A Phase I/II, Open-Label, Multiple Centre Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of LM- 302 in Combination With Toripalimab in Patients With Advanced Solid Tumors

LaNova Australia Pty Limited1 site in 1 country20 target enrollmentMay 10, 2022

ConditionsAdvanced Solid Tumor

InterventionsLM-302 Toripalimab

Overview

Phase: Phase 1
Intervention: LM-302
Conditions: Advanced Solid Tumor
Sponsor: LaNova Australia Pty Limited
Enrollment: 20
Locations: 1
Primary Endpoint: RP2D
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

A Phase I/II, Open-Label, Multiple Centre Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of LM- 302 in Combination with Toripalimab in Patients with Advanced Solid Tumors

Detailed Description

This is a study of LM-302 in combination with toripalimab in patients with advanced solid tumors .The study includes phase I (dose escalation) and phase II (dose expansion). All participants enrolled in the study will be administered every 3 weeks (1 cycle=21 days) with a dose of LM-302 intravenous infusion followed by toripalimab intravenous infusion on day 1 until meet the criteria of treatment discontinuation or withdraw, whichever occurs earlier.

Registry

clinicaltrials.gov

Start Date

May 10, 2022

End Date

November 14, 2023

Last Updated

last year

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

LaNova Australia Pty Limited

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects who are fully informed of the purpose, nature, method and possible adverse reactions of the study, and are willing to participate in the study and sign the informed consent form (ICF) prior to any procedure.
•Aged ≥18 years old when sign the ICF, male or female.
•Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, and no deterioration within 2 weeks prior to the first dose.
•Life expectancy ≥ 3 months.
•Subjects must have histological or cytological confirmation of recurrent or refractory advanced solid tumors, and have progressed on standard therapy, or are intolerable for available standard therapy, or there is no available standard therapy.
•CLDN18.2 test should be performed for the enrolled subjects if the archived tumor tissue samples are available.
•At least one measurable lesion for phase II dose expansion, according to RECIST v1.1 as assessed by the investigator.
•Subjects must show appropriate organ and marrow function in laboratory examinations within 7 days prior to the first dose:
•Bone marrow reserve: Platelet count (PLT) ≥ 90 × 109/L; Absolute neutrophil count (ANC) ≥ 1.5 × 109/L; Haemoglobin ≥ 9 g/dL, without receiving EPO, G-CSF, or GM-CSF within 14 days and blood transfusion including red blood cell and platelet transfusion in at least 7 days prior to first dose.
•Coagulation function: INR ≤ 1.5; APTT ≤ 1.5 × ULN.

Exclusion Criteria

•Participate in any other clinical trial within 28 days prior to 1st dosing of investigational medicinal product (IMP).
•Subjects with anti-tumor treatment within 21 days prior to 1st dosing of IMP, including radiotherapy, chemotherapy, biotherapy, endocrine therapy and immunotherapy, etc. the following treatments have different time limits:
•Local small-scale palliative radiotherapy (bone metastasis radiotherapy to control pain) within 14 days prior to 1st dosing.
•Oral anti-tumor therapy, including fluorouracil antitumor drugs and small molecular targeted drugs, etc. within 14 days or 5 half-lives of the drug (whichever is longer) prior to 1st dosing.
•Traditional herbal medicine with anti-tumor indication within 14 days prior to 1st dosing.
•Nitrosourea or Mitomycin C within 42 days prior to 1st dosing.
•Subjects who experienced grade 3 or higher hypersensitivity to the treatment that contains monoclonal antibody, e.g., monoclonal antibody therapy, ADC etc.
•Subjects who were intolerable to the treatment with MMAE based ADCs or anti-CLDN18.2 antibodies, but they can be enrolled if they were tolerable to the treatments and have experienced a 28-day's washout period prior to 1st dosing of IMP.
•Subjects who were intolerable to the immunotherapy targeting PD-1 receptor, or its ligand PD-L
•Any adverse event from prior anti-tumor therapy has not yet recovered to ≤ grade 1 of CTCAE v5.

Arms & Interventions

LM-302 monotherapy dose escalation

LM-302 monotherapy dose escalation (part Ia). Accelerated titration combined with traditional 3+3 design will be used for monotherapy dose escalation (part Ia).

Intervention: LM-302

LM-302 in combination therapy dose escalation

LM-302 in combination therapy dose escalation (part Ib).Accelerated titration combined with traditional 3+3 design will be used for LM-302 in combination with fixed dose Toripalimab dose escalation (part Ib).

Intervention: LM-302