Recruiting
Phase 1
Phase 1 Study Evaluating the Safety and PK of ADU-1805 in Advanced Solid Tumors
Condition(s) studied
Solid Tumor, AdultMetastatic Solid TumorRefractory CancerCRC, Colorectal CancerRCC, Clear Cell AdenocarcinomaNSCLC (Advanced Non-small Cell Lung Cancer)Endometrial Cancer
Investigational drug(s) / intervention(s)
ADU-1805: anti-SIRPα monoclonal antibody
Pembrolizumab: Keytruda
Study 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
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 (11)
| Facility | City | Region | Status |
| Henry Ford Cancer Institute |
Detroit |
Michigan |
Recruiting |
| Washington University Medical Campus |
St Louis |
Missouri |
Recruiting |
| Atrium Health Carolinas Medical Center |
Charlotte |
North Carolina |
Recruiting |
| Gabrail Cancer & Research Center |
Canton |
Ohio |
Recruiting |
| The Ohio State University Comprehensive Cancer Center |
Columbus |
Ohio |
Recruiting |
| University of Texas Southwestern Medical Center |
Dallas |
Texas |
Recruiting |
| Start Center for Cancer Research - Mountain Region |
West Valley City |
Utah |
Recruiting |
| Virginia Cancer Specialists |
Fairfax |
Virginia |
Recruiting |
| Grand Hopital de Charleroi (GHdC) - Hopital Notre Dame |
Charleroi |
Belgium |
Recruiting |
| Hosp 12 de Octubre |
Madrid |
Spain |
Recruiting |
| Hospital General Universitario Gergorio Maranon |
Madrid |
Spain |
Recruiting |
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