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

Sponsor

LaNova Medicines Limited (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05255484

Collaborator

(none)

Enrollment

Locations

Arms

27.7

Anticipated Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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

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 Design

Study Type:

Interventional

Anticipated 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

Anticipated Primary Completion Date :

Jul 31, 2024

Anticipated Study Completion Date :

Sep 14, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Key Inclusion Criteria:

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

Key Exclusion Criteria:

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

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ocala Oncology Center	Ocala	Florida	United States	34474
2	Indiana University Melvin and Bren Simon Comprehensive Cancer Center	Indianapolis	Indiana	United States	46202
3	Gabrail Cancer and Research Center	Canton	Ohio	United States	44718
4	The Christ Hospital	Cincinnati	Ohio	United States	45219
5	University of Oklahoma	Norman	Oklahoma	United States	73104
6	Mary Crowley Cancer Research	Dallas	Texas	United States	75230

Sponsors and Collaborators

LaNova Medicines Limited

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

LaNova Medicines Limited

ClinicalTrials.gov Identifier:

NCT05255484

Other Study ID Numbers:

LM108-01-102

First Posted:

Feb 24, 2022

Last Update Posted:

Jun 2, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neoplasms

Antibodies

Study Results

No Results Posted as of Jun 2, 2022