Phase 1 Oesophageal Cancer Trial, Recruiting

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

Who might be able to join this trial:

• People who have been diagnosed (confirmed by tissue or cell testing) with advanced stomach, gastroesophageal junction, or esophageal cancer that cannot be surgically removed or has spread, and the cancer is either adenocarcinoma or squamous cell carcinoma type.
• People whose cancer can be measured or tracked using standard imaging guidelines (RECIST 1.1).
• People who have a tumour area that can be safely biopsied for research purposes (this requirement may be waived by the lead doctor after discussion with the treating doctor).
• People with adenocarcinoma who have had their HER2 status (a protein marker on cancer cells) tested before joining; results from an approved local laboratory are acceptable.
• For the dose escalation phase: people whose cancer has been confirmed as HER2 negative.
• For the dose expansion phase: people whose cancer is either HER2 positive or HER2 negative (separate groups will be enrolled for each).
• People who have not had prior systemic (whole-body) treatment for their unresectable or advanced stomach, gastroesophageal junction, or esophageal cancer, with the following exceptions allowed:
  • Pre- or post-surgery systemic therapy is allowed, provided surgery and any chemotherapy finished more than 3 months before the planned first treatment day.
  • Up to two prior cycles of a chemotherapy regimen called FOLFOX are allowed.
  • Prior chemoradiation given with curative intent is allowed if it finished more than 3 months before the planned first treatment day.
  • Prior palliative radiation (including to the brain) is allowed if the last treatment was more than 10 days before the planned first treatment day.
• People aged 18 or older.
• People who are generally well enough to carry out normal daily activities, rated as ECOG 0 or 1 (fully active or restricted in strenuous activity only).
• People whose blood counts and organ function meet specific minimum levels, including white blood cells, platelets, haemoglobin, liver function markers, blood clotting measurements, and kidney function (confirm specific values with the trial site).
• People whose muscle enzyme level (CPK) is not significantly elevated at screening (below a certain threshold — confirm with trial site).
• People taking a cholesterol-lowering statin medication who have been on a stable dose for at least 3 weeks before starting the study.
• For one specific expansion group only: people whose heart pumping function (measured by a heart scan) is above the lower limit of normal.
• People of childbearing potential (both women and men) who agree to use reliable contraception throughout the study and for 3 months after finishing; women who become pregnant or suspect pregnancy must inform their treating doctor immediately.
• People who are able to understand the study and are willing to sign a written consent form (or whose legal representative can do so on their behalf).

Who may not be able to join:

• People currently using or planning to use alternative, holistic, naturopathic, or herbal/botanical treatments for cancer purposes (use of medical marijuana is permitted).
• People with a history of another cancer, unless all treatment for that cancer was completed at least 2 years before enrolment with no signs of disease remaining, or unless the other cancer is a slow-growing type that does not require treatment and is unlikely to affect the management of their stomach, gastroesophageal junction, or esophageal cancer.
• People who have previously had an organ or stem cell transplant from a donor.
• People currently receiving any other experimental treatment (investigational imaging tracers are allowed with a 7-day gap).
• People who currently have a stent (a tube used to keep a passage open) inside their digestive tract — for example in the stomach, oesophagus, small bowel, or colon (biliary stents in the bile duct are allowed).
• People with a history of significant bleeding from their tumour(s), such as bleeding that required a blood transfusion or more than one procedure to stop the bleeding.
• People with an untreated ulcerating (open-sore) tumour; people who have had the ulcer treated by a scope procedure may still be considered — the lead doctor will assess eligibility.
• People who have recently used blood-thinning medications (including daily low-dose aspirin), anti-platelet drugs (such as clopidogrel or prasugrel), or anti-inflammatory painkillers (NSAIDs) — specific timing restrictions apply based on each drug (confirm with trial site).
• People with active brain metastases (cancer spread to the brain) that have not been treated; treated and symptom-free brain metastases may be allowed at the lead doctor's discretion, provided brain radiation was completed more than 10 days before the planned first treatment day.
• People with a history of severe allergic reactions to drugs similar in makeup to the study drugs (CA-4948, FOLFOX, nivolumab, trastuzumab, or other agents used in the study).
• People currently taking medications known to cause a specific type of irregular heartbeat (prolonged QTc or Torsades de Pointes), or people with a personal history of risk factors for that condition.
• People with moderate to severe lung inflammation (interstitial lung disease or pneumonitis graded 2 or higher).
• People who have received a live vaccine within 30 days before enrolment.
• People whose heart's electrical activity (QTc interval, measured on an ECG) is above a certain threshold at screening.
• People with a digestive condition that would prevent them from properly absorbing or swallowing the study drug CA-4948.
• People with uncontrolled ongoing illness, including active infection, certain heart conditions such as heart failure, unstable chest pain, or heart rhythm problems.
• People who are pregnant or breastfeeding; women of childbearing potential must have a negative pregnancy test within 7 days of starting the study.
• People living with HIV whose CD4+ immune cell count is below 350 cells/mcL, or who have had a serious HIV-related infection in the past 12 months; people with well-controlled HIV may be considered, though certain HIV medications may interact with study drugs (confirm with trial site).
• People with active or suspected autoimmune disease (some mild or stable autoimmune conditions may be permitted after discussion with the lead doctor — confirm with trial site).
• People who have required regular steroid tablets or other immune-suppressing medications (above a low threshold dose) within 14 days of starting the study, with some exceptions for short courses or inhaled/topical forms (confirm with trial site).
• People who are unwilling to follow the lifestyle guidance outlined in the study protocol.

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