Cure My Disease

Don't miss your cure!

 Log in / Sign up

New Immune-Boosting drug GEN1042 tested in japanese cancer patients

NCT ID NCT06057038

Disease control Sponsor: Genmab Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 05, 2026 · Updated 5 times

Summary

This early-stage study tests a new drug called GEN1042, which aims to help the immune system fight cancer. It is being tested alone or with other cancer drugs in 42 Japanese adults with advanced solid tumors. The main goal is to check safety and find the right dose.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
GEN1042 (a biologic drug that targets CD40 and 4-1BB to boost immune response against cancer)
What this could lead to
If successful, this could lead to a new treatment option for Japanese patients with advanced solid tumors, potentially improving tumor control.
What could go wrong
This is an early Phase 1 trial with only 42 participants, focused on safety and dosing. It is too small and early to know if the drug will work or be safe for broader use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

8 people

The number who actually took part.

Started

Nov 2023

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: 1. Must have measurable disease according to RECIST v1.1. 2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1. 3. Acceptable organ and bone marrow function. 4. Participant must have a life expectancy of at least 3 months. Key Exclusion Criteria: 1. Has clinically significant toxicities from previous anticancer therapies. 2. Has rapidly progressing disease. 3. Has a history of noninfectious pneumonitis/interstitial lung disease. 4. Has a history of liver disease. 5. Has had an allogeneic tissue/solid organ transplant or autologous or allogeneic bone marrow transplant, or stem cell rescue within 3 months prior to the first dose of GEN1042. 6. Has any history of intracerebral arteriovenous malformation, cerebral aneurysm, or progressive brain metastases or stroke. 7. Has had major surgery within 4 weeks before Screening. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Head and neck squamous cell carcinoma are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

cancer head and neck squamous cell carcinoma non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Malignant solid tumor

Contacts and locations

Locations

  • National Cancer Center East

    Kashiwa, Japan

  • National Cancer Center Hospital

    Tokyo, Japan

  • Tokyo Medical University Hospital

    Tokyo, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.