Phase 1 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:

For the main cancer arms of the trial (Substudies 1, 2, 3 and Dose Expansion):

• People who have read and signed a consent form showing they understand the study and agree to take part before any study procedures begin.
• People aged 18 or older (or 19 or older in some locations) at the time of screening.
• People with advanced or metastatic solid tumour cancer that cannot be cured, and whose cancer has stopped responding to — or who could not tolerate — existing treatments that are known to help their condition.
• People with inactive brain metastases (stable for at least 4 weeks after surgery or radiation, with symptoms mostly resolved and no new lesions on imaging) may be eligible during the dose escalation phase (confirm with trial site).
• People joining the Triple Negative Breast Cancer (TNBC) group must have breast cancer that has been confirmed by lab testing as triple negative (meaning the cancer does not respond to oestrogen, progesterone, or a protein called HER2), and whose cancer has worsened after receiving certain standard chemotherapy treatments (such as anthracycline or taxane-based therapy), or other approved therapies if those were not suitable.
• People joining the gastric/gastroesophageal junction cancer group must have a confirmed diagnosis of stomach or junction cancer, must have received certain standard chemotherapy regimens, and must have no more than 3 prior lines of treatment for advanced disease.
• In Substudy 3 or certain dose expansion cohorts, people who previously received a taxane chemotherapy must have had their cancer worsen more than 12 months after finishing that treatment (this waiting period does not apply if the taxane was used but the cancer did not progress on it).
• People joining the Dose Expansion part must have received at least one prior treatment course for advanced or metastatic disease (in Korea, specific local treatment requirements apply — confirm with trial site).
• People with a general health/activity level rated as 0 or 1 on the ECOG scale (meaning fully active or able to carry out light work, but not more restricted than that).
• People who have at least one measurable area of cancer that can be tracked on scans, according to standard measurement guidelines (applies from a certain stage of the trial onwards — confirm with trial site).
• People whose blood counts and organ function results (such as blood cell counts, liver function, kidney function, and protein levels) meet the minimum levels required by the trial, as measured in screening blood tests.
• Women who could become pregnant must have a negative pregnancy blood test at screening.
• All people who could father or become pregnant must agree to use effective contraception during the study and for at least 6 months after the last dose of the study drug.

For the blood cancer arm (Substudy 4 — Acute Myeloid Leukaemia/AML):

• People who have read and signed a consent form showing they understand the study and agree to take part before any study procedures begin.
• People aged 18 or older (or 19 or older in some locations) at the time of screening.
• People with a general health/activity level rated as 0, 1, or 2 on the ECOG scale (meaning fully active up to capable of limited self-care).
• People with an estimated life expectancy of at least 8 weeks.
• People with a confirmed diagnosis of AML (a type of blood cancer) — either newly developed or arising from a prior blood condition — whose disease has come back or has not responded to standard treatments or a stem cell transplant. A specific subtype called acute promyelocytic leukaemia (APL) is not included.
• People whose cancer cell counts in the blood and bone marrow are at or below certain levels at the start of the study (a medication called hydroxyurea or a blood-filtering procedure may be used beforehand to bring these counts down if needed — confirm with trial site).
• People whose kidney function, liver function, protein levels, and blood clotting results meet the minimum levels required by the trial, as measured in screening blood tests.
• All people who could father or become pregnant must agree to use effective contraception during the study and for at least 6 months after the last dose of the study drug.

Who may not be able to join:

• People whose general health status is rated lower than required on the ECOG scale (below 0–1 for most arms, or below 0–2 for the AML arm).
• People with blood counts or organ function results that fall below the minimum levels required by the trial at screening.
• People with active or unstable brain metastases (in the non-AML arms, only stable, inactive brain involvement may be considered — confirm with trial site).
• People with the specific leukaemia subtype called acute promyelocytic leukaemia (APL) — this group is excluded from the AML arm.
• People who are pregnant or unwilling to use contraception during the study and for at least 6 months after the last dose.
• People in the TNBC group whose cancer has not been confirmed as triple negative by lab testing, or who have not received the required prior chemotherapy treatments.
• People in the gastric cancer group who have received more than 3 prior lines of treatment for advanced disease.
• People in Substudy 3 or certain dose expansion cohorts who previously received a taxane and whose cancer worsened within 12 months of finishing that treatment (unless they did not progress on the taxane).

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