First in Human Study of AZD9592 in Solid Tumors

NCT05647122
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Phase
Phase 1
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Recruitment status
Active, not recruiting
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Participants
167
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Lead sponsor
AstraZeneca
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Start date
2022-12-21
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Number of sites
46
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Summary
This is a first-in-human (FIH) Phase I, multi-center, open-label, study of AZD9592, in patients with advanced solid tumors. The study consists of several study modules, each evaluating the safety, tolerability, preliminary efficacy, pharmacokinetics (PK), pharmacodynamics, anti-tumor activity, and immunogenicity of AZD9592, as monotherapy or in combination with anti-cancer agents.
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Acronym
EGRET
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Short title
First in Human Study of AZD9592 in Solid Tumors
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Official title
A Phase I, Multicenter, Open-label, First-in-Human, Dose Escalation and Expansion Study of AZD9592 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumors
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Active, not recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2028-08-03
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First posted
2022-12-12
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Registry last updated
2026-06-11
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Primary completion date
2028-08-03
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Start date
2022-12-21
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Actual participants
167
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Participants
167
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Participant count basis
Actual
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Protocol amendments
6
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Number of sites
46
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
AstraZeneca
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05647122
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ClinicalTrials.gov ID
NCT05647122
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Registry record
Open registry record
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Allocation
Not randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Incidence of Adverse Events (AEs)

    Timeframe: From time of Informed Consent to 30 days post last dose of AZD9592

    Number of patients with adverse events by system organ class and preferred term

  2. Incidence of Serious Adverse Events (SAEs)

    Timeframe: From time of Informed Consent to 30 days post last dose of AZD9592

    Number of patients with serious adverse events by system organ class and preferred term

  3. Incidence of dose-limiting toxicities (DLT) as defined in the protocol

    Timeframe: From time of first dose of AZD9592 to end of DLT period (approximately 21 days)

    Number of patients with at least 1 dose-limiting toxicity (DLT), which is any toxicity defined as a DLT in the Clinical Study Protocol

  4. Incidence of baseline laboratory finding, ECG and vital signs changes

    Timeframe: From time of Informed Consent to 30 days post last dose of AZD9592

    measured by laboratory and vital sign variables over time including change from baseline

  5. Proportion of patients with radiological response (ORR)

    Timeframe: From date of first dose of AZD9592 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)

    Assessed by overall response rate (ORR) defined as the proportion of patients who have a confirmed complete or partial radiological response by the Investigator according to RECIST v1.1 (for patients in the dose expansion cohorts, only)

  1. Objective Response Rate (ORR)

    Timeframe: From date of first dose of AZD9592 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)

    The percentage or number of patients with a confirmed investigator assessed complete or partial response according to response criteria in solid tumours (RECIST v1.1)

  2. Duration of Response (DoR)

    Timeframe: From date of first dose of AZD9592 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)

    The time from date of first response until date of disease progression or last evaluable assessment (RECIST v1.1) in the absence of progression

  3. Disease Control Rate (DCR) at 12 weeks

    Timeframe: From date of first dose of AZD9592 up until progression, or the last evaluable assessment in the absence of progression (for each patient this is expected to be measured at 12 weeks)

    The percentage of patients with confirmed CR or PR or having SD maintained (RECIST v1.1) for \>=11 weeks from first dose

  4. Progression free Survival (PFS)

    Timeframe: From date of first dose of AZD9592 up until date of progression or death due to any cause (approximately 2 years)

    The time from first dose until RECIST 1.1 defined disease progression or death due to any cause

  5. Overall Survival (OS)

    Timeframe: From date of first dose of AZD9592 up until the date of death due to any cause (approximately 2 years)

    The time from the date of the first dose of study treatment until death due to any cause.

