Solid Tumor, Adult study: ADU-1805 vs Pembrolizumab
Official title Phase 1 Study Evaluating the Safety and PK of ADU-1805 in Advanced Solid Tumors
ClinicalTrials.gov ID: NCT05856981
What this study is testing
What is ADU-1805?
An investigational injectable antibody being studied as a potential treatment for certain solid tumors in adults. It is designed to block the SIRPα protein on immune cells to help the body’s immune system attack cancer cells.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study looks at how safe the drug is and how it behaves in the body, including its effects on the immune system.
- Who it's for
- Adults with advanced or metastatic solid tumors that have not responded to other treatments, such as colorectal, kidney, lung, or endometrial cancer.
- What's involved
- Participants receive the drug by injection, either alone or together with pembrolizumab, and have regular blood tests and scans to monitor safety and drug levels.
- Time commitment
- The study lasts several weeks to months, with multiple clinic visits for dosing, blood draws, and imaging to track safety and drug activity.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- Escalation Phase: Patients that suffer from melanoma, brain tumors, glioblastoma, sarcoma and pancreatic ductal adenocarcinoma (PDAC)
- \> 3 lines of prior systemic treatments
- MSS colorectal cancer (CRC): liver metastasis present
- Pregnancy or breast-feeding
- 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...
See the full eligibility 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...
- Escalation Phase: Patients that suffer from melanoma, brain tumors, glioblastoma, sarcoma and pancreatic ductal adenocarcinoma (PDAC)
- \> 3 lines of prior systemic treatments
- MSS colorectal cancer (CRC): liver metastasis present
- Pregnancy or breast-feeding
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Detroit, Michigan, United States
- St Louis, Missouri, United States
- Charlotte, North Carolina, United States
- Durham, North Carolina, United States
- Canton, Ohio, United States
- Dallas, Texas, United States
- West Valley City, Utah, United States
- Fairfax, Virginia, United States
- Charleroi, Belgium
- Madrid, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Detroit, Michigan, United States; St Louis, Missouri, United States; Charlotte, North Carolina, United States; Durham, North Carolina, United States; Canton, Ohio, United States; Dallas, Texas, United States and 4 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.