New drug combo trial hopes to tackle advanced cancers

NCT ID NCT06682780

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time

Summary

This study is testing an experimental drug called LM-2417, given alone or with other cancer drugs, in people with advanced solid tumors that have not responded to standard treatments. The main goals are to check safety, find the best dose, and see early signs of tumor shrinkage. About 320 participants will be enrolled across multiple sites.

What this could mean

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

Active substance
LM-2417 (an experimental drug given by IV)
What this could lead to
If successful, this could lead to a new treatment option for people with advanced solid tumors that have stopped responding to standard therapies.
What could go wrong
This is an early-phase trial (phase I/II) with a small number of participants, so the drug may not prove effective or may have unexpected side effects. The combination treatments also add complexity and risk.

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 320 people

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

Started

Sep 2025

Expected to finish

Dec 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 to 80 years

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: 1. Subjects who are willing to participate in the study and sign the informed consent form (ICF) prior to any procedure. 2. Aged 18-80 years old (including boundary values) , male or female. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 4. Life expectancy ≥ 3 months. 5. Subjects must have histological or cytological confirmation of recurrent or refractory advanced solid tumors, or currently lack or are intolerant of, standard therapy. 6. Subjects must have Archived Samples or fresh tumor tissue specimens are required for testing. 7. At least one evaluable lesion. 8. Subjects must show appropriate organ and marrow function inlaboratory examinations within 7 days prior to the first dose. 9. Women of childbearing potential (WOCBP) must agree to use highly effective methods of contraception prior to study entry, during the study and for 6 months after the last dose of study drug. 10. Subjects who can communicate well with investigators and understand and adhere to the requirements of this study. Single-agent dose of 6mg/kg, 12mg/kg and and combined cohort:Subjects tested positive for biomarkers. Exclusion Criteria: 1. Previously received with same target therapy. 2. Subjects has participated in any other interventional clinical trial within 28 days prior to the first dosing of LM-2417. 3. Subjects with anti-tumor treatment within 21 days prior to the first dosing of LM-2417, including radiotherapy, chemotherapy, endocrine therapy, and immunotherapy, etc. 4. Any adverse event from prior anti-tumor therapy has not yet recovered to ≤ grade 1 of CTCAE v5.0. 5. Poorly controlled tumor-related pain. 6. Subjects with symptomatic/active central nervous system (CNS)metastases. 7. Subject who have uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeated drainage. 8. Subjects with known hypersensitivity to antibody therapy; 9. Subjects who take systemic corticosteroids (\> 10 mg daily prednisone equivalents) for more than 7 days or other systemic immunosuppressive medications within 2 weeks prior to the first dosing of LM-2417. 10. Previous or current known autoimmune disease. 11. Subject who has interstitial lung disease or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management. 12. Use of any live vaccine or live attenuated vaccines within 28 days prior to the first dosing of LM-2417.; 13. Subjects who are using therapeutic doses of anticoagulants such as heparin or vitamin K antagonists. 14. Subjects who received major surgery or interventional treatment within28 days prior to the first dosing of LM-2417. 15. Subject who have history of severe cardiovascular disease. 16. Subjects who have uncontrolled or severe illness. 17. HIV infection, active HBV or HCV infection. 18. Subjects who have other active invasive cancers, other than the one treated in this trial, within 5 years prior to screening. 19. Child-bearing potential female who have positive results in pregnancy test or are lactating. 20. Subject who have a known psychiatric diseases or disorders that may affect compliance with the trial. 21. Subject who is judged as not eligible to participate in this study by the investigator.

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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

    1 site. 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

  • FuDan University Shanghai Cancer Center

    RECRUITING

    Shanghai, Shanghai Municipality, China

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