Primary Outcome Measures Number of participants treated with Alintegimod monotherapy with treatment related adverse events as assessed by CTCAEv5.0 Number of participants treated with Alintegimod in combination with treatment related adverse events as assessed by CTCAEv5.0 Define RPTDs for Alintegimod Secondary Outcome Measures Characterize Pharmacokinetics of Alintegimod monotherapy by measuring[…]
Clinical Trials
A Study of Oral 7HP349 (Alintegimod) in Combination With Ipilimumab Followed by Nivolumab Monotherapy
This study is an open-label Phase Ib (Part A) dose escalation followed by a blinded, randomized, multi cohort Phase 2a (Part B) comparison of combination vs. reference regimens.
Currently study will only be enrolling the Phase 1b and the Phase 2a protocol requirements will be added to the study near completion of the Phase 1b
A Phase 1a/1b Study of ACTM-838 in Patients With Advanced Solid Tumors
This is a first in human (FIH) 2-part study using ACTM-838 in patients with advanced solid tumors resistant to standard of care treatment. Part 1a will evaluate dose escalation and Part 1b will evaluate dose expansion.
Study of Pembrolizumab Plus Chemotherapy With Lenvatinib for Malignant Pleural Mesothelioma (PENINSULA)
In this Phase-II study, the investigators will investigate the efficacy and safety of lenvatinib in combination with pembrolizumab and chemotherapy in patients with malignant pleural mesothelioma.
Exercise to Boost Immunity in Advanced Cancer (BICEP)
The trial is a prospective feasibility trial conducted in Sheffield. Recruitment will include twenty patients receiving first line palliative immunotherapy for advanced, unresectable or metastatic mesothelioma and patients receiving first line systemic anti-cancer treatment for pancreatic cancer. Patients will attend the AWRC for a supervised exercise session once a week to include aerobic exercise along with an unsupervised weekly exercise session for 3 months. Blood samples will be collected at baseline and then monthly for 3 months, pre and post the supervised exercise session. Cytokine, myokine and immune cell concentration will be analysed using cytokine bead-based multiplex immune assays and RNA-seq to full profile changes in gene and protein expression
NM32-2668 in Adult Patients With Selected Advanced Solid Tumors
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.
Treatment Pleural Carcinosis of Pressurized IntraThoracic Hyperthermic Aerosol Cisplatin Administration (PITHAC)
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).
GPC3/Mesothelin-CAR-γδT Cells Against Cancers
Primary Outcome Measures Number of Patients with Dose Limiting Toxicity Secondary Outcome Measures Percent of Patients with best response as either complete remission or partial remission. Median γδT cell persistence Inclusion Criteria 1. Patients with advanced cancer that expresses GPC3 or Mesothelin protein; 2. Life expectancy >12 weeks; 3. Adequate[…]
Induction Chemo+Immunotherapy in Resectable Epithelioid and Biphasic Pleural Mesothelioma (CHIMERA Study) (CHIMERA)
Primary Outcome Measures Primary endpoint – To evaluate the activity of neo-adjuvant treatment by the determination of pathological complete response rate (pCR) Secondary Outcome Measures Secondary endpoint – To further evaluate the activity of neo-adjuvant treatment in terms of major pathological response. Secondary endpoint – To further evaluate the activity[…]
Decitabine/Cedazuridine (INQOVI), an Oral DNA Demethylating Agent, in Subjects With BAP1 Cancer Predisposition Syndrome and Subclinical, Early-Stage Mesothelioma
Primary Outcome Measures To determine stabilization or disease improvement rates in participants with early-stage mesotheliomas arising in the context of BAP1 CPDS following decitabine/cedazuridine treatment Secondary Outcome Measures To evaluate the safety of decitabine/cedazuridine To determine PFS in participants receiving decitabine/cedazuridine Inclusion Criteria Participants with history of germline BRCA1-Associated Protein-1[…]
