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New drug AZD9592 enters first human trials for tough cancers

NCT ID NCT05647122

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial tests an experimental drug called AZD9592, alone or with other cancer drugs, in about 167 adults with advanced solid tumors (including lung, head & neck, and colorectal cancers). The main goals are to check safety, find the right dose, and see if the drug shrinks tumors. Because it is a first-in-human study, the results will help decide if larger trials should move forward.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AZD9592 (an experimental drug given intravenously)
What this could lead to
If it works, this could point toward a new treatment option for people with advanced solid tumors that have not responded to other therapies.
What could go wrong
This is a very early (Phase 1) trial with only 167 participants, so the drug may not be effective or could cause unexpected side effects. It is not yet known if AZD9592 will work better than existing treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

167 people

The number who actually took part.

Started

Dec 2022

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal carcinoma colorectal neoplasm head and neck neoplasm Head and Neck Neoplasms head and neck squamous cell carcinoma neoplasm non-small cell lung carcinoma oral cavity squamous cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced solid tumours Carcinoma, non-small-cell lung Colorectal neoplasms Head and neck neoplasms

Contacts and locations

Locations

  • Research Site

    Duarte, California, 91010, United States

  • Research Site

    North Haven, Connecticut, 06473, United States

  • Research Site

    Washington D.C., District of Columbia, 20016, United States

  • Research Site

    Chicago, Illinois, 60637, United States

  • Research Site

    Baltimore, Maryland, 21224, United States

  • Research Site

    Baltimore, Maryland, 21231, United States

  • Research Site

    Milford, Massachusetts, 01757, United States

  • Research Site

    Mineola, New York, 11501, United States

  • Research Site

    New York, New York, 10016, United States

  • Research Site

    New York, New York, 10021, United States

  • Research Site

    New York, New York, 10029, United States

  • Research Site

    Philadelphia, Pennsylvania, 19104, United States

  • Research Site

    Providence, Rhode Island, 02903, United States

  • Research Site

    Houston, Texas, 77030, United States

  • Research Site

    Fairfax, Virginia, 22031, United States

  • Research Site

    Kogarah, 2217, Australia

  • Research Site

    Melbourne, 3000, Australia

  • Research Site

    Edmonton, Alberta, T6G 1Z2, Canada

  • Research Site

    Toronto, Ontario, M5G 1X6, Canada

  • Research Site

    Beijing, 100142, China

  • Research Site

    Chongqing, 400030, China

  • Research Site

    Guangzhou, 510100, China

  • Research Site

    Wuhan, 430022, China

  • Research Site

    Marseille, 13385, France

  • Research Site

    Rennes, 35000, France

  • Research Site

    Villejuif, 94805, France

  • Research Site

    Milan, 20162, Italy

  • Research Site

    Orbassano, 10043, Italy

  • Research Site

    Rozzano, 20089, Italy

  • Research Site

    Verona, 37134, Italy

  • Research Site

    Chūōku, 104-0045, Japan

  • Research Site

    Kashiwa, 277-8577, Japan

  • Research Site

    Kōtoku, 135-8550, Japan

  • Research Site

    Kuala Lumpur, 59100, Malaysia

  • Research Site

    Kuching, 93586, Malaysia

  • Research Site

    Seoul, 03080, South Korea

  • Research Site

    Seoul, 03722, South Korea

  • Research Site

    Seoul, 05505, South Korea

  • Research Site

    Seoul, 06351, South Korea

  • Research Site

    Barcelona, 8035, Spain

  • Research Site

    Madrid, 28040, Spain

  • Research Site

    Seville, 41013, Spain

  • Research Site

    Taichung, 40705, Taiwan

  • Research Site

    Taipei, 10002, Taiwan

  • Research Site

    Taipei, 11217, Taiwan

  • Research Site

    Taoyuan, 333, Taiwan

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