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A Study Evaluating the Safety, Pharmacokinetics and Early Efficacy of AVA6000 in Solid Tumours

Primary Purpose

Pancreatic Cancer, Colorectal Cancer, Non-small Cell Lung Cancer

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
AVA6000
Sponsored by
Avacta Life Sciences Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  1. Willing and able to give written informed consent
  2. Male or female patients, ≥18 years of age
  3. Histological or cytological confirmation of a locally advanced (unresectable) and/or metastatic pancreatic, CRC, NSCLC, SCCHN, ovarian, breast, soft tissue sarcoma and bladder cancer, who have either relapsed or progressed on SoC treatment or are intolerant or nonamenable to SoC treatment
  4. In Phase 1b part of the study only: At least 1 lesion, not previously irradiated, that can be accurately measured at baseline as ≥10mm in the largest diameter (except lymph nodes, which must have a short axis ≥15 mm) with CT or MRI scan and that is suitable for accurate repeated measurements.
  5. Life expectancy of greater than 12 weeks, in the opinion of the investigator
  6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
  7. Recovered from all acute toxic effects of any prior radiotherapy, chemotherapy, or surgical procedure (must have resolved to CTCAE grade ≤1 or returned to baseline, except alopecia and peripheral neuropathy, which can be up to CTCAE grade 2)
  8. Adequate haematological function (applies only to patients not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable dose):

    1. Neutrophil count of ≥1.5× 10^9 cells/L
    2. Haemoglobin ≥9g/dL (with or without transfusion support)
    3. Platelet count of ≥75,000/μL (without transfusion within 2 weeks prior to Cycle 1, Day 1)
    4. International normalised ratio (INR) and activated partial thromboplastin time (aPTT) ≤1.5 times the upper limit of normal (ULN)
  9. Adequate liver function:

    1. Total bilirubin ≤1.5 × ULN (in patients with Gilbert's Syndrome, <3 × ULN is allowed)
    2. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN (in patients with liver metastases, <5 × ULN is allowed)
    3. Alkaline phosphatase (ALP) <5 × ULN (patients with documented liver or bone metastases only)
  10. Adequate renal function:

    a. Serum creatinine ≤1.5 × ULN (in patients for whom, in the Investigator's judgment, serum creatinine levels do not adequately reflect renal function, creatinine clearance by Cockcroft-Gale formula ≥ 50 mL/min may be used)

  11. Women of childbearing potential (WOCBP) and women who have ≤ 2 years amenorrhea after start of menopause: has a negative serum pregnancy test within 7 days prior to Cycle 1, Day 1
  12. Contraception requirements:

    1. Female patients of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or use a highly effective contraceptive method (Pearl Index failure rate <1% per year) during the treatment period and for at least 6 months after the last dose of study drug
    2. Male patients with female partners of childbearing potential must agree to use 2 acceptable methods of contraception (Pearl Index failure rate <1% per year), including a barrier method (with or without spermicide) during the treatment period and for at least 6 months after the last dose of study drug

Key Exclusion Criteria:

  1. Received trastuzumab within 7 months of the planned Cycle 1, Day 1 AVA6000 infusion
  2. Received a prior total cumulative anthracycline dose of >350mg/m^2 doxorubicin hydrochloride (or equivalent anthracycline dose)
  3. Clinically significant or untreated central nervous system (CNS) metastases requiring treatment, as determined by the Investigator.
  4. Has leptomeningeal disease
  5. Any history of an active (requiring treatment) other malignancy (except any in-situ carcinoma, non-melanoma skin carcinoma and early prostate cancer with a normal PSA) within 2 years of study entry
  6. Has a significant, uncontrolled, concomitant disease that could affect compliance with the protocol
  7. Has uncontrolled hypertension (systolic blood pressure [SBP] >150 mmHg and/or diastolic [DBP] >100 mm Hg), unstable angina, congestive heart failure (New York Heart Association (NYHA) Class >II), left ventricular ejection fraction (LVEF) <55% or the low limit of institutional normal limit (whichever is lower) by echocardiogram (ECHO), serious cardiac arrhythmia requiring treatment (exceptions include atrial fibrillation, paroxysmal supraventricular tachycardia), history of myocardial infarction within 6 months prior to Cycle 1, Day 1; history of uncontrolled cardiovascular disease or high-sensitivity troponin above normal at baseline
  8. Screening baseline mean QTcF interval (Fridericia's) of >470 msec, obtained from 3 electrocardiograms (ECGs). Has any clinically significant abnormalities in rhythm, conduction, or morphology of resting ECG (e.g., complete left bundle branch block, third-degree heart block, second-degree heart block, PR interval >250msec). Has any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, known family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval, a baseline resting bradycardia <45 beats/min or a baseline resting tachycardia of >100 beats/min
  9. Known uncontrolled HIV infection
  10. Active hepatitis B (HBV) or hepatitis C (HCV) infection:

    1. Positive hepatitis B surface antigen (HBsAG) test at Screening. Patients with a past or resolved HBV infection (defined as having a negative HBsAG test and a positive antibody to hepatitis B core antigen [antiHBc] antibody test) are eligible.
    2. Patients positive for HCV antibody are eligible only if PCR is negative for HCV RNA
  11. Severe infection(requiring IV treatment)within 21 days prior to Cycle 1, Day 1 including, but not limited to, hospitalisation for complications of infection, bacteraemia, or severe pneumonia
  12. Any other clinically significant active disease, metabolic dysfunction, physical examination finding, clinical laboratory finding, or reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drugin the opinion of the investigator.
  13. Major surgery within 21 days prior to Cycle 1, Day 1 (excluding biopsies) or anticipates the need for major surgery during study treatment
  14. Has dementia or altered mental status that in the opinion of the investigator would preclude providing informed consent
  15. Pregnant or breastfeeding woman
  16. Known hypersensitivity to any of the components of AVA6000 or any excipient related to the product
  17. Received prior investigational therapy (defined as a treatment for which there is no Regulatory Authority-approved indication) within 21 or 42 days of Cycle 1 Day 1, for small molecule and biologic investigational therapies, respectively.
  18. Received any approved anticancer therapy, including chemotherapy or hormonal therapy, within 28 days prior to Cycle 1, Day 1, with the following exceptions:

    1. Hormone-replacement therapy or oral contraceptives
    2. Tyrosine kinase inhibitors (TKIs) that have been discontinued more than 7 days prior to Cycle1, Day 1
  19. Is planned for on study treatment or has received within 21 days prior to Cycle 1, Day 1: St John's Wort, any strong inhibitor or inducer of CYP3A4, CYP2D6, narrow therapeutic index CYP1A2, CYP2B6, or P-glycoprotein (PGP) ̧ or any moderate OATP1B3 inhibitor (will include statins)
  20. Received systemic immunosuppressive medication (for any indication) at doses of >10mg prednisolone (or equivalent) within 28 days prior to Cycle 1, Day 1.
  21. Received radiotherapy within 28 days prior to Cycle 1, Day 1, except for limited field palliative radiotherapy. Patients who have received prior or concomitant radiotherapy to the mediastinal area are also excluded.

Sites / Locations

  • Memorial Sloan Kettering Cancer CenterRecruiting
  • Fred Hutchinson Cancer CenterRecruiting
  • The Beatson West of Scotland Cancer Centre, NHS Greater Glasgow & ClydeRecruiting
  • St James's University Hospital, The Leeds Teaching Hospitals NHS TrustRecruiting
  • The Royal Marsden, NHS Foundation TrustRecruiting
  • The Christie NHS Foundation TrustRecruiting
  • The Freeman Hospital, Newcastle-upon-Tyne NHS Foundation TrustRecruiting
  • Weston Park Cancer Centre, Sheffield Teaching Hospitals NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

AVA6000 Phase 1a

AVA6000 Phase 1b

Arm Description

Patients in Phase Ia will receive escalating doses of AVA6000 following a 3+3 design, commencing with a starting dose of 80mg/m2, once every 3 weeks (Q3W) starting on Cycle 1, Day 1 (C1D1), until disease progression, unacceptable toxicities, withdrawal from treatment for other reasons, reaching maximum lifetime cumulative exposure to doxorubicin (or other anthracyclines), or death, whichever occurs first.

Patients in Phase Ib will receive the RP2D dose of AVA6000, once every 3 weeks (Q3W) starting on Cycle 1, Day 1 (C1D1), until disease progression, unacceptable toxicities, withdrawal from treatment for other reasons, reaching maximum lifetime cumulative exposure to doxorubicin (or other anthracyclines), or death, whichever occurs first. One to three tumour types will be selected based on the assessment of Phase 1a data.

Outcomes

Primary Outcome Measures

Number of participants with dose-limiting toxicities (DLTs)
Percentage of patients with Dose-Limiting toxicities (DLTs) of AVA6000 during the DLT period
Maximum-tolerated dose (MTD) or Recommended Phase 2 dose (RP2D)
Percentage of patients with Adverse Events (AEs) at RP2D AVA6000 dose level in tumour-specific expansion arms.

Secondary Outcome Measures

Maximum drug concentration (Cmax) of AVA6000 & Doxorubicin
Cmax (maximum plasma concentration) of AVA6000 and Doxorubicin after administration after Cycle 1 and 2 for 72 hours post-dose.
Area under the concentration versus time curve (AUC) of AVA6000 & Doxorubicin
AUC (Area under the concentration versus time curve) of AVA6000 and Doxorubicin after administration after Cycle 1 and 2 for 72 hours post-dose.
Elimination half-life (t1/2) of AVA6000 & Doxorubicin
t1/2 (Elimination half-life) of AVA6000 and Doxorubicin after administration after Cycle 1 and 2 for 72 hours post-dose.
Renal clearance (CLr) of AVA6000 & Doxorubicin
CLr (Renal clearance) of AVA6000 and Doxorubicin after administration after Cycle 1 and 2 for 72 hours post-dose.
Objective response rate (ORR)
ORR is defined as the proportion of patients achieving a best overall response of confirmed partial responses (PR) or complete response (CR), per Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
Duration of Response (DoR)
DoR is defined as the duration of time from date of first response to date of disease progression, as per RECIST v1.1
Progression-free-survival (PFS)
PFS is defined as the time from the date of the first dose to the date of the first documentation of confirmed disease progression or death, whichever occurs first, as per RECIST v1.1
Overall survival (OS)
Overall survival (OS), defined as the date of first dose) to the occurrence of death from any cause

