Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Recruiting
Sponsor: Jacobio Pharmaceuticals Co., Ltd.
No Placebo Group
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?This trial is testing a new drug called JAB-3312, combined with other drugs, in adults with advanced solid tumors. The goal is to see if it is safe and to find the best dose. The treatment helps the immune system fight cancer or stops cancer cells from growing.
Eligibility Criteria
Adults with advanced solid tumors, including non-small cell lung cancer, who are in good physical condition (ECOG score of 0 or 1), have a tumor that can be measured and confirmed by medical tests, and whose organs function well. People with active hepatitis B/C, HIV, heart issues (LVEF ≤50%), distinct cancer history, certain heart rhythm problems (QTcF >470 msec), brain metastases not treated or controlled, or a history of lung inflammation/disease cannot join.Inclusion Criteria
ECOG performance status score of 0 or 1.
Must be able to provide an archived tumor sample
Exclusion Criteria
You have a history of a different type of cancer than the one being studied.
Active or untreated central nervous system (CNS) metastases
You have a history of lung disease or inflammation.
You have a serious medical condition that is not under control.
Treatment Details
The trial is testing the safety and how well patients tolerate JAB-3312 when given with other drugs like Sotorasib, Binimetinib, Pembrolizumab, and Osimertinib. These combinations are for adults with advanced solid tumors to see which mix works best.
8Treatment groups
Experimental Treatment
Group I: JAB-3312+Sotorasib dose escalationExperimental Treatment2 Interventions
Dose escalation
Group II: JAB-3312+Pembrolizumab dose expansionExperimental Treatment2 Interventions
Dose expansion
Group III: JAB-3312+Pembrolizumab dose escalationExperimental Treatment2 Interventions
Dose escalation
Group IV: JAB-3312+Binimetinib dose expansionExperimental Treatment2 Interventions
Dose expansion
Group V: JAB-3312+ Sotorasib dose expansionExperimental Treatment2 Interventions
Dose expansion
Group VI: JAB-3312+ Osimertinib dose expansionExperimental Treatment2 Interventions
Dose expansion
Group VII: JAB-3312+ Osimertinib dose escalationExperimental Treatment2 Interventions
Dose escalation
Group VIII: JAB-3312+ Binimetinib dose escalationExperimental Treatment2 Interventions
Dose escalation
Binimetinib is already approved in United States, European Union, Canada, Japan for the following indications:
🇺🇸 Approved in United States as Mektovi for:
- Unresectable or metastatic melanoma with a BRAF V600E or V600K mutation
🇪🇺 Approved in European Union as Mektovi for:
- Unresectable or metastatic melanoma with a BRAF V600 mutation
🇨🇦 Approved in Canada as Mektovi for:
- Unresectable or metastatic melanoma with a BRAF V600E or V600K mutation
🇯🇵 Approved in Japan as Mektovi for:
- Unresectable or metastatic melanoma with a BRAF V600 mutation
Find a clinic near you
Research locations nearbySelect from list below to view details:
Research SiteOrange City, FL
Research SiteNew Haven, CT
Research SiteLos Angeles, CA
Research SiteChicago, IL
More Trial Locations
Loading ...
Who is running the clinical trial?
Jacobio Pharmaceuticals Co., Ltd.Lead Sponsor
AbbVieIndustry Sponsor