Patients With Advanced Solid TumorsPhase 1NCT07661797
Phase I Clinical Study of LNF2105 in Patients With Advanced Solid Tumors
A Phase 1 study testing LNF2105(Antibody-Drug Conjugate (ADC) targeting Nectin-4) in people with Patients With Advanced Solid Tumors, run by Shandong New Time Pharmaceutical Co., LTD.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Advanced Solid Tumors
- What is being tested?
- LNF2105(Antibody-Drug Conjugate (ADC) targeting Nectin-4)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 294 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Aug 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
- 7) ECOG score 0-1. 8) Expected survival ≥ 3 months. 9) Willing to participate and sign informed consent form, and willing to follow the trial treatment protocol and visitation plan.
Who cannot join
- 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).
- 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.
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- 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.
- Patients with a history of organ transplantation or allogeneic bone marrow transplantation, or who received autologous stem cell transplantation within 3 months prior to the first dose.
- Patients who underwent major surgery within 4 weeks prior to the first dose or have not yet recovered from surgery.
- Patients with any of the following laboratory findings.
- Patients with uncontrolled or severe cardiovascular disease, including those who developed NYHA Class II or higher congestive heart failure, unstable angina, myocardial infarction, or other cardiovascular diseases within 6 months prior to the first dose; or those with uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg after treatment).
- Patients with active infections requiring intravenous anti-infective therapy or a history of the following conditions, including but not limited to active autoimmune diseases, severe mental illness, severe endocrine disorders such as severe thyroid dysfunction.
- Patients with the following ocular diseases: a) active infection or corneal ulcer; b) history of corneal transplantation; c) expected contact lens wear during the study period; d) poorly controlled glaucoma; e) poorly controlled or progressive retinopathy, wet macular degeneration, uveitis, papilledema, or optic disc disease; f) or other currently existing ocular diseases that would affect the assessment of ocular toxicity after the trial intervention.
- Glycated hemoglobin (HbA1c) ≥ 8.0%.
- Suffering from severe and/or uncontrolled comorbidities, such as decompensated cirrhosis, nephrotic syndrome, uncontrolled metabolic disorders, active inflammatory bowel disease, gastrointestinal perforation, intestinal obstruction, or gastrointestinal bleeding.
- Having a bleeding tendency (e.g., abnormal coagulation function tests, clinically significant as determined by the investigator, or clinically significant bleeding symptoms as assessed by the investigator).
- Having received any other clinical trial drug/device treatment within 4 weeks prior to the first dose.
- Having a history of drug abuse or alcoholism within 6 months prior to the first dose.
- Having a history of severe allergies, or a known history of allergy to macromolecular protein preparations/monoclonal antibodies, or to any component of the investigational drug.
- Having received a live or attenuated live vaccine within 4 weeks prior to the first dose.
- Pregnant or breastfeeding women, female participants of childbearing age, or male participants whose partners are women of childbearing age who do not agree to use medically approved effective contraception (such as an intrauterine device or condom) during the study period and for 6 months after the last study drug treatment.
- Individuals deemed unsuitable for enrollment by the investigator.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Antitumor Efficacy of LNF2105 in Patients With Advanced Solid Tumors.
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.
- Conditions
- Patients With Advanced Solid Tumors
- Being tested
- LNF2105(Antibody-Drug Conjugate (ADC) targeting Nectin-4)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LNF2105(Antibody-Drug Conjugate (ADC) targeting Nectin-4)Drug
The dosage of LNF2105 was increased sequentially from 0.3 mg/kg, 0.6 mg/kg, 1.2 mg/kg, 2.0 mg/kg, 3.0 mg/kg, to 4.5 mg/kg.
| Study group | Role | What they receive |
|---|---|---|
| LNF2105 | Experimental | The dosage was increased sequentially from 0.3 mg/kg, 0.6 mg/kg, 1.2 mg/kg, 2.0 mg/kg, 3.0 mg/kg, to 4.5 mg/kg. Receives: Drug: LNF2105(Antibody-Drug Conjugate (ADC) targeting Nectin-4) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate of Safety and Tolerability of LNF2105 in Patients with Advanced Solid Tumors
Numbers of treatment emergent adverse events with severity determined using NCI CTCAE v6.0 after single or multiple doses of LNF2105.
