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

NCT05856981 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2025-12-17

No results posted yet for this study

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

Interventions

DRUG

ADU-1805

anti-SIRPα monoclonal antibody

DRUG

Pembrolizumab

Keytruda

Sponsors & Collaborators

  • Sairopa B.V.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-03
Primary Completion
2027-05-31
Completion
2027-07-31
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05856981 on ClinicalTrials.gov