AZD0901 for Stomach Cancer

Recruiting in Palo Alto (17 mi)

+37 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: AstraZeneca

Must not be taking: QT prolonging drugs, CYP3A4 inhibitors

Disqualifiers: Peptic ulcer, CNS metastases, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications, but it does mention that certain medications, like those that prolong the QT/QTc interval or affect specific enzymes, may not be allowed. It's best to discuss your current medications with the trial team to see if any adjustments are needed.

Research Team

Eligibility Criteria

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.

Inclusion Criteria

I have had no more than 2 treatments for my cancer that cannot be surgically removed.

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

My organs and bone marrow are working well.

Exclusion Criteria

My cancer has spread to my brain.

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

I have conditions that could affect my heart's rhythm.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive AZD0901 monotherapy or in combination with anti-cancer agents

11 weeks

Regular visits for treatment administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

90 days

Long-term Follow-up

Participants are monitored for progression-free survival and overall survival

Approximately 2 years

Treatment Details

Interventions

• AZD0901 (Monoclonal Antibodies)

Trial Overview 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.

Participant Groups

Group I: Sub Study 3: AZD0901 MONOTHERAPY IN BILIARY TRACT CANCER Experimental Treatment 1 Intervention

Substudy 3 Further evaluate the preliminary anti-tumour activity of AZD0901 monotherapy by assessment of DRR.

Group II: Sub Study 2 - AZD0901 IN COMBINATION WITH ANTI-CANCER AGENTS IN PANCREATIC DUCTAL ADENOCARCINOMA Experimental Treatment 7 Interventions

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

Group III: Sub Study 1 - AZD0901 MONOTHERAPY Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology