Clinical trial NCT05255484: Study of LM-108 as a Single Agent or in Combination With Pembrolizumab in Subjects With Advanced Solid Tumours
Official title: A Phase I/II, Open-Label, Dose Escalation and Expansion Study of LM-108 as a Single Agent or in Combination With Pembrolizumab in Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Advanced Solid Tumor
Lead sponsor: LaNova Medicines Limited
Sponsor class: INDUSTRY
First posted: 2022-02-24
Enrollment: 24
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: 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).

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: AEs
timeFrame: 126 weeks
measure: DLT
timeFrame: 21 days
measure: SAE
timeFrame: 126 weeks
measure: Incidence of clinical significant in laboratory examinations
timeFrame: 126 weeks
Secondary outcomes:
measure: Incidence of anti-drug antibodies to LM-108
timeFrame: 126 weeks
measure: Cmax
timeFrame: 126 weeks
measure: Cmin
timeFrame: 126 weeks
measure: Tmax
timeFrame: 126 weeks
measure: AUC
timeFrame: 126 weeks
measure: Cmax,ss
timeFrame: 126 weeks
measure: Cmin, ss
timeFrame: 126 weeks
measure: CLss
timeFrame: 126 weeks
measure: Rac
timeFrame: 126 weeks
measure: t 1/2
timeFrame: 126 weeks
measure: Vss
timeFrame: 126 weeks
measure: DF
timeFrame: 126 weeks
Other outcomes:
Locations:
city: Ocala
country: United States
facility: Ocala Oncology Center
state: Florida
city: Indianapolis
country: United States
facility: Indiana University Melvin and Bren Simon Comprehensive Cancer Center
state: Indiana
city: Canton
country: United States
facility: Gabrail Cancer and Research Center
state: Ohio
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Norman
country: United States
facility: University of Oklahoma
state: Oklahoma
city: Dallas
country: United States
facility: Mary Crowley Cancer Research
state: Texas
Study officials:
References: