103 Participants NeededMy employer runs this trial

GEN1106 for Bladder Cancer

Recruiting at 9 trial locations
GT
Overseen ByGenmab Trial Information
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess the safety and effectiveness of a new drug, GEN1106, for treating certain types of cancer, including bladder cancer. It consists of three parts: testing different doses for safety, refining the doses, and evaluating effectiveness with the chosen doses. Individuals with bladder cancer that has progressed despite standard treatments, such as chemotherapy or specific cancer drugs, might be suitable for the trial. All participants will receive active treatment, with no placebos involved. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the trial?

The trial requires that you stop taking any anticancer agents at least 4 weeks before starting the trial treatment, or for systemic therapies, within 5 half-lives of the drug, whichever is shorter. Other medications are not specifically mentioned, so it's best to discuss with the trial team.

Is there any evidence suggesting that GEN1106 is likely to be safe for humans?

Research has shown that GEN1106 is being tested for safety and effectiveness in treating certain cancers, such as bladder cancer. In earlier studies on solid tumors, GEN1106 showed promise with manageable side effects. Participants reported common side effects, including tiredness and nausea, which are typical for cancer treatments.

As an early-phase trial, the goal is to determine the right dose and ensure the treatment's safety. The trial's progression indicates that GEN1106 was safe enough in lab tests and earlier human studies to proceed. However, as with any new treatment, some uncertainty remains, and researchers closely monitor participants to ensure their safety.12345

Why do researchers think this study treatment might be promising?

GEN1106 is unique because it represents a novel approach to treating bladder cancer. Unlike traditional treatments like chemotherapy and immunotherapy, which often have broad effects on the body, GEN1106 is designed to target specific pathways involved in cancer cell growth. This targeted mechanism may offer a more precise treatment with potentially fewer side effects. Researchers are excited about GEN1106 because it could lead to more effective and personalized therapy options for patients struggling with bladder cancer.

What evidence suggests that GEN1106 might be an effective treatment for bladder cancer?

Initial findings suggest that researchers are testing GEN1106 to treat solid tumors, including bladder cancer. Research shows that the drug aims to stop tumors from growing or spreading. In an earlier study, 27% of patients with a specific type of bladder cancer experienced a complete response, meaning their cancer was not detectable after six months. While these results are promising, more studies are needed to confirm GEN1106's effectiveness specifically for bladder cancer. In this trial, participants will enroll in different parts to test escalating, refined, and expanded doses of GEN1106 to determine the best doses and further explore its effectiveness. Remember, these results are early, and ongoing trials continue to test the best doses and further explore its effectiveness.12456

Who Is on the Research Team?

SO

Study Official

Principal Investigator

Genmab

Are You a Good Fit for This Trial?

This trial is for adults with certain solid tumors, including bladder cancer and metastatic urothelial carcinoma, whose cancer has worsened after standard treatments or who have no other good treatment options. Participants must be in generally good physical condition and have measurable disease.

Inclusion Criteria

I have been diagnosed with metastatic urothelial carcinoma.
I have tried all standard treatments for my cancer and they no longer work for me.
* Have measurable disease according to RECIST v1.1.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

3 weeks
1 visit (in-person)

Treatment

Participants receive GEN1106 with dose escalation and refinement to determine safety and efficacy

5 months
Frequent visits during the first 6 weeks, then less frequent

Follow-up

Participants are monitored for safety and effectiveness after treatment

11 months
Regular site visits for tests and procedures

What Are the Treatments Tested in This Trial?

Interventions

  • GEN1106

Trial Overview

The study tests different doses of a new drug called GEN1106 to find the safest and most effective dose for people with advanced cancers. All participants receive GEN1106; there is no placebo group. The trial includes regular checkups, blood tests, and scans over about 17 months.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: Part 3: Dose ExpansionExperimental Treatment1 Intervention
Group II: Part 2: Dose RefinementExperimental Treatment1 Intervention
Group III: Part 1: Dose EscalationExperimental Treatment1 Intervention

Find a Clinic Near You

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

A Study of GEN1106 in Participants With Solid Tumors

BRIEF SUMMARY. The purpose of this trial is to learn about the safety and effectiveness of GEN1106 when it is used for the treatment of participants with ...

A Study of GEN1106 in Participants With Solid Tumors

The purpose of this trial is to learn about the safety and effectiveness of GEN1106 when it is used for the treatment of participants with certain types of ...

A Study of GEN1106 in Participants With Solid Tumors

The purpose of this trial is to learn about the safety and effectiveness of GEN1106 when it is used for the treatment of participants with certain types of…

GEN1106: Uses, Side Effects, Dosing & 1 Clinical Trials

GEN1106 is being investigated as a potential treatment for various types of solid tumors, with the aim of inhibiting their growth or progression ...

Updated review on novel therapies and ongoing clinical trials ...

The results showed that 27% of patients with carcinoma in situ (CIS) achieved a complete response at six months. 9.3% of patients experienced ...

GEN1106 for Bladder Cancer

This Phase 1 medical study run by Genmab is evaluating whether GEN1106 will have tolerable side effects & efficacy for patients with Transitional Cell ...