Full Information

First Posted
June 22, 2021
Last Updated
April 11, 2023
Sponsor
Avacta Life Sciences Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT04969835
Brief Title
A Study Evaluating the Safety, Pharmacokinetics and Early Efficacy of AVA6000 in Solid Tumours
Official Title
A Phase 1, Open Label, Dose-Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics and Initial Therapeutic Activity of AVA6000, a Novel FAP-activated Doxorubicin Prodrug Administered Intravenously in Patients With Locally Advanced or Metastatic Selected Solid Tumours
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 16, 2021 (Actual)
Primary Completion Date
May 31, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Avacta Life Sciences Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This open-label, First-into-Human (FIH) study will evaluate the safety, tolerability, pharmacokinetics (PK) and early efficacy of AVA6000, a FAP-activated pro-drug of doxorubicin, in patients with locally advanced and/or metastatic solid tumours. In Phase Ia, using a 3+3 design, escalating doses of AVA6000 will be administered to patients with a range of solid tumour types to determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D). In Phase 1b, the selected RP2D dose will be assessed in one to three tumour types.
Detailed Description
This study is a first-in-human (FIH), Phase 1, open-label, multicentre, dose-escalation study investigating AVA6000 monotherapy administered intravenously (IV) in patients with locally advanced (unresectable) and/or metastatic solid tumours. The study will be conducted in two parts: Phase 1a (Dose Escalation) and Phase 1b (Dose Expansion): Phase 1a (Dose Escalation): The dose-escalation phase is designed to evaluate the safety, tolerability and MTD and/or RP2D of AVA6000, administered as monotherapy Phase 1b (Dose Expansion): The dose-expansion phase will comprise 1 to 3 expansion arms in specific tumour types to evaluate the safety and tolerability of AVA6000 at the MTD or RP2D when administered as monotherapy. The tumour types to be explored in Phase 1b, will be determined based on evaluation of the Phase 1a data and the protocol will be amended accordingly.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer, Colorectal Cancer, Non-small Cell Lung Cancer, Head and Neck Cancer, Cancer of Unknown Primary Site, Ovarian Cancer, Breast Cancer, Soft Tissue Sarcoma, Bladder Cancer, Oesophageal Cancer, Prostate Cancer, Biliary Tract Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Model Description
This Phase I study will follow a standard 3+3 design in Part 1a to determine the maximum tolerated dose (MTD) and/or recommended dose of AVA6000, given as an intravenous infusion, to be used in Part 1b in the dose-expansion phase in up to 3 tumour types.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AVA6000 Phase 1a
Arm Type
Experimental
Arm Description
Patients in Phase Ia will receive escalating doses of AVA6000 following a 3+3 design, commencing with a starting dose of 80mg/m2, once every 3 weeks (Q3W) starting on Cycle 1, Day 1 (C1D1), until disease progression, unacceptable toxicities, withdrawal from treatment for other reasons, reaching maximum lifetime cumulative exposure to doxorubicin (or other anthracyclines), or death, whichever occurs first.
Arm Title
AVA6000 Phase 1b
Arm Type
Experimental
Arm Description
Patients in Phase Ib will receive the RP2D dose of AVA6000, once every 3 weeks (Q3W) starting on Cycle 1, Day 1 (C1D1), until disease progression, unacceptable toxicities, withdrawal from treatment for other reasons, reaching maximum lifetime cumulative exposure to doxorubicin (or other anthracyclines), or death, whichever occurs first. One to three tumour types will be selected based on the assessment of Phase 1a data.
Intervention Type
Drug
Intervention Name(s)
AVA6000
Intervention Description
AVA6000 is a FAP-activated prodrug of doxorubicin. AVA6000 will be administered via IV infusion every 3 weeks. Dosing will occur based on the calculated patient's BSA on the day of dosing.
Primary Outcome Measure Information:
Title
Number of participants with dose-limiting toxicities (DLTs)
Time Frame
Cycle 1, 21 days
Title
Percentage of patients with Dose-Limiting toxicities (DLTs) of AVA6000 during the DLT period
Time Frame
Cycle 1, 21 days
Title
Maximum-tolerated dose (MTD) or Recommended Phase 2 dose (RP2D)
Time Frame
Cycle 1, 21 days
Title
Percentage of patients with Adverse Events (AEs) at RP2D AVA6000 dose level in tumour-specific expansion arms.
Time Frame
Cycle 1, 21 days
Secondary Outcome Measure Information:
Title
Maximum drug concentration (Cmax) of AVA6000 & Doxorubicin
Description
Cmax (maximum plasma concentration) of AVA6000 and Doxorubicin after administration after Cycle 1 and 2 for 72 hours post-dose.
Time Frame
Cycle 1 and Cycle 2, 0-72 hours post dose (Dose Escalation)
Title
Area under the concentration versus time curve (AUC) of AVA6000 & Doxorubicin
Description
AUC (Area under the concentration versus time curve) of AVA6000 and Doxorubicin after administration after Cycle 1 and 2 for 72 hours post-dose.
