Phase 2 Endometrial 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 are willing and able to sign a consent form before any study activities begin.
• People aged 18 or older.
• Cohort 3 (advanced prostate cancer group) is open to men only; all other groups have no gender restriction.
• People with advanced solid tumours who fit into one of the following groups:
  • Cohort 1: People with recurring or spreading head and neck squamous cell cancer (including nasopharyngeal cancer) that has been confirmed by lab testing and has continued to grow after receiving standard treatment that included a PD-1/PD-L1 immunotherapy drug.
  • Cohort 2: People with confirmed advanced cancer of the urinary tract (bladder, kidney pelvis, ureter, or urethra) that cannot be treated with surgery and has continued to grow after standard treatment that included a PD-1/PD-L1 immunotherapy drug.
  • Cohort 3: Men with confirmed metastatic castration-resistant prostate cancer (not of a neuroendocrine or small cell type) that has spread to other parts of the body (confirmed by scans), has progressed on at least one second-generation hormone-blocking drug (such as abiraterone, enzalutamide, or apalutamide), is still progressing at the time of screening, and where testosterone levels are at castration levels due to ongoing hormone therapy or prior surgical removal of the testicles.
  • Cohort 4: People with confirmed extensive-stage small cell lung cancer that has progressed after first-line standard treatment.
  • Cohort 5a: People with confirmed locally advanced or spreading non-small cell lung cancer who have previously used and become resistant to EGFR-targeting drugs, and whose cancer has progressed on standard treatment.
  • Cohort 5b: People with confirmed locally advanced or spreading non-small cell lung cancer with no identified driver gene mutations, whose cancer has progressed on standard treatment that included a PD-1/PD-L1 immunotherapy drug.
  • Cohort 6: People with other advanced solid tumours not covered by the above groups, whose cancer has progressed on standard treatment. For recurring or spreading cervical cancer, it must be confirmed as squamous cell cancer by lab testing, have progressed after standard systemic treatment, and not be suitable for curative treatment.
• For people whose cancer progressed while on a PD-1/PD-L1 immunotherapy drug: the person must have received at least 2 doses of an approved PD-1/PD-L1 drug, and there must be documented evidence on scans that the cancer continued to grow after starting that treatment.
• People who are able to provide tumour tissue samples (either previously stored or freshly collected) and blood samples for research testing, where possible.
• People with a life expectancy of at least 3 months.
• People who have at least one tumour that can be measured on scans, according to standard criteria (RECIST 1.1).
• People with a good general level of physical functioning, rated 0 or 1 on a standard scale used by doctors (ECOG scale — broadly meaning someone is fully active or restricted in strenuous activity but able to carry out light work).
• People whose major organs (such as liver, kidneys, and bone marrow) are functioning adequately.
• Women who could become pregnant, and men, who agree to use effective contraception during the study and for 6 months after the last dose.

Who may not be able to join:

• People in Cohort 1 whose cancer has been confirmed as neuroendocrine carcinoma, small cell carcinoma, salivary gland cancer, other non-squamous cell types (such as adenocarcinoma or sarcoma), or squamous cell cancer with an unknown primary origin (this does not apply to nasopharyngeal cancer).
• People in Cohort 3 who have serious bone damage from cancer spread to the bones — including severe uncontrolled bone pain, bone fractures, or spinal cord compression that happened in the last 6 months or is expected soon — or who have previously received any treatment targeting certain immune system pathways (T-cell co-stimulation or checkpoint pathways).
• People in Cohort 5 who have previously received treatments targeting T-cell immune pathways other than PD-1/PD-L1 drugs, or (for Cohort 5a only) who have other targetable gene changes in addition to EGFR, such as ALK, ROS1, or BRAFV600E mutations.
• People who previously stopped a PD-1, PD-L1, PD-L2, or similar immunotherapy drug because of a severe immune-related side effect (Grade 3 or higher).
• People who have previously been treated with an EZH2 or EZH1/2 inhibitor drug (such as tazemetostat).
• People who are known to be allergic to the study drug or any of its ingredients, or who have had a severe allergic reaction to another monoclonal antibody treatment in the past.
• People who have received anti-cancer treatments (including chemotherapy, immunotherapy, targeted therapy, major radiotherapy, or surgery) within 4 weeks or 5 half-lives of the drug (whichever is shorter) before the first study dose, or palliative radiotherapy within 2 weeks before the first dose.
• People who have taken part in another clinical trial of an anti-cancer treatment within 28 days before the first study dose.
• People who have had major surgery within 4 weeks before starting the study, or who are expected to need major surgery during the study (minor procedures such as biopsies are generally acceptable).
• People who have had a bone marrow transplant from a donor or a solid organ transplant.
• People who have needed systemic treatment with corticosteroids at doses above 10 mg of prednisone (or equivalent) per day, or other immune-suppressing medications, within 14 days before starting the study drug. Low-dose inhaled or topical steroids, or hormone replacement for adrenal or pituitary conditions, may be acceptable.
• People who have taken moderate or strong medications that affect a liver enzyme called CYP3A4 within 14 days before the first dose (confirm specific medications with the trial site).
• People who have received a live vaccine (including live-attenuated vaccines) within 28 days before starting the study drug. Non-live (inactivated) vaccines are generally permitted.
• People who still have unresolved side effects from previous cancer treatment that have not reduced to a mild level (Grade 1 or lower), except for certain effects the doctor considers unlikely to affect safety (such as hair loss).
• People who have been diagnosed with another cancer within the past 3 years that has not been considered clinically cured. Some exceptions apply, including certain skin cancers treated locally and considered cured, early-stage bladder cancer, cervical cancer in situ, breast ductal cancer in situ, and papillary thyroid cancer.
• People who have active, symptomatic cancer spread to the brain or central nervous system. People with stable brain metastases may be eligible (confirm with trial site).
• People with an active autoimmune disease that has required systemic treatment (such as disease-modifying drugs, steroids, or immune-suppressing medications) within the past 2 years. Hormone replacement therapies (such as thyroid hormone or insulin) are not considered systemic treatments for this purpose.
• People who have a history of, or currently have, non-infectious lung inflammation (pneumonitis or interstitial lung disease) that required steroid treatment, or a history of radiation-related lung inflammation.
• People with serious psychiatric conditions that would make it difficult to participate in the study.
• People with an active infection requiring systemic (whole-body) treatment.
• People currently being treated for tuberculosis.
• People with a known history of HIV, or a positive test for syphilis antibodies.
• People with active hepatitis B or hepatitis C infection, as defined by specific blood test results (confirm details with the trial site).
• People with a history of a type of blood cancer called T-cell lymphoblastic lymphoma or T-cell lymphoblastic leukaemia.
• People with a history of certain bone marrow disorders, including myelodysplastic syndrome (MDS), or abnormal blood test results suggesting MDS or related bone marrow conditions.
• People who are pregnant or breastfeeding.

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