A Study of Docetaxel for Injection (Albumin-bound) in Combination With Nivolumab in Patients With Head and Neck (SCCHN)

NCT05027204 | Unknown Phase 1

• 1 other identifier: HB1801-CSP-003
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is a single-arm, multicenter phase Ib/II clinical study to evaluate the efficacy and safety of Docetaxel for Injection (Albumin-bound) combined with Nivolumab and the pharmacokinetic characteristics of Docetaxel in patients with recurrent or metastatic SCCHN who are positive for PD-L1 expression and have progressed on or after platinum-based therapy.

Conditions

Squamous Cell Carcinoma of Head and Neck

Outcome Measures

Primary Outcomes (2)

• Phase Ib: Incidence of adverse events and serious adverse events

  Incidence of adverse events and serious adverse events

  6 weeks

• Phase II: Objective response rate (ORR)

  Objective response rate

  2 years

Secondary Outcomes (12)

• The pharmacokinetic parameters (free docetaxel and total docetaxel) : AUC0-last

  24 hours

• The pharmacokinetic parameters (free docetaxel and total docetaxel) : AUC0-∞

  24 hours

• The pharmacokinetic parameters (free docetaxel and total docetaxel) : Cmax

  24 hours

• The pharmacokinetic parameters (free docetaxel and total docetaxel) : Tmax

  24 hours

• The pharmacokinetic parameters (free docetaxel and total docetaxel) : t½

  24 hours

Study Arms (1)

Docetaxel combined with Nivolumab

EXPERIMENTAL

Phase Ib: The eligible patients with SCCHN will received Docetaxel for Injection (Albumin-bound) 75 mg/m\^2 or 100 mg/m\^2 sequentially in combination with Nivolumab 360 mg to evaluate safety and efficacy and explore RP2D. Phase II: According to the RP2D determined in the phase Ib study, patients will be treated with Docetaxel for Injection (Albumin-bound) combined with Nivolumab until participants meet the criteria for termination or withdrawal criteria, for a maximum of 2 years.

Drug: Docetaxel; Drug: Nivolumab

Interventions

Docetaxel DRUG

Docetaxel for Injection (Albumin-bound), Q3W, i.v. 60 min

Docetaxel combined with Nivolumab

Nivolumab DRUG

Nivolumab, Q3W, i.v. 30 min

Docetaxel combined with Nivolumab

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years old and voluntarily signed the informed consent form.
• Patients with histologically or cytologically confirmed SCCHN (primary tumor located in the oral cavity, oropharynx, larynx or hypopharynx), with positive PD-L1 expression, and who are not suitable for local radical therapy.
• Patients with platinum-based regimen failure, defined as:
• Recurrent or metastatic SCCHN with disease progression during or after platinum-based therapy;
• Locally advanced head and neck carcinoma with recurrence or metastasis within 6 months after platinum-based therapy in previous multimodal therapy.
• Previous or qualified tumor tissue samples are available for testing PD-L1.
• Patients with oropharyngeal carcinoma should provide previous HPVp16 immunohistochemical test results, or eligible tumor tissue samples for testing HPV status.
• At least one measurable lesion confirmed by CT or MRI according to RECISTv1.1 (previously irradiated, progressive disease or tumor persistence ≥ 3 months after radiotherapy can be considered as measurable lesions).
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
• Life expectancy ≥ 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 administration of the investigational product).
• Absolute neutrophil count ≥1.5×10\^9/L Platelets ≥90×10\^9/L Hb≥90 g/L or ≥5.6 mmol/L Serum creatinine ≤ 1.5×ULN or creatinine clearance rate ≥ 40 mL/min 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); Activated Partial Thromboplastin Time (APTT) ≤ 1.5×ULN, International Normalized Ratio (INR) ≤ 1.5×ULN.
• Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days prior to the first dose of the investigational drug. The patient and his/her spouse must agree to take adequate contraception from signing of ICF through 6 months after last dose, during which time women should be nonlactating and men should refrain from donating sperm.

You may not qualify if:

• Histologically or cytologically confirmed recurrent or metastatic nasopharyngeal carcinoma, SCCHN with unknown primary lesion, salivary gland carcinoma, or non-squamous tissue carcinoma (e.g., mucosal melanoma).
• Patients with active brain metastasis and leptomeningeal metastasis. Patients with brain metastasis for whom there is no evidence of PD by MRI at least 8 weeks after treatment and within 28 days before the first dose of the investigational drug can be included; Those who do not require systemic cortisol therapy (prednisone \> 10 mg/day or equivalent) at least 2 weeks before the first dose of the investigational drug can be included; Patients with skull base lesions without definite evidence of dural or parenchymal brain involvement can be considered to be included only after discussion with the sponsor's medical monitor.
• History of other malignancies within 5 years prior to the first dose of the investigational drug, except for the following: a. Any other invasive malignancy (for which the patient has received adequate treatment) with disease free status lasting \> 3 years, which will not affect the assessment of tumor efficacy as assessed by the investigator; b. Cured basal cell or squamous cell skin carcinoma, superficial bladder cancer, prostate cancer, cervical cancer, or breast cancer in situ, and other locally curable cancers.
• Patients with known or suspected autoimmune disease within 2 years before the first dose of the investigational drug, except for the following: a. well-controlled type I diabetes; b. well-controlled hypothyroidism requiring only hormone replacement therapy; c. skin diseases (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment; d. patients who are not expected to relapse in the absence of external triggers.
• Patients with an uncontrollable third space effusion (e.g. pleural effusion, ascites, or pericardial effusion), who, in the judgment of the investigator, are not suitable for the study.
• Patients with a history of severe cardiovascular disease within 6 months before the first dose of the investigational drug, 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 and coronary artery bypass surgery;
• Heart failure with New York Heart Association (NYHA) Classification of Class III and above;
• Poorly controlled hypertension.
• 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 and/or with left ventricular ejection fraction (LVEF) ≤ 50% by echocardiography (ECHO) or multi-gated acquisition (MUGA) during the screening period;
• Patients with positive HCV antibody (+) (patients with negative HCV RNA can be included, and anti-HCV treatment other than interferon is allowed), active hepatitis B (patients with HBV DNA ≤ 500 IU/mL can be included, and anti-HBV treatment other than interferon is allowed), known HIV positive or known acquired immunodeficiency syndrome (AIDS) during the screening period.
• Patients who have undergone major organ surgery within 4 weeks before the first dose of the investigational drug, or who need to undergo elective surgery during the study.
• Patients who fail to recover from the toxic responses caused by previous anti-tumor treatment to Grade 1 and below (CTCAE 5.0), except for the following: Grade 2 neuropathy, alopecia, hypothyroidism caused by previous anti-tumor treatment (including hormone replacement therapy) and toxicity without safety risks as judged by the investigator.
• Patients who have previously received T cell costimulating drugs or drugs acting on immune checkpoint pathways (including PD-1, PD-L1/2, CTLA-4 inhibitors, etc.).

Sponsors & Collaborators

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

Study Sites (1)

Guo Ye

Shanghai, Shanghai Municipality, 200031, China

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Docetaxel; Nivolumab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

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: August 19, 2021
• First Posted: August 30, 2021
• Study Start: March 4, 2022
• Primary Completion: October 31, 2023
• Study Completion: December 31, 2023
• Last Updated: October 13, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)