Time Frame
Cycle 1 and Cycle 2, 0-72 hours post dose (Dose Escalation)
Title
Elimination half-life (t1/2) of AVA6000 & Doxorubicin
Description
t1/2 (Elimination half-life) of AVA6000 and Doxorubicin after administration after Cycle 1 and 2 for 72 hours post-dose.
Time Frame
Cycle 1 and Cycle 2, 0-72 hours post dose (Dose Escalation)
Title
Renal clearance (CLr) of AVA6000 & Doxorubicin
Description
CLr (Renal clearance) of AVA6000 and Doxorubicin after administration after Cycle 1 and 2 for 72 hours post-dose.
Time Frame
Cycle 1 and Cycle 2, 0-72 hours post dose (Dose Escalation)
Title
Objective response rate (ORR)
Description
ORR is defined as the proportion of patients achieving a best overall response of confirmed partial responses (PR) or complete response (CR), per Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
Time Frame
Up to one year
Title
Duration of Response (DoR)
Description
DoR is defined as the duration of time from date of first response to date of disease progression, as per RECIST v1.1
Time Frame
Up to one year
Title
Progression-free-survival (PFS)
Description
PFS is defined as the time from the date of the first dose to the date of the first documentation of confirmed disease progression or death, whichever occurs first, as per RECIST v1.1
Time Frame
Up to one year
Title
Overall survival (OS)
Description
Overall survival (OS), defined as the date of first dose) to the occurrence of death from any cause
Time Frame
Up to one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Willing and able to give written informed consent Male or female patients, ≥18 years of age Histological or cytological confirmation of a locally advanced (unresectable) and/or metastatic pancreatic (PDAC), CRC, NSCLC, HNSCC, CUP, ovarian, breast, soft tissue sarcoma, bladder, oesophageal, prostate, and biliary tract cancer, who have either relapsed or progressed on SoC treatment or are intolerant or nonamenable to SoC treatment In Phase 1b part of the study only: At least 1 lesion, not previously irradiated, that can be accurately measured at baseline as ≥10mm in the largest diameter (except lymph nodes, which must have a short axis ≥15 mm) with CT or MRI scan and that is suitable for accurate repeated measurements. Life expectancy of greater than 12 weeks, in the opinion of the investigator Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 Recovered from all acute toxic effects of any prior radiotherapy, chemotherapy, or surgical procedure (must have resolved to CTCAE grade ≤1 or returned to baseline, except alopecia and peripheral neuropathy, which can be up to CTCAE grade 2) Adequate haematological function (applies only to patients not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable dose): Neutrophil count of ≥1.5× 10^9 cells/L Haemoglobin ≥9g/dL (with or without transfusion support) Platelet count of ≥75,000/μL (without transfusion within 2 weeks prior to Cycle 1, Day 1) International normalised ratio (INR) and activated partial thromboplastin time (aPTT) ≤1.5 times the upper limit of normal (ULN) Adequate liver function: Total bilirubin ≤1.5 × ULN (in patients with Gilbert's Syndrome, <3 × ULN is allowed) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN (in patients with liver metastases, <5 × ULN is allowed) Alkaline phosphatase (ALP) <5 × ULN (patients with documented liver or bone metastases only) Adequate renal function: a. Serum creatinine ≤1.5 × ULN (in patients for whom, in the Investigator's judgment, serum creatinine levels do not adequately reflect renal function, creatinine clearance by Cockcroft-Gale formula ≥ 50 mL/min may be used) Women of childbearing potential (WOCBP) and women who have ≤ 2 years amenorrhea after start of menopause: has a negative serum pregnancy test within 7 days prior to Cycle 1, Day 1 Contraception requirements: Female patients of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or use a highly effective contraceptive method (Pearl Index failure rate <1% per year) during the treatment period and for at least 6 months after the last dose of study drug Male patients with female partners of childbearing potential must agree to use 2 acceptable methods of contraception (Pearl Index failure rate <1% per year), including a barrier method (with or without spermicide) during the treatment period and for at least 6 months after the last dose of study drug Key Exclusion Criteria: Received trastuzumab within 7 months of the planned Cycle 1, Day 1 AVA6000 infusion Received a prior total cumulative anthracycline dose of >350mg/m^2 doxorubicin hydrochloride (or equivalent anthracycline dose) Clinically significant or untreated central nervous system (CNS) metastases requiring treatment, as determined by the Investigator. Has leptomeningeal disease Any history of an active (requiring treatment) other malignancy (except any in-situ carcinoma, non-melanoma skin carcinoma and early prostate cancer with a normal PSA) within 2 years of study entry Has a significant, uncontrolled, concomitant disease that could affect compliance with the protocol Has uncontrolled hypertension (systolic blood pressure [SBP] >150 