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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05255484
Recruitment Status : Recruiting
First Posted : February 24, 2022
Last Update Posted : June 2, 2022
Sponsor:
Information provided by (Responsible Party):
LaNova Medicines Limited

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

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Drug: LM-108 Drug: An Anti-PD-1 Antibody Phase 1 Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 26, 2022
Estimated Primary Completion Date : July 31, 2024
Estimated Study Completion Date : September 14, 2024

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




Primary Outcome Measures :
  1. Incidence of adverse events (AEs) [ Time Frame: 126 weeks ]
  2. Incidence of dose-limiting toxicity (DLT) [ Time Frame: 21 days ]
  3. Incidence of serious adverse event (SAE) [ Time Frame: 126 weeks ]
  4. Incidence of clinical significant in laboratory examinations, including hematology, urinalysis, blood biochemistry, coagulation tests and thyroid function. [ Time Frame: 126 weeks ]

Secondary Outcome Measures :
  1. Incidence of anti-drug antibodies to LM-108 [ Time Frame: 126 weeks ]
  2. Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax) for LM-108 [ Time Frame: 126 weeks ]
  3. PK Parameter: Minimum Observed Concentration (Cmin) for LM-108 [ Time Frame: 126 weeks ]
  4. PK Parameter: Time of Maximum Observed Concentration (Tmax) for LM-108 [ Time Frame: 126 weeks ]
  5. PK Parameter: Area Under the Concentration-time Curve (AUC) for LM-108 [ Time Frame: 126 weeks ]
  6. PK Parameter: Steady State Maximum Concentration (Cmax,ss) [ Time Frame: 126 weeks ]
  7. PK Parameter: Steady State Minimum Concentration (Cmin, ss) [ Time Frame: 126 weeks ]
  8. PK Parameter: Systemic Clearance at Steady State (CLss) [ Time Frame: 126 weeks ]
  9. PK Parameter: Accumulation Ratio (Rac) [ Time Frame: 126 weeks ]
  10. PK Parameter: Elimination Half-life (t 1/2) [ Time Frame: 126 weeks ]
  11. PK Parameter: Volume of Distribution at Steady-State (Vss) [ Time Frame: 126 weeks ]
  12. PK Parameter: Degree of Fluctuation (DF) [ Time Frame: 126 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05255484


Contacts
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Contact: LaNova PM 15962581534 ginnyzhang@lanovamed.com

Locations
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United States, Florida
Ocala Oncology Center Not yet recruiting
Ocala, Florida, United States, 34474
Contact: Rama Balaraman         
United States, Indiana
Indiana University Melvin and Bren Simon Comprehensive Cancer Center Not yet recruiting
Indianapolis, Indiana, United States, 46202
Contact: Mateusz Opyrchal         
United States, Ohio
Gabrail Cancer and Research Center Recruiting
Canton, Ohio, United States, 44718
Contact: Nashat Gabrail         
The Christ Hospital Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Alex Starodub         
United States, Oklahoma
University of Oklahoma Not yet recruiting
Norman, Oklahoma, United States, 73104
Contact: Abdul Naqash         
United States, Texas
Mary Crowley Cancer Research Not yet recruiting
Dallas, Texas, United States, 75230
Contact: Minal Barve         
Sponsors and Collaborators
LaNova Medicines Limited
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Responsible Party: LaNova Medicines Limited
ClinicalTrials.gov Identifier: NCT05255484    
Other Study ID Numbers: LM108-01-102
First Posted: February 24, 2022    Key Record Dates
Last Update Posted: June 2, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms
Antibodies
Immunologic Factors
Physiological Effects of Drugs