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Monoclonal Antibodies

INBRX-106 + Pembrolizumab for Lung Cancer

Verified Trial

Phase 1 & 2

Recruiting

Research Sponsored by Inhibrx Biosciences, Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has your disease progressed or came back despite treatment?

Do you have locally advanced or metastatic non-small cell lung cancer?

Must not have

Has your tumor tested positive for the EGFR mutations and/or the ALK gene? Check your biomarker test results.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up ~2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying a new drug to see if it is safe and effective at treating locally advanced or metastatic non small cell lung cancer when given in combination with pembrolizumab (Keytruda).

Who is the study for?

This trial is for adults with advanced non-small cell lung cancer who have tried at least one standard of care treatment. They must not have certain gene mutations (EGFR, ALK) or prior exposure to OX40 agonists and should be free of serious heart conditions, active infections, and immune-related side effects from previous therapies.

What is being tested?

The study tests INBRX-106 alone and combined with Pembrolizumab (keytruda) in different doses to find the safest and most effective amount for treating solid tumors.

What are the potential side effects?

Possible side effects include typical immune therapy reactions like inflammation in various organs, skin rashes, fatigue, and potential worsening of existing heart conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My disease has worsened or returned after treatment.

Exclusion Criteria

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ ~2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and ~2 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Antitumor activity of INBRX-106 in combination with pembrolizumab in expansion cohorts

Frequency and severity of adverse events of INBRX-106 in combination with pembrolizumab and chemotherapy in adults with locally advanced or metastatic NSCLC

Frequency of adverse events of INBRX-106 as single agent and in combination with pembrolizumab

+2 more

Secondary study objectives

Area under the serum concentration time curve (AUC) of INBRX-106

Immunogenicity of INBRX-106

Maximum observed serum concentration (Cmax) of INBRX-106

+2 more

Other study objectives

Anti-tumor activity of INBRX-106 as single agent and in combination with pembrolizumab with or without chemotherapy

Awards & Highlights

No Placebo-Only Group

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

Trial Design

14Treatment groups

Experimental Treatment

Active Control

Group I: Part 4(Cohort F7c)INBRX-106 Expansion with pembrolizumab, (Nab)-paclitaxel and carboplatin in NSCLCExperimental Treatment2 Interventions

Subjects with advanced/metastatic NSCLC, any PD-L1 TPS will be treated with INBRX-106 0.1mg/kg, 200mg pembrolizumab, 200mg/m2 paclitaxel and carboplatin AUC-6 IV every 3 weeks OR INBRX-106, 200mg pembrolizumab, 100mg/m2 nab-paclitaxel (dosed Days 1,8 and 15 every cycle) and carboplatin AUC-6 IV every 3 weeks. Treating physician to determine if paclitaxel or nab-paclitaxel will be given

Group II: Part 4 (Cohort F7b) INBRX-106 Expansion with pembrolizumab, pemetrexed and cisplatin in NSCLCExperimental Treatment5 Interventions

Subjects with advanced/metastatic NSCLC, any PD-L1 TPS will be treated with INBRX-106 0.1mg/kg, 200mg pembrolizumab, 500mg/m2 pemetrexed and 75mg/m2 cisplatin IV every 3 weeks

Group III: Part 4 (Cohort F7a) INBRX-106 Expansion with pembrolizumab, pemetrexed and carboplatin in NSCLCExperimental Treatment4 Interventions

Subjects with advanced/metastatic NSCLC, any PD-L1 TPS will be treated with INBRX-106 0.1mg/kg, 200mg pembrolizumab, 500mg/m2 pemetrexed and carboplatin AUC-5 IV every 3 weeks

Group IV: Part 4 (Cohort F6) INBRX-106 Expansion with pembrolizumab in Uveal MelanomaExperimental Treatment4 Interventions

Subjects with ocular (uveal) melanoma who are relapsed or refractory to checkpoint inhibitor (CPI) therapy will be treated with INBRX-106 and 200 mg pembrolizumab IV every 3 weeks

Group V: Part 4 (Cohort F5)INBRX-106 Expansion with pembrolizumab in MSI/TMB-high/MMRd tumors Not RecuritingExperimental Treatment2 Interventions

Subjects with solid tumors that have confirmed MSI-high, TMB-high or MMR-deficient states who are relapsed or refractory to checkpoint inhibitor (CPI) therapy will be treated with INBRX-106 and 200 mg pembrolizumab IV every 3 weeks

Group VI: Part 4 (Cohort F4) INBRX-106 Expansion in Combination with pembrolizumabExperimental Treatment2 Interventions

Subjects with melanoma (any type), head and neck squamous cell carcinoma (non-nasopharyngeal) OR nasopharyngeal carcinoma, MSI-high, TMB-high or MMR-deficient tumors, will be treated with INBRX-106 in combination with 200mg pembrolizumab IV every 3 weeks.

Group VII: Part 4 (Cohort F3d) INBRX-106 Expansion in Combination with pembrolizumab in NSCLC (concurrent)Experimental Treatment1 Intervention

Subjects with non-small cell lung cancer will be treated concurrently every 6 weeks with INBRX-106 0.1 mg/kg and 200 mg pembrolizumab IV every 3 weeks. This is one of the randomized cohorts.

Group VIII: Part 4 (Cohort F3b) INBRX-106 Expansion in Combination with pembrolizumab in NSCLCExperimental Treatment3 Interventions

Subjects with non-small cell lung cancer will be given a 0.3 mg/kg priming dose of INBRX-106 in cycle 1, followed by 0.1 mg/kg INBRX-106 and 200 mg pembrolizumab IV every 3 weeks in subsequent cycles. This is one of the randomized cohorts.

Group IX: Part 4 (Cohort F3a) INBRX-106 Expansion in Combination with pembrolizumab in NSCLC (alternating)Experimental Treatment2 Interventions

Subjects with non-small cell lung cancer will be treated with alternating dosing of INBRX-106 0.3 mg/kg Q6W and 400 mg pembrolizumab IV Q6W. This is one of the randomized cohorts.

Group X: Part 3 INBRX-106 Escalation in Combination with pembrolizumab (Not Recruiting)Experimental Treatment2 Interventions

INBRX-106 will be escalated, in combination with pembrolizumab, in subjects with locally advanced or metastatic solid tumors.

Group XI: Part 2 (Cohorts C1/C2) INBRX-106 Escalation in Various Solid Tumor Types (Not Recruiting)Experimental Treatment2 Interventions

Subjects with melanoma (any type), head and neck squamous cell carcinoma, renal cell carcinoma, urothelial carcinoma or MSI/TMB-high tumors that are relapsed or refractory to prior checkpoint inhibitor (CPI) therapy will be treated with INBRX-106

Group XII: Part 2 (Cohort C3) INBRX-106 Escalation in NSCLCExperimental Treatment1 Intervention

Subjects with non-small cell carcinoma relapsed or refractory to prior checkpoint inhibitor (CPI) therapy will be treated with INBRX-106

Group XIII: Part 1 INBRX-106 Escalation (Not Recruiting)Experimental Treatment1 Intervention

INBRX-106 will be escalated in subjects with locally advanced or metastatic solid tumors.

Group XIV: Part 4 (Cohort F3c) Pembrolizumab Expansion Arm (Not Recruiting)Active Control1 Intervention

Subjects with non-small cell lung cancer will be treated with 200 mg pembrolizumab IV every 3 weeks. This is one of the randomized cohorts.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Paclitaxel 200mg/m2

2017