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

Advanced Solid Tumor Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05255484
• Other study ID #: LM108-01-102
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: May 26, 2022
• Est. completion date: October 6, 2023

Study information

• Verified date: October 2023
• Source: LaNova Medicines Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: October 6, 2023
• Est. primary completion date: October 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Gabrail Cancer and Research Center	Canton	Ohio
United States	The Christ Hospital	Cincinnati	Ohio
United States	Mary Crowley Cancer Research	Dallas	Texas
United States	Indiana University Melvin and Bren Simon Comprehensive Cancer Center	Indianapolis	Indiana
United States	University of Oklahoma	Norman	Oklahoma
United States	Ocala Oncology Center	Ocala	Florida

Sponsors (1)

Lead Sponsor	Collaborator
LaNova Medicines Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AEs	Incidence of adverse events	126 weeks
Primary	DLT	Incidence of dose-limiting toxicity (DLT)	21 days
Primary	SAE	Incidence of serious adverse event	126 weeks
Primary	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	Incidence of anti-drug antibodies to LM-108	Incidence of anti-drug antibodies to LM-108	126 weeks
Secondary	Cmax	Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax) for LM-108	126 weeks
Secondary	Cmin	PK Parameter: Minimum Observed Concentration (Cmin) for LM-108	126 weeks
Secondary	Tmax	PK Parameter: Time of Maximum Observed Concentration (Tmax) for LM-108	126 weeks
Secondary	AUC	PK Parameter: Area Under the Concentration-time Curve (AUC) for LM-108	126 weeks
Secondary	Cmax,ss	PK Parameter: Steady State Maximum Concentration (Cmax,ss)	126 weeks
Secondary	Cmin, ss	PK Parameter: Steady State Minimum Concentration (Cmin, ss)	126 weeks
Secondary	CLss	PK Parameter: Systemic Clearance at Steady State (CLss)	126 weeks
Secondary	Rac	PK Parameter: Accumulation Ratio (Rac)	126 weeks
Secondary	t 1/2	PK Parameter: Elimination Half-life (t 1/2)	126 weeks
Secondary	Vss	PK Parameter: Volume of Distribution at Steady-State (Vss)	126 weeks
Secondary	DF	PK Parameter: Degree of Fluctuation (DF)	126 weeks