GEN1053 for Solid Tumors, Adult

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Sarah Cannon Research Institute - Tennessee Oncology Nashville, Nashville, TN
Solid Tumors, Adult+1 More
GEN1053 - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The drug that will be investigated in the study is GEN1053. GEN1053 is an antibody designed to (re)activate and increase antitumor immunity. Since this is the first study of GEN1053 in humans, the main purpose is to evaluate safety. Besides safety, the study will determine the recommended GEN1053 dose to be tested in a larger group of participants and assess preliminary clinical activity of GEN1053. GEN1053 will be studied in a broad group of cancer patients, having different kinds of solid tumors. All participants will get GEN1053. The study consists of two parts: Part 1 tests increasing doses of GEN1053 ("escalation"), followed by Part 2 which tests the recommended phase 2 dose GEN1053 dose from Part 1 ("expansion").

Eligible Conditions

  • Solid Tumors, Adult

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Solid Tumors, Adult

Study Objectives

3 Primary · 11 Secondary · Reporting Duration: Throughout the trial until the end of the safety follow-up period (60 days after last dose)

Day 60
Anti-drug antibody response (ADA)
Maximum (peak) concentration (Cmax) after dosing
Day 21
Escalation: Dose Limiting Toxicities (DLTs)
Year 5
Disease control rate (DCR)
Duration of response (DOR)
Reduction in tumor size according to response assessment by Objective Response (ORR)
Day 60
Adverse Events (AEs) by incidence and severity
Amount of drug in the body (volume of distribution)
Area-under-the-concentration-time curve (AUC0-C last) and from time 0 to last quantifiable sample (AUC0-C infinity)
Elimination half-life of the drug (T1/2)
Number of participants with clinically significant shifts from baseline in clinical laboratory parameters
Rate at which the drug is removed from the body (clearance)
Time after dosing at which Cmax was observed (Tmax)
Time after dosing at which the lowest drug concentration is observed before the next dose is administered, pre-dose trough concentration (CTrough)

Trial Safety

Safety Progress

1 of 3

Other trials for Solid Tumors, Adult

Trial Design

1 Treatment Group

GEN1053 Monotherapy
1 of 1
Experimental Treatment

103 Total Participants · 1 Treatment Group

Primary Treatment: GEN1053 · No Placebo Group · Phase 1 & 2

GEN1053 Monotherapy
Biological
Experimental Group · 1 Intervention: GEN1053 · Intervention Types: Biological

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: throughout the trial until the end of the safety follow-up period (60 days after last dose)
Closest Location: Sarah Cannon Research Institute - Tennessee Oncology Nashville · Nashville, TN
Photo of Nashville 1Photo of Nashville 2Photo of Nashville 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Solid Tumors, Adult
0 CompletedClinical Trials

Who is running the clinical trial?

GenmabLead Sponsor
40 Previous Clinical Trials
6,929 Total Patients Enrolled
BioNTech SEIndustry Sponsor
47 Previous Clinical Trials
82,474 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are 18 years of age or older.
You have had at least one prior radiographic failure of the disease.
ANC > 1.5×10^9/L.\n
Total bilirubin ≤ upper limit of normal (ULN).
You have a hemoglobin level of at least 9.0 g/dL.
Platelet count ≥150×10^9/L.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.