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First Time in Human Study of AZD8701 With or Without Durvalumab in Participants With Advanced Solid Tumours

Primary Purpose

Clear Cell Renal Cell Cancer, Non-Small-Cell Lung Cancer, Triple Negative Breast Neoplasms

Status
Active
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
AZD8701
Durvalumab
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Clear Cell Renal Cell Cancer focused on measuring Solid Tumours, Durvalumab, MEDI4736, AZD8701, Non Small cell Lung cancer, ccRenal Cancer, TNBC, first time in human, PD-L1, T regulatory cells, FOXP3

Eligibility Criteria

18 Years - 101 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

The study is comprised of 2 main parts Monotherapy (AZD8701) and Combined Therapy (AZD8701 and Durvalumab).

Inclusion criteria Dose escalation stages:

  • Histological or cytological confirmation of a solid, malignant tumour including HNSCC, TNBC, NSCLC, ccRCC, gastroesophageal cancer, melanoma, cervical cancer, SCLC, and/or participants with other solid tumours who have demonstrated a response to prior anti-PD-(L)1 treatment
  • Participant with progressive disease that is refractory to standard therapies or for which no standard therapies exist and a clinical trial is the best option for next treatment based on prior response and/or tolerability to standard of care

Inclusion Criteria Dose Expansions:

Non Small Lung Cancer Participants who have received prior PD(L)1 treatment. Clear Cell Renal Cancer Participants who have not received prior PD(L)1 treatment.

Triple negative Breast Cancer participants who have who have not received prior PD(L)1 treatment.

General inclusion criteria:

  • Must be 18 year old at the time of screening
  • Body weight > 35 kg
  • Male and Female participants of childbearing potential must use effective methods of contraception
  • Capable of giving signed informed consent
  • ECOG performance status of 0 to 1
  • A serum albumin > 30g/L
  • Life expectancy of > 12 weeks
  • At least 1 lesion, that qualifies as a RECIST 1.1 target lesion at baseline. Tumour assessment by CT scan or MRI must be performed within 28 days prior to treatment.
  • Participants must provide a new or previous tumour sample
  • Adequate organ system functions

Exclusion Criteria:

  • A condition that, in the opinion of the Investigator, would interfere with evaluation of the study intervention or interpretation of participant safety or study results
  • History of allogeneic organ transplantation.
  • Active or prior documented autoimmune or inflammatory disorders Uncontrolled intercurrent illness
  • Significant cardiac disease
  • History of another primary malignancy except for

    1. Malignancy treated with curative intent and with no known active disease ≥ 5 years
    2. non-melanoma skin cancer
    3. Adequately treated carcinoma in situ without evidence of disease.
  • Participant with previous or confirmed Covid 19 diagnosis requiring significant medical intervention
  • Current clinical signs and symptoms consistent with COVID-19 or confirmed current infection by appropriate laboratory test within the last 4 weeks prior to screening
  • Any major unresolved toxicity from previous anticancer therapy
  • Known allergy or hypersensitivity to any of the study interventions or any of the study intervention excipients.

Prior/Concomitant Therapy

  • Receipt of the last dose of anticancer therapy within 5 half-lives or ≤ 21 days prior to the first dose of study
  • Prior treatment with potential Treg depletion therapies including agents targeting OX40 or CD357 (GITR) for 90 days prior to enrolment on study.
  • Participants who have received prior anti-PD-1, anti-PD-L1, or anti-CTLA-4:

    1. Must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy.
    2. All AEs while receiving prior immunotherapy must have completely resolved or resolved to baseline
    3. Must not have experienced a ≥ Grade 3 imAE or a neurologic or ocular imAE of any grade while receiving prior immunotherapy.
    4. Must not have required the use of additional immunosuppression other than corticosteroids for the management of an AE
  • Current or prior use of immunosuppressive medication within 14 days before the first dose of study drug. b. The following are exceptions to this criterion:

    1. Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra-articular injection).
    2. Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent
    3. Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication)
  • Any concurrent chemotherapy, investigational product, biologic, or hormonal therapy for cancer treatment
  • Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study intervention.
  • Major surgical procedure within 28 days prior to the first dose
  • Participants receiving anticoagulation therapy with vitamin K antagonists (eg warfarin)
  • Participation in another clinical study with study intervention administered in the last 30 days
  • Female participants who are pregnant or breastfeeding or male and female participants of reproductive potential who are not willing to employ effective birth control

Sites / Locations

  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Monotherapy

Combination Therapy

Arm Description

Participants will receive AZD8701 intravenously, on Day 1, 3, 5 and 8 and then weekly for a maximum of 2 years.

