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

NCT05856981 | Recruiting Phase 1 FDA Drug

• 1 other identifier: SRP-22C102
• Study Type: interventional
• Target: 130
• Locations: 3 countries
• Sites: 7

Brief 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).

Conditions

Solid Tumor, Adult; Metastatic Solid Tumor; Refractory Cancer; CRC, Colorectal Cancer; RCC, Clear Cell Adenocarcinoma; NSCLC (Advanced Non-small Cell Lung Cancer); Endometrial Cancer

Keywords

Immunotherapy

Outcome Measures

Primary Outcomes (2)

• Escalation Phase: Incidence and severity of dose limiting toxicity (DLT), treatment-emergent adverse events (TEAEs), and changes from baseline in safety parameters

  Incidence of DLTs and incidence and severity of TEAEs, classified according to NCI-CTCAE v. 5.0

  First 21 days of treatment

• Expansion Phase: Evaluate the clinical response of ADU-1805 plus pembrolizumab administered as an intravenous (IV) infusion.

  Objective tumor response rate (ORR) per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

  Through study completion, up to 2,5 years

Secondary Outcomes (3)

• Escalation and Expansion Phase: Pharmacokinetics of ADU-1805 monotherapy and ADU-1805 plus pembrolizumab, serum concentration-time profile and PK parameters

  Through study completion, up to 2,5 years

• Escalation and Expansion Phase: Immunogenicity of ADU-1805 monotherapy and ADU-1805 plus pembrolizumab

  Through study completion, up to 2,5 years

• Expansion Phase: To confirm safety of ADU-1805 in combination with pembrolizumab as an IV infusion

  Through study completion, up to 2,5 years

Other Outcomes (2)

• Escalation and Expansion Phase: Pharmacodynamics of ADU-1805 monotherapy and ADU-1805 plus pembrolizumab

  Through end of treatment, up to 2 years

• Escalation and Expansion Phase: Preliminary Clinical activity of ADU-1805 monotherapy and ADU-1805 plus pembrolizumab

  Through study completion, up to 2,5 years

Study Arms (3)

Monotherapy dose escalation, IV, Q3W, multiple dose levels

EXPERIMENTAL

ADU-1805 monotherapy dose escalation

Drug: ADU-1805

Combination dose escalation, IV, Q3W, multiple dose levels, pembrolizumab at fixed dose

EXPERIMENTAL

ADU-1805 plus pembrolizumab dose escalation

Drug: ADU-1805; Drug: Pembrolizumab

Combination dose expansion, IV, Q3W, multiple dose levels, pembrolizumab at fixed dose

EXPERIMENTAL

ADU-1805 plus pembrolizumab dose expansion

Drug: ADU-1805; Drug: Pembrolizumab

Interventions

ADU-1805 DRUG

anti-SIRPα monoclonal antibody

Combination dose escalation, IV, Q3W, multiple dose levels, pembrolizumab at fixed dose; Combination dose expansion, IV, Q3W, multiple dose levels, pembrolizumab at fixed dose; Monotherapy dose escalation, IV, Q3W, multiple dose levels

Pembrolizumab DRUG

Keytruda

Also known as: Keytruda

Combination dose escalation, IV, Q3W, multiple dose levels, pembrolizumab at fixed dose; Combination dose expansion, IV, Q3W, multiple dose levels, pembrolizumab at fixed dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sairopa B.V.: lead

Study Sites (7)

Henry Ford Cancer Institute

Detroit, Michigan, 48202, United States

RECRUITING

Washington University Medical Campus

St Louis, Missouri, 63110, United States

RECRUITING

Gabrail Cancer & Research Center

Canton, Ohio, 44718, United States

RECRUITING

Virginia Cancer Specialists

Fairfax, Virginia, 22205, United States

RECRUITING

Grand Hopital de Charleroi (GHdC) - Hopital Notre Dame

Charleroi, Belgium

RECRUITING

Hosp 12 de Octubre

Madrid, Spain

RECRUITING

Hospital General Universitario Gergorio Maranon

Madrid, Spain

RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis; Neoplasms; Colorectal Neoplasms; Carcinoma, Renal Cell; Carcinoma, Non-Small-Cell Lung; Endometrial Neoplasms

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Genital Diseases, Female; Genital Diseases

Central Study Contacts

Sairopa Clinical Team

CONTACT

0031 85 90 26 939; clinical@sairopa.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2023
• First Posted: May 12, 2023
• Study Start: April 3, 2023
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: December 17, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); ES (2); US (4)