JAB-3312 Based Combination Therapy in Adult Patients With Advanced Solid Tumors

Phase 2CompletedNCT04720976

Allist Pharmaceuticals, Inc.58 enrolled

Overview

To evaluate the safety and tolerability of JAB-3312 administered in investigational regimens in adult participants with advanced solid tumors.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Solid Tumor NSCLC

Interventions

JAB-3312DRUG

JAB-3312 will be administered orally, variable dose.

BinimetinibDRUG

Binimetinib will be administered orally.

PembrolizumabDRUG

Pembrolizumab will be administered as an intravenous infusion.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (15)

Research Site

Phoenix, Arizona, United States

Research Site

Scottsdale, Arizona, United States

Research Site

Los Angeles, California, United States

Outcomes

Primary Outcomes

Number of participants with dose limiting toxicities

Incidence of dose limiting toxicities (DLTs) in the dose escalation phase. A DLT is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first treatment cycle. (Dose escalation phase)

Time frame: 24 months

Objective response rate (ORR)

ORR is defined as the proportion of participants with complete response or partial response (CR+PR). (Dose expansion phase)

Time frame: 24 months

Duration of response (DOR)

DOR is defined as the time from the participant's initial objective response (CR or PR) to study drug therapy, to disease progression or death due to any cause, whichever occurs first. (Dose expansion phase)

Time frame: 24 months

Duration of response (DCR)

DCR is defined as proportion of participants with complete response, partial response, stable disease(CR+PR+SD). (Dose expansion phase)

Time frame: 24 months

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 or death which occurs first. (Dose expansion phase)

Time frame: 24 months

Overall survival (OS)

OS is defined as the interval of time between the date of first treatment until death, loss to follow up or termination of the study by the sponsor. (Dose expansion phase)

Time frame: 24 months

Number of participants with adverse events

All patients participating in this study will be assessed for incidence and severity of adverse events (AEs) and serious AEs, including changes in laboratory values, vital signs, electrocardiograms, cardiac imaging and ophthalmological assessments (Dose escalation phase)

Data from ClinicalTrials.gov

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Secondary Outcomes

Objective response rate (ORR)

ORR is defined as the proportion of participants with complete response or partial response (CR+PR). (Dose escalation phase)

Time frame: 24 months

Duration of response (DOR)

Time frame: 24 months

Duration of response (DCR)

DCR is defined as proportion of participants with complete response, partial response, stable disease(CR+PR+SD). (Dose escalation phase)

Time frame: 24 months

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 or death which occurs first. (Dose escalation phase)

Time frame: 24 months

Overall survival (OS)

OS is defined as the interval of time between the date of first treatment until death, loss to follow up or termination of the study by the sponsor(Dose escalation phase)

Time frame: 24 months

Plasma concentration (Cmax)

Highest observed plasma concentration of JAB-3312(dose escalation phase)

Time frame: 24 months

Time to achieve Cmax (Tmax)

Time of highest observed plasma concentration of JAB-3312(dose escalation phase)

Time frame: 24 months

Area under the plasma concentration-time curve (AUC)

Area under the plasma concentration time curve of JAB-3312(dose escalation phase)

Time frame: 24 months

Number of participants with adverse events

Time frame: 24 months