dose Expansion phase: Area under the plasma concentration versus time curve (AUC)
timeFrame: Up to 4 years
measure: Dose Escalation phase: Overall response rate (ORR)
timeFrame: Up to 4 years - from baseline to RECIST confirmed Progressive Disease
measure: Dose Escalation phase: Duration of response ( DOR )
timeFrame: Up to 4 years
measure: Dose Escalation and Dose Expansion phase: Disease Control Rate ( DCR )
timeFrame: Up to 4 years
measure: Dose Escalation and Dose Expansion phase: Progression-free survival (PFS)
timeFrame: Up to 4 years
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinc
state: Arizona
city: Scottsdale
country: United States
facility: Mayo Clinc
state: Arizona
city: Jacksonville
country: United States
facility: Mayo Clinc
state: Florida
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
References: