What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include chemotherapy, immunotherapy, and targeted therapies. Chemotherapy agents such as pemetrexed, carboplatin, and docetaxel often cause nausea, vomiting, fatigue, hair loss, and increased infection risk. Immunotherapy agents like pembrolizumab and nivolumab can lead to immune-related side effects including pneumonitis, colitis, hepatitis, and skin reactions. Targeted therapies, potentially similar to JAB-3312, may cause rash, diarrhea, liver enzyme abnormalities, and hypertension. The severity and frequency of these side effects can vary among patients.

What prior FDA approvals exist?

The FDA has approved several targeted therapies and immunotherapies for the treatment of Non-Small Cell Lung Cancer (NSCLC). Notable approvals include epidermal growth factor receptor (EGFR) inhibitors like erlotinib and osimertinib, which target specific mutations in the EGFR gene. Additionally, immune checkpoint inhibitors such as pembrolizumab, nivolumab, and atezolizumab have been approved for their ability to enhance the immune system's response against cancer cells by targeting PD-1/PD-L1 pathways. Bevacizumab, an angiogenesis inhibitor, has also been approved for use in combination with chemotherapy. These treatments aim to disrupt pathways critical for tumor growth and survival, similar to the investigational approach of JAB-3312.

What other types of research exist?

Promising novel alternatives for NSCLC patients include FLT3 inhibitors combined with non-cytotoxic agents like BCL-2 inhibitors, and therapies targeting the menin-MLL complex pathway. Additionally, pembrolizumab plus cetuximab and metronomic chemotherapy are being investigated for their efficacy in solid tumors and may offer potential benefits.

← Back to Search

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 be able to provide an archived tumor sample

Must not have

History of cancer that is histologically distinct from the cancers under study

Active or untreated central nervous system (CNS) metastases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

No Placebo-Only Group

Summary

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.

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.

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.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

You have a history of a different type of cancer than the one being studied.

Select...

You have a history of lung disease or inflammation.

Select...

You have a serious medical condition that is not under control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants with dose limiting toxicities

Secondary study objectives

Area under the plasma concentration-time curve (AUC)

Duration of response (DCR)

Duration of response (DOR)

+6 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~1250

Pembrolizumab

2017

Completed Phase 3

~3150

Osimertinib

FDA approved

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Non-Small Cell Lung Cancer (NSCLC) include targeted therapies and immunotherapies. Targeted therapies, such as EGFR antagonists, inhibit specific molecules that drive cancer cell proliferation and survival. Immunotherapies, like immune checkpoint inhibitors, enhance the immune system's ability to recognize and destroy cancer cells. These treatments are significant for NSCLC patients as they offer more personalized and potentially more effective options with fewer side effects compared to traditional chemotherapy. Investigational drugs like JAB-3312, which likely target pathways involved in solid tumor progression, aim to disrupt specific molecular mechanisms, providing hope for improved outcomes in advanced NSCLC.

Emerging therapeutic agents for lung cancer.A tabulated summary of targeted and biologic therapies for non-small-cell lung cancer.Targeted therapy for the treatment of advanced non-small cell lung cancer: a review of the epidermal growth factor receptor antagonists.