No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
130 (estimated)
Sponsor
Sairopa B.V. · Industry
Who this trial is looking for
This trial is looking for adults with advanced solid tumors that have not responded to standard treatments. Participants will receive an experimental treatment called ADU-1805, either on its own or with another therapy.
Are You a Good Fit for This Trial?
Rules you outActive infectionSevere cardiac diseaseHIVHepatitis BHepatitis CActive tuberculosisSolid organ transplant
You may be able to join if
I am at least 18 years old.
I have signed an informed consent form.
I have measurable disease.
I have a good performance status and can take care of myself.
I have been diagnosed with metastatic solid tumors that don’t have standard treatments.
I have advanced colorectal cancer, endometrial cancer, renal cell carcinoma, or non-small cell lung cancer with measurable disease.
You may not be able to join if
I have melanoma, brain tumors, or certain types of cancer like pancreatic cancer.
I have received more than 3 lines of prior systemic treatment.
I have liver metastasis if I have colorectal cancer.
I am pregnant or breastfeeding.
I have had certain treatments within specified timeframes before starting the trial.
I have active untreated brain metastases.
I have a serious infection needing treatment.
I have had major surgery recently.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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).
Trial Locations
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Status
Eligibility Criteria
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 di…
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
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