GEN1286 for Cancer

Recruiting at 3 trial locations

Overseen By Genmab Trial Information

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Genmab

Must not be taking: Topoisomerase 1-based ADCs

Disqualifiers: Advanced solid tumors, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

260 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and effectiveness of a new treatment called GEN1286 for individuals with advanced solid tumors, which are cancers forming in solid organs. Researchers aim to understand how GEN1286 interacts with the body and its effectiveness in fighting cancer. The trial consists of two parts: one to determine the appropriate dose and another to focus on specific tumor types. Individuals with advanced cancer that has not responded to other treatments might be suitable candidates. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in humans.

Will I have to stop taking my current medications?

The trial requires a washout period (time without taking certain medications) of 2 weeks for chemotherapy or small molecule therapy and 4 weeks for antibody-based treatments before starting the study drug. If your disease has progressed on treatment, a 2-week washout period is needed. The protocol does not specify about other medications, so it's best to discuss with the trial team.

Is there any evidence suggesting that GEN1286 is likely to be safe for humans?

Research has shown that GEN1286 is being carefully studied to understand its safety in humans. At this stage, researchers are testing the treatment in people for the first time. The goal is to assess how well participants tolerate it and identify any side effects.

Since this is an early stage of research, detailed safety information is not yet available. However, these trials focus heavily on safety. Researchers closely monitor every participant for any unwanted effects. This helps them learn how the treatment works in the body and what side effects might occur.

If GEN1286 proves to be safe and well-tolerated, it could lead to fewer side effects and better outcomes for patients. Each step forward in these trials helps build a clearer picture of the treatment's safety profile. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about GEN1286 because it targets cancer cells in a novel way. Unlike many traditional cancer treatments that attack both healthy and cancerous cells, GEN1286 is designed to specifically target and disrupt the growth of cancer cells, potentially reducing side effects. This precision targeting is a significant advancement over the broader approaches of chemotherapy or radiation, which often affect healthy tissues. By focusing on the cancer cells themselves, GEN1286 has the potential to offer more effective and safer treatment options for patients.

What evidence suggests that GEN1286 might be an effective treatment for cancer?

Research has shown that GEN1286, the investigational treatment in this trial, targets specific proteins called EGFR and cMet, which aid cancer cell growth and survival. By focusing on these proteins, GEN1286 might stop or slow tumor growth. Although limited data from human studies exist, the drug has shown promise in early lab research. These initial results suggest that GEN1286 could be an effective new treatment for advanced solid tumors. ^{1 3 6 7 8}

Who Is on the Research Team?

Study Official

Principal Investigator

Genmab

Are You a Good Fit for This Trial?

This trial is for adults with advanced solid tumors that have spread or can't be removed by surgery. Participants should have tried other treatments unless they couldn't, didn't want to, or the treatment wasn't available locally. They must be mostly healthy otherwise (with minor exceptions) and able to do daily activities without much help.

Inclusion Criteria

My cancer is confirmed to be an advanced solid tumor.

I am fully active or can carry out light work.

Measurable disease at baseline as defined per RECIST version 1.1

Exclusion Criteria

Concurrent participation in another clinical trial of an investigational therapy

Other serious underlying medical condition that, in the opinion of the investigator, would impair the participant's ability to receive or tolerate the planned treatment and follow-up

I have waited the required time after my last cancer treatment before starting a new one.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation and Expansion

Part A involves dose escalation and dose level expansion to evaluate safety and tolerability

21 days per cycle

Tumor-specific Expansion

Part B involves tumor-specific expansion with dose optimization to assess anti-tumor activity

Up to approximately 3 years 9 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• GEN1286

Trial Overview GEN1286 is being tested for its safety and effectiveness against advanced solid tumors. The trial has two parts: Part A finds the right dose and expands it; Part B focuses on specific tumor types with optimized dosing.

How Is the Trial Designed?

Group I: GEN1286 Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Genmab

Lead Sponsor

Trials

76

Recruited

15,300+

Dr. Jan van de Winkel

Genmab

Chief Executive Officer since 2010

PhD in Immunology, University of Utrecht

Dr. Judith Klimovsky

Genmab

Chief Medical Officer since 2019

MD, University of Copenhagen

Citations

1. tipranks.com tipranks.com/news/company-announcements/genmabs-gen1286-study-a-potential-game-changer-in-cancer-treatment

Genmab's GEN1286 Study: A Potential Game-Changer in ... The study aims to assess the safety, tolerability, pharmacokinetics, anti-tumor activity, and immunogenic potential of GEN1286, a promising drug ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06685068

NCT06685068 | A Phase 1/2 Study of GEN1286 in Patients ... Toxicities will be graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria version 5.0.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12581271/

Overcoming resistance to antibody-drug conjugates Also, BV has demonstrated significant clinical efficacy in these malignancies, achieving an overall response rate of 75%, a complete response ( ...

4. massgeneral.trialstoday.org massgeneral.trialstoday.org/?page=eJyLVspLrShR0lHycw4xMDW1NDIzMlPS0bWEAR1jPUMjYwMgw9Dc1MTAwAyIgUBHKS.5xMDU0sLYxNhIKRYARoEP4Q--

Mass General - Division of Clinical Research The purpose of this trial is to evaluate the safety, tolerability, pharmacokinetics (PK), anti-tumor activity and immunogenic potential of GEN1286 in ...

5. ir.genmab.com ir.genmab.com/static-files/e17c16da-89cb-4e68-a34e-9222da5e4098

Genmab Interim Report GEN1286 is an ADC targeting EGFR and cMet, two validated cancer targets. A Phase 1/2 clinical study of. GEN1286 in advanced solid tumors is ...

6. abbvieclinicaltrials.com abbvieclinicaltrials.com/study/?id=GCT1286-01

A Phase 1/2 Study of GEN1286 in Patients With Advanced ... The purpose of this trial is to evaluate the safety, tolerability, pharmacokinetics (PK), anti-tumor activity and immunogenic potential of GEN1286 in ...

7. clinicaltrial.be clinicaltrial.be/en/details/458266?per_page=20&only_recruiting=0&only_eligible=0&only_active=0

A Phase 1/2 Study of GEN1286 in Patients With Advanced ... The purpose of this trial is to evaluate the safety, tolerability, pharmacokinetics (PK), anti-tumor activity and immunogenic potential of GEN1286 in ...

8. trialx.com trialx.com/clinical-trials/listings/297958/a-phase-12-study-of-gen1286-in-patients-with-advanced-solid-tumors/

A Phase 1/2 Study of GEN1286 in Patients With Advanced ... The purpose of this trial is to evaluate the safety, tolerability, pharmacokinetics (PK), anti-tumor activity and immunogenic potential of ...