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Malignant TumorsPhase 1/2NCT06650566

Study of LM-299 in Subjects Advanced Malignant Tumors

A Phase 1/2 study testing LM-299 in people with Malignant Tumors, run by LaNova Medicines Limited at 6 sites in 2 countries.

Recruiting

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

Sites and contacts
Official record
Search all trials

Trial summary

For Phase I Dose Escalation Stage, to assess the safety and tolerability of LM-299 in patients with advanced solid tumors,determine the maximum tolerated dose (MTD) or optimal biological dose (OBD), and explorethe recommended dose for expansion (RDE) in patients with advanced solid tumours.. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Malignant Tumors
What is being tested?
LM-299
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
6 sitesin 2 countries
Study dates
9 Oct 2024to Jul 2027
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects who are willing to participate in the study and sign the informed consent form (ICF) prior to any procedure.
  • Participant must be 18- 18 years or the legal age of consent at the time of signing the ICF.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • Life expectancy ≥ 3 months.
  • Patients with advanced solid tumors confirmed by histopathological diagnosis who have failed standard treatment, are intolerant to standard treatment, or for whom standard treatment is currently unsuitable.
  • Pre-treatment archived tumour tissue (within 5 years) or fresh samples could be provided for biomarker analysis.
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  • Must have at least one measurable lesion according to RECIST v1.1.
  • Adequate organ and bone marrow function as defined by protocol.
  • Female subjects of childbearing potential or male subjects with partners of childbearing potential agree to use highly effective contraception.
  • 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-299.
  • Subjects who have received the anti-tumor treatments within the specified time periods prior to the first dosing of LM-299.
  • Any adverse event from prior anti-tumour therapy has not yet recovered to ≤ grade 1 of CTCAE v5.0.
  • Subjects with uncontrolled tumour-related pain.
  • Subjects with known central nervous system (CNS) or meningeal metastasis.
  • Qualitative urine protein results ≥ 3+.
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  • Clinically significant hemoptysis or tumor bleeding within 2 weeks prior to 1st dosing of LM-299.
  • Any life-threatening bleeding event that occurred within 3 months prior to 1st dosing of LM-299.
  • Subjects with esophageal or gastric varices requiring immediate intervention or a history of variceal bleeding .
  • Hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh class B or more severe liver cirrhosis.
  • Subjects who have clinically uncontrollable third-space fluid accumulatio.
  • Radiographic evidence of tumor invading surrounding vital organs or the risk of esophagotracheal fistula or esophagopleural fistula, tumor surrounding or invading the major blood vessels, or presence of intratumoral cavity formation.
  • History of gastrointestinal perforation and/or fistula within 6 months prior to the first dose of the study drug.
  • Patients with complete or incomplete intestinal obstruction within 3 months prior to the first dose of the study drug or patientswho are currently at the risk of intestinal perforation.
  • Subjects who are known to be allergic to antibody treatment.
  • Subjects who take systemic corticosteroids (≥ 10 mg/day of prednisone or equivalent) for more than 7 days within 2 weeks prior to the first dose of LM-299.
  • Subjects with the known history of autoimmune disease.
  • Patients with a history of active or previously confirmed inflammatory bowel disease.
  • Patients with a history of or currently having interstitial pneumonia requiring systemic corticosteroid treatment.
  • Received live vaccines or attenuated live vaccines within 28 days prior to the first dose of the study drug.
  • Currently using anticoagulants such as therapeutic doses of heparin or vitamin K antagonists.
  • Subjects who received major surgery or interventional treatment within 28 days prior to 1st dosing of LM-299 (excluding tumour biopsy, puncture, etc.).
  • Subjects who have severe cardiovascular and and cerebrovascular diseases.
  • Patients with severe infections within 4 weeks prior to the first dose.
  • Patients with a history of immunodeficiency.
  • Individuals with HIV infection, active HBV or HCV infection .
  • Patients with known active tuberculosis (TB). Suspected active TB should be ruled out through clinical examination.
  • Patients who have had other malignancies within 5 years prior to the first dose of the study drug.
  • Women of childbearing age who test positive for pregnancy within 7 days prior to the first dose of the study drug or are breastfeeding.
  • Individuals with known psychiatric disorders or illnesses that may affect adherence to the trial.
  • Patients with local or systemic diseases caused by non-malignant tumors.
  • Subject who is judged as not eligible to participate in this study by the investigator.

