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Pembrolizumab for Nasopharyngeal Carcinoma

Massachusetts General Hospital, Boston, MA
Nasopharyngeal Carcinoma+22 More ConditionsPembrolizumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Nasopharyngeal Nonkeratinizing Carcinoma
  • Nasopharyngeal Carcinoma
  • Nasopharyngeal Cancer
  • Stage III Nasopharyngeal Carcinoma
  • Oral Cancer
  • Head and Neck Squamous Cell Carcinoma (HNSCC)
  • Non-Small Cell Lung Cancer
  • Melanoma
  • Bladder Cancer
  • Stage IV Nasopharyngeal Carcinoma
  • Kidney Cancer
  • Esophageal Cancer
  • Stage I Nasopharyngeal Carcinoma
  • Nonkeratinizing Nasopharyngeal Carcinoma
  • Solid Metastatic Tumor
  • Stage II Nasopharyngeal Carcinoma
  • Stage IVC Nasopharyngeal Carcinoma
  • Stage IVA Nasopharyngeal Carcinoma
  • Metastatic Nasopharyngeal Undifferentiated Carcinoma
  • Stomach Cancer

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Similar Trials

1
PDR001
1
ATRC-101
1
Pembrolizumab

Study Objectives

3 Primary · 5 Secondary · Reporting Duration: Up to 2-3 years

Up to 2-3 years
Anti-tumor activity of INBRX-105
Area under the serum concentration time curve (AUC) of INBRX-105
Frequency of adverse events of INBRX-105
Immunogenicity of INBRX-105
Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of INBRX-105
Maximum observed serum concentration (Cmax) of INBRX-105
Severity of adverse events of INBRX-105
Time to Cmax (Tmax) of INBRX-105
Trough observed serum concentration (Ctrough) of INBRX-105

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
PDR001
1
ATRC-101
1
Pembrolizumab

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

14 Treatment Groups

Expansion Cohort Nasopharyngeal or Oropharyngeal Carcinoma
1 of 14
Combination Expansion Cohort Non-small Cell Lung Cancer
1 of 14
Combination Expansion Cohort CPI Naive Non-small Cell Lung Cancer
1 of 14
Combination Expansion Cohort Melanoma
1 of 14
Expansion Cohort Head and Neck Squamous Cell Carcinoma
1 of 14
Expansion Cohort Non-small Cell Lung Cancer
1 of 14
Combination Expansion Cohort HNSCC
1 of 14
Combination Expansion Cohort Treatment Naive Non-small Cell Lung Cancer
1 of 14
Combination Expansion Cohort CPI Naive HNSCC
1 of 14
Combination Expansion Cohort Cohort PD-L1 Positive Basket
1 of 14
Single Agent Escalation
1 of 14
Expansion Cohort Melanoma
1 of 14
Expansion Cohort PD-L1 Positive Basket
1 of 14
INBRX-105 Escalation in Combination with Pembrolizumab
1 of 14

Experimental Treatment

300 Total Participants · 14 Treatment Groups

Primary Treatment: Pembrolizumab · No Placebo Group · Phase 2

Expansion Cohort Nasopharyngeal or Oropharyngeal Carcinoma
Drug
Experimental Group · 1 Intervention: INBRX-105 - PDL1x41BB antibody · Intervention Types: Drug
Combination Expansion Cohort Non-small Cell Lung CancerExperimental Group · 2 Interventions: Pembrolizumab, INBRX-105 - PDL1x41BB antibody · Intervention Types: Drug, Drug
Combination Expansion Cohort CPI Naive Non-small Cell Lung CancerExperimental Group · 2 Interventions: Pembrolizumab, INBRX-105 - PDL1x41BB antibody · Intervention Types: Drug, Drug
Combination Expansion Cohort MelanomaExperimental Group · 2 Interventions: Pembrolizumab, INBRX-105 - PDL1x41BB antibody · Intervention Types: Drug, Drug
Expansion Cohort Head and Neck Squamous Cell Carcinoma
Drug
Experimental Group · 1 Intervention: INBRX-105 - PDL1x41BB antibody · Intervention Types: Drug
Expansion Cohort Non-small Cell Lung Cancer
Drug
Experimental Group · 1 Intervention: INBRX-105 - PDL1x41BB antibody · Intervention Types: Drug
Combination Expansion Cohort HNSCCExperimental Group · 2 Interventions: Pembrolizumab, INBRX-105 - PDL1x41BB antibody · Intervention Types: Drug, Drug
Combination Expansion Cohort Treatment Naive Non-small Cell Lung CancerExperimental Group · 2 Interventions: Pembrolizumab, INBRX-105 - PDL1x41BB antibody · Intervention Types: Drug, Drug
Combination Expansion Cohort CPI Naive HNSCC
Drug
Experimental Group · 1 Intervention: INBRX-105 - PDL1x41BB antibody · Intervention Types: Drug
Combination Expansion Cohort Cohort PD-L1 Positive BasketExperimental Group · 2 Interventions: Pembrolizumab, INBRX-105 - PDL1x41BB antibody · Intervention Types: Drug, Drug
Single Agent Escalation
Drug
Experimental Group · 1 Intervention: INBRX-105 - PDL1x41BB antibody · Intervention Types: Drug
Expansion Cohort Melanoma
Drug
Experimental Group · 1 Intervention: INBRX-105 - PDL1x41BB antibody · Intervention Types: Drug
Expansion Cohort PD-L1 Positive Basket
Drug
Experimental Group · 1 Intervention: INBRX-105 - PDL1x41BB antibody · Intervention Types: Drug
INBRX-105 Escalation in Combination with PembrolizumabExperimental Group · 2 Interventions: Pembrolizumab, INBRX-105 - PDL1x41BB antibody · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2-3 years

Who is running the clinical trial?

Inhibrx, Inc.Lead Sponsor
5 Previous Clinical Trials
895 Total Patients Enrolled
Klaus Wagner, MD, PhDStudy DirectorInhibrx, Inc.
3 Previous Clinical Trials
411 Total Patients Enrolled
Vasily Andrianov, MDStudy DirectorInhibrx, Inc.
4 Previous Clinical Trials
805 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have advanced stage non-small cell lung cancer or head and neck cancer that cannot be surgically removed.
You have advanced or spreading non-small cell lung cancer, skin melanoma, head and neck cancer, or other cancer that cannot be removed with surgery. Your cancer has not responded to standard treatments, or there are no other treatment options available.

Who else is applying?

What state do they live in?
Georgia100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Emory University - Winship Cancer Institute100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%

How responsive is this trial?

Typically responds via
Email100.0%
References

Frequently Asked Questions

What health conditions is Pembrolizumab commonly used to address?

"Pembrolizumab is an effective therapy for malignant neoplasms, inoperable melanoma, and microsatellite instability high." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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