A Study to Evaluate the Safety and Efficacy of Docetaxel for Injection (Albumin-bound)in Different Dose Regimens in Patients With Advanced Solid Tumors

NCT05114915 | Unknown Phase 1

• 1 other identifier: HB1801-CSP-004
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is designed to evaluate the safety, tolerability, pharmacokinetics and preliminary antitumor activity of docetaxel for injection (albumin-bound) in different dose regimens in patients with advanced solid tumors.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (6)

• The occurrence and frequency of adverse events and serious adverse events

  Incidence of adverse events and serious adverse events

  Up to approximately 2 years

• The maximum tolerated dose (MTD) (if available) and recommended phase 2 dose (RP2D) in stage I

  The maximum tolerated dose

  At the end of Cycle 1 (each cycle is 28 or 21 days)

• Overall response rate (ORR) in stage Ⅱ

  Objective response rate

  Up to approximately 2 years

• Progression-free survival (PFS) in stage Ⅱ

  Progression-free survival

  Up to approximately 2 years

• Disease control rate (DCR) in stage Ⅱ

  Disease control rate

  Up to approximately 2 years

• Duration of response (DOR) in stage Ⅱ

  Duration of response

  Up to approximately 2 years

Secondary Outcomes (9)

• Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC0-last)

  At the end of Cycle 1 (each cycle is 28 or 21 days)

• Area under the plasma concentration-time curve from time 0 to infinity (AUC0-inf)

  At the end of Cycle 1 (each cycle is 28 or 21 days)

• Maximum plasma concentration (Cmax)

  At the end of Cycle 1 (each cycle is 28 or 21 days)

• Time to maximum plasma concentration (Tmax)

  At the end of Cycle 1 (each cycle is 28 or 21 days)

• Plasma half-life (t½)

  At the end of Cycle 1 (each cycle is 28 or 21 days)

Study Arms (3)

Docetaxel for Injection-qw 3/4 regimen

EXPERIMENTAL

Docetaxel for Injection (Albumin-bound) will be administrated once every week in the first three weeks (Day 1, 8 and 15) in every 28-day cycle, starting at a dose of 30 mg/m\^2.

Drug: Albumin-bound docetaxel

Docetaxel for Injection-q2w 2/4 regimen

EXPERIMENTAL

Docetaxel for Injection (Albumin-bound) will be administrated once every week every other week (Day 1 and 15) in every 28-day cycle, starting at a dose of 50 mg/m\^2.

Drug: Albumin-bound docetaxel

Docetaxel for Injection-qw 2/3 regimen

EXPERIMENTAL

Docetaxel for Injection (Albumin-bound) will be administrated once every week in the first two weeks (Day 1 and 8) in every 21-day cycle, starting at a dose of 30 mg/m\^2.

Drug: Albumin-bound docetaxel

Interventions

Albumin-bound docetaxel DRUG

Albumin-bound docetaxel by intravenous infusion

Docetaxel for Injection-q2w 2/4 regimen; Docetaxel for Injection-qw 2/3 regimen; Docetaxel for Injection-qw 3/4 regimen

Eligibility Criteria

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

You may qualify if:

• Patients aged ≥18, ≤75 years (subject to the date when the informed consent form is signed) and voluntarily signed the informed consent form.
• Histologically or cytologically confirmed diagnosis of advanced or metastatic solid tumors, for which standard therapy either does not exist or has proven to be ineffective, intolerable or unacceptable for the patient.
• At least one measurable lesion according to RECISTv1.1.
• Patients with Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
• Patients with estimated survival time of ≥ 3 months.
• Main organ function meets the following criteria within 7 days before treatment (no medical supportive treatments such as blood component transfusion, human granulocyte colony-stimulating factor (G-CSF), thrombopoietin (TPO), interleukin-11, and erythropoietin (EPO) within 2 weeks before baseline examination):
• Absolute neutrophil count ≥1.5×10\^9/L; Platelets ≥100×10\^9/L; Hemoglobin ≥90 g/L or ≥5.6 mmol/L; Serum creatinine ≤ 1.5×ULN or creatinine clearance rate ≥ 50 mL/min; Liver function: total bilirubin≤ 1.0 × ULN, ≤ 1.5 × ULN for patients with liver metastasis or liver cancer; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 × ULN, ≤ 2.5 × ULN for patients with liver metastasis or liver cancer.
• Fertile patients must use contraceptive measures (such as intrauterine device \[IUD\], contraceptive pill or condom) during the study period and within 6 months after the end of the study, and men should avoid sperm donation; Women of childbearing age must have negative serum pregnancy test within 7 days before study enrollment, and must be non-lactating women.

You may not qualify if:

• \. Patients with central nervous system metastasis or meningeal metastasis, accompanied by the following conditions:
• Patients with clinical symptoms related to central nervous system metastasis or meningeal metastasis;
• New lesions in the brain or progression of the original lesions on imaging from the end of brain radiotherapy or surgery to the first administration;
• Central nervous system metastasis with cortical alcohols, radiotherapy, dehydration drugs and other drugs for symptoms control within the last two weeks;
• Patients has brain stem (midbrain, pons, medulla oblongata) metastasis;
• \. HCV antibody (+) or active hepatitis B (HBsAg positive and HBV DNA \> 500 IU/mL) and uncontrolled active infection (those who must receive systematic anti infection treatment, or those with unexplained body temperature \> 38 ℃ (axillary temperature) before administration).
• \. Patients have a history of serious cardiovascular diseases, including but not limited to:
• Severe heart rhythm or conduction abnormalities, such as ventricular arrhythmia requiring clinical intervention and third-degree atrioventricular block;
• History of myocardial infarction, angina pectoris, angioplasty, coronary artery bypass surgery;
• Patients with prolonged QT/QTc interval (QTcF \> 480 ms, Fridericia's formula: QTcF = QT/RR\^0.33, RR = 60/heart rate) by ECG during the screening period;
• left ventricular ejection fraction (LVEF) ≤ 50% by echocardiography (ECHO) or multi-gated acquisition (MUGA) during the screening period;
• Heart failure with New York Heart Association (NYHA) Classification of Class Ш and above;
• Poorly controlled hypertension (systolic blood pressure ≥ 150 mmHg and/or diastolic blood pressure ≥ 95 mmHg despite optimal treatment);
• Previous or current cardiomyopathy;
• Patients with severe pulmonary hypertension or a history of pulmonary embolism within 6 months.

Sponsors & Collaborators

• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: lead

Study Sites (1)

Liu yunjiang

Shijiazhuang, Hebei, 050011, China

RECRUITING

Central Study Contacts

Yunjiang Liu, Doctor

CONTACT

+86-13703297890; Lyj818326@126.com

Mingxia Wang, Doctor

CONTACT

+86-13933105988; hb4thgp@126.com

Study Design

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

Study Record Dates

• First Submitted: October 12, 2021
• First Posted: November 10, 2021
• Study Start: January 7, 2022
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: January 31, 2022

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)