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New drug combo aims to shrink Hard-to-Treat tumors

NCT ID NCT07694765

Disease control Sponsor: LaNova Medicines Limited 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 10, 2026 · Last updated Jul 10, 2026

Summary

This study tests an experimental drug called LM-364, given alone or with another cancer drug (tislelizumab), in people with advanced solid tumors that have not responded to standard treatments. The goal is to find a safe dose and see if the drug can shrink tumors. About 90 adults will take part in this early-phase trial.

What this could mean

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

Active substance
LM-364 (an experimental drug) and tislelizumab (an immunotherapy)
What this could lead to
If successful, this could provide a new treatment option for people with advanced solid tumors that have not responded to other therapies.
What could go wrong
This is an early-phase trial with a small number of participants, so the drug may not prove effective or may cause significant side effects. Success in this trial does not guarantee broader benefits.

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 90 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Dec 2030

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: 1. Participants who are willing to participate in the study and sign the informed consent form (ICF) prior to any procedure. 2. Participants must be ≥18 years or the legal age of consent at the time of signing the ICF. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 4. Life expectancy ≥ 3 months. 5. Adequate organ and bone marrow function as defined by protocol. 6. Participants who are able to communicate well with investigators and understand and adhere to the requirements of this study. Exclusion Criteria: 1. Participant in any other clinical trial within 28 days prior to 1st dosing of LM-364. 2. Any adverse event from prior anti-tumour therapy has not yet recovered to ≤ grade 1 of CTCAE v6.0. 3. Participants with uncontrolled tumour-related pain. 4. Use of any live attenuated vaccines within 28 days prior to 1st dosing of LM-364. 5. Participants who received major surgery or interventional treatment within 28 days prior to 1st dosing of LM-364. 6. Participants who have severe cardiovascular disease. 7. Participants who have uncontrolled or severe illness. 8. Participants who have a history of immunodeficiency disease. 9. Participants with a known history of autoimmune disease. 10. Participants who have other active malignancies which are likely to require the treatment. 11. Child-bearing potential female who have positive results in pregnancy test or are lactating. 12. Participants who have psychiatric illness or disorders that may preclude study compliance. 13. Participants 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.

cancer neoplasm

As listed by the trial registrant

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

Malignant tumors

How to take part

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

  1. The places running it

    3 sites. 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

  • Cancer Care Wollongong Hospital

    Wollongong, New South Wales, Australia

  • Icon Cancer Centre South Brisbane

    Brisbane, Queensland, Australia

  • Macquarie University

    North Ryde, New South Wales, Australia

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