Recruiting
This is a multicenter, single-arm, phase II clinical study to evaluate the safety and efficacy of Cadonilimab combined with gemcitabine, or vinorelbine, or pemetrexed in the treatment of patients with recurrent / refractory pleural mesothelioma.
This is a first-in-human, open-label, multi-center, Phase 1, dose-escalation study with expansion cohorts to evaluate NM32-2668 for safety and immunogenicity, to determine the maximal tolerated dose and recommended Phase 2 dose, define the pharmacokinetics, to explore the pharmacodynamics, and to obtain preliminary evidence of the clinical activity in adult patients with selected advanced solid tumors.
Within the context of pleural carcinosis, the present study is a dose escalation with determination of the maximum tolerated doses (MTD) of pressurized cisplatin administration associated to moderate hyperthermia in the pleura. This will be followed by an expansion phase at the recommended dose (RD).
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 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 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 Phase 1 – Establish the recommended Phase 2 dose (RP2D) according to dose-limiting toxicity (DLT) of defined adverse events. [ Time Frame: DLTs within 28 days post-treatment ] Phase 1 -The number and percent of patients in the DLT evaluable set who experienced DLTs from the first administration of study drug up to 28 days post…
Primary Outcome Measures The maximum tolerable dose (MTD) [ Time Frame: After two completed cycles of therapy (each cycle is 1 week) ] The primary endpoint of the study is to determine the maximum tolerable dose (MTD) of intraperitoneal (IP) paclitaxel monotherapy, for patients with malignant peritoneal mesothelioma (MPM) who are not eligible to undergo CRS-HIPEC. Secondary Outcome Measures…
Primary Outcome Measures CD8 TILs density / gross tumor volume (GTV) [ Time Frame: Up to five years ] The primary objective of the study is to demonstrate that low dose cyclophosphamide in combination with sub-ablative radiation can enhance the anti-tumoral immune response compared to sub-ablative radiation alone Secondary Outcome Measures Survival [ Time Frame: Up to five years ] Demonstrate the safety…
