What side effects are associated with this type of intervention?

Common side effects of immune-modulating agents and targeted therapies, such as those similar to GEN1042, include fatigue, diarrhea, skin toxicities (e.g., rash, pruritus), and gastrointestinal issues. Severe side effects can include pneumonitis, infusion-related reactions, and immune-related adverse events affecting various organs. These treatments may also cause specific toxicities like mucositis, hypertension, and cardiac issues, depending on the exact mechanism of the drug.

What prior FDA approvals exist?

The FDA has approved several immune-modulating agents and targeted therapies for cancer treatment. Durvalumab is approved for unresectable, stage III non-small cell lung cancer following chemotherapy and radiation. Ipilimumab and nivolumab, either alone or in combination, are used for advanced melanoma and have shown improved response rates, particularly in patients with high tumor mutational burden. Pembrolizumab is approved for various cancers, including metastatic melanoma, with flexible dosing schedules. Cabozantinib, a tyrosine kinase inhibitor, is approved for medullary thyroid cancer and has demonstrated activity in clinical trials. These agents work by enhancing the immune response against tumors or directly inhibiting pathways critical for tumor growth and metastasis.

What other types of research exist?

Promising alternatives to GEN1042 for cancer treatment in 2024 include: 1) Immune checkpoint inhibitors such as nivolumab and pembrolizumab, which have shown efficacy in various cancers including lung, renal cell carcinoma, and gliomas. 2) Combination therapies like atezolizumab plus bevacizumab, which have been effective in renal cell carcinoma. 3) Targeted therapies such as cabozantinib, which has shown activity in medullary thyroid cancer and renal cell carcinoma. 4) Novel agents like enfortumab vedotin, which has demonstrated efficacy in urothelial carcinoma. These alternatives offer diverse mechanisms of action and have shown promising results in clinical trials.

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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

Must be age ≥ 18 years of age

Subjects with confirmed metastatic PDAC with no previous radiotherapy, surgery, chemotherapy, or investigational therapy for the treatment of metastatic disease.

Must not have

Toxicities from previous anti-cancer therapies that have not resolved

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called GEN1042 to see if it can help treat advanced cancer. It focuses on patients whose cancer has spread or is hard to treat. The goal is to find out if GEN1042 can safely reduce or stop tumor growth.

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.

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.

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

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I am 18 years old or older.

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I have metastatic pancreatic cancer and haven't received any treatment for it.

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My lung cancer is advanced, and I haven't had any cancer treatments yet.

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My cancer has spread, cannot be surgically removed, and there's no standard treatment for it.

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I have advanced melanoma that cannot be surgically removed and haven't received systemic treatment for it.

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I am fully active or can carry out light work.

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My head/neck cancer has returned or spread, hasn't been treated yet, and shows PD-L1.

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My melanoma, NSCLC, or CRC has returned or didn’t respond to treatment and there’s no standard therapy left for me.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I still have side effects from past cancer treatments.

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I haven't had chemotherapy, biological therapy, or major surgery within the last 3 weeks or 5 half-lives of the drug before starting the trial.

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I haven't taken high-dose steroids or immunosuppressants in the last 14 days.

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I have or had lung inflammation treated with steroids.

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I haven't had any radiotherapy in the last 14 days or lung radiation over 30 Gy in the last 6 months.

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I have not had radiotherapy in the last 14 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 3 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 and Safety Run-in Parts: Number of Participants With Dose-Limiting Toxicities (DLTs)

Dose Expansion: Objective Response Rate (ORR)

Secondary study objectives

All Parts: Disease Control Rate (DCR)

All Parts: Duration of Objective Response (DOR)

All Parts: Number of Participants With Anti-drug Antibody (ADA) Response to GEN1042

+3 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

Group II: Combination Therapy - Safety Run-in and Expansion PartsExperimental Treatment9 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3130

Cisplatin

2013

Completed Phase 3

~3120

5-FU

2014

Completed Phase 3

~3100

Nab paclitaxel

2014

Completed Phase 2

~580

Pemetrexed

2014

Completed Phase 3

~5550

Paclitaxel

2011

Completed Phase 4

~5450

Gemcitabine

2017

Completed Phase 3

~1920

Carboplatin

2014

Completed Phase 3

~6120

0 / 14Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common cancer treatments include immune-modulating agents and targeted therapies. Immune-modulating agents, such as immune checkpoint inhibitors, enhance the body's immune response by blocking proteins that allow cancer cells to evade detection. Targeted therapies focus on specific molecules involved in cancer growth and survival, such as tyrosine kinases or mutated genes. These treatments are important for cancer patients as they provide more personalized and potentially effective options with fewer side effects compared to traditional chemotherapy.

New molecular targets in malignant gliomas.