AZD0901 for Stomach Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment called AZD0901 for individuals with certain types of advanced cancers. The study evaluates the safety and effectiveness of AZD0901, both alone and in combination with other cancer treatments. The trial includes three groups: one for stomach cancer, one for pancreatic cancer, and one for biliary tract cancer. Individuals with advanced or metastatic cancer who have specific markers, such as CLDN18.2, and have undergone limited previous treatments might be suitable candidates for this trial. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group, providing access to potentially effective new therapies.
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.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that AZD0901, when used alone, has a safety profile that patients with advanced stomach or esophagus cancer can handle well. Most patients managed the treatment without major issues, and while some side effects occurred, they were manageable.
In studies where AZD0901 was combined with other cancer drugs, patients also experienced manageable side effects. This suggests that the treatment is generally well-tolerated when used with other therapies.
For those considering joining a trial with AZD0901, these findings offer some reassurance about its safety. However, as with any treatment, individual reactions may vary, so discussing potential risks with a healthcare provider is important.12345Why are researchers excited about this trial's treatments?
AZD0901 is unique because it offers a new approach to treating cancers like stomach, pancreatic, and biliary tract cancer by potentially enhancing the effectiveness of existing chemotherapy agents or working on its own. Unlike standard treatments that often focus on killing cancer cells directly, AZD0901 may work by targeting specific pathways that help cancer cells grow and survive, potentially leading to better outcomes. Researchers are excited because this could mean more effective treatment options with fewer side effects, giving patients a better quality of life.
What evidence suggests that this trial's treatments could be effective for stomach cancer?
Research has shown that AZD0901 targets a protein called Claudin 18.2, often found in stomach cancer cells. Early results suggest this could help stop tumor growth. Studies on similar treatments, such as the drug CMG901, have shown promising results in shrinking tumors in patients with advanced stomach cancer. These findings offer hope that AZD0901 might also effectively treat stomach cancer, as it works similarly. While more information is needed, these early signs are encouraging for those seeking new treatment options.12678
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive AZD0901 monotherapy or in combination with anti-cancer agents
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term Follow-up
Participants are monitored for progression-free survival and overall survival
What Are the Treatments Tested in This Trial?
Interventions
- AZD0901
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.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Substudy 3 Further evaluate the preliminary anti-tumour activity of AZD0901 monotherapy by assessment of DRR.
Substudy 2 will investigate the safety and efficacy of AZD0901 as first line systemic treatment used in combination with different chemotherapy agents
Sub Study 1 will investigate AZD0901 monotherapy in order to evaluate the safety, tolerability, and efficacy of AZD0901.
Find a Clinic Near You
Who Is Running the Clinical Trial?
AstraZeneca
Lead Sponsor
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
Citations
CLARITY-Gastric 01: A randomized phase 3 study of ...
All efficacy endpoints will assess the selected AZD0901 dose arm versus Arm 3. Safety and tolerability will be assessed in all pts who receive ≥ ...
Claudin 18.2-targeting antibody-drug conjugate CMG901 ...
CMG901 showed a manageable safety profile and had promising antitumour activity in patients with advanced gastric or gastro-oesophageal junction cancer.
Study Details | NCT06219941 | AZD0901 in Participants ...
The purpose of this study is to assess the safety, tolerability, efficacy, pharmacokinetics (PK), and immunogenicity of AZD0901 as monotherapy and in ...
Claudin 18.2-targeting antibody–drug conjugate CMG901 ...
CMG901 showed a manageable safety profile and had promising antitumour activity in patients with advanced gastric or gastro-oesophageal junction cancer.
AZD0901 in participants with advanced solid tumours ...
The purpose of this study is to assess the safety, tolerability, efficacy, pharmacokinetics (PK), and immunogenicity of AZD0901 as monotherapy and in ...
CLARITY-PanTumor01: A phase 2 trial of the claudin 18.2- ...
Here we describe an ongoing, Phase 2 study of AZD0901 in patients with CLDN18.2-expressing advanced solid tumors, including G/GEJ cancer and PDAC.
ANZCTR - Registration
To investigate the safety and tolerability, of AZD0901 monotherapy or in combination with anti-cancer agents in particpants with advanced or metastatic solid ...
CMG901, a Claudin18.2-specific antibody-drug conjugate ...
CMG901 is a Claudin18.2-specific ADC. CMG901 kills tumor cells via direct cytotoxicity, ADCC, CDC, and bystander killing effects.
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