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

Launched by SAIROPA B.V. · May 3, 2023

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment called ADU-1805 for patients with advanced solid tumors, which are types of cancers that are hard to treat with standard therapies. The main goal of the study is to find out if ADU-1805 is safe for patients and how it works in the body. This trial is open to adult patients aged 18 and older who have a specific type of cancer that hasn’t responded to other treatments and who meet certain health criteria. However, some patients, like those with specific types of tumors, active infections, or serious heart problems, may not be eligible to participate.

Participants in the trial will receive either ADU-1805 alone or in combination with another treatment called pembrolizumab. Throughout the study, researchers will closely monitor participants for any side effects and how their cancer responds to the treatment. If you or a loved one are considering joining this trial, it’s important to discuss it with your healthcare team to see if it might be an appropriate option based on your specific situation.

Gender

ALL

Eligibility 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