Participants will receive AZD8701 (intravenously, on Day 1, 3, 5 and 8 and then weekly) and durvalumab (MEDI4736) intravenously monthly for a maximum of 2 years.

Outcomes

Primary Outcome Measures

Maximum Tolerated dose (or optimal dose or maximum feasible dose) and RP2D of AZD8701 as monotherapy and in combination with Durvalumab assessed through evaluation of AEs and SAEs
Determined according to Incidence and treatment related AEs and SAEs
Maximum Tolerated dose (or optimal dose or maximum feasible dose) and RP2D of AZD8701 as monotherapy and in combination with Durvalumab assessed through evaluation of Dose Limiting Toxicities (DLTs)
Determined according to Incidence of DLTs (during the first 28 day cycle)
Maximum Tolerated dose (or optimal dose or maximum feasible dose) and RP2D of AZD8701 as monotherapy and in combination with Durvalumab assessed through evaluation of vital signs and abnormal laboratory parameters
Determined according to Incidence of abnormal vital signs and laboratory parameters
Incidence of AEs and SAEs related to AZD8701 as monotherapy and in combination with Durvalumab in disease specific expansions treated at the MTD/OBD/MFD
Safety and tolerability of the MTD/OBD/MFD assessed through incidence of AEs and SAEs
Objective Response Rate according to RECIST 1.1 by investigator assessment in disease specific expansions treated at the MTD/OB/MFD
The proportion of subjects achieving a confirmed complete or partial response according to RECIST 1.1 by investigator assessment

Secondary Outcome Measures

Progression-free survival according to RECIST 1.1 by investigator assessment
Time from start of study treatment to the date of objective disease progression or death (by any cause in the absence of progression)
Duration of Response according to RECIST 1.1 by investigator assessment
Time from first documented response (that is subsequently confirmed) to the date of objective disease progression or death (by any cause in the absence of progression)
Disease Control Rate at 16 weeks according to RECIST 1.1 by investigator assessment
The proportion of subjects with a best response of CR or PR in the first 16 weeks or SD for at least 16 weeks according to RECIST 1.1 by investigator assessment
Time to Response according to RECIST 1.1 by investigator assessment
Time from the start of study treatment until the date of first documented response (which is subsequently confirmed)
Best percentage change in tumour size according to RECIST 1.1 by investigator assessment
Best percentage change from baseline in sum of the diameters of target lesions
Overall Survival at 18 months
The survival rate of subjects at 18 months from start of treatment
Maximum concentration (Cmax) of AZD8701 in plasma when administered as monotherapy and in combination with Durvalumab
Maximum concentration (Cmax) of AZD8701 in plasma
Time to maximum concentration (tmax) of AZD8701 in plasma when administered as monotherapy and in combination with Durvalumab
Time to maximum concentration (tmax) of AZD8701 in plasma
Exposure to AZD8701 through measurement of area under the curve (AUC) in plasma when administered as monotherapy and in combination with Durvalumab
Exposure to AZD8701 through measurement of area under the curve (AUC) in plasma
Maximum concentration (Cmax) of AZD8701 in urine when administered as monotherapy and in combination with Durvalumab
Maximum concentration (Cmax) of AZD8701 in urine
Time to maximum concentration (tmax) of AZD8701 in urine when administered as monotherapy and in combination with Durvalumab
Time to maximum concentration (tmax) of AZD8701 in urine
Exposure to AZD8701 through measurement of area under the curve (AUC) in urine when administered as monotherapy and in combination with Durvalumab
Exposure to AZD8701 through measurement of area under the curve (AUC) in urine
Urine concentrations of AZD8701 to assess renal clearance when administered as monotherapy and in combination with Durvalumab
Urine samples will be collected to assess urine concentrations of AZD8701 at a series of timepoints to derive renal clearance
Maximum concentration (Cmax) of Durvalumab in serum when administered in combination with AZD8701
Maximum concentration (Cmax) of Durvalumab in serum
Minimum concentration (Cmin) of Durvalumab in serum when administered in combination with AZD8701
Minimum concentration (Cmin) of Durvalumab in serum
Change in FOXP3 mRNA expression
Percentage change in FOXP3 mRNA expression from pre-treatment (baseline) to post treatment

