Clinical Trials
Primary Outcome Measures Phase 1 (Dose Escalation): Incidence of adverse events [ Time Frame: From CTX131 infusion up to 28 days post-infusion ] Defined as dose-limiting toxicities Phase 2 (Cohort Expansion): Objective response rate (ORR) [ Time Frame: From CTX131 infusion up to 60 months post-infusion ] ORR based on Independent Review Committee (IRC) assessment, defined as the proportion of subjects who have…
Primary Outcome Measures Proportion of patients that experienced (S)AEs possibly, probably or definitely related to pemetrexed and/or cisplatin/carboplatin and/or atezolizumab and/or WT1/DC vaccination [ Time Frame: through study completion, an average of 2 years ] The relationship of an AE to the investigational agents will be determined by the Investigator as either related or non-related, based on their clinical…
Primary Outcome Measures Phase 1 Maximum Tolerated Dose [ Time Frame: 28 days ] To determine the maximum tolerated dose (MTD) of TNG462 Phase 1 Dosing Schedule [ Time Frame: 28 days ] To determine the dosing schedule of TNG462 Phase 2 Anti-neoplastic Activity [ Time Frame: 16 weeks ] To assess anti-neoplastic activity of TNG462 in patients with MTAP-deleted advanced solid tumors by RECIST v1.1 Secondary…
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 Dose limiting toxicity (DLT) of PRT3645 [ Time Frame: Baseline through Day 28 ] Dose limiting toxicity will be evaluated over the 28-day observation period Safety and tolerability of PRT3645: AEs, CTCAE Assessments [ Time Frame: Baseline through approximately 2 years ] Safety and tolerability will be evaluated by incidence of DLTs, laboratory measurements, severity of adverse events (AEs) according…
