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Advanced Solid Tumors (Phase 1)Phase 1NCT06752447

A Phase I Study OfLNF2007 Monotherapy in Patients with Advanced Solid Tumors

A Phase 1 study testing LNF2007 in people with Advanced Solid Tumors (Phase 1), run by Shandong New Time Pharmaceutical Co., LTD.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

A non-randomized, open-ended, phase I dose-escalation and dose-expansion study was designed to evaluate the safety, tolerability, antitumor efficacy, PK and immunogenic characteristics of LNF2007 in patients with advanced solid tumors Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Solid Tumors (Phase 1)
What is being tested?
LNF2007
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
94 participants
Where
No sites listed yet
Study dates
20 Jan 2025to Dec 2026
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Study participants must meet all of the following inclusion criteria to be enrolled in the study:
  • Age ≥18 years old, gender unlimited;
  • United States Eastern Oncology Consortium (ECOG) physical strength score 0-1;
  • Expected survival ≥12 weeks;
  • Patients with advanced solid tumors confirmed histologically or cytologically (gastric cancer, pancreatic cancer, and cholangiocarcinoma are preferred) who have failed after adequate standard treatment, or who lack standard treatment options (standard treatment is defined as the standard treatment guidelines that have been agreed in the country (if applicable) or the standard treatment status in the country); Standard treatment failure is defined as disease progression or tumor recurrence or metastasis during or after treatment, or intolerance);
  • Agree to provide archived tumor tissue specimens or fresh tissue specimens within 2 years of the primary or metastatic lesion (to explore the characteristics of biomarkers in tumor tissue); If the subject is unable to provide a tumor tissue sample, the participant can be enrolled after evaluation by the investigator, provided that other inclusion criteria are met.
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  • There is at least one evaluable tumor lesion according to RECIST V1.1;
  • Tumor tissue samples were confirmed to be Claudin18.2 positive by immunohistochemical (IHC) detection, and positive was defined as ≥1+ by IHC detection (only applicable to patients in the dose escalation phase of 60μg/kg or above and in the dose expansion phase);
  • Adequate organ function before the first administration of the test drug (no blood components, cell growth factors, whitening drugs, platelet enhancing drugs, etc., have been used within 14 days before the first administration) 1.Absolute neutrophil count ≥1.5×109/L; 2.Platelet ≥100×109/L; 3.Hemoglobin ≥90g/L; 4.Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN (for liver cancer or liver metastasis, ≤5×ULN); Total bilirubin (TBIL) ≤1.5×ULN (liver cancer or liver metastasis, ≤3×ULN); 5. Serum creatinine (Cr) ≤1.5×ULN, creatinine clearance (CLcr) ≥50mL/min when Cr > 1.5×ULN (CLcr was calculated using Cockcroft-Gault equation); 6.Activated partial thromboplastin time (APTT) ≤1.5×ULN, International Normalized ratio (INR) ≤1.5×ULN.
  • Understand and voluntarily sign informed consent.

Who cannot join

  • Study participants with any of the following were not eligible for the study:
  • Received any antitumor therapy within 4 weeks prior to the first use of the investigational drug or within 5 half-lives of the drug (whichever is shorter);
  • Had undergone major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks prior to the first use of the trial drug, or required elective surgery during the trial;
  • Received systemic corticosteroid (systemic corticosteroid equivalent to prednisone >10mg daily) or other immunosuppressive therapy within 2 weeks prior to the first use of the experimental drug;
  • Prior to first administration of the investigational drug, all reversible adverse effects of previous antitumor therapy did not return to CTCAE v5.0 rating ≤1, excluding alopecia (any grade) and ≤2 peripheral sensory neuropathy or other toxicities deemed by the investigators to be of no safety risk;
  • Received dual antibody or CAR-T drug therapy targeting Claudin18.2 within 3 months before the first use of the experimental drug;
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  • have an active autoimmune disease and have had systemic systemic treatment within 3 months prior to the first use of the trial drug;
  • Patients with clinical symptoms of central nervous system metastasis and other evidence of uncontrolled central nervous system metastasis were judged by the investigators to be unsuitable for inclusion; Any meningeal metastases;
  • Subjects with a known history of severe hypersensitivity to other monoclonal antibodies or intravenous gamma globulin, and a known history of hypersensitivity or hypersensitivity to LNF2007 components;
  • have a severe systemic active infection that currently requires systemic anti-infection therapy;
  • Patients with active gastrointestinal bleeding or other gastrointestinal diseases deemed unsuitable for inclusion by researchers as having high risk factors for gastrointestinal bleeding, such as active gastrointestinal perforation requiring clinical intervention, pyloric obstruction, complete or incomplete intestinal obstruction, etc.;
  • There are clinical symptoms of pleural effusion, pericardial effusion or ascites requiring frequent drainage (≥1 time/month);
  • Impaired heart function or suffering from major cardiovascular and cerebrovascular diseases, including but not limited to:
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  • myocardial infarction, unstable angina pectoris, cerebrovascular accident, acute or persistent myocardial ischemia, symptomatic heart failure (grade 2 or higher according to the New York Heart Association Functional Scale), symptomatic or poorly controlled arrhythmia, or any arterial thromboembolism event in the six months prior to initial administration;
  • History of deep vein thrombosis, pulmonary embolism, or other serious thromboembolism within 3 months prior to the first dose;
  • aortic aneurysm, aortic dissection aneurysm, internal carotid artery stenosis and other major vascular diseases that may be life-threatening or require surgery within 6 months;
  • Previous history of myocarditis and cardiomyopathy;
  • Left ventricular ejection fraction (LVEF) < 50%; 13) Patients currently suffering from interstitial lung disease or pulmonary fibrosis, pneumoconiosis, radiation pneumonia, severe impairment of lung function, etc., which may interfere with the detection and management of suspected drug-related pulmonary toxicity; 14) Hepatitis B patients (if HBsAg and/or HBcAb positive and HBV-DNA≥200IU/ml (or 1000cps/ml)); Hepatitis C patients (HCV antibody positive and HCV-RNA testing indicates viral replication); Syphilis screening positive (specific antibody test positive, non-specific antibody test negative and combined with clinical judgment confirmed as inactive infection), known HIV positive history or HIV screening positive; 15) The patient is known to have a history of psychotropic substance abuse, alcohol abuse or drug use; 16) Pregnant or lactating women, female subjects of childbearing age, or male subjects with partners of women of childbearing age who did not consent to contraception during the study period and within 6 months after the last study drug treatment; 17) Two or more malignancies in the 5 years prior to the first dose. With the exception of early stage malignancies that have been cured (carcinoma in situ or stage I tumours), such as carcinoma in situ of the cervix, basal cell or squamous cell skin cancer that has been adequately treated; 18)Patients who were not suitable for enrollment according to the judgment of 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.

