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New treatment option for Malignant Tumors
Official title Study of LM-299 in Subjects Advanced Malignant Tumors
ClinicalTrials.gov ID: NCT06650566
What this study is testing
What is LM-299?
LM-299 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for malignant tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- For Phase I Dose Escalation Stage, to assess the safety and tolerability of LM-299 in patients with advanced solid tumors,determine the maximum tolerated dose (MTD) or optimal biological dose (OBD), and explorethe recommended dose for expansion (RDE) in patients with advanced solid tumours.. For Phase II Dose Expansion Stage, to assess the antitumor activity of LM-299 in patients with various advanced solid tumors.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- people who are willing to participate in the study and sign the informed consent form (ICF) prior to any procedure.
- Participant must be 18- 18 years or the legal age of consent at the time of signing the ICF.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Life expectancy ≥ 3 months.
- Patients with advanced solid tumors confirmed by histopathological diagnosis who have failed standard treatment, are intolerant to standard...
You likely can't join if
- Participate in any other clinical trial within 28 days prior to 1st dosing of LM-299.
- people who have received the anti-tumor treatments within the specified time periods prior to the first dosing of LM-299.
- Any adverse event from prior anti-tumour therapy has not yet recovered to ≤ grade 1 of CTCAE v5.0.
- people with uncontrolled tumour-related pain.
- people with known central nervous system (CNS) or meningeal metastasis.
- Qualitative urine protein results ≥ 3+.
See the full eligibility criteria
- people who are willing to participate in the study and sign the informed consent form (ICF) prior to any procedure.
- Participant must be 18- 18 years or the legal age of consent at the time of signing the ICF.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Life expectancy ≥ 3 months.
- Patients with advanced solid tumors confirmed by histopathological diagnosis who have failed standard treatment, are intolerant to standard treatment, or for whom standard treatment is currently unsuitable.
- Pre-treatment archived tumour tissue (within 5 years) or fresh samples could be provided for biomarker analysis.
- Must have at least one measurable lesion according to RECIST v1.1.
- Adequate organ and bone marrow function as defined by protocol.
- Female people of childbearing potential or male people with partners of childbearing potential agree to use highly effective contraception.
- people who are able to communicate well with investigators and understand and adhere to the requirements of this study.
- Participate in any other clinical trial within 28 days prior to 1st dosing of LM-299.
- people who have received the anti-tumor treatments within the specified time periods prior to the first dosing of LM-299.
- Any adverse event from prior anti-tumour therapy has not yet recovered to ≤ grade 1 of CTCAE v5.0.
- people with uncontrolled tumour-related pain.
- people with known central nervous system (CNS) or meningeal metastasis.
- Qualitative urine protein results ≥ 3+.
- Clinically significant hemoptysis or tumor bleeding within 2 weeks prior to 1st dosing of LM-299.
- Any life-threatening bleeding event that occurred within 3 months prior to 1st dosing of LM-299.
- people with esophageal or gastric varices requiring immediate intervention or a history of variceal bleeding .
- Hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh class B or more severe liver cirrhosis.
- people who have clinically uncontrollable third-space fluid accumulatio.
- Radiographic evidence of tumor invading surrounding vital organs or the risk of esophagotracheal fistula or esophagopleural fistula, tumor surrounding or invading the major blood vessels, or presence of intratumoral...
- History of gastrointestinal perforation and/or fistula within 6 months prior to the first dose of the study drug.
- Patients with complete or incomplete intestinal obstruction within 3 months prior to the first dose of the study drug or patientswho are currently at the risk of intestinal perforation.
- people who are known to be allergic to antibody treatment.
- people who take systemic corticosteroids (≥ 10 mg/day of prednisone or equivalent) for more than 7 days within 2 weeks prior to the first dose of LM-299.
- people with the known history of autoimmune disease.
- Patients with a history of active or previously confirmed inflammatory bowel disease.
- Patients with a history of or currently having interstitial pneumonia requiring systemic corticosteroid treatment.
- Received live vaccines or attenuated live vaccines within 28 days prior to the first dose of the study drug.
- Currently using anticoagulants such as therapeutic doses of heparin or vitamin K antagonists.
- people who received major surgery or treatment treatment within 28 days prior to 1st dosing of LM-299 (excluding tumour biopsy, puncture, etc.).
- people who have severe cardiovascular and and cerebrovascular diseases.
- Patients with severe infections within 4 weeks prior to the first dose.
- Patients with a history of immunodeficiency.
- Individuals with HIV infection, active HBV or HCV infection .
- Patients with known active tuberculosis (TB). Suspected active TB should be ruled out through clinical examination.
- Patients who have had other malignancies within 5 years prior to the first dose of the study drug.
- Women of childbearing age who test positive for pregnancy within 7 days prior to the first dose of the study drug or are breastfeeding.
- Individuals with known psychiatric disorders or illnesses that may affect adherence to the trial.
- Patients with local or systemic diseases caused by non-malignant tumors.
- Subject who is judged as not eligible to participate in this study by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Perth, Western Australia, Australia
- Xinxiang, Henan, China
- Liaocheng, Shandong, China
- Zibo, Shandong, China
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Perth, Western Australia, Australia; Xinxiang, Henan, China; Liaocheng, Shandong, China; Zibo, Shandong, China; Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.