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

NCT05255484 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: LM108-01-102
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 6

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

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (12)

• Incidence of anti-drug antibodies to LM-108

  126 weeks

• Cmax

  126 weeks

• Cmin

  126 weeks

• Tmax

  126 weeks

• AUC

  126 weeks

Study Arms (4)

LM-108 Dose Escalation

EXPERIMENTAL

Drug: LM-108 Administered intravenously

Drug: LM-108

LM-108 Dose Expansion

EXPERIMENTAL

Drug: LM-108 Administered intravenously

Drug: LM-108

LM-108 Combination Dose Escalation

EXPERIMENTAL

Drug: LM-108 Administered intravenously Drug: An Anti-PD-1 Antibody Administered intravenously

Drug: LM-108; Drug: An Anti-PD-1 Antibody

LM-108 Combination Dose Expansion

EXPERIMENTAL

Drug: LM-108 Administered intravenously Drug: An Anti-PD-1 Antibody Administered intravenously

Drug: LM-108; Drug: An Anti-PD-1 Antibody

Interventions

LM-108 DRUG

Administered intravenously

LM-108 Combination Dose Escalation; LM-108 Combination Dose Expansion; LM-108 Dose Escalation; LM-108 Dose Expansion

An Anti-PD-1 Antibody DRUG

Administered intravenously

LM-108 Combination Dose Escalation; LM-108 Combination Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
• 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.
• At least one measurable disease for expansion cohorts per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1.
• Subjects must show appropriate organ and marrow function in laboratory examinations within 7 days prior to the first dose

You may not qualify if:

• Any adverse event from prior anti-tumour therapy has not yet recovered to ≤grade 1 of CTCAE v5.0
• Uncontrolled tumour-related pain
• Known central nervous system (CNS)
• Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
• Use of inhaled corticosteroids
• Known history of autoimmune disease
• Use of any live attenuated vaccines within 28 days
• Have severe cardiovascular disease
• Uncontrolled or severe illness
• History of immunodeficiency disease
• Active malignancies which are likely to require the treatment.
• Child-bearing potential female
• Have psychiatric illness or disorders

Sponsors & Collaborators

• LaNova Medicines Limited: lead

Study Sites (6)

Ocala Oncology Center

Ocala, Florida, 34474, United States

Location

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Gabrail Cancer and Research Center

Canton, Ohio, 44718, United States

Location

The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

University of Oklahoma

Norman, Oklahoma, 73104, United States

Location

Mary Crowley Cancer Research

Dallas, Texas, 75230, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2022
• First Posted: February 24, 2022
• Study Start: May 26, 2022
• Primary Completion: October 6, 2023
• Study Completion: October 6, 2023
• Last Updated: October 25, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)