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PD-L1 Inhibitor

GEN-001 for Oral Squamous Cell Carcinoma

Phase 1
Waitlist Available
Led By Shivaani Kummar, MD
Research Sponsored by Genome & Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Disease progression on anti-PD-(L)1 based therapy (as monotherapy or combination therapy) and must meet criteria for acquired resistance as defined in the protocol
Estimated life expectancy of at least 3 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial is testing a new drug, GEN-001, to see if it is safe and has any effect on solid tumors that have progressed despite treatment with other drugs.

Eligible Conditions
  • Oral Squamous Cell Carcinoma
  • Solid Tumors
  • Non-Small Cell Lung Cancer
  • Squamous Cell Carcinoma
  • Bladder Cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
Your disease has gotten worse while receiving a type of treatment called anti-PD-(L)1 therapy, either by itself or in combination with other treatments. You must also meet specific criteria for how your disease has changed.
Select...
You are expected to live for at least 3 more months.
Select...
You have been diagnosed with advanced lung cancer, head and neck cancer, or bladder cancer that cannot be surgically removed.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose Escalation: Incidence of Adverse Events
Dose Escalation: Incidence of Laboratory abnormalities
Dose Escalation: Incidence of dose-limiting toxicity (DLT)
+1 more
Secondary outcome measures
Duration of response (DoR)
Incidence of Adverse Events
Incidence of Laboratory Abnormalities
+4 more
Other outcome measures
ADA
Ctrough
Microbiota

Side effects data

From 2020 Phase 2 trial • 19 Patients • NCT03006848
17%
Musculoskeletal and connective tissue disorders
11%
Injury, poisoning and procedural complications
6%
Nervous system disorders
6%
Gastrointestinal disorders
6%
General disorders and administration site conditions
6%
Metabolism and nutrition disorders
6%
Immune system disorders
6%
Investigations
6%
Cardiac disorders
6%
Endocrine disorders
6%
Blood and lymphatic system disorders
6%
Neoplasms benign, malignant and unspecified
6%
Infections and infestations
6%
Respiratory, thoracic and mediastinal disorders
6%
Renal and urinary disorders
6%
Skin and subcutaneous tissue disorders
100%
80%
60%
40%
20%
0%
Study treatment Arm
Avelumab

Trial Design

1Treatment groups
Experimental Treatment
Group I: GEN-001 with avelumabExperimental Treatment2 Interventions
Dose Escalation Cohort includes patients with advanced or metastatic solid tumors who have progressed on at least two lines of approved therapy for their histological subtypes which includes an anti-PD-1 or anti-PD-L1 based therapy (as mono or combination) will be enrolled. 3 or 6 patients will be enrolled per escalating or de-escalating dose levels. Dose Expansion Cohort includes patients with advanced or metastatic NSCLC, SCCHN, and UC who have progressed on at least two lines of approved therapy for their histological subtypes which includes an anti-PD-1 or anti-PD-L1 based therapy (as mono or combination)will be enrolled.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Avelumab
FDA approved
GEN-001
2020
Completed Phase 1
~20

Find a Location

Who is running the clinical trial?

Merck KGaA, Darmstadt, GermanyIndustry Sponsor
435 Previous Clinical Trials
114,611 Total Patients Enrolled
PfizerIndustry Sponsor
4,556 Previous Clinical Trials
10,907,672 Total Patients Enrolled
Genome & CompanyLead Sponsor
3 Previous Clinical Trials
270 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does GEN-001 pose any potential hazards for humans?

"Due to the preliminary nature of GEN-001, Power assigned a score of 1 in regards to its safety profile. This is because there are limited data regarding both efficacy and protection from harm at this stage of development."

Answered by AI

Could you provide a compendium of clinical trials involving GEN-001?

"The journey of GEN-001 began in 2014 at Port Macquarie Base Hospital, and 48 trials have since been completed. Currently 111 more are currently recruiting patients, with a significant amount of the studies being hosted out of Atlanta, Georgia."

Answered by AI

Is this investigation a pioneering endeavor?

"A multitude of clinical trials involving GEN-001 are currently underway, spanning 1024 cities and 52 nations. The foremost trial for this medication was conducted by EMD Serono Research & Development Institute in 2014 - which included 204 patients and successfully concluded its Phase 2 drug approval procedure. Since said study's conclusion, 48 more have been carried out."

Answered by AI

What is the scope of enrollment for this research trial?

"Affirmative, according to information hosted on clinicaltrials.gov the medical trial is actively enrolling patients at this time. It was initially published on October 26th 2020 and its last edits were made in August 1st 2022; with 93 candidates being sought from 3 different locations."

Answered by AI

Is enrollment now open for this research endeavor?

"Confirmed - this clinical trial is currently open for enrollment. The study was initially made available to the public on October 26th 2020 and its details were most recently updated on August 1st 2022."

Answered by AI
~2 spots leftby Mar 2025