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PD-L1 Inhibitor

GEN-001 for 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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

All Individual Drugs Already Approved

Summary

This trial tests a new drug, GEN-001, combined with an existing treatment, avelumab, in patients with advanced cancers that haven't responded to other treatments. The goal is to see if this combination can help the immune system better fight cancer. Avelumab is an immunotherapy drug that has shown promise in treating various cancers, including bladder cancer, by improving overall survival.

Eligible Conditions

Squamous Cell Carcinoma
Solid Tumors
Non-Small Cell Lung Cancer
Bladder Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dose Escalation: Incidence of Adverse Events

Dose Escalation: Incidence of Laboratory abnormalities

Dose Escalation: Incidence of dose-limiting toxicity (DLT)

+1 more

Secondary study objectives

Duration of response (DoR)

Incidence of Adverse Events

Incidence of Laboratory Abnormalities

+3 more

Other study objectives

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

General disorders and administration site conditions

Nervous system disorders

Endocrine disorders

Metabolism and nutrition disorders

Investigations

Cardiac disorders

Gastrointestinal disorders

Infections and infestations

Immune system disorders

Blood and lymphatic system disorders

Neoplasms benign, malignant and unspecified

Respiratory, thoracic and mediastinal disorders

Renal and urinary disorders

Skin and subcutaneous tissue disorders

100%

80%

60%

40%

20%

Study treatment Arm

Avelumab

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active 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

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

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