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Monoclonal Antibodies

INBRX-105 + Pembrolizumab for Head and Neck Cancer (PDL1x41BB Trial)

Phase 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
Patients with Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
Patients with relapsed or refractory non-small cell lung cancer, cutaneous melanoma, head and neck squamous cell carcinoma, MSI/TMB-high or MMRd solid tumors
Must not have
Active interstitial lung disease (ILD) or pneumonitis or a history of ILD or pneumonitis requiring treatment with steroids or other immunosuppressive medications
Anti-infectious drug treatments (i.e., antibiotics) within 4 weeks prior to the first dose of study drug
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2-3 years
Awards & highlights

Summary

This trial will test the safety of a new drug, INBRX-105, to see what doses are tolerated by humans. The drug targets the human PD-L1 receptor and the human 4-1BB receptor.

Who is the study for?
This trial is for adults with certain advanced solid tumors, including lung, head and neck, stomach, kidney cancers and melanoma. Participants must have tried standard treatments without success or have no other options available. They should be in good physical condition (ECOG PS of 0 or 1) and have proper organ function. Those with untreated non-small cell lung cancer (NSCLC) must show a specific level of PD-L1 protein presence.Check my eligibility
What is being tested?
The study tests INBRX-105 alone and combined with Pembrolizumab in patients to find the safest dose that can be tolerated. INBRX-105 is an innovative antibody targeting two proteins on cancer cells: PD-L1 which helps them hide from the immune system, and 4-1BB which activates T-cells against the tumor.See study design
What are the potential side effects?
Possible side effects include reactions related to immune system activation such as inflammation in various organs, skin rashes, fatigue, changes in blood counts leading to increased infection risk or bleeding tendencies. Specific side effects will depend on how each patient's body reacts to the treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or can carry out light work.
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My cancer has returned or didn't respond to treatment, and it's one of the specified types.
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My cancer has spread, doesn't respond to treatment, and can't be surgically removed.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My cancer has spread, doesn't respond to treatment, and there are no standard treatments left.
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My cancer has spread and cannot be removed by surgery, and standard treatments have not worked or are not suitable for me.
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My cancer has spread and doesn't respond to standard treatments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have or had lung inflammation treated with steroids or other immune-suppressing drugs.
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I haven't taken antibiotics in the last 4 weeks.
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I have a blood cancer such as leukemia, lymphoma, or myeloma.
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I have had an organ or bone marrow transplant.
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I have been treated with 4-1BB agonists before.
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I have not had major surgery in the last 4 weeks.
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I do not have recent severe heart issues or uncontrolled high blood pressure.
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I have not had a serious lung blood clot in the last 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2-3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2-3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Frequency of adverse events of INBRX-105
Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of INBRX-105
Severity of adverse events of INBRX-105
Secondary outcome measures
Area under the serum concentration time curve (AUC) of INBRX-105
Immunogenicity of INBRX-105
Maximum observed serum concentration (Cmax) of INBRX-105
+2 more
Other outcome measures
Anti-tumor activity of INBRX-105

