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Monoclonal Antibodies

Sub Study 1 - AZD0901 MONOTHERAPY for Pancreatic Adenocarcinoma

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)

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

Study Summary

This trial aims to test the safety, effectiveness, and how well the drug AZD0901 works alone or when combined with other cancer treatments in patients with advanced or spreading tumors that have a certain protein

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

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

Nanoliposomal Irinotecan

2019

Completed Phase 1

~50

Gemcitabine

2017

Completed Phase 3

~2070

Irinotecan

2017

Completed Phase 4

~2680

Leucovorin

2005

Completed Phase 4

~5730

l-leucovorin

2017

Completed Phase 3

~440

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor

4,271 Previous Clinical Trials

288,612,736 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are researchers currently seeking participants for this ongoing medical study?

"Indeed, according to the information available on clinicaltrials.gov, this trial is actively enrolling participants. The study was initially posted on December 13th, 2023 and underwent its most recent update on January 12th, 2024."

Answered by AI

At present, how many locations are hosting this particular clinical trial?

"This clinical trial is currently enrolling patients from a total of 26 sites. These sites are located in various cities such as Orange, Kashiwa, and Louisville, among others. If you decide to participate, it may be advantageous to choose the site closest to your location in order to minimize travel obligations."

Answered by AI

What is the current number of individuals actively involved in this medical study?

"Indeed, as per the records on clinicaltrials.gov, this ongoing clinical trial is actively seeking individuals to participate. The study was initially posted on December 13th, 2023 and last updated on January 12th, 2024. A total of 123 patients will be enrolled across a network of 26 different locations."

Answered by AI

Has the Food and Drug Administration officially granted approval for Sub Study 1 - AZD0901 MONOTHERAPY?

"Since this is a Phase 2 trial, there is limited safety data available for Sub Study 1 - AZD0901 monotherapy. Therefore, our team at Power rates its safety as a 2 on a scale of 1 to 3."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2

2023. "AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06219941.

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