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Advanced Solid TumorPhase 1/2NCT06187402

A Study of LM-24C5 For Advanced Solid Tumors

A Phase 1/2 study testing LM-24C5 in people with Advanced Solid Tumor, run by LaNova Medicines Limited at 6 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

To assess the safety and tolerability, obtain the recommended phase 2 dose (RP2D)/optimal biologic dose (OBD) and/or Maximum Tolerated Dose (MTD) for LM-24C5 in subjects with advanced solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumor
What is being tested?
LM-24C5
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
6 sitesUnited States
Study dates
20 Dec 2023to 30 Dec 2026
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects who are fully informed of the purpose, nature, method and possible adverse reactions of the study, and are willing to participate in the study and sign the informed consent form (ICF) prior to any study related procedures.
  • Aged ≥18 years old when sign the ICF, male or female.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, and no deterioration within 2 weeks prior to the first dose.
  • Life expectancy ≥ 3 months.
  • Subjects must have histological or cytological confirmation of recurrent or refractory advanced solid tumors, and have progressed on standard therapy, or are intolerable for available standard therapy, or there is no available standard therapy.
  • Formalin-fixed paraffin-embedded (FFPE) tumor tissue samples meet the minimum requirements.
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  • At least one measurable lesion according to RECIST v1.1.
  • Subjects must show appropriate organ and marrow function in laboratory examinations within 7 days prior to the first dose.
  • Subjects who are able to communicate well with investigators and understand and adhere to the requirements of this study.

Who cannot join

  • Participate in any other clinical trial within 28 days prior to 1st dosing of LM-24C5.
  • Any prior treatments towards the investigational target.
  • Subjects with anti-tumor treatment within 21 days prior to 1st dosing of LM-24C5, including radiotherapy, chemotherapy, biotherapy, endocrine therapy and immunotherapy, etc. the following treatments have different time limits.
  • Any adverse event from prior anti-tumor therapy has not yet recovered to≤ grade 1 of CTCAE v5.0.
  • Subjects with uncontrolled pain.
  • Subjects with known central nervous system (CNS) or meningeal metastasis.
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  • Subjects who have uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
  • Subjects who experienced grade 3 or higher hypersensitivity to the treatment that contains any monoclonal antibody.
  • Subjects who take systemic corticosteroids (> 10 mg daily prednisone equivalents) or other systemic immunosuppressive medications within 2 weeks prior to the first dosing of LM-24C5.
  • Subjects with the known history of autoimmune disease.
  • Subjects with the history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
  • Use of any live attenuated vaccines within 28 days prior to 1st dosing of LM-24C5.
  • Subjects who are taking therapeutic doses of anticoagulants such as heparin or vitamin K antagonists for presence of active thromboembolic disease.
  • Subjects who received major surgery or interventional treatment within 28 days prior to 1st dosing of LM-24C5.
  • Subjects who have severe cardiovascular disease.
  • Subjects who have uncontrolled or severe illness, including but not limited to ongoing or active infection
  • Subjects who have a history of immunodeficiency disease, including other acquired or congenital immunodeficiency diseases, or organ transplantation, or allogeneic bone marrow transplantation, or autologous hematopoietic stem cell transplantation.
  • HIV infection, active infection including tuberculosis, HBV and HCV infection, with the exception:
  • Subjects who have other active malignancies which are likely to require the treatment.
  • Child-bearing potential female who have positive results in pregnancy test or are lactating.
  • Subjects who have psychiatric illness or disorders that may preclude study compliance.
  • Subject who is judged as not eligible to participate in this study by the investigator.

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Alex Yuan contact

+8615901815211

alexyuan@lanovamed.com

Paul Kong contact

+8613564682439

paulkong@lanovamed.com

6 sites in 1 country

United States6 sites, 6 recruiting

  • The Christ Hospital

    Cincinnati, Ohio, 45219

    Alex Starodub

    Not yet recruiting

  • Mary Crowley Cancer Research Center

    Dallas, Texas, 75230

    Minal Barve

    Not yet recruiting

  • Virginia Cancer Specialists, P.C.

    Fairfax, Virginia, 22031

    Alexander Spira

    Not yet recruiting

  • Indiana University Melvan and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

    Mateusz Opyrchal

    Not yet recruiting

  • University of Southern California (USC) - Norris Comprehensive Cancer Center

    Los Angeles, California, 90089

    Heinz-Josef Lenz

    Not yet recruiting

  • Ocala Oncology

    Ocala, Florida, 34474

    Rama Balaraman

    Recruiting

Other trials in United States

About this study

Official title: A Phase I/II, First-in-Human (FIH), Open-Label, Multiple Centre Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of LM-24C5 in Patients With Advanced Solid Tumors

To assess the safety and tolerability, obtain the recommended phase 2 dose (RP2D)/optimal biologic dose (OBD) and/or Maximum Tolerated Dose (MTD) for LM-24C5 in subjects with advanced solid tumors.