Measured: Approximately 24months
To confirm Dose Limiting Toxicities (DLT) and determine MTD and RP2D for LNF2105
Occurrence of Dose Limiting Toxicities as defined in the protocol
Measured: 28 days
Secondary outcomes (11)
Maximum observed plasma concentration of LNF2105 (ADC), Total Antibody and Free Payload (Cmax)
Maximum observed plasma concentration ofLNF2105 (ADC), Total Antibody and Free Payload after single and multiple doses
Measured: Approximately 24 months
Time to reach Cmax of LNF2105 (ADC), Total Antibody and Free Payload (Tmax)
The amount of time to reach Cmax after single and multiple dose administration of LNF2105 (ADC), Total Antibody and Free Payload
Measured: 24 month
Total Area Under the plasma concentration-time curve of LNF2105 (ADC), Total Antibody and Free Payload (AUC)
Area under the plasma concentration versus time curve after single and multiple dose administration of LNF2105 (ADC), Total Antibody and Free Payload
Measured: 24 month
Minimum Plasma Concentration (Cmin) of LNF2105 (ADC), Total Antibody and Free Payload
Minimum Plasma Concentration (Cmin) of of LNF2105 (ADC), Total Antibody and Free Payload after multiple doses
Measured: 24 month
To evaluate the preliminary antitumor activity of LNF2105: Overall response rate (ORR)
ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)
Measured: Approximately 24months
To evaluate the preliminary antitumor activity of LNF2105: Progression free survival (PFS)
PFS per investigator assessed RECIST 1.1
Measured: Approximately 24months
To evaluate the preliminary antitumor activity of LNF2105: Duration of response (DOR)
Anti-tumor preliminary efficacy will be evaluated of LNF2105 in accordance with RECIST v1.1
Measured: Approximately 24months
To evaluate the preliminary antitumor activity of LNF2105: Disease control rate (DCR)
DCR per investigator assessed RECIST 1.1
Measured: Approximately 24months
To evaluate the preliminary antitumor activity of LNF2105: Time to response (TTR)
TTR per investigator assessed RECIST 1.1
Measured: Approximately 24months
To evaluate the preliminary antitumor activity of LNF2105: Overall survival (OS)
OS per investigator assessed RECIST 1.1
Measured: Approximately 24months
To evaluate the immunogenicity of LNF2105
To evaluate the levels of anti-drug antibody (ADA) generated by study participants. Confirmatory testing will be performed on ADA-positive samples; confirmed positive samples will undergo subsequent titer determination as appropriate.
Measured: Approximately 24months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by Shandong New Time Pharmaceutical Co., LTDThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 294 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong New Time Pharmaceutical Co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07661797
- Sponsor's protocol ID
- NTP-LNF2105-001
- Status last verified
- Apr 2026
- First submitted
- 8 Apr 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Antitumor Efficacy of LNF2105 in Patients With Advanced Solid Tumors.
- ClinicalTrials.gov ID
- NCT07661797
- Acronym / sponsor ID
- NTP-LNF2105-001
- Conditions
- Patients With Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 294 participants (estimated)
- Lead sponsor
- Shandong New Time Pharmaceutical Co., LTDIndustry (pharma, biotech, devices)
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LNF2105 | Experimental | Drug: LNF2105(Antibody-Drug Conjugate (ADC) targeting Nectin-4)The dosage was increased sequentially from 0.3 mg/kg, 0.6 mg/kg, 1.2 mg/kg, 2.0 mg/kg, 3.0 mg/kg, to 4.5 mg/kg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (23 listed)
- 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).
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LNF2105(Antibody-Drug Conjugate (ADC) targeting Nectin-4)The dosage of LNF2105 was increased sequentially from 0.3 mg/kg, 0.6 mg/kg, 1.2 mg/kg, 2.0 mg/kg, 3.0 mg/kg, to 4.5 mg/kg. | Drug | LNF2105 |
Primary outcome
To evaluate of Safety and Tolerability of LNF2105 in Patients with Advanced Solid Tumors
Time frame: Approximately 24months
Numbers of treatment emergent adverse events with severity determined using NCI CTCAE v6.0 after single or multiple doses of LNF2105.
To confirm Dose Limiting Toxicities (DLT) and determine MTD and RP2D for LNF2105
Time frame: 28 days
Occurrence of Dose Limiting Toxicities as defined in the protocol
11 secondary outcomes
Maximum observed plasma concentration of LNF2105 (ADC), Total Antibody and Free Payload (Cmax)
Time frame: Approximately 24 months
Time to reach Cmax of LNF2105 (ADC), Total Antibody and Free Payload (Tmax)
Time frame: 24 month
Total Area Under the plasma concentration-time curve of LNF2105 (ADC), Total Antibody and Free Payload (AUC)
Time frame: 24 month
Minimum Plasma Concentration (Cmin) of LNF2105 (ADC), Total Antibody and Free Payload
Time frame: 24 month
To evaluate the preliminary antitumor activity of LNF2105: Overall response rate (ORR)
Time frame: Approximately 24months
To evaluate the preliminary antitumor activity of LNF2105: Progression free survival (PFS)
Time frame: Approximately 24months
To evaluate the preliminary antitumor activity of LNF2105: Duration of response (DOR)
Time frame: Approximately 24months
To evaluate the preliminary antitumor activity of LNF2105: Disease control rate (DCR)
Time frame: Approximately 24months
To evaluate the preliminary antitumor activity of LNF2105: Time to response (TTR)
Time frame: Approximately 24months
To evaluate the preliminary antitumor activity of LNF2105: Overall survival (OS)
Time frame: Approximately 24months
To evaluate the immunogenicity of LNF2105
Time frame: Approximately 24months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LNF2105(Antibody-Drug Conjugate (ADC) targeting Nectin-4) in people with Patients With Advanced Solid Tumors, run by Shandong New Time Pharmaceutical Co., LTD.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shaohong Yin (86-15265901803, yinshaohong@lunan.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate of Safety and Tolerability of LNF2105 in Patients with Advanced Solid Tumors (time frame: Approximately 24months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.