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New drug CS5007 targets tough cancers in first human trial

NCT ID NCT07622524

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 14, 2026 · Updated 2 times

Summary

This early-stage trial tests a new drug called CS5007 in people with advanced solid tumors that cannot be removed by surgery. The drug is designed to seek out and attack cancer cells while sparing healthy ones. The study will first find the safest dose and then check if the drug shrinks tumors. About 310 participants will take part across multiple centers.

What this could mean

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

Active substance
CS5007 (a bispecific antibody-drug conjugate targeting EGFR and HER3)
What this could lead to
If successful, this could lead to a new treatment option for people with advanced solid tumors that have not responded to other therapies.
What could go wrong
This is a very early Phase I trial, so the drug may not be safe or effective. Side effects are unknown, and it will take years before any potential benefit is confirmed.

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

About 310 people

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

Started

Jul 2026

Expected to finish

Jan 2029

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: * Evidence of a personally signed and dated informed consent document. * Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. * Being ≥ 18 years of age on the day of signing informed consent. * Pathologically or cytologically confirmed, unresectable advanced solid tumors. * Participants must have at least one measurable lesion according to RECIST Version1.1. * Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1. * Adequate organ function. * Life expectancy ≥ 3 months. * Fertile men and women of childbearing potential must agree to use an effective method of birth control from providing signed consent and for 180 days after the last study drug administration Exclusion Criteria: * Has disease that is suitable for local treatment administered with curative intent. * Has a history of a second malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured. * Known primary central nervous system (CNS) tumor or solid tumor CNS metastasis that is symptomatic, untreated, or requires therapy. * Has life-threatening bleeding event or severe bleeding within 3 months prior to first dose. * Has uncontrolled pleural effusion, pericardial effusion, or ascites. * Has immune deficient disease or received systemic immunosuppressive treatment. * Has intestinal obstruction,or history of inflammatory bowel disease,or chronic diarrhea. * Has history of (non-infectious) interstitial lung disease/pneumonitis that required steroids. * Has active infections requiring systemic therapy. * Has significant cardiovascular disease or cerebrovascular accident within specified timeframes prior to first dose. * Insufficient washout from prior anti-tumor therapy. * Received live vaccine within 28 days prior to first dose. * History of allogeneic organ or hematopoietic stem cell transplantation. * History of hypersensitivity to excipients of study drug or any monoclonal antibody. * Any toxic effects of prior therapy unresolved to Grade ≤1. * Active alcohol or drug abuse. * Pregnant or breastfeeding women. * Other acute or chronic medical or psychiatric conditions that may increase risk or interfere with study results, in the investigator's judgment.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    7 sites in 2 countries. The list below names each one and where it is.

  2. 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 ↗

  3. 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

Locations

  • Calvary Mater Newcastle

    RECRUITING

    Waratah, New South Wales, 2298, Australia

  • Icon Cancer Centre South Brisbane

    RECRUITING

    South Brisbane, Queensland, 4101, Australia

  • Linear Clinical Research Ltd

    RECRUITING

    Nedlands, Western Australia, 6009, Australia

  • Macquarie University

    RECRUITING

    North Ryde, New South Wales, 2109, Australia

  • Shanghai Chest Hospital

    NOT_YET_RECRUITING

    Shanghai, Shanghai Municipality, 200030, China

  • St Vincent's Hospital Melbourne

    NOT_YET_RECRUITING

    Fitzroy, Victoria, 3065, Australia

  • St Vincent's Hospital Sydney

    NOT_YET_RECRUITING

    Darlinghurst, New South Wales, 2010, Australia

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