Clinical trial NCT05199753: Study of LM-108 as a Single Agent or in Combination With Anti-PD-1 Antibody in Subjects With Advanced Solid Tumours
Official title: A Phase I/II, First-in-Human (FIH), 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 Anti-PD-1 Antibody in Subjects With Advanced Solid Tumours
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Advanced Solid Tumor
Lead sponsor: LaNova Medicines Limited
Sponsor class: INDUSTRY
First posted: 2022-01-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a first-in-human, Phase I/II, open-label, multi-centre, dose escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumour activity of LM-108 as a single agent or in combination with an anti-PD-1 mAb in subjects with solid tumours.


Eligibility 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/Exclusion criteria may apply.

Primary outcomes:
measure: Incidence of adverse events (AEs)
timeFrame: 126 weeks
measure: Incidence of dose-limiting toxicity (DLT)
timeFrame: 126 weeks
measure: Incidence of serious adverse event (SAE)
timeFrame: 126 weeks
measure: Incidence of clinical significant in laboratory examinations, including hematology, urinalysis, blood biochemistry, coagulation tests and thyroid function.
timeFrame: 126 weeks
Secondary outcomes:
measure: Incidence of anti-drug antibodies to LM-108
timeFrame: 126 weeks
measure: Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax) for LM-108
timeFrame: 126 weeks
measure: PK Parameter: Minimum Observed Concentration (Cmin) for LM-108
timeFrame: 126 weeks
measure: PK Parameter: Time of Maximum Observed Concentration (Tmax) for LM-108
timeFrame: 126 weeks
measure: PK Parameter: Area Under the Concentration-time Curve (AUC) for LM-108
timeFrame: 126 weeks
measure: PK Parameter: Steady State Maximum Concentration (Cmax,ss)
timeFrame: 126 weeks
measure: PK Parameter: Steady State Minimum Concentration (Cmin, ss)
timeFrame: 126 weeks
measure: PK Parameter: Systemic Clearance at Steady State (CLss)
timeFrame: 126 weeks
measure: PK Parameter: Accumulation Ratio (Rac)
timeFrame: 126 weeks
measure: PK Parameter: Elimination Half-life (t 1/2)
timeFrame: 126 weeks
measure: PK Parameter: Volume of Distribution at Steady-State (Vss)
timeFrame: 126 weeks
measure: PK Parameter: Degree of Fluctuation (DF)
timeFrame: 126 weeks
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Blacktown Hospital
state: New South Wales
city: Birtinya
country: Australia
facility: Sunshine Coast University Private Hospital
state: Queensland
city: South Brisbane
country: Australia
facility: ICON Cancer Centre
state: Queensland
city: Malvern
country: Australia
facility: Cabrini Health Limited
state: Victoria
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
city: Nedlands
country: Australia
facility: One Clinical Research Pty Ltd.
state: Western Australia
Study officials:
References: