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Testing AZD9592 in patients with advanced solid tumors

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

Phase 1 Interventional AstraZeneca · NCT05647122

This study is testing a new drug called AZD9592 to see if it can safely help people with advanced solid tumors, either on its own or with other cancer treatments.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment403 (estimated)
Ages18 Years and up
SexAll
SponsorAstraZeneca Industry-sponsored
Drugs / interventionsprednisone
Locations51 sites (Duarte, California and 50 other locations)
Trial IDNCT05647122 on ClinicalTrials.gov

What this trial studies

This is a first-in-human Phase I study evaluating the safety and efficacy of AZD9592 in patients with advanced solid tumors. The study will assess the drug's tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity, both as a standalone treatment and in combination with other anti-cancer agents. Participants will be enrolled based on specific cancer types and will undergo various assessments throughout the trial.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with specific types of advanced solid tumors, such as non-small cell lung cancer or colorectal cancer.

Not a fit: Patients with certain pre-existing conditions, such as active infections or significant lung issues, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors.

How similar studies have performed: Other studies involving antibody drug conjugates have shown promise, suggesting potential for success in this novel approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 4 weeks prior to start of study treatment.
* Participants with cardiac comorbidities as defined in the study protocol

Where this trial is running

Duarte, California and 50 other locations

+1 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Advanced Solid TumoursCarcinoma Non-small Cell LungHead and Neck NeoplasmsColorectal NeoplasmsCancerFirst in HumanAntibody Drug ConjugateSolid Tumour
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.