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Monoclonal Antibodies
INBRX-105 + Pembrolizumab for Head and Neck Cancer (PDL1x41BB Trial)
Phase 2
Recruiting
Research Sponsored by Inhibrx, 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2-3 years
Awards & highlights
PDL1x41BB Trial 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.
PDL1x41BB Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
Select...
My cancer has spread, doesn't respond to treatment, and can't be surgically removed.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My cancer has spread, doesn't respond to treatment, and there are no standard treatments left.
Select...
My cancer has spread and cannot be removed by surgery, and standard treatments have not worked or are not suitable for me.
Select...
My cancer has spread and doesn't respond to standard treatments.
PDL1x41BB Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2-3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2-3 years
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 moreOther outcome measures
Anti-tumor activity of INBRX-105
PDL1x41BB 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
Find a Location
Who is running the clinical trial?
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
Josep Garcia, PhDStudy DirectorInhibrx, Inc.
1 Previous Clinical Trials
240 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have active brain tumors or cancer spread to the brain, with certain exceptions.I am fully active or can carry out light work.My cancer has returned or didn't respond to treatment, and it's one of the specified types.I have or had lung inflammation treated with steroids or other immune-suppressing drugs.I haven't taken antibiotics in the last 4 weeks.My cancer has spread, doesn't respond to treatment, and can't be surgically removed.I haven't taken any experimental or approved cancer drugs in the last 4 weeks.I have a blood cancer such as leukemia, lymphoma, or myeloma.I have had an organ or bone marrow transplant.I have been treated with 4-1BB agonists before.I had severe side effects from previous immunotherapy that made me stop the treatment.I have had hepatitis or cirrhosis, but fit the exceptions.I have not had major surgery in the last 4 weeks.I have had cancer before, but it fits the exceptions allowed.I have a history of hepatitis B, C, or HIV, with some exceptions.My lung or head and neck cancer cannot be removed by surgery and has not responded to specific immune treatments.You have tested positive for PD-L1 using a specific method called immunohistochemistry.I am fully active or restricted in physically strenuous activity but can do light work.I have an autoimmune disease but haven't needed strong medication for it.I haven't taken any immune-weakening drugs in the last 4 weeks.My cancer did not respond to treatments targeting PD-1, PD-L1, or CTLA4.My cancer has been tested for PD-L1 and meets the required score for treatment.I do not have recent severe heart issues or uncontrolled high blood pressure.I have advanced NSCLC without prior treatment, my PD-L1 is between 1% and 49%, and I lack certain gene mutations.My cancer has spread, doesn't respond to treatment, and there are no standard treatments left.My cancer has spread and cannot be removed by surgery, and standard treatments have not worked or are not suitable for me.My cancer has spread and doesn't respond to standard treatments.I have not had a serious lung blood clot in the last 3 months.My blood, liver, and kidney functions are within normal ranges.
Research Study Groups:
This trial has the following groups:- Group 1: Expansion Cohort Nasopharyngeal or Oropharyngeal Carcinoma
- Group 2: Expansion Cohort Melanoma
- Group 3: INBRX-105 Escalation in Combination with Pembrolizumab
- Group 4: Expansion Cohort Non-small Cell Lung Cancer
- Group 5: Combination Expansion Cohort Non-small Cell Lung Cancer
- Group 6: Expansion Cohort PD-L1 Positive Basket
- Group 7: Combination Expansion Cohort Melanoma
- Group 8: Combination Expansion Cohort Cohort PD-L1 Positive Basket
- Group 9: Combination Expansion Cohort CPI Naive Non-small Cell Lung Cancer
- Group 10: Combination Expansion Cohort CPI Naive HNSCC
- Group 11: Single Agent Escalation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What health conditions is Pembrolizumab commonly used to address?
"Pembrolizumab is an effective therapy for malignant neoplasms, inoperable melanoma, and microsatellite instability high."
Answered by AI
How many medical facilities have implemented this experiment?
"At present, this experiment is being conducted at 13 sites throughout the country with locations ranging from Grand Rapids to Fairfax and West Valley City. Therefore, it would be advantageous for participants to choose a nearby site in order to limit travel burdens if they become involved."
Answered by AI
Are any new participants being added to this research trial?
"This clinically-verified trial is currently accepting participants, as stated on clinicaltrials.gov. It was first posted in January 2019 and has been updated recently in February 2022."
Answered by AI
What other research projects have employed Pembrolizumab to understand its effects?
"Pembrolizumab was initially tested in 2010 at the City of Hope. As of now, there are 251 completed studies with 963 currently recruiting patients; many of those trials taking place within Grand Rapids, Michigan."
Answered by AI
What is the size of the population being assessed in this experiment?
"Affirmative, the information on clinicaltrials.gov confirms that this trial is actively recruiting patients. It was first made available to the public on January 30th 2019 and its most recent update was February 2nd 2022. 170 individuals must be sourced from 13 different medical sites for participation in this project."
Answered by AI
What ultimate goals are the researchers aiming to accomplish with this medical experiment?
"This study will span up to 2-3 years and its core aim is to gauge the severity of INBRX-105's adverse events. Secondary objectives include ascertaining immunogenicity, establishing a time frame for Cmax (Tmax), and measuring AUC of serum concentrations in relation to INBRX-105."
Answered by AI
What potential risks can be associated with Pembrolizumab treatment?
"The safety profile of Pembrolizumab was assessed at a score 1 due to the experimental nature of this Phase 1 trial, with limited evidence supporting its efficacy and safety."
Answered by AI
Who else is applying?
What state do they live in?
Georgia
How old are they?
18 - 65
What site did they apply to?
Emory University - Winship Cancer Institute
What portion of applicants met pre-screening criteria?
Met criteria
How responsive is this trial?
Typically responds via
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