RecruitingPhase 1NCT05856981

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

An Open-Label, Multicenter, Multi-arm Phase 1 Study Evaluating the Safety and Pharmacokinetics of ADU-1805 in Adults With Advanced Solid Tumors

Sponsor

Sairopa B.V.

Enrollment

130 participants

Start Date

Apr 3, 2023

Study Type

INTERVENTIONAL

Conditions

Metastatic Solid Tumor Solid Tumor, Adult Refractory Cancer

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

Min Age: 18 Years

Inclusion Criteria7

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 Criteria22

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