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

Allist Pharmaceuticals

Status and phase: Completed; Phase 2; Phase 1

Conditions: Solid Tumor; NSCLC

Treatments: Drug: Sotorasib; Drug: Pembrolizumab; Drug: Osimertinib; Drug: Binimetinib; Drug: JAB-3312

Study type: Interventional

Funder types: Industry

Identifiers

NCT04720976

JAB-3312-1003

Details and patient eligibility

About

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

Full 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.

Enrollment: 58 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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58 participants in 8 patient groups

JAB-3312+Pembrolizumab dose escalation

Experimental group

Description:

Dose escalation

Treatment:

Drug: JAB-3312

Drug: Pembrolizumab

JAB-3312+ Binimetinib dose escalation

Experimental group

Description:

Dose escalation

Treatment:

Drug: JAB-3312

Drug: Binimetinib

JAB-3312+Pembrolizumab dose expansion

Experimental group

Description:

Dose expansion

Treatment:

Drug: JAB-3312

Drug: Pembrolizumab

JAB-3312+Binimetinib dose expansion

Experimental group

Description:

Dose expansion

Treatment:

Drug: JAB-3312

Drug: Binimetinib

JAB-3312+Sotorasib dose escalation

Experimental group

Description:

Dose escalation

Treatment:

Drug: JAB-3312

Drug: Sotorasib

JAB-3312+ Osimertinib dose escalation

Experimental group

Description:

Dose escalation

Treatment:

Drug: JAB-3312

Drug: Osimertinib

JAB-3312+ Sotorasib dose expansion

Experimental group

Description:

Dose expansion

Treatment:

Drug: JAB-3312

Drug: Sotorasib

JAB-3312+ Osimertinib dose expansion

Experimental group

Description:

Dose expansion

Treatment:

Drug: JAB-3312

Drug: Osimertinib