An Open, Dose-escalating Phase Ia Clinical Study to Evaluate the Tolerability, Safety, Pharmacokinetics and Preliminary Antitumor Activity of QLF31907 Injection in Patients With Advanced Cancer

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• 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)

⁃ Coagulation function: prothrombin time ≤ 1.5 × ULN, activated partial thromboplastin time ≤ 1.5 × ULN, international normalized ratio ≤ 1.5 × ULN

⁃ Cardiac left ventricular ejection fraction (LVEF) \> 50%

• Subjects (both female and male) agree to use effective contraception from the time they sign the informed consent form until 180 days after the last use of the trial drug.

• Recovery from all the other reversible AEs from prior antineoplastic therapy prior to the first administration of the trail drug (i.e. ≤ grade 1, according to CTCAE v5.0), excluding alopecia (any grade) and ≤ grade 2 peripheral sensory neuropathy or lymphocytopenia. Subjects who develop other abnormalities without clinically significant or investigator-judged risk-free toxicity will be enrolled only after discussion and approval by the sponsor and investigator.

Locations
Other Locations
China
Sichuan Cancer Hospital
RECRUITING
Chengdu
Time Frame
Start Date: 2021-10-19
Estimated Completion Date: 2024-06-01
Participants
Target number of participants: 54
Treatments
Experimental: QLF31907
single arm with QLF31907 treatment
Related Therapeutic Areas
Sponsors
Leads: Qilu Pharmaceutical Co., Ltd.

This content was sourced from clinicaltrials.gov