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New bispecific drug targets Hard-to-Treat cancers in early trial

NCT ID NCT06840119

Disease control Sponsor: Immunocore Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new drug called IMC-R117C, alone or with other cancer drugs, in people with advanced colorectal, esophageal, stomach, or ovarian cancers that have a specific genetic marker (HLA-A*02:01) and produce a protein called PIWIL1. The trial aims to find safe doses and check if the drug can shrink tumors. About 600 participants will be enrolled.

What this could mean

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

Active substance
IMC-R117C (a bispecific protein that targets cancer cells and immune cells)
What this could lead to
If successful, this could lead to a new treatment option for certain advanced cancers that have not responded to standard therapies.
What could go wrong
This is an early first-in-human trial, so safety and effectiveness are not yet known. The drug may cause side effects or fail to shrink tumors.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 600 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2024

Expected to finish

Nov 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.

Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 * HLA-A\*02:01-positive * Histologically confirmed advanced colorectal, esophageal, gastric, or ovarian carcinoma * Archived or fresh tumor tissue sample that must be confirmed as adequate * Evaluable/Measurable disease per RECIST 1.1 * Previously received applicable standard treatments * Male and female participants of childbearing potential who are sexually active with a non-sterilized partner must agree to use highly effective methods of birth control Exclusion Criteria: * Symptomatic or untreated central nervous system metastasis * Recent bowel obstruction * Ongoing ascites or effusion requiring recent drainages * Significant ongoing toxicity from prior anticancer treatment * Out-of-range laboratory values * Clinically significant lung, heart, or autoimmune disease * Ongoing requirement for immunosuppressive treatment * Significant secondary malignancy * Hypersensitivity to study drug or excipients * Pregnant or lactating

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Conditions

The condition(s) this trial relates to.

cancer carcinoma of esophagus colorectal carcinoma gastric carcinoma neoplasm ovarian carcinoma

As listed by the trial registrant

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

Cancer HLA-A*02:01-positive

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    12 sites in 6 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Antoni van Leeuwenhoek

    RECRUITING

    Amsterdam, Netherlands

  • Centro Integral Oncologico Clara Campal

    RECRUITING

    Madrid, Spain

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    RECRUITING

    Roma, Italy

  • Hospital HM Nou Delfos

    RECRUITING

    Barcelona, Spain

  • Hospital Universitario Fundacion Jimenez Diaz

    RECRUITING

    Madrid, Spain

  • Institut Jules Bordet

    RECRUITING

    Anderlecht, 1070, Belgium

  • Peter MacCallum Cancer Centre

    RECRUITING

    Melbourne, Australia

  • St Vincent's Hospital

    ACTIVE_NOT_RECRUITING

    Darlinghurst, Sydney, NSW 2010, Australia

  • UZ Leuven

    RECRUITING

    Leuven, 3000, Belgium

  • Universitaetsklinikum Heidelberg

    RECRUITING

    Heidelberg, Germany

  • Universitair Ziekenhuis Gent

    RECRUITING

    Ghent, Belgium

  • VHIO, Vall d'Hebron University Hospital

    RECRUITING

    Barcelona, Spain

  • nstituto Clinico Humanitas

    RECRUITING

    Rozzano, 20089, Italy

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