JAB-3312 Based Combination Therapy in Adult Patients With Advanced Solid Tumors
- Interventional
- Recruiting
- NCT04720976
Contact Information
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
- 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