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First in Human Study to Evaluate AZD8205 in Patients With Advanced or Metastatic Solid Malignancies

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ClinicalTrials.gov Identifier: NCT05123482
Recruitment Status : Recruiting
First Posted : November 17, 2021
Last Update Posted : November 27, 2023
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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Brief Summary:
This research study is studying a new compound, AZD8205, as a possible treatment for advanced or metastatic solid tumours

Condition or disease Intervention/treatment Phase
Breast Cancer Biliary Tract Carcinoma Ovarian Cancer Endometrial Cancer Drug: AZD8205 Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 248 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: This is a first time in human (FTiH) Phase I/IIa, open-label, multi-center study of AZD8205 administered to participants with advanced or metastatic solid malignancies. The study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of AZD8205.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/IIa Multi-center, Open-label Master Protocol to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Antitumor Activity of AZD8205 in Participants With Advanced or Metastatic Solid Malignancies
Actual Study Start Date : October 18, 2021
Estimated Primary Completion Date : June 30, 2025
Estimated Study Completion Date : June 30, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Sub-Study 1 AZD8205 Monotherapy

Sub-Study 1 has two parts:

Part A : The aim is to determine the safety, tolerability, Recommended Phase 2 Dose(RP2D), and/or the Maximum Tolerated Dose (MTD) of AZD8205.

Part B: The aim of dose expansion is to evaluate anti-tumor activity of AZD8205 as monotherapy in select solid tumors.

 Drug: AZD8205
AZD8205 is an antibody drug conjugate that has the potential to treat a wide variety of solid tumors including but not limited to breast cancer, Biliary Tract Cancer, ovarian, and endometrial cancers


Outcome Measures
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Primary Outcome Measures :
  1. The number of patients with adverse events [ Time Frame: From time of Informed consent to 30 days post last dose (approximately 1 year). ]
    Number of patients with adverse events by system organ class and preferred term

  2. The number of patients with serious adverse events [ Time Frame: From time of Informed consent to 30 days post last dose (approximately 1 year) ]
    Number of patients with serious adverse events by system organ class and preferred term

  3. The number of patients with dose-limiting toxicity (DLT), as defined in the protocol. [ Time Frame: From first dose of study treatment until the end of Cycle 1 (approximately 21 days). ]
    A DLT is defined as any toxicity that occurs from the first dose of study treatment up to and including the planned end of Cycle 1 (the DLT assessment period) that is assessed as unrelated to the disease or disease-related processes under investigation and which includes pre-defined haematological and non-haematological toxicities.

  4. The number of patients with changes from baseline laboratory findings, ECGs and vital signs [ Time Frame: From time of informed consent to 30 days post last dose (approximately 1 year) ]
    Description of laboratory findings and vital signs variables over time including change from baseline.


Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: From first dose of AZD8205 to progressive disease or death in the absence of disease progression ( approx. 2 years ) ]
    The percentage of patients with a confirmed investigator assessed complete or partial response according to response criteria in solid tumours (RECIST 1.1).

  2. Duration of response (DoR) [ Time Frame: From the first documented response to confirmed progressive disease or death ( approx. 2 years ) ]
    The time from the date of first response until date of disease progression or death in the absence of disease progression.

  3. Progression free Survival (PFS) [ Time Frame: From first dose of AZD8205 to progressive disease or death in the absence of disease progression ( approx. 2 years ) ]
    The time from first dose until RECIST 1.1 defined disease progression or cessation of study treatment.

  4. Disease Control Rate at 12 weeks (DCR-12) [ Time Frame: Measured from first dose until progression. For each patient, this is expected to be at 12 weeks ]
    Percentage of patients with confirmed CR or PR or having SD maintained for >= 11 weeks from first dose.

  5. Overall Survival (OS) [ Time Frame: From first dose of AZD8205 to death ( approx. 2 years ) ]
    The time from the date of the first dose of study treatment until death due to any cause.

