Phase 1 Study Evaluating the Safety and PK of ADU-1805 in Advanced Solid Tumors

• Status: Not yet recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sairopa B.V.
• Treatments: Pembrolizumab

Criteria

Inclusion Criteria:

• Male or female aged ≥18 years

• Signed and dated informed consent form

• 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

• Measurable disease according to RECIST (Safety Expansion only)

• ECOG Performance status of 0 or 1

• Adequate organ and marrow function

Exclusion Criteria:

• Patients that suffer from melanoma, brain tumors, glioblastoma, sarcoma and pancreatic ductal adenocarcinoma (PDAC)

• Pregnancy or breast-feeding

• Prior treatment with or receipt of:

• biological agents, including monoclonal antibodies and immunotherapies, within 28 days prior to the first dose of ADU-1805

• chemotherapy, targeted small molecule therapy, hormonal therapy or radiation therapy within 21 days prior to the first dose of ADU-1805 and within 42 days for nitrosoureas and mitomycin C.

• anti-SIRPα or anti-CD47-directed therapy

• systemic chronic steroid therapy or immunosuppressive therapy within 14 days prior to the first dose of ADU-1805

• other investigational new drug or investigational device within 28 days prior to the first dose of ADU-1805

• vaccine containing live virus within 28 prior to the first dose of ADU-1805

• Active untreated brain metastases

• Active infection requiring systemic therapy

• Impaired cardiac function or clinically significant cardiac disease

• Current Grade >2 toxicity related to prior anti-cancer therapy

• History of drug-induced severe immune-related adverse reaction

• Prior severe hypersensitivity to other monoclonal antibodies or ADU-1805 excipients

• Major surgery within defined period

• Diagnosis or positive test of HIV, hepatitis B, hepatitis C, or active tuberculosis

• Allogenic tissue/solid organ transplant

• Any intercurrent illness that is life-threatening or of such clinical significance that it would interfere with the patient's safety or ability to participate in the study