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

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShandong New Time Pharmaceutical Co., LTD

About this trial

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

Eligibility criteria

Qualifiers

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);

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • LNF2007

Treatment groups

94 Participants
are divided into 1 treatment group

Locations

This trial has no locations