Actively Recruiting
A Phase I/II, First-in-Human, Open-Label Dose Escalation and Expansion Study to Evaluate Safety, Pharmacokinetics, and Preliminary Efficacy of LM-168 Alone or With Toripalimab in Advanced Solid Tumors
Led by LaNova Medicines Limited · Updated on 2025-09-12
87
Participants Needed
6
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating LM-168 alone or in combination with toripalimab in people with advanced solid tumors. This phase I/II study aims to assess the safety, tolerability, and best dose of LM-168 and to look at its initial anti-tumor effects by measuring objective response rate. The study is open-label and includes dose escalation and expansion phases to gather important information about these treatments in this patient population. Participants will receive LM-168 by intravenous drip every three weeks, either alone or combined with toripalimab, also given intravenously every three weeks. The study includes a dose escalation stage to find the recommended phase 2 dose or maximum tolerated dose, followed by a dose expansion stage to further evaluate safety and effectiveness. Both single-agent and combination treatments are studied in different groups. During the study, participants will have regular monitoring including vital signs like temperature, pulse, and blood pressure, as well as laboratory tests such as blood routine, urine routine, blood biochemistry, coagulation function, and thyroid function. Heart function tests including echocardiography and electrocardiograms will be performed. The Eastern Cooperative Oncology Group (ECOG) performance status and tumor response will be assessed over a follow-up period extending up to 130 weeks. Safety, tolerability, pharmacokinetics, and preliminary efficacy are key outcomes being measured throughout the trial.
CONDITIONS
Brief Title
A Study of LM-168 as a Single Agent or in Combination With Toripalimab in Subjects With Advanced Solid Tumours
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willingness to participate and signing informed consent
- Age 18 years or older, male or female
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Life expectancy of at least 3 months
- Histological or cytological confirmation of recurrent or refractory advanced solid tumors for dose escalation stage
- Histological or cytological confirmation of selected advanced solid tumors for dose expansion stage
- Optional provision of pre-treatment archived tumor tissue or on-treatment tumor biopsy for biomarker analysis
- At least one measurable disease
- Adequate organ and marrow function based on recent laboratory tests within 7 days before first dose
- Ability to communicate and adhere to study requirements
You will not qualify if you...
- Participation in another clinical trial within 28 days before first dosing
- Prior anti-CTLA-4 or other immunotherapy within 28 days before LM-168 treatment or permanent discontinuation due to toxicity
- Recent anti-tumor treatments within specified time periods before first dosing
- Unresolved adverse events from prior anti-tumor therapy above grade 1
- Uncontrolled tumor-related pain
- Known central nervous system or meningeal metastasis
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring frequent drainage
- Esophageal or gastric varices requiring immediate intervention or history of variceal bleeding
- Severe liver cirrhosis or related complications
- Tumor invasion threatening vital organs or risk of fistula formation
- History of active or confirmed inflammatory bowel disease
- Severe hypersensitivity to monoclonal antibody treatments
- Previous severe immune-related adverse events or discontinuation due to such events
- Use of systemic corticosteroids above specified doses or immunosuppressive drugs within 2 weeks prior
- Known autoimmune disease
- History of severe lung diseases or active pneumonitis
- Use of live attenuated vaccines within 28 days prior
- Use of certain antiplatelet or anticoagulant medications prior to first dose
- Major surgery or interventional treatment within 28 days before first dosing (excluding biopsy)
- Severe cardiovascular disease or uncontrolled severe illness
- History of immunodeficiency or active infections including HIV, tuberculosis, HBV, HCV
- History of other malignancies within 5 years
- Positive pregnancy test or lactation in females of childbearing potential
- Psychiatric illness affecting compliance
- Investigator judgment of ineligibility
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 78 weeks
Participants receive LM-168 alone or in combination with Toripalimab given by intravenous infusion every three weeks.
Visits every 3 weeks for drug administration and safety assessments
Duration - From week 78 to week 130 (52 weeks)
Participants are monitored for safety, response to treatment, and other health outcomes for up to 52 weeks after treatment.
Regular visits during follow-up for assessments
Trial Site Locations
Total: 6 locations
1
Macquarie University
Ryde, New South Wales, Australia, 2109
Actively Recruiting
2
MUPharm Pty Limited trading as Macquarie University Hospital Parmarcy
Ryde, New South Wales, Australia, 2109
Actively Recruiting
3
Cancer Care Wollongong Pty Limited
Wollongong, New South Wales, Australia
Actively Recruiting
4
Bayview Health-Investigational Drug Services
Perth, Western Australia, Australia, 6009
Actively Recruiting
5
One Clinical Reasearch
Perth, Western Australia, Australia, 6009
Actively Recruiting
6
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Not Yet Recruiting
Research Team
A
Alex Yuan
P
Paul Kong
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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