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NCT05856981 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Endometrial Cancer and Solid Tumor, Adult, sponsored by Sairopa B.V..

Recruiting
Registry status
Phase 1
Development phase
130
Enrollment target
7
Study locations

NCT05856981: Recruiting Phase 1 study of Endometrial Cancer and Solid Tumor, Adult, sponsored by Sairopa B.V..

NCT05856981 is a Phase 1 study of Endometrial Cancer and Solid Tumor, Adult that is actively recruiting participants, run by Sairopa B.V.. The registered enrollment target is 130 participants, below the 523-participant average among 181 other Endometrial Cancer trials with a reported enrollment target (75% lower). The trial reports 7 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05856981, a Phase 1 study of Endometrial Cancer and Solid Tumor, Adult, is actively recruiting participants, sponsored by Sairopa B.V..

RECRUITING
Registry status
Phase 1
Development phase
130 participants
Enrollment target
7
Study locations

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).

Primary Outcome

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

Interventions

  • DRUG Pembrolizumab
  • DRUG ADU-1805

Study Locations (7)

Other

  • Grand Hopital de Charleroi (GHdC) - Hopital Notre Dame - Charleroi
  • Hosp 12 de Octubre - Madrid
  • Hospital General Universitario Gergorio Maranon - Madrid

Michigan

  • Henry Ford Cancer Institute - Detroit

Missouri

  • Washington University Medical Campus - St Louis

Ohio

  • Gabrail Cancer & Research Center - Canton

Virginia

  • Virginia Cancer Specialists - Fairfax

Trial Details

FieldValue
Enrollment Target 130 participants
Start Date 2023-04-03
Est. Completion 2027-07
Phase Phase 1
Sairopa B.V.

1 total trials

What NCT05856981 shows while recruiting

NCT05856981 is an interventional study that assigns participants to a tested intervention. The registered 130 participants enrollment target is mid-sized for trials with a published cap, below the 523-participant average among 181 other Endometrial Cancer trials with a reported enrollment target (75% lower).

The record links to 7 conditions, with Endometrial Cancer appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.

NCT05856981 lists 7 locations in 5 states (Other, Michigan, Missouri).

Frequently Asked Questions

What is clinical trial NCT05856981 about?

NCT05856981 is a clinical study titled "Phase 1 Study Evaluating the Safety and PK of ADU-1805 in Advanced Solid Tumors". 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).

What is the current status of trial NCT05856981?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 130 participants. The study started on 2023-04-03. Estimated completion is 2027-07.

What conditions does trial NCT05856981 study?

This clinical trial studies the following conditions: Endometrial Cancer, Solid Tumor, Adult, Metastatic Solid Tumor, Refractory Cancer, CRC, Colorectal Cancer.

What interventions are being tested in trial NCT05856981?

The interventions under investigation include: Pembrolizumab (DRUG), ADU-1805 (DRUG).

Who is sponsoring clinical trial NCT05856981?

This trial is sponsored by Sairopa B.V., which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05856981 being conducted?

This trial has 7 study locations across Michigan, Missouri, Ohio, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Endometrial Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05856981's enrollment target sits among peer trials

130 84th of 181 higher than 98 of 181 other Endometrial Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Endometrial Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05856981, the US trial registry maintained by the National Library of Medicine. NCT05856981 (mid enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.