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RecruitingLast updated: 2 February 2024

EGRET: This phase I study is trying to determine how safe and effective a new cancer drug (AZD9592) is alone, and in combination with targeted therapy (osimertinib), in people with advanced solid cancersA 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

Clinical summary

Summary

This dose escalation and expansion study has two modules, and each module has two parts. In Module 1, participants will receive AZD9592 as monotherapy. Module 1 Part A aims to determine how safe, tolerable and what the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of AZD9592. Module 1 Part B aims to determine how safe, tolerable and evaluate the effectiveness of AZD9592 in select solid cancers. In Module 2, participants will receive AZD9592 in combination with Osimertinib. Module 2 Part A aims to determine how safe, tolerable and what the MTD and/or RP2D of AZD9592 is when given in combination with Osimertinib. Module 2 Part B aims to determine how safe, tolerable and evaluate the effectiveness of AZD9592 is when given in combination with Osimertinib in people with EGFRm non-small cell lung cancer.

Conditions

This trial is treating patients with advanced solid cancers

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I

Trial Acronym

EGRET

More information

Trial Identifiers

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Trial sponsor

AstraZeneca

Scientific 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

Eligibility

Inclusion

  • 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.

Exclusion

  • 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 4 weeks prior to start of study treatment.
  • Participants with cardiac comorbidities as defined in the study protocol

Inclusion

  • You are able to swallow medication by mouth.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
Message

Clinical trials have complex eligibility criteria.

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