A First-in-Human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety and Anti-tumor Activity of GEN1042 in Subjects With Malignant Solid Tumors

GEN1042 Cancer Trial: Safety and Effectiveness in Solid Tumors

NCT: NCT04083599 · Status: ACTIVE NOT RECRUITING · Phase: Phase 2 · Sponsor: Genmab · Started: 2019-09-17 · Est. Completion: 2026-11

Plain English Summary

GEN1042 Safety Trial and Anti-tumor Activity in Participants With Malignant Solid Tumors is a Phase 2 clinical trial sponsored by Genmab studying Malignant Solid Tumor, Non-Small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC), Melanoma, Head and Neck Squamous Cell Carcinoma (HNSCC), Pancreatic Ductal Adenocarcinoma (PDAC). This trial tests a new drug called GEN1042, alone or with other cancer treatments, to see how safe it is and if it can shrink tumors. It is for adults with advanced solid tumors, including lung cancer, colorectal cancer, melanoma, head and neck cancer, and pancreatic cancer, who have not responded to standard treatments or have no other options. Participation involves receiving GEN1042, possibly with other drugs, through an IV. It includes regular check-ups, blood tests, and scans to monitor your health and the cancer's response. Alternative treatments may include standard chemotherapy, radiation, surgery, or other targeted therapies, depending on the specific cancer type and stage. The trial aims to enroll 350 participants.

Official Summary

The goal of this trial is to learn about the antibody GEN1042 when it is used alone and when it is used together with another antibody cancer drug, pembrolizumab (with or without chemotherapy), for treatment of participants with certain types of cancer.

Who Can Participate

Here is what you need to know about eligibility for this trial. Adults aged 18 or older with specific types of advanced solid tumors. Patients whose cancer has spread or cannot be removed by surgery and for whom standard treatments are no longer effective or available. Individuals with measurable disease and good general health (ECOG 0-1) with adequate organ function (liver, kidney, heart, bone marrow). People with active autoimmune diseases, recent radiation therapy, or severe reactions to previous antibody treatments may not be eligible. This trial is studying Malignant Solid Tumor, Non-Small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC), Melanoma, Head and Neck Squamous Cell Carcinoma (HNSCC), Pancreatic Ductal Adenocarcinoma (PDAC), so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcome measures, like the rate of tumor shrinkage (Objective Response Rate), will show how well GEN1042 works to control or reduce the cancer. The specific primary outcome measures are: Dose Escalation and Safety Run-in Parts: Number of Participants With Dose-Limiting Toxicities (DLTs) (First Cycle (21 days)); Dose Expansion: Objective Response Rate (ORR) (Up to approximately 2 years and 4 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.

Why This Trial Matters

This trial is important because it explores a new approach to treating various solid tumors that have not responded to existing therapies, potentially filling a critical gap in cancer treatment option Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Malignant Solid Tumor, Non-Small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC), Melanoma, Head and Neck Squamous Cell Carcinoma (HNSCC), Pancreatic Ductal Adenocarcinoma (PDAC), where improved treatment options are needed.

Investor Insight

This trial signals a focus on novel antibody-based therapies for solid tumors, a growing market with significant unmet needs, suggesting potential for future drug development and investment if safety Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor about the potential benefits and risks of GEN1042, how it might interact with your current health, and what to expect during treatment. Be prepared for regular clinic visits for IV infusions, blood draws, and imaging scans to monitor your response and any side effects. Keep a detailed record of any symptoms or side effects you experience and report them promptly to your healthcare team. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Secondary Outcomes

Full Eligibility Criteria

Key Inclusion Criteria:

Monotherapy - Dose Escalation and Dose Expansion Parts

* Participants with non-CNS solid tumors that is metastatic or unresectable and for whom there is no available standard therapy.
* Participants 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

Combination Therapy - Dose Expansion Part

* Participants with unresectable Stage III or Stage IV melanoma with no prior systemic anticancer therapy for unresectable or metastatic disease. Primary ocular or mucosal melanoma is excluded.
* Participants with Stage IV metastatic or recurrent NSCLC with no prior systemic anticancer therapy, no actionable mutation.
* Participants with recurrent or metastatic HNSCC with no prior systemic therapy administered in the recurrent or metastatic setting.
* Participants with confirmed metastatic PDAC with no previous radiotherapy, surgery, chemotherapy, or investigational therapy for the treatment of metastatic disease.

