Study of LM-108 as a Single Agent or in Combination With Pembrolizumab in Subjects With Advanced Solid Tumours

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

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

Study Overview

• Status: Terminated
• Conditions: Advanced Solid Tumor
• Intervention / Treatment: Drug: LM-108; Drug: An Anti-PD-1 Antibody

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).

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Ocala, Florida, United States, 34474
      • Ocala Oncology Center
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Melvin and Bren Simon Comprehensive Cancer Center
  • Ohio
    • Canton, Ohio, United States, 44718
      • Gabrail Cancer and Research Center
    • Cincinnati, Ohio, United States, 45219
      • The Christ Hospital
  • Oklahoma
    • Norman, Oklahoma, United States, 73104
      • University of Oklahoma
  • Texas
    • Dallas, Texas, United States, 75230
      • Mary Crowley Cancer Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LM-108 Dose Escalation; Drug: LM-108 Administered intravenously	Drug: LM-108; Administered intravenously
Experimental: LM-108 Dose Expansion; Drug: LM-108 Administered intravenously	Drug: LM-108; Administered intravenously
Experimental: LM-108 Combination Dose Escalation; Drug: LM-108 Administered intravenously Drug: An Anti-PD-1 Antibody Administered intravenously	Drug: LM-108; Administered intravenously; Drug: An Anti-PD-1 Antibody; Administered intravenously
Experimental: LM-108 Combination Dose Expansion; Drug: LM-108 Administered intravenously Drug: An Anti-PD-1 Antibody Administered intravenously	Drug: LM-108; Administered intravenously; Drug: An Anti-PD-1 Antibody; Administered intravenously

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AEs	Incidence of adverse events	126 weeks
DLT	Incidence of dose-limiting toxicity (DLT)	21 days
SAE	Incidence of serious adverse event	126 weeks
Incidence of clinical significant in laboratory examinations	Incidence of clinical significant in laboratory examinations, including hematology, urinalysis, blood biochemistry, coagulation tests and thyroid function.	126 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of anti-drug antibodies to LM-108	Incidence of anti-drug antibodies to LM-108	126 weeks
Cmax	Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax) for LM-108	126 weeks
Cmin	PK Parameter: Minimum Observed Concentration (Cmin) for LM-108	126 weeks
Tmax	PK Parameter: Time of Maximum Observed Concentration (Tmax) for LM-108	126 weeks
AUC	PK Parameter: Area Under the Concentration-time Curve (AUC) for LM-108	126 weeks
Cmax,ss	PK Parameter: Steady State Maximum Concentration (Cmax,ss)	126 weeks
Cmin, ss	PK Parameter: Steady State Minimum Concentration (Cmin, ss)	126 weeks
CLss	PK Parameter: Systemic Clearance at Steady State (CLss)	126 weeks
Rac	PK Parameter: Accumulation Ratio (Rac)	126 weeks
t 1/2	PK Parameter: Elimination Half-life (t 1/2)	126 weeks
Vss	PK Parameter: Volume of Distribution at Steady-State (Vss)	126 weeks
DF	PK Parameter: Degree of Fluctuation (DF)	126 weeks

Collaborators and Investigators

• Sponsor: LaNova Medicines Limited

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2022
• Primary Completion (Actual): October 6, 2023
• Study Completion (Actual): October 6, 2023

Study Registration Dates

• First Submitted: February 14, 2022
• First Submitted That Met QC Criteria: February 16, 2022
• First Posted (Actual): February 24, 2022

Study Record Updates

• Last Update Posted (Actual): October 25, 2023
• Last Update Submitted That Met QC Criteria: October 24, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Physiological Effects of Drugs; Immunologic Factors; Antibodies
• Other Study ID Numbers: LM108-01-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No