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

Sponsor: Jacobio Pharmaceuticals Co., Ltd.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04720976

Patient View

This trial evaluates the safety and tolerability of JAB-3312 with PD1 or MEK inhibitors in advanced solid tumors. Eligible participants must have confirmed tumors, measurable lesions, and good organ function. Exclusions include distinct cancer history, CNS metastases, and certain infections. Interventions include JAB-3312, Binimetinib, Pembrolizumab, Sotorasib, and Osimertinib.

Patient Parameters

Program Overview

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

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

Get This Program In Your Inbox

You can sign up and apply your patients for this program.