Malignant Tumors
Conditions
Brief summary
For Phase I, 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-364 as a single agent or in combination with tislelizumab in participants with advanced solid tumors. For Phase II, to assess the preliminary anti-tumor activity of IMP in participants with advanced solid tumors.
Interventions
DRUGLM-364 for injection
Q3W, Intravenous Drip
DRUGTislelizumab
Q3W, Intravenous Drip
Sponsors
LaNova Medicines Limited
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of dose-limiting toxicity (DLT) | 78 weeks | Phase I |
| Incidence of Treatment-Emergent Adverse Events (AEs) | 78 weeks | Phase I |
| Incidence of serious adverse events (SAEs) | 78 weeks | Phase I |
| Temperature (Celsius) | 78 weeks | Phase I |
| Pulse in BPM(Beat per Minute) | 78 weeks | Phase I |
| Blood Pressure in mmHg | 78 weeks | Phase I |
| Weight in Kg | 78 weeks | Phase I |
| Height in centimeters | 78 weeks | Phase I |
| Blood Routine examination -> Complete Blood Count | 78 weeks | Phase I |
| Urine Routine examination ->Urinalysis | 78 weeks | Phase I |
| Blood Biochemistry test -> Electrolytes and Metabolic Parameters | 78 weeks | Phase I |
| Coagulation function test-For the detection of Prothrombin time (PT), Activated partial thromboplastin time (APTT), | 78 weeks | Phase I |
| Pregnancy test | 78 weeks | Phase I |
| Thyroid Function Test-For the detection of thyroid-stimulating hormone (TSH), free triiodothyronine (FT3) and free thyroxine (FT4) | 78 weeks | Phase I |
| Echocardiography- LVEF (Left Ventricular Ejection Fraction) in percentage | 78 weeks | Phase I |
| 12-lead electrocardiogram (ECG) in HR | 78 weeks | Phase I |
| 12-lead electrocardiogram (ECG) in RR | 78 weeks | Phase I |
| 12-lead electrocardiogram (ECG) in QRS | 78 weeks | Phase I |
| 12-lead electrocardiogram (ECG) in QT | 78 weeks | Phase I |
| 12-lead electrocardiogram (ECG) in QTcF | 78 weeks | Phase I |
| ECOG(Eastern Cooperative Oncology Group) score | 78 weeks | Phase I |
| Objective Response Rate (ORR) | 130 weeks | Phase II |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax) | 130 weeks | Phase I/II |
| PK Parameter:Time of Maximum Observed Concentration (Tmax) | 130 weeks | Phase I/II |
| PK Parameter: Area Under the Concentration-time Curve (AUC) | 130 weeks | Phase I/II |
| PK Parameter: Steady State Maximum Concentration (Cmax,ss) PK Parameter: Steady State Maximum Concentration(Cmax,ss) | 130 weeks | Phase I/II |
| PK Parameter: Steady State Minimum Concentration (Cmin,ss) | 130 weeks | Phase I/II |
| PK Parameter: Systemic Clearance at Steady State (CLss) | 130 weeks | Phase I/II |
| PK Parameter: Accumulation Ratio (Rac) | 130 weeks | Phase I/II |
| PK Parameter: Elimination Half-life (t1/2) | 130 weeks | Phase I/II |
| PK Parameter: Volume of Distribution at Steady-State (Vss) | 130 weeks | Phase I/II |
| PK Parameter: Degree of Fluctuation (DF) | 130 weeks | Phase I/II |
| Immunogenicity testing->Anti-Drug Antibody test | 130 weeks | Phase I/II |
| Objective Response Rate (ORR) | 130 weeks | Phase I/II |
| Duration of Response (DOR) in Month | 130 weeks | Phase I/II |
| Disease control rate (DCR) in percentage | 130 weeks | Phase I/II |
| Progression-free survival (PFS) in Month | 130 weeks | Phase I/II |
| Overall survival (OS) in Month | 130 weeks | Phase I/II |
| Changes of target lesions from baseline in Millimeter | 130 weeks | Phase I/II |
| Incidence of adverse events (AEs) | 130 weeks | Phase II |
| Incidence of serious adverse events (SAEs) | 130 weeks | Phase II |
| Temperature (Celsius) | 130 weeks | Phase II |
| Pulse in BPM(Beat per Minute) | 130 weeks | Phase II |
| Blood Pressure in mmHg | 130 weeks | Phase II |
| Weight in Kg | 130 weeks | Phase II |
| Height in centimeters | 130 weeks | Phase II |
| Blood Routine examination -> Complete Blood Count | 130 weeks | Phase II |
| Urine Routine examination ->Urinalysis | 130 weeks | Phase II |
| Blood Biochemistry test -> Electrolytes and Metabolic Parameters | 130 weeks | Phase II |
| Coagulation function test-For the detection of Prothrombin time (PT), Activated partial thromboplastin time (APTT), International normalized ratio (INR) | 130 weeks | Phase II |
| Pregnancy test | 130 weeks | Phase II |
| Thyroid Function Test-For the detection of thyroid-stimulating hormone (TSH), free | 130 weeks | Phase II |
| Echocardiography- LVEF (Left Ventricular Ejection Fraction) in percentage | 130 weeks | Phase II |
| ECOG(Eastern Cooperative Oncology Group) score | 130 weeks | Phase II |
| 12-lead electrocardiogram (ECG) in HR | 130 weeks | Phase II |
| 12-lead electrocardiogram (ECG) in RR | 130 weeks | Phase II |
| 12-lead electrocardiogram (ECG) in PR | 130 weeks | Phase II |
| 12-lead electrocardiogram (ECG) in QRS | 130 weeks | Phase II |
| 12-lead electrocardiogram (ECG) in QT | 130 weeks | Phase II |
| 12-lead electrocardiogram (ECG) in QTcF | 130 weeks | Phase II |
| Biomarker test -> Tumor tissue biomarker test | 130 weeks | Phase I/II |
| QTc-PK relationship -> Correlation concentrations (total antibody, free DXd) vs ΔQTcF (Fridericia's correction) | 12 weeks | Phase I |
Countries
Australia
Contacts
CONTACTAlex Yuan
Outcome results
None listed