What side effects are associated with this type of intervention?

Common treatments for Pancreatic Adenocarcinoma, such as FOLFIRINOX and gemcitabine plus cisplatin, are associated with several side effects. FOLFIRINOX can cause neutropenia, fatigue, nausea, vomiting, diarrhea, and peripheral neuropathy. Gemcitabine plus cisplatin may lead to myelosuppression, renal toxicity, and gastrointestinal disturbances. PARP inhibitors, used for patients with BRCA or PALB2 mutations, can cause anemia, fatigue, nausea, and increased risk of infections. These treatments aim to manage the disease but come with significant adverse effects that need to be monitored and managed by healthcare providers.

What prior FDA approvals exist?

The FDA has approved several treatments for Pancreatic Adenocarcinoma, primarily focusing on chemotherapy and targeted therapies. Notable approvals include gemcitabine, often used in combination with nab-paclitaxel, and FOLFIRINOX, a regimen that includes leucovorin, fluorouracil, oxaliplatin, and irinotecan. Additionally, treatments targeting specific genetic mutations, such as PARP inhibitors for patients with BRCA mutations, have also been approved. While specific FDA-approved treatments targeting CLDN18.2 are not mentioned, ongoing research like the AZD0901 trial aims to explore new targeted therapies for advanced solid tumors expressing CLDN18.2.

What other types of research exist?

Promising novel alternatives to AZD0901 for Pancreatic Adenocarcinoma patients include: 1) AZD1152-HQPA, which enhances the effectiveness of oxaliplatin and gemcitabine, 2) AZM475271, which shows significant antitumor and antimetastatic activity when combined with gemcitabine, and 3) NSC1892, which targets the CUL4A-DDB1 interaction and inhibits colorectal cancer cell growth, potentially applicable to pancreatic cancer.

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Monoclonal Antibodies

AZD0901 for Stomach Cancer

Phase 2

Recruiting

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant must be ≥ 18 years or the legal age of consent at the time of signing the ICF

Advanced or metastatic GC/GEJC (Sub study 1 specific)

Must not have

Central nervous system metastases or CNS pathology

Peripheral neuropathy ≥ Grade 2 at screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of first dose of azd0901 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years).

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing AZD0901, a new drug, in patients with advanced gastric esophageal cancer and pancreatic cancer. The drug targets a specific protein on cancer cells to help the immune system attack them.

Who is the study for?

Adults with advanced stomach or gastroesophageal cancers that express CLDN18.2 can join this trial. They must have a measurable tumor, be in good physical condition, and expected to live at least 12 weeks. Participants should not have severe neuropathy, active ulcers or bleeding, lung inflammation history, brain metastases, certain heart risks or other cancers.

What is being tested?

AZD0901 is being tested alone and with cancer drugs like Nanoliposomal Irinotecan and Gemcitabine for safety and effectiveness against tumors expressing CLDN18.2. The study will also look at how the body processes these drugs and if they cause immune reactions.

What are the potential side effects?

Potential side effects include typical chemotherapy-related issues such as nausea, fatigue, diarrhea, low blood counts leading to increased infection risk or bleeding tendencies; nerve damage symptoms; allergic reactions; and possibly liver function changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older, or at the legal age of consent.

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My cancer is advanced or has spread beyond the stomach or gastroesophageal junction.

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I have been diagnosed with advanced pancreatic cancer.

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My cancer is CLDN18.2 positive.

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I weigh more than 35 kilograms.

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My cancer is a type of stomach or gastroesophageal junction cancer.

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I haven't received treatments for my cancer that can't be surgically removed or has spread.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has spread to my brain.

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I do not have moderate or severe numbness, tingling, or pain in my hands or feet.

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I do not have active stomach ulcers or recent serious bleeding in my digestive tract.

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I have been treated with a drug that delivers chemotherapy directly to the cancer cells before.

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I need regular draining for fluid buildup in my abdomen.

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I have had another type of cancer.

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I have not been treated with CLDN18.2 targeted agents, except for anti-CLDN18.2 monoclonal antibody.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of first dose of azd0901 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of first dose of azd0901 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years).

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of first dose of azd0901 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of adverse events (AEs), serious AEs (SAEs). Changes from baseline in clinical laboratory parameters, vital signs, ECGs and physical examination. Rate of AEs leading to discontinuation of AZD0901, Occurrence of DLTs.

Objective Response Rate (ORR).

Secondary study objectives

ADA status will be determined along with prevalence and incidence of anti-drug antibodies to AZD0901, and titer established.

Clinical activity by baseline and/or on-treatment tissue-based biomarkers including, but not limited to, gene expression, mutation profiles, DNA damage, protein expression, immune response and/or mechanisms of resistance.

Disease control rate (DCR)

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Sub Study 2 - AZD0901 IN COMBINATION WITH ANTI-CANCER AGENTSExperimental Treatment7 Interventions

Substudy 2 will investigate the safety and efficacy of AZD0901 as first line systemic treatment used in combination with different chemotherapy agents

Group II: Sub Study 1 - AZD0901 MONOTHERAPYExperimental Treatment1 Intervention

Sub Study 1 will investigate AZD0901 monotherapy in order to evaluate the safety, tolerability, and efficacy of AZD0901.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

5-Fluorouracil

2012

Completed Phase 3

~7800

Irinotecan

2017

Completed Phase 3

~2590

Gemcitabine

2017

Completed Phase 3

~1920

l-leucovorin

2017

Completed Phase 3

~440

Leucovorin

2005

Completed Phase 4

~6010

Nanoliposomal Irinotecan

2019

Completed Phase 1

~50

0 / 14Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Pancreatic Adenocarcinoma include platinum-based chemotherapies like FOLFIRINOX and gemcitabine plus cisplatin, which work by causing DNA damage that cancer cells cannot repair, leading to cell death. PARP inhibitors are used for patients with BRCA or PALB2 mutations and prevent cancer cells from repairing DNA damage, thereby enhancing the effects of chemotherapy. Immune checkpoint inhibitors, such as anti-PD-1 or anti-CTLA-4 antibodies, help the immune system recognize and attack cancer cells. These treatments are crucial as they target the cancer cells' ability to grow and survive. The trial AZD0901 focuses on targeting and inhibiting CLDN18.2, a protein expressed in some pancreatic cancers, which could provide a more specific and potentially effective treatment option by directly targeting cancer cells expressing this protein.

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