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

October 24, 2023 updated by: LaNova Medicines Limited

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
AEs
Time Frame: 126 weeks
Incidence of adverse events
126 weeks
DLT
Time Frame: 21 days
Incidence of dose-limiting toxicity (DLT)
21 days
SAE
Time Frame: 126 weeks
Incidence of serious adverse event
126 weeks
Incidence of clinical significant in laboratory examinations
Time Frame: 126 weeks
Incidence of clinical significant in laboratory examinations, including hematology, urinalysis, blood biochemistry, coagulation tests and thyroid function.
126 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of anti-drug antibodies to LM-108
Time Frame: 126 weeks
Incidence of anti-drug antibodies to LM-108
126 weeks
Cmax
Time Frame: 126 weeks
Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax) for LM-108
126 weeks
Cmin
Time Frame: 126 weeks
PK Parameter: Minimum Observed Concentration (Cmin) for LM-108
126 weeks
Tmax
Time Frame: 126 weeks
PK Parameter: Time of Maximum Observed Concentration (Tmax) for LM-108
126 weeks
AUC
Time Frame: 126 weeks
PK Parameter: Area Under the Concentration-time Curve (AUC) for LM-108
126 weeks
Cmax,ss
Time Frame: 126 weeks
PK Parameter: Steady State Maximum Concentration (Cmax,ss)
126 weeks
Cmin, ss
Time Frame: 126 weeks
PK Parameter: Steady State Minimum Concentration (Cmin, ss)
126 weeks
CLss
Time Frame: 126 weeks
PK Parameter: Systemic Clearance at Steady State (CLss)
126 weeks
Rac
Time Frame: 126 weeks
PK Parameter: Accumulation Ratio (Rac)
126 weeks
t 1/2
Time Frame: 126 weeks
PK Parameter: Elimination Half-life (t 1/2)
126 weeks
Vss
Time Frame: 126 weeks
PK Parameter: Volume of Distribution at Steady-State (Vss)
126 weeks
DF
Time Frame: 126 weeks
PK Parameter: Degree of Fluctuation (DF)
126 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
LaNova Medicines Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 26, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 6, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 6, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 14, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 24, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 25, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Advanced Solid Tumor

Clinical Trials on LM-108

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings