Phase 2 Stomach Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

All participants must meet these general criteria:

• People who have at least one tumour lesion that has not been previously treated with radiation and can be safely biopsied, or who have an archived tumour tissue sample taken within the last 6 months after their cancer worsened on their most recent treatment
• Adults aged 18 or older
• People who have at least one tumour that can be measured on a CT or MRI scan
• People whose cancer has been confirmed by scans to have grown or spread after receiving a previous standard treatment
• People who are relatively well and able to carry out daily activities with little or no limitation (as assessed by a standard medical scoring system)

People with endometrial cancer (EC) may also need to meet these criteria:

• A confirmed diagnosis of endometrial cancer of any type, including carcinosarcoma, regardless of certain tumour genetic markers
• Cancer that has returned or worsened after receiving both platinum-based chemotherapy and an immune checkpoint inhibitor therapy (given together or one after the other), with no more than 3 prior treatment courses overall (confirm with trial site)

People with head and neck squamous cell cancer (HNSCC) may also need to meet these criteria:

• A confirmed diagnosis of inoperable or metastatic squamous cell cancer of the mouth, throat, voice box, or lower throat — not including certain other head and neck locations
• Cancer that has worsened after platinum-based and immune checkpoint inhibitor treatment, with no more than 2 prior treatment courses in total
• No imaging evidence of cancer growing into or tightly surrounding a major blood vessel
• No history of severe (Grade 3 or higher) bleeding related to their head and neck cancer in the 28 days before starting the study
• A documented result for a protein marker called p16 (for throat cancers involving the oropharynx)

People with pancreatic cancer (PDAC) may also need to meet these criteria:

• A confirmed diagnosis of inoperable or metastatic pancreatic adenocarcinoma that has worsened after one course of gemcitabine-based treatment, or after two courses if targeted therapy was also received
• No previous treatment with a class of drugs called topoisomerase I inhibitors (such as irinotecan or topotecan)

People with colorectal cancer (CRC) may also need to meet these criteria:

• A confirmed diagnosis of inoperable or metastatic colorectal cancer with a specific genetic marker called microsatellite stable (MSS)
• Cancer that has worsened after one or two prior treatment courses (depending on whether targeted therapy was also received), including specific chemotherapy regimens
• No previous treatment with topoisomerase I inhibitors (such as irinotecan or topotecan)

People with liver cancer (HCC) may also need to meet these criteria:

• A confirmed diagnosis of inoperable or metastatic liver cancer (certain subtypes are not eligible — confirm with trial site), or a non-invasive diagnosis meeting specific liver disease guidelines
• Cancer that has worsened after one course of immune checkpoint inhibitor therapy (up to two prior courses total)
• Cancer classified as Stage B or C under a specific liver cancer staging system
• Liver function meeting specific medical thresholds (confirm with trial site)
• Specific blood test results within 7 days before the first dose (confirm with trial site)
• People with large swollen veins in the oesophagus at risk of bleeding must have already received standard medical treatment for this

People with oesophageal, stomach junction, or gastric cancer (Ad-eso/GEJ/Gastric) may also need to meet these criteria:

• A confirmed diagnosis of inoperable or metastatic cancer of this type that has worsened after one prior treatment course; people with certain tumour markers may also need to have received immune checkpoint inhibitor therapy if that is standard care in their country
• People with a known HER2-positive tumour, or another specific actionable genetic change, must have already received a targeted therapy

People with urothelial cancer (UC — bladder, kidney, ureter, or urethra) may also need to meet these criteria:

• A confirmed diagnosis of inoperable or metastatic urothelial cancer where urothelial cells are the main cancer type (certain subtypes are not allowed)
• Cancer that has worsened after at least one course of immune checkpoint inhibitor therapy and one course of chemotherapy, with no more than 3 prior treatment courses total; in countries where a drug called enfortumab vedotin is approved and available, at least one prior treatment course must have included it

People with cervical cancer (CC) may also need to meet these criteria:

• A confirmed diagnosis of inoperable or metastatic cervical cancer that has been treated with at least one prior course of systemic therapy; people with actionable genetic changes must have already received targeted therapy
• Prior treatment with specific immunotherapy and/or another targeted drug must have been received if those are standard care in the person's country, unless they were not suitable for those treatments

People with ovarian, primary peritoneal, or fallopian tube cancer (OVC) may also need to meet these criteria:

• A confirmed diagnosis of a specific high-grade type of ovarian, peritoneal, or fallopian tube cancer previously treated with at least one platinum-based treatment course and a drug called bevacizumab (unless not suitable for bevacizumab)
• The treating doctor considers platinum-based therapy no longer appropriate, or the cancer has worsened within 180 days of the last platinum treatment
• The cancer did not fail to respond to platinum treatment from the very beginning, and did not worsen during or within 4 weeks of completing platinum treatment

People with bile duct or gallbladder cancer (BTC) may also need to meet these criteria:

• A confirmed diagnosis of inoperable or metastatic bile duct cancer (inside or outside the liver) or gallbladder cancer
• Cancer that has worsened after at least one (or two, if targeted therapy was also received) prior treatment course
• The cancer must not be one of several specific subtypes that are not allowed in this trial (confirm with trial site)

People with HER2-low breast cancer may also need to meet these criteria:

• A confirmed diagnosis of inoperable or metastatic breast cancer
• Tumour testing showing low levels of a protein called HER2 (as defined by specific laboratory testing standards)
• Cancer that has worsened after treatment with a drug called trastuzumab deruxtecan (T-DXd)
• Cancer that has worsened after at least 2 but no more than 3 prior treatment courses overall

People with HER2-negative (IHC 0) breast cancer may also need to meet these criteria:

• A confirmed diagnosis of inoperable or metastatic breast cancer
• Tumour testing showing no detectable HER2 protein (as defined by specific laboratory testing standards)
• Cancer that has worsened after at least 2 but no more than 3 prior treatment courses overall

People with skin (cutaneous) melanoma may also need to meet these criteria:

• A confirmed diagnosis of cutaneous melanoma (including acral and non-acral types)
• Cancer that has worsened during or after at least one course of immune checkpoint inhibitor therapy; people with a specific BRAF gene change or other actionable mutation must also have had disease worsening on targeted therapy

Who may not be able to join:

• People who have previously been treated with specific drugs targeting a protein called B7-H3 (including orlotamab, enoblituzumab, or a drug called I-DXd)
• People who had to stop a specific type of cancer drug (called an antibody-drug conjugate containing an exatecan derivative, such as trastuzumab deruxtecan) because of serious side effects from that treatment
• People who have active, symptomatic, or untreated cancer that has spread to the brain or spinal cord, or who need steroids or anti-seizure medicines to manage symptoms from brain or spinal cord involvement
• People who have not waited long enough after their most recent cancer treatment before joining the trial (the required waiting period is defined in the trial protocol — confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.