Evaluating a new treatment for advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This first-in-human, open-label, multicenter, multi-arm dose-escalation study aims to assess the safety, pharmacokinetics, and pharmacodynamics of ADU-1805, an anti-SIRPα monoclonal antibody. The study will begin with a dose escalation of ADU-1805 as a monotherapy, followed by a combination with pembrolizumab after determining the maximum target engagement. The design follows an i3+3 approach to establish the recommended phase 2 dose (RP2D) for both treatment arms.

Why it matters

Who can join: the full rules

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

Where it's running

• Henry Ford Cancer Institute
  Detroit, Michigan, United States Recruiting
• Washington University Medical Campus
  St Louis, Missouri, United States Recruiting
• Atrium Health Carolinas Medical Center
  Charlotte, North Carolina, United States Recruiting
• Duke Health - Duke University Hospital
  Durham, North Carolina, United States Recruiting
• Gabrail Cancer & Research Center
  Canton, Ohio, United States Recruiting
• University of Texas Southwestern Medical Center
  Dallas, Texas, United States Recruiting

Study contacts

• Study coordinator: Sairopa Clinical Team
• Email: clinical@sairopa.com
• Phone: 0031 85 90 26 939

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.