A Phase Ia Clinical Study of QLF31907 Injection in Patients With Advanced Malignant Tumors

NCT05150405 | Unknown Phase 1

• 1 other identifier: QLF31907-101
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to evaluate the safety and tolerability of QLF31907 injection, to identify the maximum tolerated dose (MTD) and dose-limiting toxicity(DLT), and determine the recommended phase Ib dose(RPIbD) and recommended phase II dose (RP2D)in patients with advanced malignant tumors.

Conditions

Solid Tumor; Lymphoma, Non-Hodgkin

Outcome Measures

Primary Outcomes (2)

• Dose-limiting toxicity(DLT)

  The DLT of QLF31907 will be determined.

  28 days

• Maximum tolerated dose(MTD)

  The MTD of QLF31907 will be determined.

  up to 2 years

Secondary Outcomes (6)

• Frequency of adverse events of QLF31907

  up to 2 years

• Cmax of QLF31907

  up to 2 years

• AUC of QLF31907

  up to 2 years

• Tmax of QLF31907

  up to 2 years

• Immunogenicity of QLF31907

  up to 2 years

Study Arms (1)

QLF31907

EXPERIMENTAL

single arm with QLF31907 treatment

Drug: QLF31907

Interventions

QLF31907 DRUG

In this study, seven dose groups were proposed. The frequency of administration was once every two weeks, and four weeks was one therapeutic cycle. The subjects will receive six cycles of QLF31907 treatment at most.

QLF31907

Eligibility Criteria

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

You may qualify if:

• Subjects voluntarily participated and signed a written informed consent form
• Age ≥ 18 years, male or female
• ECOG performance status of 0 or 1
• Expected life-expectancy of more than 3 months
• Solid tumors:
• Patients with histologically diagnosed head and neck squamous cell carcinoma (HNSCC), esophageal cancer (EC), renal cancer (RCC), melanoma, cervical cancer (CC), non-oncogene driver NSCLC and other solid tumors (requiring MSI-H/ dMMR signature gene) that are locally advanced, recurrent or metastatic that have failed or are intolerant to standard therapy.
• Hematologic tumors: patients with histologically diagnosed mediastinal large B-cell lymphoma (PMBCL), diffuse large B-cell lymphoma (DLBCL), mesenchymal large cell lymphoma (ALCL), peripheral T-cell lymphoma (PTCL), NKT-cell lymphoma, and high-grade B-cell lymphoma (R/R HGBL) that are intolerant or relapsed/refractory to standard therapy.
• Patients with solid tumors have at least 1 measurable lesion according to RECIST v1.1. Patients with lymphoma have at least 1 measurable lesion or hypermetabolic lesion with 18F-FDG (18F-fluorodeoxyglucose) uptake according to Lugano2014 evaluation criteria.
• Adequate organ function prior to first use of the trail drug (no blood components, cell growth factors, leukocyte-raising drugs, platelet-raising drugs, etc., or hepatoprotective therapy is allowed within 14 days prior to obtaining laboratory tests)
• Absolute neutrophil count ≥ 1.5 x 109/L
• Platelet count ≥ 80 × 109/L (≥ 90 × 109/L in patients with hepatocellular carcinoma)
• Hemoglobin ≥ 90g/L
• Serum creatinine ≤ 1.5 × upper limit of normal (ULN); for patients with creatinine level \> 1.5 × ULN, according to Cockcroft-Gault formula for creatinine clearance (CLcr) ≥ 60 mL / min
• Total bilirubin ≤ 1.5 × ULN
• AST and ALT ≤ 2.5 × ULN (for Gilbert's syndrome, hepatocellular carcinoma or the presence of liver metastases, ≤ 5 × ULN)

You may not qualify if:

• Previous treatment with 4-1BB agonist or 4-1BB recombinant fusion protein
• Received antitumor therapy with chemotherapy, biologic therapy, endocrine therapy, immunotherapy, or monoclonal antibodies within 4 weeks prior to the first use of the trail drug, with special circumstances as follows.
• Including those who have received oral fluorouracil analogues, small-molecule targeted drugs and herbal or Chinese patent medicine with antitumor indications within 2 weeks prior to the first use of the trail drug
• Including those who have received mitomycin or nitrosoureas within 6 weeks prior to the first use of the trail drug
• Including those who have received cell-based therapy or antitumor vaccine within 8 weeks prior to the first use of the trail drug
• In subjects with a high tumor burden, treatment to reduce tumor burden for the purpose of preventing tumor lysis syndrome during the course of the trial is excluded
• Subjects with central nervous system (CNS) metastases or clinical manifestations of CNS involvement, soft meningeal metastases, or spinal cord compression due to metastases prior to signing informed consent. Except for symptomatic CNS metastases that have been treated and stable for ≥4 weeks prior to the first administration of the investigational drug and who have been off systemic hormone (at any dose) therapy for \>2 weeks.
• Subjects with uncontrolled exudate or leaky fluid (thoracic, pericardial, or abdominal) or one of thoracic fluid \>500 ml, pericardial fluid \>100 ml, or abdominal fluid ≥1000 ml
• History of autoimmune disease (including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, autoimmune hepatitis, interstitial pneumonia, uveitis, enterocolitis, hepatitis, pituitary gland inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism \[except for subjects who can be controlled by hormone replacement therapy only\]; except for subjects with skin diseases that do not require systemic treatment such as vitiligo, psoriasis and alopecia areata; except for type I diabetes or asthma that has completely resolved in childhood and does not require any intervention in adulthood, such as asthma patients who require medical intervention with bronchodilators are not included)
• Have had other active malignancies within 3 years prior to study entry (from the time of signing informed consent form). Cured basal or squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix, intraductal carcinoma in situ of the breast and papillary thyroid cancer were excluded
• Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), active hepatitis (hepatitis B: defined as positive hepatitis B virus surface antigen \[HBsAg\] and e antigen \[HBeAg\] test results, or HBV-DNA ≥ 20 IU/ml, or HBV-DNA ≥ 1000 copies/ml, or persistent liver function abnormal, or tissue biopsy with hepatitis pathology, or cirrhosis; hepatitis C: defined as positive hepatitis C antibody \[HCV-Ab\] and HCV-RNA above the lower limit of detection of the analytical method), combined hepatitis B and C co-infection; syphilis spirochete infection; Mycobacterium tuberculosis infection
• History of hepatitis (non-alcoholic steatohepatitis, alcoholic or autoimmune hepatitis) and cirrhosis
• Subjects with the following cardiovascular events including but not limited to: myocardial infarction, severe/unstable angina, NYHA class 2 or higher cardiac insufficiency and clinically significant supraventricular or ventricular arrhythmias, prolonged QT interval and need for clinical intervention within 6 months prior to study entry (from the time of signing informed consent form); congenital heart disease such as clinically significant heart valve stenosis, insufficiency of closure and cardiomyopathy
• Systemic antibiotic use for ≥ 7 days within 4 weeks prior to first dose, or unexplained fever \> 38.5°C during screening/prior to first dose (fever due to oncologic causes may be enrolled, as determined by the investigator)
• Subjects with a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation/history of bone marrow transplantation treatment, autologous stem cell transplantation within 180 days

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Sichuan Cancer Hospital

Chengdu, Sichuan, 610041, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: October 28, 2021
• First Posted: December 9, 2021
• Study Start: October 19, 2021
• Primary Completion: March 31, 2024
• Study Completion: June 1, 2024
• Last Updated: January 23, 2024

Record last verified: 2024-01

Locations

CN (1)