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

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.

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