Full Information

First Posted
July 16, 2020
Last Updated
September 20, 2023
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT04504669
Brief Title
First Time in Human Study of AZD8701 With or Without Durvalumab in Participants With Advanced Solid Tumours
Official Title
A Phase I First-in-Human Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of AZD8701 Administered Intravenously as Monotherapy and in Combination With Durvaluamb (MEDI4736) in Participants With Advanced Solid Tumours.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 18, 2020 (Actual)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
December 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

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

5. Study Description

Brief Summary
The purpose of this study is to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Antitumor Activity of AZD8701 Alone and in Combination with Durvalumab (MEDI4736) in Adult Subjects with Select Advanced Solid Tumors
Detailed Description
This is a Phase I, First in Human, multicentre, open-label, multiple arm study with dose escalations and expansions at selected doses. Dose-escalation will occur with AZD8701 in monotherapy (Part 1) and in combination with durvalumab (Part 3) in selected participants with HNSCC, TNBC, NSCLC, ccRCC, gastroesophageal cancer, melanoma, cervical cancer, small-cell lung cancer and/or participants with solid tumours who have demonstrated a response to prior PD-(L)1 treatment. Disease specific expansions will occur with a selected dose of AZD8701 in participants with NSCLC (Part 2) and with a selected dose of AZD8701 and durvalumab in participants with TNBC and clear cell RCC (Part 4).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clear Cell Renal Cell Cancer, Non-Small-Cell Lung Cancer, Triple Negative Breast Neoplasms, Squamous Cell Cancer of Head and Neck, Small Cell Lung Cancer, Gastroesophageal Cancer, Melanoma, Cervical Cancer, Advanced Solid Tumours
Keywords
Solid Tumours, Durvalumab, MEDI4736, AZD8701, Non Small cell Lung cancer, ccRenal Cancer, TNBC, first time in human, PD-L1, T regulatory cells, FOXP3

