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

NCT06752447 | Not Yet Recruiting Phase 1

• 1 other identifier: NTP-LNF2007-001
• Study Type: interventional
• Target: 94
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Advanced Solid Tumors (Phase 1)

Outcome Measures

Primary Outcomes (3)

• The incidence of LNF2007 treatment-emergent adverse events

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

  Through up to approximately 30 days following last dose of LNF2007

• 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

  Within 28 days after first target dose

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

  Dose Finding

  the first 3 weeks of treatment

Study Arms (1)

LNF2007 monotherapy

EXPERIMENTAL

Drug: LNF2007

Interventions

LNF2007 DRUG

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.

LNF2007 monotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);
• 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.

You may not qualify if:

• 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;
• have an active autoimmune disease and have had systemic systemic treatment within 3 months prior to the first use of the trial drug;
• 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;
• 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;

Sponsors & Collaborators

• Shandong New Time Pharmaceutical Co., LTD: lead

Central Study Contacts

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

CONTACT

0539-8330397; jianxiangzhang@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2024
• First Posted: December 30, 2024
• Study Start: January 20, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 30, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share