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New drug combo shows promise for Hard-to-Treat cancers

NCT ID NCT05199753

Disease control Sponsor: LaNova Australia Pty 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This early-phase trial tested an experimental drug called LM-108, alone or combined with another immunotherapy, in 78 people with advanced solid tumors that had stopped responding to standard treatments. The main goals were to check safety and find the right dose. Researchers also looked for early signs that the drug might shrink tumors.

What this could mean

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

Active substance
LM-108 (an experimental drug) and an anti-PD-1 antibody (a type of immunotherapy)
What this could lead to
If successful, this could point toward a new treatment option for people with advanced solid tumors that have stopped responding to standard therapies.
What could go wrong
This is a very early, first-in-human trial with only 78 participants, so the main goal is safety, not effectiveness. The drug may not shrink tumors or could cause side effects.

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

78 people

The number who actually took part.

Started

Mar 2022

Finished

Dec 2024

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. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 2. Histological or cytological confirmation of recurrent or refractory advanced solid tumours, and have progressed on standard therapy, or are intolerable for available standard therapy, or there is no available standard therapy. 3. At least one measurable disease for expansion cohorts per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1. 4. Subjects must show appropriate organ and marrow function in laboratory examinations within 7 days prior to the first dose Key Exclusion Criteria: 1. Any adverse event from prior anti-tumour therapy has not yet recovered to ≤grade 1 of CTCAE v5.0 2. Uncontrolled tumour-related pain 3. Known central nervous system (CNS) 4. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures 5. Use of inhaled corticosteroids 6. Known history of autoimmune disease 7. Use of any live attenuated vaccines within 28 days 8. Have severe cardiovascular disease 9. Uncontrolled or severe illness 10. History of immunodeficiency disease 11. Active malignancies which are likely to require the treatment. 12. Child-bearing potential female 13. Have psychiatric illness or disorders Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

neoplasm

As listed by the trial registrant

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

Advanced solid tumor

Contacts and locations

Locations

  • Alfred Hospital

    Melbourne, Victoria, VIC 3004, Australia

  • Blacktown Hospital

    Sydney, New South Wales, NSW 2148, Australia

  • Cabrini Health Limited

    Malvern, Victoria, VIC 3144, Australia

  • ICON Cancer Centre

    South Brisbane, Queensland, QLD 4101, Australia

  • One Clinical Research Pty Ltd.

    Nedlands, Western Australia, WA 6009, Australia

  • Sunshine Coast University Private Hospital

    Birtinya, Queensland, QLD 4575, Australia

More trials for these conditions

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