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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06650566




Registration number
NCT06650566
Ethics application status
Date submitted
14/10/2024
Date registered
21/10/2024

Titles & IDs
Public title
Study of LM-299 in Subjects Advanced Malignant Tumors
Scientific 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
Secondary ID [1] 0 0
LM299-01-102
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malignant Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - LM-299

Experimental: LM-299 Dose Escalation at different dose levels -

Experimental: LM-299 Dose Escalation Backfill Cohorts -


Treatment: Drugs: LM-299
Q2W/Q3W,Intravenous Drip
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of dose-limitingtoxicity (DLT)
Timepoint [1] 0 0
53 weeks
Primary outcome [2] 0 0
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Timepoint [2] 0 0
53 weeks
Primary outcome [3] 0 0
Echocardiography- LVEF(Left Ventricular Ejection Fraction) in percentage
Timepoint [3] 0 0
53 weeks
Primary outcome [4] 0 0
Overall Response Rate (ORR)
Timepoint [4] 0 0
50 weeks
Secondary outcome [1] 0 0
PK Parameter: Area Under the Concentration-time Curve(AUClast)
Timepoint [1] 0 0
103 weeks
Secondary outcome [2] 0 0
PK Parameter: Area Under the Concentration-time Curve(AUCtau)
Timepoint [2] 0 0
103 weeks
Secondary outcome [3] 0 0
Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax)
Timepoint [3] 0 0
103 weeks
Secondary outcome [4] 0 0
PK Parameter:Time of Maximum Observed Concentration (Tmax)
Timepoint [4] 0 0
103 weeks
Secondary outcome [5] 0 0
PK Parameter: Elimination Half-life (t1/2)
Timepoint [5] 0 0
103 weeks
Secondary outcome [6] 0 0
PK Parameter: Steady State Maximum Concentration(Cmax,ss)
Timepoint [6] 0 0
103 weeks
Secondary outcome [7] 0 0
PK Parameter: Steady State Minimum Concentration(Cmin,ss)
Timepoint [7] 0 0
103 weeks
Secondary outcome [8] 0 0
PK Parameter: Systemic Clearance at Steady State (CLss)
Timepoint [8] 0 0
103 weeks
Secondary outcome [9] 0 0
PK Parameter: Volume of Distribution at Steady-State (Vss)
Timepoint [9] 0 0
103 weeks
Secondary outcome [10] 0 0
PK Parameter: Accumulation Ratio (Rac AUC)
Timepoint [10] 0 0
103 weeks
Secondary outcome [11] 0 0
PK Parameter: Degree of Fluctuation (DF)
Timepoint [11] 0 0
103 weeks
Secondary outcome [12] 0 0
Overall Response Rate (ORR)
Timepoint [12] 0 0
53 weeks
Secondary outcome [13] 0 0
Duration of Response (DOR) in Month
Timepoint [13] 0 0
103 weeks
Secondary outcome [14] 0 0
Disease control rate (DCR) in percentage
Timepoint [14] 0 0
103 weeks
Secondary outcome [15] 0 0
progression-free survival (PFS) in Month
Timepoint [15] 0 0
103 weeks
Secondary outcome [16] 0 0
Overall survival (OS) in Month
Timepoint [16] 0 0
103 weeks
Secondary outcome [17] 0 0
PK Parameter: Accumulation Ratio (Rac Cmax)
Timepoint [17] 0 0
103 weeks

Eligibility
Key inclusion criteria
1. Subjects who are willing to participate in the study and sign the informed consent form (ICF) prior to any procedure.
2. Participant must be 18- 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. 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.
6. Pre-treatment archived tumour tissue (within 5 years) or fresh samples could be provided for biomarker analysis.
7. Must have at least one measurable lesion according to RECIST v1.1.
8. Adequate organ and bone marrow function as defined by protocol.
9. Female subjects of childbearing potential or male subjects with partners of childbearing potential agree to use highly effective contraception.
10. Subjects who are able to communicate well with investigators and understand and adhere to the requirements of this study.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Participate in any other clinical trial within 28 days prior to 1st dosing of LM-299.
2. Subjects who have received the anti-tumor treatments within the specified time periods prior to the first dosing of LM-299.
3. Any adverse event from prior anti-tumour therapy has not yet recovered to = grade 1 of CTCAE v5.0.
4. Subjects with uncontrolled tumour-related pain.
5. Subjects with known central nervous system (CNS) or meningeal metastasis.
6. Qualitative urine protein results = 3+.
7. Clinically significant hemoptysis or tumor bleeding within 2 weeks prior to 1st dosing of LM-299.
8. Any life-threatening bleeding event that occurred within 3 months prior to 1st dosing of LM-299.
9. Subjects with esophageal or gastric varices requiring immediate intervention or a history of variceal bleeding .
10. Hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh class B or more severe liver cirrhosis.
11. Subjects who have clinically uncontrollable third-space fluid accumulatio.
12. 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.
13. History of gastrointestinal perforation and/or fistula within 6 months prior to the first dose of the study drug.
14. 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.
15. Subjects who are known to be allergic to antibody treatment.
16. 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.
17. Subjects with the known history of autoimmune disease.
18. Patients with a history of active or previously confirmed inflammatory bowel disease.
19. Patients with a history of or currently having interstitial pneumonia requiring systemic corticosteroid treatment.
20. Received live vaccines or attenuated live vaccines within 28 days prior to the first dose of the study drug.
21. Currently using anticoagulants such as therapeutic doses of heparin or vitamin K antagonists.
22. Subjects who received major surgery or interventional treatment within 28 days prior to 1st dosing of LM-299 (excluding tumour biopsy, puncture, etc.).
23. Subjects who have severe cardiovascular and and cerebrovascular diseases.
24. Patients with severe infections within 4 weeks prior to the first dose.
25. Patients with a history of immunodeficiency.
26. Individuals with HIV infection, active HBV or HCV infection .
27. Patients with known active tuberculosis (TB). Suspected active TB should be ruled out through clinical examination.
28. Patients who have had other malignancies within 5 years prior to the first dose of the study drug.
29. Women of childbearing age who test positive for pregnancy within 7 days prior to the first dose of the study drug or are breastfeeding.
30. Individuals with known psychiatric disorders or illnesses that may affect adherence to the trial.
31. Patients with local or systemic diseases caused by non-malignant tumors.
32. Subject who is judged as not eligible to participate in this study by the investigator.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/10/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2027
Actual
Sample size
Target
108
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
West Australi
Recruitment hospital [1] 0 0
One Clinical Research - Perth
Recruitment postcode(s) [1] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Henan
Country [2] 0 0
China
State/province [2] 0 0
Shandong
Country [3] 0 0
China
State/province [3] 0 0
Shanghai

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
LaNova Medicines Limited
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Alex Yuan
Address 0 0
Country 0 0
Phone 0 0
+8615901815211
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06650566