General (all phases):

* Must be age ≥ 18 years of age on the day of signing informed consent, or the legal age of consent in the jurisdiction in which the trial is taking place.
* Measurable disease according to RECIST 1.1
* Eastern Cooperative Oncology Group (ECOG) 0-1
* Normal or adequate liver, renal, cardiac and bone marrow function

Key Exclusion Criteria:

Monotherapy - Dose Escalation and Dose Expansion Parts

* Treatment with an anti-cancer agent (within 21 days or after at least 5 half-lives of the drug, whichever is shorter), prior to GEN1042 administration
* Radiotherapy within 14 days prior to first GEN1042 administration
* Toxicities from previous anti-cancer therapies that have not resolved

Combination Therapy - Dose Expansion Part

* Has received prior systemic cytotoxic chemotherapy, biological therapy, OR major surgery within 3 weeks or at least 5 half-lives of the drug (whichever is shorter) of the first dose of trial treatment.
* Radiotherapy within 14 days of start of trial treatment or received lung radiation therapy of \> 30 Gy within 6 months of the first dose of trial treatment.

General (all phases)

* Participants has an active, known, or suspected autoimmune disease.
* History of non-infectious pneumonitis that required steroids or currently has pneumonitis.
* History of ≥ grade 3 allergic reactions to monoclonal antibody (mAb) therapy
* Participants with a condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first treatment.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial Locations

Frequently Asked Questions

What is clinical trial NCT04083599?

NCT04083599 is a Phase 2 INTERVENTIONAL study titled "GEN1042 Safety Trial and Anti-tumor Activity in Participants With Malignant Solid Tumors." It is currently active, not recruiting and is sponsored by Genmab. The trial targets enrollment of 350 participants.

What conditions does NCT04083599 study?

This trial investigates treatments for Malignant Solid Tumor, Non-Small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC), Melanoma, Head and Neck Squamous Cell Carcinoma (HNSCC), Pancreatic Ductal Adenocarcinoma (PDAC). The primary condition under study is Malignant Solid Tumor.

What treatments are being tested in NCT04083599?

The interventions being studied include: GEN1042 (BIOLOGICAL), Pembrolizumab (DRUG), Cisplatin (DRUG), Carboplatin (DRUG), 5-FU (DRUG). Intravenous

What does Phase 2 mean for NCT04083599?

Phase 2 trials test whether the treatment works for the intended condition. They involve 100-300 patients and continue to evaluate safety while measuring effectiveness.

What is the current status of NCT04083599?

This trial is currently "Active, Not Recruiting." It started on 2019-09-17. The estimated completion date is 2026-11.

Who is sponsoring NCT04083599?

NCT04083599 is sponsored by Genmab. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT04083599?

The trial aims to enroll 350 participants. The trial status is active, not recruiting.

How is NCT04083599 designed?

This is a interventional study, uses non_randomized allocation, follows a sequential design, employs none masking.

What are the primary outcomes being measured in NCT04083599?

The primary outcome measures are: Dose Escalation and Safety Run-in Parts: Number of Participants With Dose-Limiting Toxicities (DLTs) (First Cycle (21 days)); Dose Expansion: Objective Response Rate (ORR) (Up to approximately 2 years and 4 months). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT04083599 being conducted?

This trial is being conducted at 20 sites, including Anchorage, Alaska; Los Alamitos, California; San Diego, California; New Haven, Connecticut and 16 more sites (United States).

Where can I find official information about NCT04083599?

The official record for NCT04083599 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT04083599. This government database provides the most up-to-date and detailed information about the trial.

What is NCT04083599 testing in simple terms?

This trial tests a new drug called GEN1042, alone or with other cancer treatments, to see how safe it is and if it can shrink tumors. It is for adults with advanced solid tumors, including lung cancer, colorectal cancer, melanoma, head and neck cancer, and pancreatic cancer, who have not responded to standard treatments or have no other options.

Why is this trial significant?

This trial is important because it explores a new approach to treating various solid tumors that have not responded to existing therapies, potentially filling a critical gap in cancer treatment option

What are the potential risks of participating in NCT04083599?

Common side effects may include fatigue, nausea, diarrhea, and skin reactions. More serious risks can include infusion-related reactions, inflammation of the lungs (pneumonitis), or effects on liver or kidney function. The trial will closely monitor for any unexpected or severe adverse events. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT04083599?

Ask your doctor about the potential benefits and risks of GEN1042, how it might interact with your current health, and what to expect during treatment. Be prepared for regular clinic visits for IV infusions, blood draws, and imaging scans to monitor your response and any side effects. Keep a detailed record of any symptoms or side effects you experience and report them promptly to your healthcare team. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT04083599 signal from an investment perspective?

This trial signals a focus on novel antibody-based therapies for solid tumors, a growing market with significant unmet needs, suggesting potential for future drug development and investment if safety This is a Phase 2 trial, which is focused on confirming efficacy before larger pivotal studies.

What happens if the treatment in this trial doesn't work?

Participation involves receiving GEN1042, possibly with other drugs, through an IV. It includes regular check-ups, blood tests, and scans to monitor your health and the cancer's response. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.