mmHg and/or diastolic [DBP] >100 mm Hg), unstable angina, congestive heart failure (New York Heart Association (NYHA) Class >II), left ventricular ejection fraction (LVEF) <55% or the low limit of institutional normal limit (whichever is lower) by echocardiogram (ECHO), serious cardiac arrhythmia requiring treatment (exceptions include atrial fibrillation, paroxysmal supraventricular tachycardia), history of myocardial infarction within 6 months prior to Cycle 1, Day 1; history of uncontrolled cardiovascular disease or high-sensitivity troponin above normal at baseline Screening baseline mean QTcF interval (Fridericia's) of >470 msec, obtained from 3 electrocardiograms (ECGs). Has any clinically significant abnormalities in rhythm, conduction, or morphology of resting ECG (e.g., complete left bundle branch block, third-degree heart block, second-degree heart block, PR interval >250msec). Has any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, known family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval, a baseline resting bradycardia <45 beats/min or a baseline resting tachycardia of >100 beats/min Known uncontrolled HIV infection Active hepatitis B (HBV) or hepatitis C (HCV) infection: Positive hepatitis B surface antigen (HBsAG) test at Screening. Patients with a past or resolved HBV infection (defined as having a negative HBsAG test and a positive antibody to hepatitis B core antigen [antiHBc] antibody test) are eligible. Patients positive for HCV antibody are eligible only if PCR is negative for HCV RNA Severe infection(requiring IV treatment)within 21 days prior to Cycle 1, Day 1 including, but not limited to, hospitalisation for complications of infection, bacteraemia, or severe pneumonia Any other clinically significant active disease, metabolic dysfunction, physical examination finding, clinical laboratory finding, or reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drugin the opinion of the investigator. Major surgery within 21 days prior to Cycle 1, Day 1 (excluding biopsies) or anticipates the need for major surgery during study treatment Has dementia or altered mental status that in the opinion of the investigator would preclude providing informed consent Pregnant or breastfeeding woman Known hypersensitivity to any of the components of AVA6000 or any excipient related to the product Received prior investigational therapy (defined as a treatment for which there is no Regulatory Authority-approved indication) within 21 or 42 days of Cycle 1 Day 1, for small molecule and biologic investigational therapies, respectively. Received any approved anticancer therapy, including chemotherapy or hormonal therapy, within 28 days prior to Cycle 1, Day 1, with the following exceptions: Hormone-replacement therapy or oral contraceptives Tyrosine kinase inhibitors (TKIs) that have been discontinued more than 7 days prior to Cycle1, Day 1 Is planned for on study treatment or has received within 21 days prior to Cycle 1, Day 1: St John's Wort, any strong inhibitor or inducer of CYP3A4, CYP2D6, narrow therapeutic index CYP1A2, CYP2B6, or P-glycoprotein (PGP) ̧ or any moderate OATP1B3 inhibitor (will include statins) Received systemic immunosuppressive medication (for any indication) at doses of >10mg prednisolone (or equivalent) within 28 days prior to Cycle 1, Day 1. Received radiotherapy within 28 days prior to Cycle 1, Day 1, except for limited field palliative radiotherapy. Patients who have received prior or concomitant radiotherapy to the mediastinal area are also excluded.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Avacta Life Sciences
Phone
+44 (0)1904 21 7070
Email
clinicaltrials@avacta.com
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr William Tap
Facility Name
Fred Hutchinson Cancer Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Professor Lee Cranmer
Facility Name
The Beatson West of Scotland Cancer Centre, NHS Greater Glasgow & Clyde
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Professor Jeff Evans
Facility Name
St James's University Hospital, The Leeds Teaching Hospitals NHS Trust
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Professor Chris Twelves
Facility Name
The Royal Marsden, NHS Foundation Trust
City
London
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Professor Udai Banerji
Facility Name
The Christie NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Natalie Cook
Facility Name
The Freeman Hospital, Newcastle-upon-Tyne NHS Foundation Trust
City
Newcastle upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Professor Ruth Plummer
Facility Name
Weston Park Cancer Centre, Sheffield Teaching Hospitals NHS Foundation Trust
City
Sheffield
ZIP/Postal Code
S10 2SJ
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Robin Young

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Qualified researchers may request access to individual patient-level data through clincialtrials@avacta.com

Learn more about this trial

A Study Evaluating the Safety, Pharmacokinetics and Early Efficacy of AVA6000 in Solid Tumours

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