  6. Pharmacokinetics of AZD9592: Plasma PK concentrations

    Timeframe: From date of first dose of AZD9592 up until 30 days post last dose

    Measurement of plasma concentrations of AZD9592, total antibody and total unconjugated warhead

  7. Pharmacokinetics of AZD9592: Area under the concentration time curve (AUC)

    Timeframe: From date of first dose of AZD9592 up until 30 days post last dose

    Measurement of PK parameters: Area under the concentration time curve (AUC)

  8. Pharmacokinetics of AZD9592: Maximum plasma concentration of the study drug (C-max)

    Timeframe: From date of first dose of AZD9592 up until 30 days post last dose

    Measurement of PK parameters: Maximum observed plasma concentration of the study drug (C-max)

  9. Pharmacokinetics of AZD9592: Time to maximum plasma concentration of the study drug (T-max)

    Timeframe: From date of first dose of AZD9592 up until 30 days post last dose

    Measurement of PK parameters: Time to maximum observed plasma concentration of the study drug (T-max)

  10. Pharmacokinetics of AZD9592: Clearance

    Timeframe: From date of first dose of AZD9592 up until 30 days post last dose

    Measurement of PK parameters: the volume of plasma from which the study drug is completely removed per unit time (Clearance)

  11. Pharmacokinetics of AZD9592: Half-life

    Timeframe: From date of first dose of AZD9592 up until 30 days post last dose

    Measurement of PK parameters: Terminal elimination half-life (t 1/2)

  12. Immunogenicity of AZD9592: Anti-Drug Antibodies (ADA)

    Timeframe: From date of first dose of AZD9592 up until 30 days post last dose

    Evaluating the number and percentage of patients who develop Anti-drug antibody (ADA) during treatment

Sources for outcomes
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Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

Key Inclusion Criteria:

  • Age ≥ 18 years
  • Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1
  • Life expectancy ≥ 12 weeks
  • Measurable disease per RECIST v1.1
  • Adequate organ and marrow function as defined in the protocol

Additional Inclusion Criteria for Module 1:

• Histologically or cytologically confirmed metastatic or locally advanced EGFRmut., NSCLC; metastatic EGFRwt. NSCLC; recurrent or metastatic HNSCC of the oral cavity; metastatic CRC.

Additional Inclusion Criteria for Module 2:

• Histologically or cytologically confirmed metastatic NSCLC EGFRmut.

Additional Inclusion Criteria for Module 3:

• Histologically or cytologically confirmed metastatic CRC.

Key Exclusion Criteria:

  • 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.
  • Spinal cord compression or a history of leptomeningeal carcinomatosis.
  • Active infection including tuberculosis and HBV, HCV or HIV
  • Brain metastases unless treated (prior treatment required only for Module 1), asymptomatic, stable, and not requiring continuous corticosteroids at a dose of > 10 mg prednisone/day or equivalent for at least 2 weeks prior to start of study treatment.
  • Participants with cardiac comorbidities as defined in the study protocol
Sources for eligibility
clinicaltrials.gov

  • Research SiteDuarte, United States
  • Research SiteNorth Haven, United States
  • Research SiteWashington D.C., United States
  • Research SiteChicago, United States
  • Research SiteBaltimore, United States
  • Research SiteBaltimore, United States
  • Research SiteMilford, United States
  • Research SiteMineola, United States
  • Research SiteNew York, United States
  • Research SiteNew York, United States
  • Research SiteNew York, United States
  • Research SitePhiladelphia, United States
  • Research SiteProvidence, United States
  • Research SiteHouston, United States
  • Research SiteFairfax, United States
  • Research SiteKogarah, Australia
  • Research SiteMelbourne, Australia
  • Research SiteEdmonton, Canada
  • Research SiteToronto, Canada
  • Research SiteBeijing, China
  • Research SiteChongqing, China
  • Research SiteGuangzhou, China
  • Research SiteWuhan, China
  • Research SiteMarseille, France
  • Research SiteRennes, France

And 21 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Other registry identifiers

  • 2022-501570-18-00
Sources for references
clinicaltrials.gov

Related records

Drugs (4)

Lead sponsors (1)

Conditions (3)

Targets (3)