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:

• People who have been confirmed (by lab testing of tissue or cells) to have a solid tumour that has spread to other parts of the body or cannot be surgically removed, and where standard curative treatment is no longer an option.
• People who are able to provide a fresh tumour tissue sample taken at or around the time of joining the trial, if it is safe and possible to do so.
• People whose tumour can be biopsied (sampled with a needle or small procedure), if safe and possible.
• People whose cancer can be measured using standard imaging scans (following a system called RECIST 1.1).
• People who are generally well enough to carry out everyday activities, with only minor limitations (scored 0 or 1 on a standard fitness scale called ECOG).
• People who are expected to live for at least 12 weeks, as judged by the investigating doctor.
• People whose heart is pumping well enough, with a specific heart function measurement (called LVEF) of at least 50%, confirmed by a heart scan.
• People whose liver, kidneys, and other organs are functioning at an adequate level (confirm specific thresholds with the trial site).
• People with certain specific cancer types may be eligible for particular groups (called cohorts) within the trial, including:
  • People with head and neck squamous cell cancer (HNSCC) of the oropharynx, oral cavity, hypopharynx, or larynx who have previously received certain treatments (note: some of these groups are closed to new enrolment — confirm current status with the trial site).
  • People with metastatic colorectal cancer (mCRC) whose tumour does not carry certain genetic mutations (in KRAS, NRAS, BRAF, or EGFR) and does not show HER2 amplification, and whose tumour is classified as microsatellite stable (MSS), may be eligible for certain open cohorts (confirm with trial site).

Who may not be able to join:

• People who have cancer that has spread to the brain and is either untreated, causing symptoms, or requiring radiation, surgery, or steroid medication within the 14 days before joining.
• People whose cancer has spread to the lining surrounding the brain and spinal cord (leptomeningeal involvement).
• People who have taken part in another clinical trial or received an experimental drug within the 4 weeks before joining.
• People who have received systemic cancer treatment within 4 weeks (or within 5 half-lives of the drug, whichever is shorter) before the first dose; for certain chemotherapy drugs or immunotherapy, a longer wait of 6 weeks is required.
• People who need to take medicines that suppress the immune system, such as methotrexate or cyclophosphamide.
• People who have had major surgery or radiation treatment within 3 weeks before the first dose, or who have previously received radiation covering 25% or more of the bone marrow at any time.
• People who still have significant ongoing side effects (grade 2 or higher) from previous cancer treatments, with the exception of hair loss or mild stable nerve-related symptoms.
• People who have had a serious allergic reaction to the trial drug (petosemtamab) or to human proteins, or to any other required treatment in this trial.
• People with poorly controlled high blood pressure (above 150/100 mmHg) or unstable chest pain (unstable angina).
• People with a history of moderate-to-severe heart failure (Class II–IV on a standard scale), or a serious irregular heart rhythm requiring treatment (certain types of irregular heart rhythm may still be eligible — confirm with the trial site).
• People who have had a heart attack within the 6 months before joining.
• People who have had another cancer in the past, unless it was a type of early-stage cervical cell change, a non-melanoma skin cancer, or a cancer that was treated with the aim of cure and has shown no signs of returning for at least 3 years.
• People who are currently short of breath at rest for any reason, or who need continuous oxygen.
• People who have a history of lung inflammation or scarring (such as pneumonitis or pulmonary fibrosis), or whose baseline chest scan shows signs of this condition.
• People with serious ongoing illnesses, including uncontrolled infections, or significant lung, metabolic, or psychiatric conditions.
• People with active hepatitis B infection who are not receiving antiviral treatment, or people who test positive for active hepatitis C infection.
• People who are pregnant or breastfeeding; people who could become pregnant must use highly effective contraception before joining, throughout the trial, and for 6 months after the last dose of the trial drug.

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