GEN-001 for Squamous Cell Carcinoma of the Head and Neck

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Squamous Cell Carcinoma of the Head and Neck+9 MoreGEN-001 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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
  • Squamous Cell Carcinoma of the Head and Neck
  • Bladder Cancer
  • Solid Tumors
  • Non-Small Cell Lung Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

Study Objectives

4 Primary · 7 Secondary · Reporting Duration: 2 years

Day 28
Dose Escalation: Incidence of dose-limiting toxicity (DLT)
1 years
Dose Escalation: Incidence of Adverse Events
Dose Escalation: Incidence of Laboratory abnormalities
Objective Response (OR)
2 years
Dose Expansion: To assess objective response (OR) of GEN-001 in patients with advanced or metastatic solid tumors, when administered as combined with avelumab.
up to 2 years
ADA
Ctrough
Duration of response (DoR)
Incidence of Adverse Events
Incidence of Laboratory Abnormalities
Microbiota
Overall Survival (OS)
Progression-free survival (PFS)
irOR (Immune-related Objective Response)

Trial Safety

Safety Progress

1 of 3

Similar Trials

Side Effects for

Single Arm-arm Phase II Study of Avelumab
60%Infusion related reaction
40%Nausea
40%Fatigue
40%Diarrhea
33%Constipation
27%Anorexia
27%Fall
27%Abdominal pain
20%Chills
20%Aspartate aminotransferase increased
20%Creatinine increased
20%Dyspnea
20%Generalized muscle weakness
20%Oral pain
20%Alanine aminotransferase increased
20%Hypocalcemia
13%Anemia
13%Cough
13%Weight loss
13%Fever
13%Dyspepsia
13%Localized edema
13%Back pain
13%Dizziness
7%Pain
7%Hyperglycemia
7%Flank pain
7%Myalgia
7%Pain in extremity
7%Confusion
7%Hypoxia
7%Skin and subcutaneous tissue disorders - Other, Specify: LEFT NOSTRIL SCAB
7%Skin and subcutaneous tissue disorders - Other, Specify: RASH LEFT KNEE, MACULO-PAPULAR
7%Rash maculo-papular
7%Gastrointestinal disorders - Other, Specify: TOOTH FRACTURE
7%Glucose intolerance
7%Surgical and medical procedures - Other Specify; Brain mass removal
7%Dehydration
7%Urinary incontinence
7%Arthralgia
7%Urine discoloration
7%Urinary urgency
7%Respiratory, thoracic and mediastinal disorders - Other, Specify: YAWNING
7%Pain of skin
7%Pruritus
7%Acute kidney injury
7%Thromboembolic event
7%Delirium
7%Syncope
7%Neoplasms benign malignant and unspecified (incl cysts and polyps) - Other Specify; Brain mets
7%Hypothyroidism
7%Atrial fibrillation
7%Eye disorders - Other, Specify: DIPLOPIA
7%Blurred vision
7%Vomiting
7%Infections and infestations - Other, Specify: C. DIF
7%Malaise
7%Skin infection
7%Hyperkalemia
7%Encephalopathy
7%Restlessness
7%Alkaline phosphatase increased
7%Musculoskeletal and connective tissue disorder - Other, Specify: GROIN STRAIN
7%Hypokalemia
7%Buttock pain
7%Urinary retention
7%Skin and subcutaneous tissue disorders - Other, Specify: WOUND ON BACK
7%Tumor pain
7%Nervous system disorders - Other, Specify: CAUDA EQUINA
7%Tremor
7%Surgical and medical procedures - Other, Specify: RIGHT PERCUTANEOUS NEPHROSTOMY TUBE PLACED
7%Nail discoloration
7%Skin and subcutaneous tissue disorders - Other, Specify: ABRASION RIGHT ELBOW
7%Skin and subcutaneous tissue disorders - Other, Specify: MONS PUBIS (HERPES)
7%Flushing
7%Memory impairment
7%Fracture
7%Investigations - Other, Specify: POSITIVE FOR BLOOD IN STOOL
7%Pericarditis
7%Neck pain
7%Blood bilirubin increased
7%Bloating
7%Hyponatremia
7%Sinus bradycardia
7%Musculoskeletal and connective tissue disorder - Other, Specify: MUSCLE CRAMPS
This histogram enumerates side effects from a completed 2020 Phase 2 trial (NCT03179410) in the Single Arm-arm Phase II Study of Avelumab ARM group. Side effects include: Infusion related reaction with 60%, Nausea with 40%, Fatigue with 40%, Diarrhea with 40%, Constipation with 33%.

Trial Design

1 Treatment Group

GEN-001 with avelumab
1 of 1

Experimental Treatment

93 Total Participants · 1 Treatment Group

Primary Treatment: GEN-001 · No Placebo Group · Phase 1

GEN-001 with avelumabExperimental Group · 2 Interventions: GEN-001, Avelumab · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Avelumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years

Who is running the clinical trial?

Merck KGaA, Darmstadt, GermanyIndustry Sponsor
429 Previous Clinical Trials
112,946 Total Patients Enrolled
5 Trials studying Squamous Cell Carcinoma of the Head and Neck
889 Patients Enrolled for Squamous Cell Carcinoma of the Head and Neck
PfizerIndustry Sponsor
4,308 Previous Clinical Trials
7,110,742 Total Patients Enrolled
4 Trials studying Squamous Cell Carcinoma of the Head and Neck
893 Patients Enrolled for Squamous Cell Carcinoma of the Head and Neck
Genome & CompanyLead Sponsor
1 Previous Clinical Trials
50 Total Patients Enrolled
Shivaani Kummar, MDPrincipal InvestigatorOregon Health and Science University
6 Previous Clinical Trials
353 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have the ability to swallow and retain oral medication and no clinically significant gastrointestinal abnormalities.
You have no evidence of disease or have an ECOG performance status of 0 or 1.
You have recovered from any clinically significant AEs that occurred during prior immunotherapy.
You have objective evidence of disease progression at baseline.