Phase I Clinical Study of LNF2105 in Patients With Advanced Solid Tumors (NCT07661797) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Phase I Clinical Study of LNF2105 in Patients With Advanced Solid Tumors
294 participantsStarted 2026-06
Plain-language summary
This study is a Phase I clinical trial evaluating the safety, tolerability, pharmacokinetic characteristics, and preliminary antitumor efficacy of LNF2105 in patients with advanced solid tumors.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female aged ≥18 years.
. Patients with advanced solid tumors (including but not limited to urothelial carcinoma, breast cancer, non-small cell lung cancer, ovarian cancer, endometrial cancer, and cervical cancer) that have been histologically or cytologically confirmed as having failed/cannot tolerate/have no standard treatment/are currently unsuitable for standard treatment.
. Able to provide previous Nectin-4 expression testing results or preserved/fresh tumor tissue for Nectin-4 expression testing.
. At least one measurable lesion (CT or MRI long axis ≥ 10 mm, lymph node short axis ≥ 15 mm) according to RECIST v1.1 criteria. For lesions previously treated with radiotherapy, they will only be included as measurable lesions if there has been clear disease progression after radiotherapy.
. The function of vital organs must meet the following requirements (no blood components or cytokines may be used within 14 days prior to the first dose).
Exclusion criteria
. Prior treatment with an antibody-drug conjugate (ADC) exhibiting one of the following characteristics: payload as a topoisomerase I inhibitor (TOP 1 inhibitor); antibody target as Nectin-4.
. Received any P-glycoprotein (P-gp) inducer/inhibitor, strong CYP3A inhibitor, or breast cancer resistance protein (BCRP) inhibitor within 14 days prior to first administration (see Appendix 3 for the exclusion list).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To evaluate of Safety and Tolerability of LNF2105 in Patients with Advanced Solid Tumors
Timeframe: Approximately 24months
2
To confirm Dose Limiting Toxicities (DLT) and determine MTD and RP2D for LNF2105
. Patients who received chemotherapy within 3 weeks or radiotherapy, biotherapy, endocrine therapy, targeted therapy, immunotherapy, or other anti-tumor treatments within 4 weeks prior to first administration of the study drug, excluding the following.
. Patients who received systemic glucocorticoid therapy or any other form of immunosuppressive therapy (equivalent to a prednisone dose \>10 mg/day) within 2 weeks prior to the first dose.
. Patients whose adverse reactions to previous antitumor therapy have not recovered to a CTCAE 5.0 grade ≤1 or the level specified in the inclusion/exclusion criteria (excluding toxicities deemed safe by the investigator, such as alopecia, grade 2 peripheral neurotoxicity, and stable hypothyroidism after hormone replacement therapy).
. Patients with primary central nervous system (CNS) malignancies, CNS metastases that have failed local treatment, or carcinomatous meningitis; patients with asymptomatic brain metastases, or stable clinical symptoms such as neurological symptoms and who do not require corticosteroids or other treatments targeting brain metastases for ≥4 weeks may be enrolled.
. Patients with uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
. Patients with known interstitial lung disease (ILD) or non-infectious pneumonia, currently symptomatic or requiring prior systemic glucocorticoid therapy, whose toxicity assessment or management is deemed by the investigator to potentially affect the investigational treatment.