Trial Design

11Treatment groups
Experimental Treatment
Group I: Single Agent EscalationExperimental Treatment1 Intervention
INBRX-105 will be escalated in patients with locally advanced or metastatic solid tumors.
Group II: INBRX-105 Escalation in Combination with PembrolizumabExperimental Treatment2 Interventions
INBRX-105 will be escalated in combination with Pembrolizumab in pateitns with locally advanced or metastatic solid tumors.
Group III: Expansion Cohort PD-L1 Positive BasketExperimental Treatment1 Intervention
Patients with gastric or gastro-esophageal junction adenocarcinoma, renal cell carcinoma, and urothelial (transitional) cell carcinoma will be treated with single-agent INBRX-105 at either the MTD or RP2D.
Group IV: Expansion Cohort Non-small Cell Lung CancerExperimental Treatment1 Intervention
Patients will be treated with single-agent INBRX-105 at either the MTD or RP2D.
Group V: Expansion Cohort Nasopharyngeal or Oropharyngeal CarcinomaExperimental Treatment1 Intervention
Patients with head and neck squamous cell carcinoma (NPC or OPC) will be treated with single-agent INBRX-105 at either the MTD or RP2D.
Group VI: Expansion Cohort MelanomaExperimental Treatment1 Intervention
Patients will be treated with single-agent INBRX-105 at either the MTD or RP2D.
Group VII: Combination Expansion Cohort Non-small Cell Lung CancerExperimental Treatment2 Interventions
CPI relapsed/refractory patients will be treated with INBRX-105 in combination with Pembrolizumab.
Group VIII: Combination Expansion Cohort MelanomaExperimental Treatment2 Interventions
CPI relapsed/refractory patients will be treated with INBRX-105 in combination with Pembrolizumab.
Group IX: Combination Expansion Cohort Cohort PD-L1 Positive BasketExperimental Treatment2 Interventions
CPI-relapsed/refractory patients with head and neck squamous cell carcinoma, gastro-esophageal junction adenocarcinoma, renal cell carcinoma, and urothelial (transitional) cell carcinoma will be treated with INBRX-105 in combination with Pembrolizumab.
Group X: Combination Expansion Cohort CPI Naive Non-small Cell Lung CancerExperimental Treatment2 Interventions
CPI naive patients (PD-L1 IHC between 1 and 49%) will be treated with INBRX-105 in combination with Pembrolizumab.
Group XI: Combination Expansion Cohort CPI Naive HNSCCExperimental Treatment1 Intervention
CPI naive patients (PD-L1 IHC >50%) will be treated with INBRX-105 in combination with Pembrolizumab.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010

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
Common treatments for stomach cancer include immune checkpoint inhibitors like pembrolizumab and nivolumab, which target the PD-1/PD-L1 pathway. These drugs work by blocking the interaction between PD-1 on T-cells and PD-L1 on tumor cells, thereby enhancing the immune system's ability to attack cancer cells. Additionally, 4-1BB agonists, such as those being studied in the INBRX-105 trial, provide localized T-cell co-stimulation, further boosting the immune response against the tumor. These mechanisms are crucial for stomach cancer patients as they offer a targeted approach to enhance the body's natural defenses, potentially leading to better outcomes and fewer side effects compared to traditional chemotherapy.
Compound-therapy based on cancer-immunity cycle: promising prospects for antitumor regimens.Characteristics of Real-World Metastatic Non-Small Cell Lung Cancer Patients Treated with Nivolumab and Pembrolizumab During the Year Following Approval.The challenge of targeted therapies for gastric cancer patients: the beginning of a long journey.

Find a Location

Who is running the clinical trial?

Inhibrx Biosciences, IncLead Sponsor
6 Previous Clinical Trials
913 Total Patients Enrolled
Inhibrx, Inc.Lead Sponsor
8 Previous Clinical Trials
1,447 Total Patients Enrolled
Klaus Wagner, MD, PhDStudy DirectorInhibrx, Inc.
2 Previous Clinical Trials
181 Total Patients Enrolled

Media Library

INBRX-105 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03809624 — Phase 2
Stomach Cancer Research Study Groups: Expansion Cohort Nasopharyngeal or Oropharyngeal Carcinoma, Expansion Cohort Melanoma, INBRX-105 Escalation in Combination with Pembrolizumab, Expansion Cohort Non-small Cell Lung Cancer, Combination Expansion Cohort Non-small Cell Lung Cancer, Expansion Cohort PD-L1 Positive Basket, Combination Expansion Cohort Melanoma, Combination Expansion Cohort Cohort PD-L1 Positive Basket, Combination Expansion Cohort CPI Naive Non-small Cell Lung Cancer, Combination Expansion Cohort CPI Naive HNSCC, Single Agent Escalation
Stomach Cancer Clinical Trial 2023: INBRX-105 Highlights & Side Effects. Trial Name: NCT03809624 — Phase 2
INBRX-105 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03809624 — Phase 2
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