Trial locations and contacts

6 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Alex Yuan contact

+8615901815211

alexyuan@lanovamed.com

6 sites in 2 countries

China5 sites, 5 recruiting

  • Liaocheng people's hospital

    Liaocheng, Shandong

    Baozhong Wang

    Not yet recruiting

  • Shanghai Dongfang Hospital (Tongji University Affiliated Dongfang Hospital)

    Shanghai, Shanghai Municipality

    Junli Xue

    Not yet recruiting

  • Shanghai GoBroad Cancer Hospital China Pharmaceutical University

    Shanghai, Shanghai Municipality

    Jin Li

    Recruiting

  • the first affiliated hospital of Xinxiang medical University

    Xinxiang, Henan

    Weizheng Kou

    Not yet recruiting

  • Zibo municipal hospital

    Zibo, Shandong

    Rusen Zhao

    Not yet recruiting

Other trials in China

Australia1 site, 1 recruiting

  • One Clinical Research

    Perth, Western Australia

    Dr Mihitha Ariyapperuma

    Not yet recruiting

Other trials in Australia

About this study

Official title: A Phase I/II, Open-label, Dose Escalation and Dose Expansion Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of LM-299 Injection as Monotherapy or in Combination With Other Anti-tumor Therapies in Patients With Advanced Solid Tumors

For Phase I Dose Escalation Stage, to assess the safety and tolerability of LM-299 in patients with advanced solid tumors,determine the maximum tolerated dose (MTD) or optimal biological dose (OBD), and explorethe recommended dose for expansion (RDE) in patients with advanced solid tumours..

For Phase II Dose Expansion Stage, to assess the antitumor activity of LM-299 in patients with various advanced solid tumors.

Being tested
LM-299
Medical subject headings
Neoplasms

What participants receive

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

  • LM-299Drug

    Q2W/Q3W,Intravenous Drip

Study groups in NCT06650566
Study groupRoleWhat they receive
LM-299 Dose Escalation at different dose levelsExperimentalNot described
Receives: Drug: LM-299
LM-299 Dose Escalation Backfill CohortsExperimentalNot described
Receives: Drug: LM-299

What is being measured

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

  1. Incidence of dose-limitingtoxicity (DLT)

    Phase 1

    Measured: 53 weeks

  2. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Phase 1

    Measured: 53 weeks

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

    Phase 1

    Measured: 53 weeks

  4. Overall Response Rate (ORR)

    Phase 2

    Measured: 50 weeks

Secondary outcomes (17)

  1. PK Parameter: Area Under the Concentration-time Curve(AUClast)

    Phase 1 and 2

    Measured: 103 weeks

  2. PK Parameter: Area Under the Concentration-time Curve(AUCtau)

    Phase 1 and 2

    Measured: 103 weeks

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

    Phase 1 and 2

    Measured: 103 weeks

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

    Phase 1 and 2

    Measured: 103 weeks

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

    Phase 1 and 2

    Measured: 103 weeks

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

    Phase 1 and 2

    Measured: 103 weeks

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

    Phase 1 and 2

    Measured: 103 weeks

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

    Phase 1 and 2

    Measured: 103 weeks

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

    Phase 1 and 2

    Measured: 103 weeks

  10. PK Parameter: Accumulation Ratio (Rac AUC)

    Phase 1 and 2

    Measured: 103 weeks

  11. PK Parameter: Degree of Fluctuation (DF)

    Phase 1 and 2

    Measured: 103 weeks

  12. Overall Response Rate (ORR)

    Phase 1

    Measured: 53 weeks

  13. Duration of Response (DOR) in Month

    Phase 1 and 2

    Measured: 103 weeks

  14. Disease control rate (DCR) in percentage

    Phase 1 and 2

    Measured: 103 weeks

  15. progression-free survival (PFS) in Month

    Phase 1 and 2

    Measured: 103 weeks

  16. Overall survival (OS) in Month

    Phase 1 and 2

    Measured: 103 weeks

  17. PK Parameter: Accumulation Ratio (Rac Cmax)

    Phase 1 and 2

    Measured: 103 weeks

Timeline

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

  1. First posted21 Oct 2024
  2. Study start9 Oct 2024
  3. Primary completionDec 2026 (estimated)
  4. Study completionJul 2027 (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
Parallel groups
Masking
None (open label)
Enrolment
108 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06650566
Sponsor's protocol ID
LM299-01-102
Status last verified
Nov 2024
First submitted
14 Oct 2024
Last updated
2 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
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-299 in people with Malignant Tumors, run by LaNova Medicines Limited at 6 sites in 2 countries.

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 10 inclusion and 32 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 2 May 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 China, Australia. 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 dose-limitingtoxicity (DLT) (time frame: 53 weeks). The study lists 4 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 NCT06650566.

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 2 May 2025.

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