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Model Description
This is a Phase I, FIH, multicentre, open-label, multiple arm study. Dose-escalation will occur with AZD8701 in monotherapy and in combination with durvalumab in selected participants with HNSCC, TNBC, NSCLC, ccRCC, gastroesophgeal cancer, melanoma, cervical cancer, small-cell lung cancer and/or participants with solid tumours who have demonstrated a response to prior PD-(L)1 treatment. Disease specific expansions will occur with a selected dose of AZD8701 in participants with NSCLC and with a selected dose of AZD8701 and durvalumab in participants with TNBC and clear cell RCC.
Masking
None (Open Label)
Masking Description
Open Label
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Monotherapy
Arm Type
Experimental
Arm Description
Participants will receive AZD8701 intravenously, on Day 1, 3, 5 and 8 and then weekly for a maximum of 2 years.
Arm Title
Combination Therapy
Arm Type
Experimental
Arm Description
Participants will receive AZD8701 (intravenously, on Day 1, 3, 5 and 8 and then weekly) and durvalumab (MEDI4736) intravenously monthly for a maximum of 2 years.
Intervention Type
Drug
Intervention Name(s)
AZD8701
Intervention Description
FOXP3 antisense oligonucleotide
Intervention Type
Biological
Intervention Name(s)
Durvalumab
Other Intervention Name(s)
MEDI4736
Intervention Description
anti PDL-1 monoclonal antibody
Primary Outcome Measure Information:
Title
Maximum Tolerated dose (or optimal dose or maximum feasible dose) and RP2D of AZD8701 as monotherapy and in combination with Durvalumab assessed through evaluation of AEs and SAEs
Description
Determined according to Incidence and treatment related AEs and SAEs
Time Frame
From screening until 105 days after last dose of study treatment
Title
Maximum Tolerated dose (or optimal dose or maximum feasible dose) and RP2D of AZD8701 as monotherapy and in combination with Durvalumab assessed through evaluation of Dose Limiting Toxicities (DLTs)
Description
Determined according to Incidence of DLTs (during the first 28 day cycle)
Time Frame
First 28 day cycle
Title
Maximum Tolerated dose (or optimal dose or maximum feasible dose) and RP2D of AZD8701 as monotherapy and in combination with Durvalumab assessed through evaluation of vital signs and abnormal laboratory parameters
Description
Determined according to Incidence of abnormal vital signs and laboratory parameters
Time Frame
From screening until 105 days after last dose of study treatment
Title
Incidence of AEs and SAEs related to AZD8701 as monotherapy and in combination with Durvalumab in disease specific expansions treated at the MTD/OBD/MFD
Description
Safety and tolerability of the MTD/OBD/MFD assessed through incidence of AEs and SAEs
Time Frame
From screening until 105 days after last dose of study treatment
Title
Objective Response Rate according to RECIST 1.1 by investigator assessment in disease specific expansions treated at the MTD/OB/MFD
Description
The proportion of subjects achieving a confirmed complete or partial response according to RECIST 1.1 by investigator assessment
Time Frame
Every 8 weeks (first 48 weeks) and then every 12 weeks from start of treatment until the earlier of progression, death, start of subsequent anti-cancer therapy or end of study (for max 42 months)
Secondary Outcome Measure Information:
Title
Progression-free survival according to RECIST 1.1 by investigator assessment
Description
Time from start of study treatment to the date of objective disease progression or death (by any cause in the absence of progression)
Time Frame
every 8 weeks (first 48 weeks) and then every 12 weeks from start of treatment until the earlier of progression, death or end of study (for max 42 months)
Title
Duration of Response according to RECIST 1.1 by investigator assessment
Description
Time from first documented response (that is subsequently confirmed) to the date of objective disease progression or death (by any cause in the absence of progression)
Time Frame
every 8 weeks (first 48 weeks) and then every 12 weeks from start of treatment until the earlier of progression, death or end of study (for max 42 months)
Title
Disease Control Rate at 16 weeks according to RECIST 1.1 by investigator assessment
Description
