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

  • Interventional
  • Recruiting
  • NCT04720976
Eligibility Details Visit Clinicaltrials.gov

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

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.

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

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
  • Solid Tumors

At a Glance

National Government IDNCT04720976

IRB#IRB21-0534

Lead SponsorJacobio Pharmaceuticals Co., Ltd.

Lead PhysicianArdaman Shergill

Collaborator(s)N/A

EligibilityAll
18 Years and up
Recruiting