A Study of LM-108 as Monotherapy or in Combination With Antitumor Therapies in Subjects With Advanced Solid Tumors

LaNova Medicines

Status and phase: Active, not recruiting; Phase 2; Phase 1

Conditions: Advanced Solid Tumor

Treatments: Drug: LM-108; Drug: Toripalimab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05518045

LM108-01-103

Details and patient eligibility

About

A Phase I/II, Open-Label, Dose-Escalation and Dose-Expansion Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile and Preliminary Efficacy of LM-108, an Anti-CCR8 Monoclonal Antibody, as Monotherapy or in Combination with Antitumor Therapies in Patients with Advanced Solid Tumors

Enrollment: 392 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Exclusion criteria

1. Have received anti-CCR8 drug treatment or other clinical study drug or treatment not on the market within 28 days prior to the first dose.
2. Any adverse event from prior anti-tumor therapy has not yet recovered to ≤ grade 1 of CTCAE v5.0.
3. Subjects with uncontrolled tumor-related pain.
4. Subjects with known brain metastases.
5. Uncontrollable clinical third luminal effusion.
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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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392 participants in 3 patient groups

LM-108 Dose Escalation

Experimental group

Treatment:

Drug: LM-108

LM-108 Dose Expansion

Experimental group

Treatment:

Drug: LM-108

LM-108 combination dose expansion

Experimental group

Treatment:

Drug: Toripalimab

Drug: LM-108