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Protein Kinase Inhibitor

JAB-3312 Combination Therapy for Advanced Cancer

Phase 1 & 2
Recruiting
Research Sponsored by Jacobio Pharmaceuticals Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG performance status score of 0 or 1.
Must have histologically or cytologically confirmed metastatic or locally advanced solid tumor. Some cohorts must meet specific expression or gene mutation where indicated
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Study Summary

This trial is testing a new drug to see if it is safe and tolerated in adults with advanced solid tumors.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects include typical reactions to cancer therapies such as nausea, fatigue, skin rash or itching. There may also be risks related to liver health due to hepatitis risk factors and potential heart rhythm changes because of QTc interval concerns.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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Your organs (heart, lungs, liver, kidneys) are working properly.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with dose limiting toxicities
Secondary outcome measures
Area under the plasma concentration-time curve (AUC)
Duration of response (DCR)
Duration of response (DOR)
+6 more

Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sotorasib
FDA approved
Binimetinib
2018
Completed Phase 3
~1100
Pembrolizumab
2017
Completed Phase 2
~1950
Osimertinib
FDA approved

Find a Location

Who is running the clinical trial?

Jacobio Pharmaceuticals Co., Ltd.Lead Sponsor
18 Previous Clinical Trials
1,370 Total Patients Enrolled
AbbVieIndustry Sponsor
946 Previous Clinical Trials
496,272 Total Patients Enrolled

Media Library

Binimetinib (Protein Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04720976 — Phase 1 & 2
Non-Small Cell Lung Cancer Clinical Trial 2023: Binimetinib Highlights & Side Effects. Trial Name: NCT04720976 — Phase 1 & 2
Binimetinib (Protein Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04720976 — Phase 1 & 2
Non-Small Cell Lung Cancer Research Study Groups: JAB-3312+Sotorasib dose escalation, JAB-3312+Pembrolizumab dose escalation, JAB-3312+ Binimetinib dose escalation, JAB-3312+Pembrolizumab dose expansion, JAB-3312+Binimetinib dose expansion, JAB-3312+ Osimertinib dose escalation, JAB-3312+ Sotorasib dose expansion, JAB-3312+ Osimertinib dose expansion

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies available in this research program for participants?

"That is correct. According to clinicaltrials.gov, the medical trial which was initially published on March 23rd 2021 is actively searching for eligible participants; 200 individuals are needed from 15 different sites."

Answered by AI

For what medical conditions is JAB-3312 typically prescribed?

"JAB-3312 is primarily used to fight malignant neoplasms, but it can also be utilized in cases of unresectable melanoma and microsatellite instability high. Additionally, this medication may have applications for those who need treatment after chemotherapy."

Answered by AI

What is the current size of enrolment for this clinical trial?

"Affirmative. As indicated in the trial records hosted on clinicaltrials.gov, this medical research is actively seeking participants; it was initially appended to the site on March 23rd 2021 and last edited on October 26th 2022. 200 people need to be recruited from 15 different healthcare facilities for this study to move forward."

Answered by AI

Are there numerous venues conducting this clinical research in North America?

"This clinical trial is running concurrently at 15 different sites, based in metropolitan areas such as Rochester, Los Angeles and New york. To make the most of your time if you choose to participate, consider looking for a location that is closest to where you live."

Answered by AI

Could you elaborate on what other research has been conducted regarding JAB-3312?

"At the City of Hope, investigations into JAB-3312 began a decade ago and have yielded 290 completed trials. As it stands, 1,011 ongoing studies are being conducted across Rochester Minnesota alone."

Answered by AI
~50 spots leftby Mar 2025