RECRUITING

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

Conditions

Solid Tumor, Adult Metastatic Solid Tumor Refractory Cancer Immunotherapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

An Open-Label, Multicenter, Multi-arm Phase 1 Study Evaluating the Safety and Pharmacokinetics of ADU-1805 in Adults With Advanced Solid Tumors

Quick Facts

Study Start:2023-04-03

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05856981

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Sairopa Clinical Team

CONTACT

0031 85 90 26 939

clinical@sairopa.com

Study Locations (Sites)

Carolina BioOncology Institute - Cancer Research Clinic

Huntersville, North Carolina, 28078

United States

Gabrail Cancer & Research Center

Canton, Ohio, 44718

United States

Collaborators and Investigators

Sponsor: Sairopa B.V.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-03

Study Completion Date2025-12

Study Record Updates

Study Start Date2023-04-03

Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

Immunotherapy

Additional Relevant MeSH Terms

Solid Tumor, Adult
Metastatic Solid Tumor
Refractory Cancer