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

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

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorSairopa B.V.

About this trial

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).

Eligibility criteria

Qualifiers

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

Disqualifiers

Escalation Phase: Patients that suffer from melanoma, brain tumors, glioblastoma, sarcoma and pancreatic ductal adenocarcinoma (PDAC)

> 3 lines of prior systemic treatments

MSS colorectal cancer (CRC): liver metastasis present

Pregnancy or breast-feeding

Trial design

Treatments tested in this trial

ADU-1805
Pembrolizumab

Treatment groups

130 Participants

are divided into 3 treatment groups

Locations

Belgium

Grand Hopital de Charleroi (GHdC) - Hopital Notre Dame Charleroi Belgium

Spain

Hosp 12 de Octubre Madrid Spain

Hospital General Universitario Gergorio Maranon Madrid Spain

United States

Henry Ford Cancer Institute48202, DetroitMichigan, United States

Sponsors and collaborators

Sairopa B.V.

Lead sponsor

Source ClinicalTrials.gov