NCT05856981 Phase 1 Study Evaluating the Safety and PK of ADU-1805 in Advanced Solid Tumors

Eligibility & Interventions

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.

This trial targets 130 participants in total. It began in 2023-04-03 with a primary completion date of 2027-05.

Brief 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).

Eligibility Criteria

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 either advanced MSS endometrial cancer (EC), renal cell carcinoma (RCC) or non-small cell lung cancer (NSCLC) patients, and that have measurable disease according to RECIST Exclusion Criteria: * Escalation Phase: Patients that suffer from melanoma, brain tumors, glioblastoma, sarcoma and pancreatic ductal adenocarcinoma (PDAC) * Expansion Phase: * \> 3 lines of prior systemic treatments * MSS colorectal cancer (CRC): liver metastasis present * 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

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