AZD0901 Monotherapy Compared With Investigator’s Choice of Therapy in Advanced/Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

What is the Purpose of this Study?

The purpose of this study is to evaluate the effectiveness and safety of an experimental drug called AZD0901 compared to a standard therapy selected by the participant’s study doctor (per their disease status) and to better understand the patient’s disease and associated health problems. AZD0901 is a type of drug known as an antibody drug conjugate (ADC). ADCs are a type of targeted therapy that deliver anti-cancer drugs directly to cancer cells. AZD0901 recognizes cancer cells by a specific protein called Claudin 18.2, which is one of the proteins that is expressed on the surface of gastric cancer cells. AZD0901 binds to Claudin 18.2 on the cancer cell surface and is taken into the cell, where it releases the anti-cancer drug to stop the cell from reproducing and causes the cancer cell to die.   Participants will be randomly assigned to a treatment group; one group will be given AZD0901, and the other will be given a standard therapy selected by the study doctor per disease status.

Eligibility

1. Capable of giving signed informed consent prior to any study procedure.
2. Participant must be at least 18 years or the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the ICF.
3. Histologically confirmed unresectable, locally advanced or metastatic adenocarcinoma of gastric, GEJ, or distal esophagus (distal third of the esophagus) and the following requirement:

Inclusion Criteria:

1. Capable of giving signed informed consent prior to any study procedure.
2. Participant must be at least 18 years or the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the ICF.
3. Histologically confirmed unresectable, locally advanced or metastatic adenocarcinoma of gastric, GEJ, or distal esophagus (distal third of the esophagus) and the following requirement:
(a) Participants with positive CLDN18.2 expression from archival tumor collected within past 24 months or from a fresh biopsy.
4. Disease progression on or after at least one prior line of treatment (LoT) for advanced or metastatic disease, which included a fluoropyrimidine and a platinum, for advanced or metastatic disease.
5. Must have at least one measurable or evaluable lesion assessed by the Investigator based on RECIST 1.1.
6. ECOG performance status of 0 or 1 with no deterioration over the previous 2 weeks prior to baseline or day of first dosing.
7. Predicted life expectancy of ≥ 12 weeks.
8. Adequate organ and bone marrow function
9. Body weight of ≥ 35 kg.
10. Sex and Contraceptive Requirements

Exclusion Criteria:

1. Participants with known HER2 positive status as defined as IHC 3+ or IHC 2+/ISH + (Cases with HER2: CEP17 ratio ≥ 2 or an average HER2 copy number ≥ 6.0 signals/cell are considered positive by ISH). Participants must undergo local (or have had) HER2 testing by IHC/ISH, and the most recent result of HER2 status will be used to determine the eligibility.
2. Participant has significant or unstable gastric bleeding and/or untreated gastric ulcers.
3. CNS metastases or CNS pathology including: epilepsy, seizures or aphasia within 3 months prior to consent, severe brain injury, dementia, Parkinson's disease, neurodegenerative diseases, cerebellar disease, severe uncontrolled mental illness, psychosis, CNS involvement of autoimmune diseases.
4. Participant has known clinically significant corneal disease (eg, active keratitis or corneal ulcerations).
5. Persistent toxicities (CTCAE Grade ≥ 2) caused by previous anticancer therapy, excluding alopecia. Participants with irreversible toxicity that is not reasonably expected to be exacerbated by study intervention may be included (eg, hearing loss).
6. Prior exposure to any ADC with MMAE payload or any CLDN18.2 targeting treatment other than naked monoclonal antibody (eg, CLDN18.2 targeting CAR-T cell therapy, multi-specific antibody including targeting CLDN18.2, etc).
7. History of thromboembolic events:
1. Participants with venous thromboembolism within the past 6 months prior to randomization: participants with venous port or catheter thrombosis or superficial venous thrombus that do not require treatment or are stable on treatment with anticoagulants are excepted
2. History of arterial thromboembolism within the past 12 months prior to randomization
8. As judged by the Investigator, any evidence of diseases which in the Investigator's opinion, makes it undesirable for the participant to participate in the study or that would jeopardize compliance with the protocol.

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Where can I participate?

CS Cancer at Beverly Hills : Abrahm Levi
CS Cancer at Cedars-Sinai Medical Center : Abrahm Levi
Hunt Cancer Institute, an Affiliate of Cedars-Sinai Cancer

More about this Clinical Trial

What is the full name of this clinical trial?

D9802C00001: A Phase III Multi-center, Open-label, Sponsor-blinded, Randomized Study of AZD0901 Monotherapy Compared with Investigator's Choice of Therapy in Second- or Later-Line Adult Participants with Advanced/Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Claudin18.2

Study Details

Disease Type/Condition

Other Digestive Organ

Principal Investigator

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Gong, Jun

Co-Investigators

Andrew Hendifar, Andrew Horodner, Arsen Osipov, David Chan, David Hoffman, Hugo Hool, Jeremy Lorber, Justin Wayne Tiulim, Kamya Sankar, Kevin Scher, Swati Sikaria, Syed Jilani, Thomas Lowe, Vanessa Dickey

Age Group

Adult

Phase

III

IRB Number

STUDY00003567

ClinicalTrials.gov ID

NCT06346392

Key Eligibility

ClinicalTrials.gov

How do I learn more about this study?

Name

Abrahm Levi

Abrahm.Levi@cshs.org