Advanced Solid Tumor
Conditions
Brief summary
A Phase I/II, Open-Label, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of LM-108 as a Single Agent or in Combination with Pembrolizumab in Advanced Solid Tumors
Detailed description
A Phase I/II, Open-Label, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of LM-108 as a Single Agent or in Combination with Pembrolizumab in Advanced Solid Tumors The study schedule includes screening visit (28 days prior to accept the investigational medicinal product (IMP)), treatment visit (accept IMP for the first time to the end of treatment (EOT)/early withdrawal), and follow-up visit (28 days after the EOT/early withdrawal).
Interventions
DRUGLM-108
Administered intravenously
Administered intravenously
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
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AEs | 126 weeks | Incidence of adverse events |
| DLT | 21 days | Incidence of dose-limiting toxicity (DLT) |
| SAE | 126 weeks | Incidence of serious adverse event |
| Incidence of clinical significant in laboratory examinations | 126 weeks | Incidence of clinical significant in laboratory examinations, including hematology, urinalysis, blood biochemistry, coagulation tests and thyroid function. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUC | 126 weeks | PK Parameter: Area Under the Concentration-time Curve (AUC) for LM-108 |
| Cmax,ss | 126 weeks | PK Parameter: Steady State Maximum Concentration (Cmax,ss) |
| Cmin, ss | 126 weeks | PK Parameter: Steady State Minimum Concentration (Cmin, ss) |
| CLss | 126 weeks | PK Parameter: Systemic Clearance at Steady State (CLss) |
| Incidence of anti-drug antibodies to LM-108 | 126 weeks | Incidence of anti-drug antibodies to LM-108 |
| t 1/2 | 126 weeks | PK Parameter: Elimination Half-life (t 1/2) |
| Vss | 126 weeks | PK Parameter: Volume of Distribution at Steady-State (Vss) |
| DF | 126 weeks | PK Parameter: Degree of Fluctuation (DF) |
| Rac | 126 weeks | PK Parameter: Accumulation Ratio (Rac) |
| Cmax | 126 weeks | Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax) for LM-108 |
| Cmin | 126 weeks | PK Parameter: Minimum Observed Concentration (Cmin) for LM-108 |
| Tmax | 126 weeks | PK Parameter: Time of Maximum Observed Concentration (Tmax) for LM-108 |
Countries
United States
Outcome results
None listed