Last Name or Official Title * If an official title is provided contact

0539-8330397

jianxiangzhang@126.com

About this study

Official title: A Phase I Clinical Study of Safety, Tolerability, Pharmacokinetic/pharmacodynamic Characteristics and Initial Efficacy of LNF2007 Monotherapy in Patients with Advanced Solid Tumors

A non-randomized, open-ended, phase I dose-escalation and dose-expansion study was designed to evaluate the safety, tolerability, antitumor efficacy, PK and immunogenic characteristics of LNF2007 in patients with advanced solid tumors

Read the detailed description

A non-randomized, open-ended, phase I dose-escalation and dose-expansion study was designed to evaluate the safety, tolerability, antitumor efficacy, PK and immunogenic characteristics of LNF2007 in patients with advanced solid tumors. This study is divided into dose escalation stage and dose extension stage.

A total of 9 dose groups were designed in the dose escalation phase. The dose expansion phase is planned to be conducted in two dose groups (determined by discussion between the investigator and sponsor based on available trial data), enrolling approximately 20 participants at each dose. According to the results of dose escalation phase, the pre-excitation dose of dose extension phase is designed.

Being tested
LNF2007

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LNF2007Drug

    LNF2007，9 dose groups:0.2μg/kg、1μg/kg、5μg/kg、20μg/kg、60μg/kg、120μg/kg、240μg/kg、360μg/kg、540μg/kg（0.2~5μg/kg for "accelerated titration", and i3+3 ramp-up starting from 20μg/kg dose group），IV, infusion time 60min±10min, Q4W, until disease progression 、intolerable toxicity or other reasons to stop treatment, the longest administration to 2 years, whichever occurs first.

Study groups in NCT06752447
Study groupRoleWhat they receive
LNF2007 monotherapyExperimentalNot described
Receives: Drug: LNF2007

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The incidence of LNF2007 treatment-emergent adverse events

    Incidence and severity of AEs and specific laboratory abnormalities graded according to NCI-CTCAE, v5.0

    Measured: Through up to approximately 30 days following last dose of LNF2007

  2. Occurrence of dose-limiting toxicity (DLT)

    DLTs will include Grade 4 neutropenia, anemia, thrombocytopenia, ≥ Grade 3 Febrile neutropenia ，Grade 5 toxicity and other Grade 3 non-hematological toxicity etc

    Measured: Within 28 days after first target dose

  3. The maximum tolerated dose and/or the recommended phase II dose of LNF2007

    Dose Finding

    Measured: the first 3 weeks of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Dec 2024
  2. Study start20 Jan 2025 (estimated)
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
94 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06752447
Sponsor's protocol ID
NTP-LNF2007-001
Status last verified
Dec 2024
First submitted
22 Dec 2024
Last updated
30 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LNF2007 in people with Advanced Solid Tumors (Phase 1), 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 10 inclusion and 19 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 30 Dec 2024. 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 Last Name or Official Title * If an official title is provided (0539-8330397, jianxiangzhang@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence of LNF2007 treatment-emergent adverse events (time frame: Through up to approximately 30 days following last dose of LNF2007). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06752447.

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 30 Dec 2024; AzTrials last refreshed its copy on 26 Oct 2026.

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