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
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Phase I Dose Escalation:Incidence of adverse events (AEs) — 152 Weeks
Phase I Dose Escalation:Incidence of dose-limiting toxicity (DLT) — 152 Weeks
Phase I Dose Escalation:Incidence of serious adverse event (SAE) — 152 Weeks
Phase I Dose Escalation:Incidence of clinical significant in laboratory examinations, including hematology, urinalysis, blood biochemistry, coagulation tests and thyroid function. — 152 Weeks
Phase II Dose Expansion Cohort:Objective Response Rate (ORR) Evaluated by Researchers Based on RECIST v1.1 — 152 Weeks
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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