Health Trials

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

ConditionsSolid Tumor, AdultMetastatic Solid TumorRefractory CancerCRC, Colorectal CancerRCC, Clear Cell AdenocarcinomaNSCLC (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

Sponsors and collaborators

Sairopa B.V.

Lead sponsor

Source ClinicalTrials.gov