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Monoclonal Antibodies

GEN1042 for Advanced Cancers

Phase 1 & 2
Recruiting
Research Sponsored by Genmab
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects with non-CNS solid tumors that is metastatic or unresectable and for whom there is no available standard therapy.
Subjects with a confirmed diagnosis of relapsed or refractory, advanced and/or metastatic melanoma, NSCLC, or CRC and for whom there is no available standard therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the start of the study treatment until death due to any cause, assessed up to 36 months after the last subject's first treatment in the trial.
Awards & highlights
No Placebo-Only Group

Study Summary

This trial will test how safe and effective GEN1042 is in treating patients with metastatic or locally advanced solid tumors.

Who is the study for?
Adults with certain advanced cancers (melanoma, NSCLC, CRC, HNSCC, PDAC) that have relapsed or are untreatable with no standard therapy available. Participants must be in good physical condition and have not had recent cancer treatments or surgeries. Those with autoimmune diseases, severe allergies to monoclonal antibodies, ongoing pneumonitis, or requiring high-dose steroids are excluded.Check my eligibility
What is being tested?
The trial is testing GEN1042's safety and effectiveness against tumors when used alone or combined with other cancer drugs like Paclitaxel and Pembrolizumab. It targets patients who've exhausted standard treatments for their metastatic solid tumors.See study design
What are the potential side effects?
Potential side effects may include allergic reactions similar to those from other antibody therapies; however specific side effects of GEN1042 will be monitored given it's a new treatment under investigation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer has spread, cannot be surgically removed, and there's no standard treatment for it.
Select...
My melanoma, NSCLC, or CRC has returned or didn’t respond to treatment, and there’s no standard treatment left.
Select...
I am receiving treatment alone, not combined with other treatments.
Select...
My cancer has spread, cannot be surgically removed, and there's no standard treatment for it.
Select...
My melanoma, NSCLC, or CRC has returned or didn’t respond to treatment and there’s no standard therapy left for me.
Select...
I am part of the dose expansion phase of a combination therapy trial.
Select...
I have advanced melanoma that cannot be surgically removed and haven't received systemic treatment for it.
Select...
My liver, kidneys, heart, and bone marrow are functioning well.
Select...
My head/neck cancer has returned or spread, hasn't been treated yet, and shows PD-L1.
Select...
I am 18 years old or older.
Select...
My lung cancer is advanced, and I haven't had any cancer treatments yet.
Select...
I have metastatic pancreatic cancer and haven't received any treatment for it.
Select...
I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the start of the study treatment until death due to any cause, assessed up to 36 months after the last subject's first treatment in the trial.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the start of the study treatment until death due to any cause, assessed up to 36 months after the last subject's first treatment in the trial. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective Response Rate (ORR)
Percentage of Subjects With Dose-Limiting Toxicities (DLT)
Secondary outcome measures
Disease Control Rate (DCR)
Dose Escalation: Area Under the Concentration Time Curve (AUC) of GEN1042
Dose Escalation: Half-life (t1/2) of GEN1042
+9 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Monotherapy - Dose Escalation and Dose Expansion partsExperimental Treatment1 Intervention
Escalating doses of GEN1042 monotherapy in subjects with non-central nervous system (CNS) solid malignant tumors followed by monotherapy expansion cohorts at selected dose(s) in subjects with relapsed or refractory, advanced and/or metastatic melanoma, or non-small-cell lung cancer (NSCLC), or colorectal cancer (CRC).
Group II: Combination Therapy - Dose Expansion PartExperimental Treatment9 Interventions
GEN1042 safety and efficacy will be evaluated in combination with pembrolizumab with or without chemotherapy in treatment-naive subjects with advanced or metastatic melanoma, non-small-cell lung cancer [NSCLC], head and neck squamous cell carcinoma [HNSCC], and pancreatic cancer.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~2070
Cisplatin
2013
Completed Phase 3
~1940
5-FU
2014
Completed Phase 3
~3420
Nab paclitaxel
2014
Completed Phase 2
~70
Pemetrexed
2014
Completed Phase 3
~5250
Paclitaxel
2011
Completed Phase 4
~5380
Gemcitabine
2017
Completed Phase 3
~2070
Carboplatin
2014
Completed Phase 3
~6670

Find a Location

Who is running the clinical trial?

BioNTech SEIndustry Sponsor
63 Previous Clinical Trials
107,212 Total Patients Enrolled
GenmabLead Sponsor
56 Previous Clinical Trials
11,449 Total Patients Enrolled

Media Library

GEN1042 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04083599 — Phase 1 & 2
Cancer Research Study Groups: Combination Therapy - Dose Expansion Part, Monotherapy - Dose Escalation and Dose Expansion parts
Cancer Clinical Trial 2023: GEN1042 Highlights & Side Effects. Trial Name: NCT04083599 — Phase 1 & 2
GEN1042 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04083599 — Phase 1 & 2

Frequently Asked Questions

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

Is participation in this trial available at present?

"Affirmative. Documents found on clinicaltrials.gov attest to the fact that this medical trial is currently searching for participants, having been first posted in September 2019 and last updated August 2021. 447 volunteers are needed from 4 different sites for enrollment."

Answered by AI

What has been the previous research involving GEN1042?

"In 1997, GEN1042 was initially explored at City of Hope Comprehensive Cancer Center. Since then, an impressive number of 3003 trials have been completed and 2439 live studies are currently being conducted across the US with many running out of Charlotte, North carolina."

Answered by AI

How many sites are actively monitoring this clinical experiment?

"This clinical trial is now running in 4 distinct locations, including Charlotte, Nashville and Philadelphia. For those interested in the study it is vital to select a site closest to you so as not to incur excessive travel costs."

Answered by AI

What is the ambition of this research project?

"This experiment, monitored until the conclusion of its safety follow-up period (2 months after last dose), seeks to uncover the Maximum Tolerated Dose (MTD) for GEN1042 administered alone or as part of a combined treatment. The Secondary outcomes include; Adverse Events and Serious Adverse Events percentages, Area Under the Concentration Time Curve (AUC) & Maximum Concentration (Cmax) Pharmacokinetic parameters, and anti-drug antibody incidences."

Answered by AI

What conditions does GEN1042 generally address?

"GEN1042 is a popular treatment for many afflictions, notably hodgkin disease, those who have had exposure to anthracycline-containing therapy in the past and patients with metastatic cutaneous squamous cell carcinoma."

Answered by AI

How many individuals have enrolled in this medical experiment?

"Affirmative. Clinicaltrials.gov supplies evidence that this research endeavor is presently enrolling participants, which was first advertised on September 17th 2019 and edited most recently on August 22nd 2022. A total of 447 volunteers are needed to participate from four distinct sites."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
What portion of applicants met pre-screening criteria?
Did not meet criteria
What site did they apply to?
ChristianaCare
~298 spots leftby Jul 2025