The proportion of subjects with a best response of CR or PR in the first 16 weeks or SD for at least 16 weeks according to RECIST 1.1 by investigator assessment
Time Frame
Every 8 weeks from start of treatment until earlier of progression, death or start of subsequent anti-cancer therapy (for up to 24 weeks). Subjects followed to 24 weeks for assessment of SD for 16 weeks from first tumour assessment at 8 weeks
Title
Time to Response according to RECIST 1.1 by investigator assessment
Description
Time from the start of study treatment until the date of first documented response (which is subsequently confirmed)
Time Frame
Every 8 weeks (first 48 weeks) and then every 12 weeks from start of treatment until the earlier of progression, death or end of study (for max 42 months)
Title
Best percentage change in tumour size according to RECIST 1.1 by investigator assessment
Description
Best percentage change from baseline in sum of the diameters of target lesions
Time Frame
Every 8 weeks (first 48 weeks) and then every 12 weeks from start of treatment until the earlier of progression, death, start of subsequent anti-cancer therapy or end of study (for max 42 months)
Title
Overall Survival at 18 months
Description
The survival rate of subjects at 18 months from start of treatment
Time Frame
From start of treatment until the earlier of death or end of study (for max of 42 months). Each subject is followed for a minimum of 18 months and the landmark OS rate at 18 months will be estimated using a Kaplan-Meier analysis
Title
Maximum concentration (Cmax) of AZD8701 in plasma when administered as monotherapy and in combination with Durvalumab
Description
Maximum concentration (Cmax) of AZD8701 in plasma
Time Frame
Cycle 1: Day 1, 2, 3, 5, 8. Cycle 2: Day 1, 22, 23. Cycle 3 & 4: Day 1 and at 105 day follow up (up to 28 months)
Title
Time to maximum concentration (tmax) of AZD8701 in plasma when administered as monotherapy and in combination with Durvalumab
Description
Time to maximum concentration (tmax) of AZD8701 in plasma
Time Frame
Cycle 1: Day 1, 2, 3, 5, 8. Cycle 2: Day 1, 22, 23. Cycle 3 & 4: Day 1 and at 105 day follow up (up to 28 months)
Title
Exposure to AZD8701 through measurement of area under the curve (AUC) in plasma when administered as monotherapy and in combination with Durvalumab
Description
Exposure to AZD8701 through measurement of area under the curve (AUC) in plasma
Time Frame
Cycle 1: Day 1, 2, 3, 5, 8. Cycle 2: Day 1, 22, 23. Cycle 3 & 4: Day 1 and at 105 day follow up (up to 28 months)
Title
Maximum concentration (Cmax) of AZD8701 in urine when administered as monotherapy and in combination with Durvalumab
Description
Maximum concentration (Cmax) of AZD8701 in urine
Time Frame
Cycle 1: Day 1, 2. Cycle 2: Day 22, 23 (up to 2 months)
Title
Time to maximum concentration (tmax) of AZD8701 in urine when administered as monotherapy and in combination with Durvalumab
Description
Time to maximum concentration (tmax) of AZD8701 in urine
Time Frame
Cycle 1: Day 1, 2. Cycle 2: Day 22, 23 (up to 2 months)
Title
Exposure to AZD8701 through measurement of area under the curve (AUC) in urine when administered as monotherapy and in combination with Durvalumab
Description
Exposure to AZD8701 through measurement of area under the curve (AUC) in urine
Time Frame
Cycle 1: Day 1, 2. Cycle 2: Day 22, 23 (up to 2 months)
Title
Urine concentrations of AZD8701 to assess renal clearance when administered as monotherapy and in combination with Durvalumab
Description
Urine samples will be collected to assess urine concentrations of AZD8701 at a series of timepoints to derive renal clearance
Time Frame
Cycle 1: Day 1, 2. Cycle 2: Day 22, 23 (up to 2 months)
Title
Maximum concentration (Cmax) of Durvalumab in serum when administered in combination with AZD8701
Description
Maximum concentration (Cmax) of Durvalumab in serum
Time Frame
Cycle 1, 2, 3, 4 on Day 1 and 105 follow up (up to 28 months)
Title
Minimum concentration (Cmin) of Durvalumab in serum when administered in combination with AZD8701
Description
Minimum concentration (Cmin) of Durvalumab in serum
Time Frame
Cycle 1, 2, 3, 4 on Day 1 and 105 follow up (up to 28 months)
Title
Change in FOXP3 mRNA expression
Description
Percentage change in FOXP3 mRNA expression from pre-treatment (baseline) to post treatment
Time Frame
From day 1 to day 29

