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

LaNova Medicines

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Advanced Solid Tumor

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT05255484

LM108-01-102

Details and patient eligibility

About

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

Full 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).

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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24 participants in 4 patient groups

LM-108 Dose Escalation

Experimental group

Description:

Drug: LM-108 Administered intravenously

Treatment:

Drug: LM-108

LM-108 Dose Expansion

Experimental group

Description:

Drug: LM-108 Administered intravenously

Treatment:

Drug: LM-108

LM-108 Combination Dose Escalation

Experimental group

Description:

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

Treatment:

Drug: An Anti-PD-1 Antibody

Drug: LM-108

LM-108 Combination Dose Expansion

Experimental group

Description:

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

Treatment:

Drug: An Anti-PD-1 Antibody

Drug: LM-108