Status
Primary Outcome Measures Number of patients tolerating dose levels (maximum tolerated dose; MTD) in each of the combinations [ Time Frame: Assessed from baseline to 30 days after last dose of study drug ] MTD of NUC-3373 in each of the combinations in each patient Number of patients reporting treatment-emergent adverse events (TEAEs) in each of the combinations [ Time Frame: Assessed…
Primary Outcome Measures Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 [ Time Frame: through study completion; an average of 1 year. ] Inclusion Criteria Signed consent to long-term follow-up on protocol PA17-0483 Patients with advanced clear cell renal cell carcinoma, osteosarcoma or mesothelioma, with an…
Primary Outcome Measures Progression free survival [ Time Frame: From randomisation up to 2 years of follow up ] Defined as the time from randomisation to the date of disease progression Overall survival [ Time Frame: From randomisation up to 2 years of follow up ] defined as the time from randomisation to the date of death from any cause. Secondary Outcome Measures…
Primary Outcome Measures Maximum Tolerated Dose (MTD) and/or Maximum Administered Dose (MAD) [ Time Frame: 28 days during 1st cycle ] Determine the MTD and/or MAD of anti GP88 monoclonal antibody (AG-01) in subjects with advanced/refractory solid tumor malignancies for which no effective therapies exist. Antitumor Activity of AG-01 by Overall Response Rate (ORR) [ Time Frame: Every 56 Days ] To evaluate…
Primary Outcome Measures Number of participants with adverse events (AEs) [ Time Frame: Through 30 days after the last study treatment; approximately 7 months ] Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Number of participants with laboratory abnormalities [ Time Frame: Through 30 days…
Primary Outcome Measures Safety and feasibility of SynKIR-110 [ Time Frame: Date of enrollment through date of last patient visit, up to 36 months. ] • The incidence, frequency, and severity of TEAEs, incidence of AEs related to native mesothelin-expressing tissues, • Incidence of CRS and/or neurologic toxicity Secondary Outcome Measures Define the MTD or MFD of SynKIR-110 [ Time Frame: Date…
Primary Outcome Measures Time from diagnosis of pleural mesothelioma to death of any cause as median overall survival time. [ Time Frame: 54 Months ] Secondary Outcome Measures Number of TTFields treatment-related SAEs, as assessed by the CEC, within total observation period, standardized to average annual incidences. [ Time Frame: 3 years + 18 months follow up ] Changes in quality of life…
Primary Outcome Measures Determine DLTs and RP2Ds in AMXT 1501 in combination with IV DFMO [ Time Frame: 1 year ] Indicate Number of patients with DLTs in AMXT1501 in combination with IV DFMO in patients with advanced cancer to determine the RP2D within the duration of the dose escalation period of the study as defined by the DLT…
Primary Outcome Measures disease free survival or time to recurrence [ Time Frame: Through out the whole study with maximum of 2 years ] time from clearance of disease till onset of recurrence of same disease overall survival [ Time Frame: till mortality of the case or 2 years maximum ] survival of the cases till mortality Secondary Outcome Measures comorbidities [ Time Frame: Through out…
Primary Outcome Measures Progression-free survival [ Time Frame: From date of randomisation until the date of the first documented progression or date of death from any cause, whichever came first, assessed up to 18 months ] Progression-free survival is the determined by modified RECIST (pleural disease), RECIST 1.1 (for non-pleural disease), investigator reported progression or death from any cause…
