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 are willing to take part voluntarily and sign a consent form
• People who are 18 years of age or older at the time of signing the consent form
• People who have been confirmed by tissue or cell testing to have advanced or metastatic solid tumours, and whose cancer has continued to grow after previous standard treatments — or for whom no standard treatment is available, who cannot tolerate standard treatment, or who have declined standard treatment
• For the early phase (Phase Ib): People with advanced, recurrent, or hard-to-treat solid tumours, which may include the cancer types listed in the later phase
• For the main phase (Phase II), eligibility depends on the specific treatment group and cancer type:
  • Lung cancer group (Cohort 1): People with confirmed advanced or metastatic non-small cell lung cancer (NSCLC) who are being considered for second- or third-line treatment, and who have already received a type of immunotherapy (anti-PD-(L)1) and a platinum-based chemotherapy combination
  • Endometrial cancer group (Cohort 2): People with confirmed recurrent or metastatic endometrial cancer who have received at least one round of platinum-based chemotherapy and at least one immune checkpoint therapy
  • Other solid tumours group (Cohort 3): People with confirmed advanced solid tumours who have not responded to, cannot tolerate, or have no access to standard treatment
  • Ovarian cancer group (Cohort 4): People with confirmed recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer — either those whose cancer progressed after prior treatment with Olaparib (and who have not received further treatment since), or those with platinum-resistant or platinum-refractory disease who have not previously received Olaparib and have had no more than three treatment lines since developing platinum resistance
  • Small cell lung cancer group (Cohort 5): People with confirmed small cell lung cancer (SCLC) whose cancer has progressed after platinum-based chemotherapy combined with immunotherapy, or people with extensive-stage SCLC whose cancer returned or progressed within six months of completing first-line treatment
• People who have at least one tumour that can be measured using standard imaging criteria (RECIST v1.1)
• People who are able to provide enough tumour tissue for testing — either a fresh sample (preferred) or a preserved tissue sample collected within approximately the past 24 months
• People who are in reasonably good general health, rated 0 or 1 on the ECOG performance scale (meaning fully active or able to carry out light activity) within 7 days before starting the study drug
• People with an expected survival of at least 12 weeks
• People who are able to swallow tablets whole
• People whose blood counts, liver function, kidney function, and heart function fall within the ranges specified by the trial (confirmed by blood tests taken within 7 days before the first dose, without recent blood transfusions or growth factor injections)
• Women who could become pregnant must use an approved form of contraception during the trial and for 6 months after the last dose, must have a negative pregnancy blood test within 72 hours before the first dose, and must not be breastfeeding
• Men with a partner who could become pregnant must use effective contraception during the trial and for 3 months after the last dose

Who may not be able to join:

• People with primary brain or spinal tumours, active or uncontrolled brain metastases, spinal cord compression, or cancer spread to the membranes around the brain — although people with treated and stable brain metastases for at least 4 weeks, or with very small symptom-free brain metastases under 1 cm without swelling, may be considered (confirm with trial site)
• People who have had major surgery, radiation, chemotherapy, or another experimental anti-cancer treatment less than 4 weeks before the first dose (shorter windows may apply for some treatments — confirm with trial site)
• People who have taken certain strong medications known to interfere with how the study drug is processed by the body within 14 days before the first dose (including some antifungals, antibiotics, anti-seizure medications, HIV medications, and even grapefruit juice — confirm the full list with the trial site)
• People who still have significant side effects (Grade 2 or higher) from previous cancer treatment that have not resolved, except for hair loss, skin discolouration, or certain blood test abnormalities that still meet the trial's entry requirements
• People who are unable to swallow tablets or have digestive conditions that might affect how the study drug is absorbed
• People with poorly controlled high blood pressure (above 150/100 mmHg)
• People who have had a serious heart-related event within the past 6 months, such as a heart attack, unstable chest pain, stroke, or significant heart failure
• People with certain heart rhythm problems or abnormal heart electrical activity measurements
• People with an unexplained fever of 38.5°C or higher, or an active infection requiring treatment with medication, within 14 days before the first dose
• People with active hepatitis B or C infection at levels requiring treatment (eligible people with hepatitis B or C who require antiviral therapy may still be considered — confirm with trial site)
• People with active syphilis
• People with active tuberculosis
• People with immune system conditions such as HIV, a congenital or acquired immune deficiency, or a history of organ transplantation
• People with poorly controlled diabetes (fasting blood sugar above 10 mmol/L)
• People with uncontrolled fluid build-up around the lungs, heart, or abdomen, or who have needed drainage for recurring abdominal fluid in the 28 days before the first dose
• People who have had significant bleeding or a strong tendency to bleed within the past 3 months
• People who have been taking high-dose corticosteroids (more than the equivalent of 10 mg prednisone per day) or immune-suppressing medications within the past 14 days
• People with an active autoimmune disease that has required systemic treatment within the past 2 years — this applies specifically to the Phase Ib group and the Phase II immunotherapy combination group (confirm with trial site)
• People with a known severe allergy to any of the study drugs or their ingredients
• People who have had another cancer diagnosis within the past 3 years, except for certain cured skin cancers, early-stage cervical changes, or a type of thyroid cancer that has been successfully treated
• People who experienced a severe (Grade 3 or higher) immune-related side effect during previous immunotherapy, or who had to permanently stop immunotherapy because of immune-related side effects
• People who have previously been treated with TCC1727 or similar experimental drugs targeting the same biological pathways (including ATR, ATM, WEE1, or CHK1/CHK2 inhibitors)
• People with other serious physical or mental health conditions that the trial investigators consider would make participation unsafe or affect the results
• Additional exclusions that apply to specific groups:
  • Lung cancer group (Cohort 1): People whose NSCLC has certain known gene changes (EGFR, ALK, ROS1, BRAF, MET, RET, or RAS mutations), or whose tumour is a mixed NSCLC/SCLC type
  • Endometrial cancer group (Cohort 2): People with certain less common uterine cancer subtypes (uterine carcinosarcoma, endometrial leiomyosarcoma, or endometrial stromal sarcoma)
  • Other solid tumours group (Cohort 3): People whose tumours have certain gene mutations (KRAS, NRAS, or BRAF) or a characteristic called MSI-H (high microsatellite instability)
  • Ovarian cancer group (Cohort 4) and the Olaparib combination group in Phase Ib: People with a history of a blood or bone marrow condition called myelodysplastic syndrome or acute myeloid leukaemia

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