An Open-Label, Multicenter, Multi-arm Phase 1 Study Evaluating the Safety and Pharmacokinetics of ADU-1805 in Adults With Advanced Solid Tumors
Sairopa B.V.
Summary
This first-in-human, open-label, multicenter, multi-arm dose-escalation study is designed to evaluate the safety, PK, and PD of ADU-1805, an anti- SIRPα monoclonal antibody, as monotherapy and in combination with pembrolizumab (anti-PD-1 antibody).
Description
This study is designed to evaluate the safety, PK, PD and preliminary clinical activity of ADU-1805, an anti- SIRPα monoclonal antibody, as monotherapy and in combination with pembrolizumab (anti-PD-1 antibody). The study is divided into a dose escalation phase and a dose expansion phase. The dose expansion phase investigates ADU-1805 plus pembrolizumab at the respective recommended phase 2 dose (RP2D) in four advanced solid tumors: advanced PD-(L)1-naïve MSS colorectal cancer (CRC), PD-1 relapsed/refractory patients with either advanced MSS endometrial cancer (EC), renal cell carcinoma (RCC)…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Male or female aged ≥18 years * Signed and dated informed consent form * Measurable disease according to RECIST (Safety Expansion only) * ECOG Performance status of 0 or 1 * Adequate organ and marrow function * Escalation Phase: Histologically and/or cytologically confirmed diagnosis of metastatic or unresectable solid tumors that are refractory to standard therapy or for which no standard therapy exists * Expansion Phase: histologically and/or cytologically confirmed diagnosis of advanced PD-(L)1-naïve MSS colorectal cancer (CRC), PD-1 relapsed/refractory patients with…
Interventions
- DrugADU-1805
anti-SIRPα monoclonal antibody
- DrugPembrolizumab
Keytruda
Locations (7)
- Henry Ford Cancer InstituteDetroit, Michigan
- Washington University Medical CampusSt Louis, Missouri
- Gabrail Cancer & Research CenterCanton, Ohio
- Virginia Cancer SpecialistsFairfax, Virginia
- Grand Hopital de Charleroi (GHdC) - Hopital Notre DameCharleroi
- Hosp 12 de OctubreMadrid