Being tested
LM-24C5

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LM-24C5Drug

    Administered intravenously

Study groups in NCT06187402
Study groupRoleWhat they receive
LM-24C5 Dose EscalationExperimentalNot described
Receives: Drug: LM-24C5
LM-24C5 Dose ExpansionExperimentalNot described
Receives: Drug: LM-24C5

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of adverse events (AEs)

    Phase 1

    Measured: 60 weeks

  2. Incidence of dose-limiting toxicity (DLT)

    Phase 1

    Measured: 60 weeks

  3. Incidence of serious adverse event (SAE)

    Phase 1

    Measured: 60 weeks

  4. Ear Temperature

    Phase 1

    Measured: 60 weeks

  5. Pulse in BPM(Beat per Minute)

    Phase 1

    Measured: 60 weeks

  6. Blood Pressure in mmHg (Both Systolic and Diastolic blood pressure)

    Phase 1

    Measured: 60 weeks

  7. Number of participants with abnormal Hematology test results

    Phase 1

    Measured: 60 weeks

  8. Number of participants with abnormal Urinalysis test results

    Phase 1

    Measured: 60 weeks

  9. Number of participants with abnormal Blood Biochemistry test results

    Phase 1

    Measured: 60 weeks

  10. Number of participants with abnormal Coagulation test results in PT(Prothrombin time), APTT(Activated partial thromboplastin time), FIB(Fibrinogen), TT(Thrombin time) and INR(International normalized ratio).

    Phase 1

    Measured: 60 weeks

  11. Echocardiography- LVEF(Left Ventricular Ejection Fraction) in percentage

    Phase 1

    Measured: 60 weeks

  12. 12-lead electrocardiogram (ECG) in RR, PR, QRS, QT, QTcF etc.

    Phase 1

    Measured: 60 weeks

  13. ECOG(Eastern Cooperative Oncology Group) score

    Phase 1

    Measured: 60 weeks

  14. Overall Response Rate (ORR)

    Phase 2

    Measured: 36 weeks

Secondary outcomes (26)

  1. Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax)

    Phase 1 and 2

    Measured: 96 weeks

  2. PK Parameter:Time of Maximum Observed Concentration (Tmax)

    Phase 1 and 2

    Measured: 96 weeks

  3. PK Parameter: Area Under the Concentration-time Curve(AUC)

    Phase 1 and 2

    Measured: 96 weeks

  4. PK Parameter: Steady State Maximum Concentration(Cmax,ss)

    Phase 1 and 2

    Measured: 96 weeks

  5. PK Parameter: Steady State Minimum Concentration(Cmin,ss)

    Phase 1 and 2

    Measured: 96 weeks

  6. PK Parameter: Systemic Clearance at Steady State (CLss)

    Phase 1 and 2

    Measured: 96 weeks

  7. PK Parameter: Accumulation Ratio (Rac)

    Phase 1 and 2

    Measured: 96 weeks

  8. PK Parameter: Elimination Half-life (t1/2)

    Phase 1 and 2

    Measured: 96 weeks

  9. PK Parameter: Volume of Distribution at Steady-State (Vss)

    Phase 1 and 2

    Measured: 96 weeks

  10. PK Parameter: Degree of Fluctuation (DF)

    Phase 1 and 2

    Measured: 96 weeks

  11. Immunogenicity of LM-24C5

    Phase 1 and 2; Anti-Drug antibody and Nab (if necessary) will be tested.

    Measured: 96 weeks

  12. Duration of Response (DOR) in Month

    Phase 1 and 2

    Measured: 96 weeks

  13. Disease control rate (DCR) in percentage

    Phase 1 and 2

    Measured: 96 weeks

  14. progression-free survival (PFS) in Month

    Phase 1 and 2

    Measured: 96 weeks

  15. Overall survival (OS) in Month

    Phase 1

    Measured: 60 weeks

  16. Changes of target lesions from baseline in Millimeter.

    Phase 1 and 2

    Measured: 96 weeks

  17. Safety: AE/SAE (Number of participants with treatment-related adverse events as assessed by CTCAE v5.0)

    Phase 2

    Measured: 36 weeks

  18. Ear Temperature

    Phase 2

    Measured: 36 weeks

  19. Pulse in BPM (Beat per Minute)

    Phase 2

    Measured: 36 weeks

  20. Blood Pressure in mmHg (Both Systolic and Diastolic blood pressure)

    Phase 2

    Measured: 36 weeks

  21. Number of participants with abnormal Hematology test results

    Phase 2

    Measured: 36 weeks

  22. Number of participants with abnormal Urinalysis test results

    Phase 2

    Measured: 36 weeks

  23. Number of participants with abnormal Blood Biochemistry test results

    Phase 2

    Measured: 36 weeks

  24. Number of participants with abnormal Coagulation test results in PT(Prothrombin time), APTT(Activated partial thromboplastin time), FIB(Fibrinogen), TT(Thrombin time) and INR(International normalized ratio).

    Phase 2

    Measured: 36 weeks

  25. 12-lead electrocardiogram (ECG) in RR, PR, QRS, QT, QTcF etc.

    Phase 2

    Measured: 36 weeks

  26. ECOG(Eastern Cooperative Oncology Group) score

    Phase 2

    Measured: 36 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jan 2024
  2. Study start20 Dec 2023
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion30 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
49 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06187402
Sponsor's protocol ID
LM24C5-01-101
Status last verified
Sep 2025
First submitted
4 Dec 2023
Last updated
9 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing LM-24C5 in people with Advanced Solid Tumor, run by LaNova Medicines Limited at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Alex Yuan (+8615901815211, alexyuan@lanovamed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse events (AEs) (time frame: 60 weeks). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06187402.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.

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