Head: Lorenza Landi, MD
STAFF

Mission

According to the overall mission of National Cancer Institute Regina Elena, the goal of the Phase 1 trials Unit is to seamlessly integrate preclinical drug discovery, proof-of-principle phase I trials and tumour-specific evaluation of novel agents. Moreover, because our Institution is formed by Regina Elena and San Gallicano Dermatological Institute, our Center serves as hub for conduction of phase I trials of both Entities.

Ongoing and upcoming studies are involving many of the most promising molecularly targeted agents, immunotherapy and combinations of agents in early phase of development. We assure rigorous study conduction and design. The staff of Phase 1 Unit is directly responsible for patient care and adherence to study protocol.

Clinical and Research Activity

The clinical activities include an inpatient hospital service and outpatient clinics (pre-screening activities and follow-up). All patients are evaluated by a specialized team according to their specific disease condition.

Patients are treated in a dedicated Day Hospital (DH) or in a specific unit. Outpatient visits are performed in a dedicated room and treatment are delivered in a DH service, including 3 chairs and 2 beds. The inpatient service includes 2 beds dedicated to trials procedures and/or adverse events management.

In addition, according to Phase 1 procedures, we guarantee

• Technologies for monitoring and surveillance of patients as a sub-intensive therapy.
• A network of support Clinical Units and Professionals for each type of study prepared according to the AIFA Resolution n. 809/2015
• AIFA conformity certifications for phase 1 studies
• “Temperature controlled” transport systems
• Operating procedures for activities related to the investigation paths and relations with other internal or external structures of the IFO.

In 2020, a total of five studies were active and/or active/recruiting

1. Phase 1 Dose Escalation and Cohort Expansion Study of TSR-042, an anti-PD-1 Monoclonal Antibody, in Patients with Advanced Solid Tumors
2. A phase Ib, open-label, multicenter study (BO40933) evaluating the safety and efficacy of ipatasertib in combination with rucaparib in patients with advanced breast, ovarian, or prostate cancer
3. BLU-667-1101: A Phase 1/2 Study of the Highly-selective RET Inhibitor, BLU-667, in Patients with Thyroid Cancer, Non-Small Cell Lung Cancer (NSCLC) and Other Advanced Solid Tumors
4. MK-1308-001 Study of Quavonlimab (MK-1308) in Combination with Pembrolizumab (MK-3475) in Advanced Solid Tumors
5. DCC-3014-001: A Multicenter Phase 1/2, Open-Label Study of DCC-3014 to Assess the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics in Patients with Advanced Tumors and Tenosynovial Giant Cell Tumor.

Future Perspectives

The activity of the Phase 1 Clinical Trials Center is growing with a constant increased number of clinical trials including no-profit Phase 1 studies, First-in-human studies and collaboration with other institutions. Moreover, the medical staff will be increased, with the arrival of additional dedicated oncologists. Participation in multicentric studies and international meetings, will increase Center visibility and patient recruitment. The Center will also undertake general, non-trial specific advertising and screening procedures to recruit potential trial participants, prior to inviting them to participate in a specific trial. Finally, intensive educational activities involving physicians and nurses will be supported by our Center.