Phase 2 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 given written consent to participate (or whose legal representative has done so) before the screening process begins.
• People whose general physical functioning is rated at 0 or 1 on a standard oncology scale (meaning they are fully active or have minor restrictions), and who are expected to live for at least 3 months.
• People whose cancer has at least one area that can be measured using standard imaging criteria (confirm with trial site for details on which scans are accepted).
• People whose blood, liver, and kidney test results fall within acceptable ranges — including adequate blood cell counts, liver enzyme levels, kidney function, and clotting levels — without having needed a blood transfusion or growth factor support in the 14 days before screening.
• People who use highly effective contraception (methods with less than 1% failure rate per year), where there is a risk of conception.

For the dose escalation phase only, people also need to meet this criterion:

• People with a confirmed advanced or metastatic solid tumour that cannot be surgically removed, and that has stopped responding to standard treatments, cannot be tolerated, or for which no standard treatment exists.

For the dose expansion phase only, people also need to meet these criteria:

• People with a confirmed diagnosis of relapsed or treatment-resistant, advanced or metastatic non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), or oesophageal squamous cell carcinoma (ESCC), who have received at least one prior systemic treatment including an anti-PD-1 or anti-PD-L1 therapy.
• People whose tumour has been tested and has a measurable level of a protein called PD-L1.

For the NSCLC group specifically:

• People with confirmed stage IV squamous or non-squamous NSCLC whose tumour shows PD-L1 expression at a level called TPS ≥ 1%, and who do not have certain specific genetic mutations or rearrangements (including EGFR, ALK, ROS1, BRAF V600E, MET, NTRK1/2/3, or RET) (confirm details with trial site).

For the HNSCC group specifically:

• People with confirmed squamous cell carcinoma of the head and neck (excluding nasopharynx), whose cancer has not responded to or cannot tolerate platinum-based chemotherapy or chemoradiation, and whose tumour shows a PD-L1 score called CPS ≥ 1.

For the ESCC group specifically:

• People with confirmed squamous cell carcinoma of the oesophagus whose tumour shows a PD-L1 CPS score ≥ 1.

Who may not be able to join:

• People who have received cancer treatment or experimental drugs within 28 days (or within 5 half-lives of the drug, whichever is shorter) before starting the trial — with the exception of radiotherapy aimed at relieving bone pain.
• People who have had major surgery within 28 days before starting the trial (routine diagnostic biopsies are excluded from this rule).
• People who still have significant side effects from previous cancer treatments that have not sufficiently resolved, with the exception of hair loss or mild nerve-related symptoms.
• People who previously had to stop an immunotherapy treatment because of an immune-related side effect of any severity.
• People who have had another cancer diagnosis within the past 2 years, other than certain treated skin cancers, superficial bladder cancer, or very early-stage cervical or breast cancer.
• People with active cancer spread to the lining of the brain or spinal cord, or with untreated, uncontrolled brain metastases. People with previously treated and currently stable brain metastases may be considered if they meet specific additional conditions (confirm with trial site).
• People who have had an organ transplant, including bone marrow or stem cell transplants.
• People with a known positive HIV diagnosis or AIDS, untreated or unstable hepatitis B, or active hepatitis C. People with treated and stable hepatitis B or C may be considered under certain conditions (confirm with trial site).
• People with an active or historical autoimmune disease that could return — though people with Type 1 diabetes, vitiligo, psoriasis, or thyroid conditions that do not require immune-suppressing treatment may still be considered.
• People with known severe allergic reactions to monoclonal antibody treatments.
• People who are pregnant or breastfeeding. A negative pregnancy test is required for people who could become pregnant.
• People with known alcohol or drug dependence.
• People with significant, active heart or blood vessel conditions — including stroke or heart attack within the past 6 months, unstable chest pain, certain levels of heart failure, or serious uncontrolled heart rhythm problems requiring medication.
• People with a psychiatric condition that would prevent them from understanding or agreeing to participate in the trial.
• People who have received a live vaccine within 28 days before starting the trial, or who would need one during the trial.
• People with any other significant health condition that, in the treating doctor's opinion, could affect their ability to tolerate the trial treatment.

For the dose expansion phase only:

• People who have previously received a treatment that is a PD-L1 x CD137 bispecific antibody.

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