  6. Pharmacokinetics of AZD8205: Area Under the concentration-time curve (AUC) [ Time Frame: From the first dose of study intervention, at predefined intervals throughout the administration of AZD8205 ( approx 2 years ) ]
    Area under the plasma concentration-time curve

  7. Pharmacokinetics of AZD8205: Maximum plasma concentration of the study drug (Cmax) [ Time Frame: From the first dose of study intervention, at predefined intervals throughout the administration of AZD8205 ( approx 2 years ) ]
    Maximum observed plasma concentration of the study drug

  8. Pharmacokinetics of AZD8205: Time to maximum plasma concentration of the study drug (T-max) [ Time Frame: From the first dose of study intervention, at predefined intervals throughout the administration of AZD8205 ( approx 2 years ) ]
    Time to maximum observed plasma concentration of the study drug

  9. Pharmacokinetics of AZD8205: Clearance [ Time Frame: From the first dose of study intervention, at predefined intervals throughout the administration of AZD8205 ( approx 2 years ) ]
    A pharmacokinetic measurement of the volume of plasma from which the study drug is completely removed per unit time.

  10. Pharmacokinetics of AZD8205: Terminal elimination half-life (t 1/2) [ Time Frame: From the first dose of study intervention, at predefined intervals throughout the administration of AZD8205 ( approx 2 years ) ]
    Terminal elimination half life.

  11. Immunogenicity of AZD8205. [ Time Frame: From the first dose of study intervention, at predefined intervals throughout the administration of AZD8205 ( approx 2 years ) ]
    The number and percentage of participants who develop ADAs.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Age ≥ 18 years
  • Relapsed/metastatic solid tumors treated with prior adequate standard of care therapy for tumor type and stage of disease or where in the opinion of the Investigator, a clinical trial is the best option for the next treatment based on response and/or tolerability to prior therapy.
  • Measurable disease per RECIST v1.1
  • Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1
  • Life expectancy ≥ 12 weeks
  • Adequate organ and marrow function as defined in the protocol

For Sub-Study 1 Part A:

• Histologically or cytologically confirmed metastatic or locally advanced/recurrent breast cancer, ovarian cancer, BTC or endometrial cancer

For Sub-Study 1 Part B:

  • Histologically or cytologically confirmed metastatic or locally advanced and recurrent disease for the respective cohort:

    1. Cohort B1 (Biliary Tract Cancer)
    2. Cohort B2 (Ovarian Cancer)
    3. Cohort B3 (Breast Cancer)

    4. Cohort B4 (Endometrial Cancer)

      Exclusion Criteria:

  • Treatment with any of the following:

    1. Nitrosourea or mitomycin C within 6 weeks prior to the first dose of study treatment
    2. Any investigational agents or study drugs from a previous clinical study within 5 half-lives or 28 days (whichever is shorter) prior to the first dose of study treatment

    3. Any other anticancer treatment within the following time periods prior to the first dose of study intervention:

      1. Cytotoxic treatment: 21 days
      2. Non-cytotoxic drugs: 21 days or 5 half-lives (whichever is shorter)
      3. Biological products including immuno-oncology agents: 28 days
  • Spinal cord compression or a history of leptomeningeal carcinomatosis.
  • Brain metastases unless treated, asymptomatic, stable, and not requiring continuous corticosteroids at a dose of > 10 mg prednisone/day or equivalent for at least 4 weeks prior to start of study.
  • Active infection including tuberculosis and HBV, HCV or HIV
  • History of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
  • Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses

  • Participants with any of the following cardiac criteria:

    1. History of arrhythmia which is symptomatic or requires treatment (NCI CTCAE v5.0 Grade 3); symptomatic or uncontrolled atrial fibrillation, or asymptomatic sustained ventricular tachycardia.
    2. Uncontrolled hypertension.
    3. Acute coronary syndrome/acute myocardial infarction, unstable angina pectoris, coronary intervention procedure with percutaneous coronary intervention, or coronary artery bypass grafting within 6 months.
    4. History of brain perfusion problems (eg, carotid stenosis) or stroke, or transient ischemic attack in the last 6 months prior to screening.
    5. Symptomatic heart failure (NYHA class ≥ 2).
    6. Prior or current cardiomyopathy.
    7. Severe valvular heart disease.
    8. Mean resting QTcF > 470 msec.
    9. Risk factors for QTc prolongation or risk of arrhythmic events such as heart failure, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05123482


Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

Locations
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Sponsors and Collaborators
AstraZeneca
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT05123482    
Other Study ID Numbers: D6900C00001
2021-000736-66 ( EudraCT Number )
First Posted: November 17, 2021    Key Record Dates
Last Update Posted: November 27, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
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.
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.
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AstraZeneca:
First In Human, antibody drug conjugate, cancer, solid tumour, Phase I
Additional relevant MeSH terms:
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Endometrial Neoplasms
Neoplasms
Neoplasms by Site
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
 Urogenital Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Genital Diseases
Uterine Neoplasms
Uterine Diseases