Study of F527 in Patients With Relapsed or Refractory Lymphoma

NCT05293028 | Unknown Phase 1

• 1 other identifier: NTP-F527-001
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a non-randomized, open-label, phase I dose-finding and dose-expansion study to evaluate the safety, tolerability, antitumor efficacy, PK and immunogen of F527 in patients with relapsed or refractory lymphoma sexual characteristics.

Conditions

Relapsed/Refractory Lymphoma

Outcome Measures

Primary Outcomes (3)

• DLTs

  Incidence of dose-limiting toxicities (DLTs) from the first dose through the end of the DLT observation period

  Up to 21 days

• Maximum Tolerated Dose (MTD)

  Maximum Tolerated Dose

  Up to 21 days

• RP2D

  PR2D will be determined by the sponsor and investigator based on the comprehensive data obtained on drug safety and tolerability, PK, preliminary anti-tumor efficacy, etc.

  Up to 21 days

Study Arms (1)

Drug:F527

EXPERIMENTAL

F527 is dose-escalated sequentially by accelerated titration and i3+3 design.

Drug: F527

Interventions

F527 DRUG

0.001、0.01、0.1、0.3、1、3 and10 mg/kg QW

Drug:F527

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged ≥18 and ≤80 years old;
• Patients with histopathologically confirmed relapsed/refractory lymphoma; relapsed/refractory was defined as a patient who did not achieve a response (including complete or partial response) after the last systemic therapy regimen, or had disease progression after achieving a response or relapse;
• Subjects must have at least one measurable lesion assessed by the investigator (long diameter of lymph node\>15mm, long diameter of extranodal lesion\>10mm);
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-2;
• Expected survival period ≥ 3 months;
• The function of vital organs meets the following requirements (do not use any blood components and cytokines within 7 days before the first dose):
• Blood routine: neutrophil count ≥1.5×109/L; platelet count ≥75×109/L; hemoglobin ≥95g/L; Liver function: TBIL≤1.5×ULN, ALT and AST≤2.5×ULN; if there is liver metastasis, ALT and AST≤5×ULN; Renal function: creatinine≤1.5×ULN; Coagulation function: International Normalized Ratio (INR)≤1.5×ULN and Activated Partial Thromboplastin Time (APTT)≤1.5×ULN;
• Understand the test procedures and content, and sign the informed consent voluntarily.

You may not qualify if:

• Special types of lymphoma such as primary/secondary central nervous system lymphoma, etc.;
• Patients with a history of other malignant tumors within the past 5 years, except for locally curable cancers (such as basal cell or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the prostate, cervix or breast, etc.);
• History of hemolytic anemia or Evans syndrome in the last three months;
• Positive direct antiglobulin test;
• Those who have used CD47-targeted drugs or signal-regulated protein alpha (SIRPα)-targeted drugs in the past;
• Received anti-tumor-related treatments such as anti-tumor chemotherapy, radiotherapy, biological therapy, or immunotherapy/immunomodulation therapy within 2 weeks before the first administration; the toxicity of previous anti-tumor therapy has not recovered to ≤ grade 1 (except for alopecia);
• Patients who have a history of organ transplantation or allogeneic bone marrow transplantation, or who have received autologous stem cell transplantation within 3 months before the first administration or have other severe immunodeficiency;
• HIV positive patients, syphilis-infected patients (RPR positive and TPPA positive) or active hepatitis (HBsAg positive and/or HBcAb positive, and HBV-DNA positive or higher than the upper limit of normal; HCV antibody positive and HCV- RNA positive or above the upper limit of normal);
• Patients with uncontrollable or severe cardiovascular disease, who have New York Heart Association (NYHA) class II or above congestive heart failure, unstable angina, myocardial infarction and other cardiovascular diseases within 6 months before the first administration; Uncontrolled hypertension (systolic blood pressure ≥180mmHg and/or diastolic blood pressure ≥100mmHg);
• Patients who have received any other clinical trial drug treatment within 4 weeks before the first dose;
• Patients who have received live attenuated vaccine within 4 weeks before the first dose;
• Patients who have a history of severe allergies, or who are known to be allergic to macromolecular protein preparations/monoclonal antibodies and any components of the investigational drug;
• Patients with a history of mental illness or drug abuse;
• Pregnant or lactating women, female patients or male patient partners who plan to become pregnant during the study period to 6 months after the last dose, and are reluctant to use a medically recognized effective contraceptive method (such as an intrauterine device or an intrauterine device) during the trial. condoms);
• Patients who are judged by the investigator to be unsuitable for enrollment.

Sponsors & Collaborators

• Shandong New Time Pharmaceutical Co., LTD: lead

Study Sites (1)

Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200000, China

Location

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Shaohong Yin

CONTACT

86-15265901803; yinshaohong@lunan.com.cn

Study Design

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

Study Record Dates

• First Submitted: March 3, 2022
• First Posted: March 23, 2022
• Study Start: May 20, 2022
• Primary Completion: November 20, 2023
• Study Completion: May 20, 2024
• Last Updated: March 23, 2022

Record last verified: 2022-03

Locations

CN (1)