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
Sex
ALL
Min age
18 Years
Max age
—
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 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
Primary outcome measure(s)
Escalation Phase: Incidence and severity of dose limiting toxicity (DLT), treatment-emergent adverse events (TEAEs), and changes from baseline in safety parameters — First 21 days of treatment Incidence of DLTs and incidence and severity of TEAEs, classified according to NCI-CTCAE v. 5.0
Expansion Phase: Evaluate the clinical response of ADU-1805 plus pembrolizumab administered as an intravenous (IV) infusion. — Through study completion, up to 2,5 years Objective tumor response rate (ORR) per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Trial sites (7)
Facility
City
Region
Status
Henry Ford Cancer Institute
Detroit
Michigan
Recruiting
Washington University Medical Campus
St Louis
Missouri
Recruiting
Gabrail Cancer & Research Center
Canton
Ohio
Recruiting
Virginia Cancer Specialists
Fairfax
Virginia
Recruiting
Grand Hopital de Charleroi (GHdC) - Hopital Notre Dame
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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