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Advanced Solid TumorsPhase 1NCT05114915

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

A Phase 1 study testing Albumin-bound docetaxel in people with Advanced Solid Tumors, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Solid Tumors
What is being tested?
Albumin-bound docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
144 participants
Where
1 siteChina
Study dates
7 Jan 2022to Oct 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 1. 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;
  • Other evidence shows that the patient's central nervous system metastasis or meningeal metastasis has not been controlled, which is not suitable for inclusion according to the judgment of the researcher.
Show all 27Show fewer
  • 2. Known human immunodeficiency virus (HIV) test positive or known history of acquired immunodeficiency syndrome (AIDS), history of organ transplantation, history of serious autoimmune diseases judged by the researchers to be unsuitable for inclusion.
  • 3. 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).
  • 4. 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.
  • 5. Patients with a third space effusion (e.g., pleural effusion, ascites, or pericardial effusion) that is difficult to control, who, in the judgment of the investigator, are not suitable for the study.
  • 6. Allergic history to taxane or any excipients of the study drug (CTCAE 5.0 grade ≥ 3 grade).
  • 7. Adverse reactions from the previous anti-tumor treatment have not yet recovered to ≤ level 1 based on CTCAE 5.0 (except for the toxicity without safety risk judged by the investigator, such as alopecia).
  • 8. Patients who have previously received docetaxel containing regimen and progressed during treatment or within 6 months after treatment.
  • 9. Patients who have undergone major organ surgery (excluding puncture biopsy) or significant trauma within 4 weeks before the first dose of the investigational drug, or who need to undergo elective surgery during the study period.
  • 10. The time between the last anti-tumor treatment and the first medication meet the following time interval: anti-tumor treatment such as chemotherapy, radiotherapy (except local radiotherapy for pain relief), targeted therapy, immunotherapy and other clinical research drugs within 4 weeks before the first administration; oral fluorouracils, small molecule targeted drugs and traditional Chinese medicine with anti-tumor indications within 2 weeks before the first administration.
  • 11. Patients who have received corticosteroid (prednisone > 10 mg/day or equivalent) or other immunosuppressive therapies within 2 weeks before the first dose of the investigational drug, except for the following: a. use of topical, ocular, intra-articular, nasal and inhaled glucocorticoids; b. short-term use of glucocorticoids for prophylaxis (such as prevention of contrast agent allergy).
  • 12. Patients who have used potent inhibitors or inducers of CYP3A4 within 2 weeks before the first dose of the investigational drug.
  • 13. Patients with alcohol or drug dependence. 14. Patients have clear history of neurological or psychiatric disorders, including epilepsy and dementia.
  • 15. The researcher believes that the patient has other reasons that affect the safety or compliance, or is not in the best interests of the subject and is not suitable to participate in this clinical study (for example, eye diseases, venous thrombosis, etc., which affect the safety according to the judgment of the researcher).

Trial locations and contacts

1 site in 1 country.

Yunjiang Liu, Doctor contact

+86-13703297890

Lyj818326@126.com

Mingxia Wang, Doctor contact

+86-13933105988

hb4thgp@126.com

China1 site, 1 recruiting

  • Liu yunjiang

    Shijiazhuang, Hebei, 050011

    Yunjiang Liu, Doctor, +86-13703297890, Lyj818326@126.com

    Mingxia Wang, Doctor, +86-13933105988, hb4thgp@126.com

    Recruiting

Other trials in China

About this study

Official title: Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Docetaxel for Injection (Albumin-bound) in Different Dose Regimens in Patients With Advanced Solid Tumors: An Open-label, Multicenter, Phase 1b Study

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.

Read the detailed description

This study will be conducted in two stages. The first stage (Stage I) is a dose-escalation study. A classic 3+3 design will be used to determine the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D). Patients will receive the docetaxel for injection (albumin-bound) until disease progression, or intolerable toxicity, or other reasons for termination of the study. All dose-escalation decisions will be based on the safety data generated from the current highest dose group.

In the cohort-expansion study (Stage Ⅱ), patients with a potential to have better response to the study drug will be recruited. Patients will receive the docetaxel for injection (albumin-bound) at the recommended phase 2 dose (RP2D) and follow the treatment regimen established in Stage I.

Being tested
Albumin-bound docetaxel

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Albumin-bound docetaxelDrug

    Albumin-bound docetaxel by intravenous infusion

Study groups in NCT05114915
Study groupRoleWhat they receive
Docetaxel for Injection-qw 3/4 regimenExperimentalDocetaxel 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.
Receives: Drug: Albumin-bound docetaxel
Docetaxel for Injection-q2w 2/4 regimenExperimentalDocetaxel 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.
Receives: Drug: Albumin-bound docetaxel
Docetaxel for Injection-qw 2/3 regimenExperimentalDocetaxel 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.
Receives: Drug: Albumin-bound docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The occurrence and frequency of adverse events and serious adverse events

    Incidence of adverse events and serious adverse events

    Measured: Up to approximately 2 years

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

    The maximum tolerated dose

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

  3. Overall response rate (ORR) in stage Ⅱ

    Objective response rate

    Measured: Up to approximately 2 years

  4. Progression-free survival (PFS) in stage Ⅱ

    Progression-free survival

    Measured: Up to approximately 2 years

  5. Disease control rate (DCR) in stage Ⅱ

    Disease control rate

    Measured: Up to approximately 2 years

  6. Duration of response (DOR) in stage Ⅱ

    Duration of response

    Measured: Up to approximately 2 years

Secondary outcomes (9)

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

    Area under the plasma concentration-time curve

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

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

    Area under the plasma concentration-time curve

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

  3. Maximum plasma concentration (Cmax)

    Maximum plasma concentration

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

  4. Time to maximum plasma concentration (Tmax)

    Time to maximum plasma concentration

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

  5. Plasma half-life (t½)

    Plasma half-life

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

  6. Volume of distribution (Vd)

    Volume of distribution

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

  7. Plasma clearance (CL)

    Plasma clearance

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

  8. Cumulative urinary excretion rate of docetaxel prototypes

    Cumulative urinary excretion rate of docetaxel prototypes

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

  9. Preliminary identification of major metabolites in plasma and urine samples

    Preliminary identification of major metabolites in plasma and urine samples

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Nov 2021
  2. Study start7 Jan 2022
  3. Primary completionOct 2023 (estimated)
  4. Study completionOct 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
144 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05114915
Sponsor's protocol ID
HB1801-CSP-004
Status last verified
Oct 2021
First submitted
12 Oct 2021
Last updated
31 Jan 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Albumin-bound docetaxel in people with Advanced Solid Tumors, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yunjiang Liu, Doctor (+86-13703297890, Lyj818326@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The occurrence and frequency of adverse events and serious adverse events (time frame: Up to approximately 2 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05114915.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2022; AzTrials last refreshed its copy on 7 Nov 2026.

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