Intratumoural Injection of a Novel NanoZolid®-Docetaxel Depot Formulation in Patients With Advanced Solid Tumours

NCT04810208 | Terminated Phase 1 DMC

• 1 other identifier: NZ-DTX-001
• Study Type: interventional
• Target: 6
• Locations: 3 countries
• Sites: 4

Brief Summary

This is a multicentre, open-label, first in man, study of a novel NanoZolid®-docetaxel depot formulation (NZ-DTX Depot) given as an intra-tumoural injection in patients with advanced solid tumours. The study includes a dose escalation part and a dose expansion part.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (2)

• Maximum tolerated dose (MTD) of NZ-DTX Depot given as an intra-tumoural injection in solid, palpable, cutaneous or subcutaneous tumour lesions.

  The MTD will be determined by incidence of DLTs

  5 weeks

• The recommended Phase 2 dose (RP2D) of NZ-DTX Depot given as an intra-tumoural injection in a solid, palpable cutaneous or subcutaneous tumour lesion.

  The RP2D will be determined by frequency and severity of adverse events

  5 weeks

Secondary Outcomes (3)

• Frequency and severity of treatment-emergent adverse events [safety and tolerability] following an intratumoural injection of NZ-DTX Depot

  5 weeks

• Plasma concentration of docetaxel, following an intratumoural injection of NZ-DTX Depot

  5 weeks

• Anti-tumour effect following an intratumoural injection of NZ-DTX Depot

  5 weeks

Other Outcomes (2)

• Presence of immune biomarkers in plasma, following an intratumoural injection of NZ-DTX Depot

  9 weeks

• Presence of immune biomarkers in tissue, following an intratumoural injection of NZ-DTX Depot

  9 weeks

Study Arms (1)

NZ-DTX Depot

EXPERIMENTAL

Drug: Docetaxel

Interventions

Docetaxel DRUG

Docetaxel in NanoZolid formulation, for intratumoural injection

NZ-DTX Depot

Eligibility Criteria

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

You may qualify if:

• Signed written informed consent granted before undertaking any study-specific procedures;
• Male or female patient ≥18 years of age on the day of consenting to the study;
• Histologically or cytologically confirmed diagnosis of solid cancer;
• At least 1 advanced solid, palpable, cutaneous or subcutaneous tumour lesion with following characteristics:
• a cutaneous lesion with of thickness ≥4 mm and diameter ≥25 mm at the longest axis, or
• a subcutaneous lesion of diameter ≥20 mm at the longest and the shortest axis;
• Eastern Co-operative Oncology Group (ECOG) performance status (PS) 0-2;
• Patient from one the following categories:
• Patient for whom no standard therapy exists, or standard therapy is contraindicated, or
• Patient who is scheduled for other anti-cancer treatment (e.g. radiotherapy, immunological treatment, surgery) which will start after completion of at least one treatment cycle of NZ-DTX, i.e after the end-of-study (EOS) visit.

You may not qualify if:

• Known hypersensitivity to any of the excipients in the NZ-DTX Depot formulation (docetaxel, calcium sulphate, sodium carboxymethylcellulose);
• Life expectancy \<3 months;
• Bleeding deficiencies or ongoing anticoagulant therapy that would put the patient at increased risk of clinically significant bleeding, in the judgement of the Investigator. If the patient has an international normalised ratio (INR) below 1.2 the Investigator may judge if interruption of anticoagulant therapy is warranted;
• Any of the following abnormal laboratory values at screening;
• Bone marrow function:
• Absolute neutrophil count (ANC) \<1.5 x 109/l;
• Platelet count \<100 x 109/l;
• Haemoglobin \<9.0 mg/dl.
• Coagulation:
• \- International Normalized Ratio (INR) \>1.2.
• Hepatic, renal, and biochemistry parameters:
• Aspartate transaminase (AST) or alanine transaminase (ALT) \>2.5 x upper limit of normal (ULN) (\>5 x ULN if liver metastases present)\*;
• Alkaline phosphatase (ALP) \>2.5 x ULN;
• Total bilirubin \>1.5 x ULN;
• Estimated glomerular filtration rate (eGFR) \<40 ml/min/1.73 m² using the Modified Cockcroft \& Gault formula.

Sponsors & Collaborators

• Lidds AB: lead

Study Sites (4)

Herlev Hospital

Copenhagen, Denmark

Location

Lithuanian University of Health Sciences

Kaunas, Lithuania

Location

National Cancer Institute

Vilnius, Lithuania

Location

Karolinska University Hospital

Stockholm, Sweden

Location

MeSH Terms

Interventions

Docetaxel

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Charlotta Gauffin, PhD

  Lidds AB

  STUDY DIRECTOR

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: March 18, 2021
• First Posted: March 22, 2021
• Study Start: February 28, 2019
• Primary Completion: October 7, 2021
• Study Completion: October 7, 2021
• Last Updated: December 30, 2021

Record last verified: 2021-12

Locations

DK (1); LI (2); SE (1)