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
101 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The study is comprised of 2 main parts Monotherapy (AZD8701) and Combined Therapy (AZD8701 and Durvalumab). Inclusion criteria Dose escalation stages: Histological or cytological confirmation of a solid, malignant tumour including HNSCC, TNBC, NSCLC, ccRCC, gastroesophageal cancer, melanoma, cervical cancer, SCLC, and/or participants with other solid tumours who have demonstrated a response to prior anti-PD-(L)1 treatment Participant with progressive disease that is refractory to standard therapies or for which no standard therapies exist and a clinical trial is the best option for next treatment based on prior response and/or tolerability to standard of care Inclusion Criteria Dose Expansions: Non Small Lung Cancer Participants who have received prior PD(L)1 treatment. Clear Cell Renal Cancer Participants who have not received prior PD(L)1 treatment. Triple negative Breast Cancer participants who have who have not received prior PD(L)1 treatment. General inclusion criteria: Must be 18 year old at the time of screening Body weight > 35 kg Male and Female participants of childbearing potential must use effective methods of contraception Capable of giving signed informed consent ECOG performance status of 0 to 1 A serum albumin > 30g/L Life expectancy of > 12 weeks At least 1 lesion, that qualifies as a RECIST 1.1 target lesion at baseline. Tumour assessment by CT scan or MRI must be performed within 28 days prior to treatment. Participants must provide a new or previous tumour sample Adequate organ system functions Exclusion Criteria: A condition that, in the opinion of the Investigator, would interfere with evaluation of the study intervention or interpretation of participant safety or study results History of allogeneic organ transplantation. Active or prior documented autoimmune or inflammatory disorders Uncontrolled intercurrent illness Significant cardiac disease History of another primary malignancy except for Malignancy treated with curative intent and with no known active disease ≥ 5 years non-melanoma skin cancer Adequately treated carcinoma in situ without evidence of disease. Participant with previous or confirmed Covid 19 diagnosis requiring significant medical intervention Current clinical signs and symptoms consistent with COVID-19 or confirmed current infection by appropriate laboratory test within the last 4 weeks prior to screening Any major unresolved toxicity from previous anticancer therapy Known allergy or hypersensitivity to any of the study interventions or any of the study intervention excipients. Prior/Concomitant Therapy Receipt of the last dose of anticancer therapy within 5 half-lives or ≤ 21 days prior to the first dose of study Prior treatment with potential Treg depletion therapies including agents targeting OX40 or CD357 (GITR) for 90 days prior to enrolment on study. Participants who have received prior anti-PD-1, anti-PD-L1, or anti-CTLA-4: Must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy. All AEs while receiving prior immunotherapy must have completely resolved or resolved to baseline Must not have experienced a ≥ Grade 3 imAE or a neurologic or ocular imAE of any grade while receiving prior immunotherapy. Must not have required the use of additional immunosuppression other than corticosteroids for the management of an AE Current or prior use of immunosuppressive medication within 14 days before the first dose of study drug. b. The following are exceptions to this criterion: Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra-articular injection). Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication) Any concurrent chemotherapy, investigational product, biologic, or hormonal therapy for cancer treatment Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study intervention. Major surgical procedure within 28 days prior to the first dose Participants receiving anticoagulation therapy with vitamin K antagonists (eg warfarin) Participation in another clinical study with study intervention administered in the last 30 days Female participants who are pregnant or breastfeeding or male and female participants of reproductive potential who are not willing to employ effective birth control
Facility Information:
Facility Name
Research Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Research Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Research Site
City
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28078
Country
United States
Facility Name
Research Site
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37067
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Research Site
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Research Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Research Site
City
Rennes
ZIP/Postal Code
35042
Country
France
Facility Name
Research Site
City
Villejuif Cedex
ZIP/Postal Code
94805
Country
France
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Research Site
City
L'Hospitalet de Llobregat
ZIP/Postal Code
08907
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28027
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28041
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
IPD Sharing Time Frame
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD Sharing Access Criteria
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD Sharing URL
https://astrazenecagroup-dt.pharmacm.com/DT/Home
Citations:
PubMed Identifier
35387780
Citation
Revenko A, Carnevalli LS, Sinclair C, Johnson B, Peter A, Taylor M, Hettrick L, Chapman M, Klein S, Solanki A, Gattis D, Watt A, Hughes AM, Magiera L, Kar G, Ireland L, Mele DA, Sah V, Singh M, Walton J, Mairesse M, King M, Edbrooke M, Lyne P, Barry ST, Fawell S, Goldberg FW, MacLeod AR. Direct targeting of FOXP3 in Tregs with AZD8701, a novel antisense oligonucleotide to relieve immunosuppression in cancer. J Immunother Cancer. 2022 Apr;10(4):e003892. doi: 10.1136/jitc-2021-003892.
Results Reference
derived
Links:
URL
http://BreastCancerStudyLocator.com
Description
Related Info

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First Time in Human Study of AZD8701 With or Without Durvalumab in Participants With Advanced Solid Tumours

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