Clinical trial NCT04720976: JAB-3312 Based Combination Therapy in Adult Patients With Advanced Solid Tumors
Official title: A Phase 1/2a, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-3312 Based Combination Therapies in Adult Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Solid Tumor
NSCLC
Keywords: KRAS G12C, EGFR
Lead sponsor: Allist Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: AbbVie
First posted: 2021-01-22
Enrollment: 58
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: To evaluate the safety and tolerability of JAB-3312 administered in investigational regimens in adult participants with advanced solid tumors.

Detailed description: To assess the safety and tolerability and determine the Recommended phase 2 dose (RP2D) of JAB-3312 in combination with PD1 inhibitor or MEK inhibitor in patients with advanced solid tumors.

Eligibility criteria: Inclusion Criteria:

* Must have histologically or cytologically confirmed metastatic or locally advanced solid tumor. Some cohorts must meet specific expression or gene mutation where indicated
* Sufficient organ function
* Participants must have at least 1 measurable lesion as defined by RECIST v1.1
* Must be able to provide an archived tumor sample
* ECOG performance status score of 0 or 1.

Exclusion Criteria:

* History of cancer that is histologically distinct from the cancers under study
* Active or untreated central nervous system (CNS) metastases
* History of pneumonitis or interstitial lung disease (ILD)
* Has active hepatitis B, hepatitis C infection, HIV
* Any severe and/or uncontrolled medical conditions
* LVEF ≤50%
* QTcF \>470 msec

Primary outcomes:
measure: Number of participants with dose limiting toxicities
timeFrame: 24 months
measure: Objective response rate (ORR)
timeFrame: 24 months
measure: Duration of response (DOR)
timeFrame: 24 months
measure: Duration of response (DCR)
timeFrame: 24 months
measure: Progression-free survival (PFS)
timeFrame: 24 months
measure: Overall survival (OS)
timeFrame: 24 months
measure: Number of participants with adverse events
timeFrame: 24 months
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: 24 months
measure: Duration of response (DOR)
timeFrame: 24 months
measure: Duration of response (DCR)
timeFrame: 24 months
measure: Progression-free survival (PFS)
timeFrame: 24 months
measure: Overall survival (OS)
timeFrame: 24 months
measure: Plasma concentration (Cmax)
timeFrame: 24 months
measure: Time to achieve Cmax (Tmax)
timeFrame: 24 months
measure: Area under the plasma concentration-time curve (AUC)
timeFrame: 24 months
measure: Number of participants with adverse events
timeFrame: 24 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Scottsdale
country: United States
facility: Research Site
state: Arizona
city: Los Angeles
country: United States
facility: Research Site
state: California
city: New Haven
country: United States
facility: Research Site
state: Connecticut
city: Jacksonville
country: United States
facility: Research Site
state: Florida
city: Orange City
country: United States
facility: Research Site
state: Florida
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Indianapolis
country: United States
facility: Research Site
state: Indiana
city: Detroit
country: United States
facility: Research Site
state: Michigan
city: Rochester
country: United States
facility: Research Site
state: Minnesota
city: St. Louis
country: United States
facility: Research Site
state: Missouri
city: New York
country: United States
facility: Research Site
state: New York
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
city: Houston
country: United States
facility: Research Site
state: Texas
city: Salt Lake City
country: United States
facility: Research Site
state: Utah
Study officials:
References: