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

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

NCT ID: NCT05856981

Condition: Solid Tumor, Adult
Metastatic Solid Tumor
Refractory Cancer

Conditions: Official terms:
Neoplasms
Pembrolizumab

Conditions: Keywords:
Immunotherapy

Study type: Interventional

Study phase: Phase 1

Overall status: Recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Sequential Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: ADU-1805
Description: anti-SIRPα monoclonal antibody
Arm group label: Combination dose escalation, IV, Q3W, multiple dose levels, pembrolizumab at fixed dose
Arm group label: Monotherapy dose escalation, IV, Q3W, multiple dose levels

Intervention type: Drug
Intervention name: Pembrolizumab
Description: Keytruda
Arm group label: Combination dose escalation, IV, Q3W, multiple dose levels, pembrolizumab at fixed dose

Other name: Keytruda

Summary: 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).

Detailed description: The study will start with the ADU-1805 monotherapy dose escalation arm following an i3+3 design until the RP2D is defined. The ADU-1805 plus pembrolizumab dose escalation arm, also following an i3+3 design, will start after clearance of the ADU-1805 monotherapy dose level achieving maximum target engagement (e.g. ≥ 90% target engagement) and will continue until the RP2D for the combination is defined.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Carolina BioOncology Institute - Cancer Research Clinic

Address:
City: Huntersville
Zip: 28078
Country: United States

Status: Recruiting

Facility:
Name: Gabrail Cancer & Research Center

Address:
City: Canton
Zip: 44718
Country: United States

Status: Recruiting

Facility:
Name: National Institute of Oncology

Address:
City: Chișinău
Country: Moldova, Republic of

Status: Recruiting

Start date: April 3, 2023

Completion date: December 2025

Lead sponsor:
Agency: Sairopa B.V.
Agency class: Industry

Source: Sairopa B.V.

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05856981