Actively Recruiting
A Phase I/II Open-label Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of LM-299 Injection Alone or With Other Anti-tumor Therapies in Advanced Solid Tumors
Led by LaNova Medicines Limited · Updated on 2025-05-02
108
Participants Needed
6
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating LM-299 in patients with advanced solid tumors to understand its safety, tolerability, and antitumor activity. This Phase I/II open-label study aims to find the maximum tolerated or optimal biological dose of LM-299 and to assess its preliminary efficacy both as a single therapy and in combination with other anti-tumor treatments. The study is sponsored by LaNova Medicines Limited and includes adult patients with advanced malignant tumors who have limited treatment options. Participants receive LM-299 through intravenous drip either every two or three weeks. The study includes a Phase I dose escalation stage to determine the best dose, followed by a Phase II dose expansion stage to evaluate antitumor effects across various solid tumors. Different dose levels and backfill cohorts are studied without randomization or blinding. During the study, participants will undergo regular monitoring for dose-limiting toxicities, treatment-emergent adverse events, and heart function via echocardiography over approximately one year. Researchers will also assess tumor response rates and pharmacokinetic parameters for up to two years. Patients must provide tumor tissue samples and will be closely followed with evaluations including imaging and laboratory tests to monitor safety and treatment effects throughout the study period.
CONDITIONS
Brief Title
Study of LM-299 in Subjects Advanced Malignant Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing to participate and sign informed consent before any procedures
- Age between 18 and 80 years at time of consent
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of at least 3 months
- Diagnosed with advanced solid tumors confirmed by histopathology
- Failed, intolerant to, or unsuitable for standard treatments
- Able to provide archived or fresh tumor tissue samples for biomarker analysis
- At least one measurable lesion per RECIST v1.1 criteria
- Adequate organ and bone marrow function as defined by the protocol
- Agree to use highly effective contraception if of childbearing potential
- Able to understand and follow study requirements and communicate well with investigators
You will not qualify if you...
- Participation in any other clinical trial within 28 days before first LM-299 dose
- Received anti-tumor treatments within specified timeframes before first LM-299 dose
- Unresolved adverse events from prior anti-tumor therapy greater than grade 1
- Uncontrolled tumor-related pain
- Known central nervous system or meningeal metastases
- Urine protein test results 3+ or higher
- Significant hemoptysis or tumor bleeding within 2 weeks before first dose
- Life-threatening bleeding within 3 months before first dose
- Esophageal or gastric varices needing immediate treatment or history of bleeding
- Severe liver disease including hepatic encephalopathy or Child-Pugh class B or worse
- Uncontrollable third-space fluid accumulation
- Tumor invading vital organs or risk of fistula formation
- History of gastrointestinal perforation or fistula within 6 months
- Complete or incomplete intestinal obstruction within 3 months or risk of perforation
- Allergic to antibody treatment
- Use of systemic corticosteroids over 10 mg prednisone equivalent for more than 7 days within 2 weeks
- History of autoimmune disease or active inflammatory bowel disease
- Interstitial pneumonia requiring corticosteroid treatment
- Live vaccine within 28 days before first dose
- Use of therapeutic anticoagulants
- Major surgery or intervention within 28 days before first dose (excluding biopsy)
- Severe cardiovascular or cerebrovascular diseases
- Severe infections within 4 weeks before first dose
- History of immunodeficiency or active infections including HIV, HBV, HCV, or tuberculosis
- Other malignancies within 5 years prior to first dose
- Positive pregnancy test or breastfeeding within 7 days before first dose
- Psychiatric disorders affecting study adherence
- Diseases caused by non-malignant tumors
- Investigator judgment deeming participant ineligible for study participation
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 53 weeks
Participants receive LM-299 by intravenous drip every 2 to 3 weeks as part of their treatment for advanced malignant tumors.
Visits every 2 to 3 weeks for drug administration and monitoring
Duration - Up to 50 weeks following treatment
Participants are monitored for safety, treatment response, and pharmacokinetics after treatment completion.
Periodic visits for safety and efficacy assessments
Trial Site Locations
Total: 6 locations
1
One Clinical Research
Perth, Western Australia, Australia
Not Yet Recruiting
2
the first affiliated hospital of Xinxiang medical University
Xinxiang, Henan, China
Not Yet Recruiting
3
Liaocheng people's hospital
Liaocheng, Shandong, China
Not Yet Recruiting
4
Zibo municipal hospital
Zibo, Shandong, China
Not Yet Recruiting
5
Shanghai Dongfang Hospital (Tongji University Affiliated Dongfang Hospital)
Shanghai, Shanghai Municipality, China
Not Yet Recruiting
6
Shanghai GoBroad Cancer Hospital China Pharmaceutical University
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
A
Alex Yuan
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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