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

LaNova Medicines

Status and phase: Invitation-only; 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

This is a phase I/II, open-Label, dose-Escalation and dose-expansion Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of LM-108 (an Anti-CCR8 mAb) as a Single Agent or in combination with Toripalimab in Advanced Solid Tumours.

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. Subjects with anti-tumor treatment within 21 days prior to 1st dosing of LM-108, including radiotherapy, chemotherapy, biotherapy, endocrine therapy and immunotherapy, etc.
3. Any adverse event from prior anti-tumor therapy has not yet recovered to ≤ grade 1 of CTCAE v5.0.
4. Subjects with uncontrolled tumor-related pain.
5. Subjects with known brain metastases.
6. Uncontrollable clinical third luminal effusion.
7. Known history of autoimmune disease.
8. Use of any live attenuated vaccines within 28 days.
9. Have severe cardiovascular disease.
10. Uncontrolled or severe illness.
11. History of immunodeficiency disease.
12. Active malignancies which are likely to require the treatment.
13. Child-bearing potential female.
14. 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 4 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 escalation

Experimental group

Treatment:

Drug: Toripalimab

Drug: LM-108

LM-108 combination dose expansion

Experimental group

Treatment:

Drug: Toripalimab

Drug: LM-108