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NCT06402201 · ClinicalTrials.gov registry record · Phase 1

First in Human Study of CDR404 in HLA-A*02:01 Participants With MAGE-A4 Expressing Solid Tumors

A Phase 1 study of Select Advanced Solid Tumors, sponsored by CDR-Life.

Recruiting
Registry status
Phase 1
Development phase
42
Enrollment target
18
Study locations

NCT06402201: Recruiting Phase 1 study of Select Advanced Solid Tumors, sponsored by CDR-Life.

NCT06402201 is a Phase 1 study of Select Advanced Solid Tumors that is actively recruiting participants, run by CDR-Life. The registered enrollment target is 42 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower). The trial reports 18 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06402201, a Phase 1 study of Select Advanced Solid Tumors, is actively recruiting participants, sponsored by CDR-Life.

RECRUITING
Registry status
Phase 1
Development phase
42 participants
Enrollment target
18
Study locations

Study Summary

CDR404 is a highly potent and specific T-cell engaging bispecific and bivalent antibody designed for the treatment of cancers positive for the tumor-associated antigen melanoma-associated antigen 4 (MAGE-A4). This is a first-in-human study designed to evaluate the safety, tolerability, and preliminary anti-tumor activity of CDR404 in adult patients who have the appropriate germline human leukocyte antigen HLA-A\*02:01 tissue marker and whose cancer is positive for MAGE-A4.

Primary Outcome

per Protocol

Interventions

  • BIOLOGICAL CDR404

Study Locations (18)

Other

  • Universitair Ziekenhuis Antwerpen - Antwerp
  • Institut Jules Bordet - Brussels
  • Cliniques Universitaires Saint-Luc, UCL Ouvain - Brussels
  • Universitair Ziekenhuis Gent - Ghent
  • Rigshospitalet - Copenhagen
  • Istituto Clinico Humanitas - Milan
  • Isituto Europeo di Oncologia (IEO) - Milan
  • Hospital Universitari Vall d'Hebron - Barcelona
  • Institut Catala d'Oncologia, L'Hospitalet de Llobregat (ICO) - Barcelona
  • Hospital 12 de Octubre - Madrid
  • START Madrid - Madrid
  • Hospital Universitari i Politecnic La Fe - Valencia
  • Instituto de Investigacion Sanitaria (INCLIVA) - Valencia

Florida

  • University of Miami - Miami

Michigan

  • University of Michigan - Ann Arbor

Oregon

  • Providence Cancer Institute - Portland

Pennsylvania

  • Pennsylvania Hospital - Philadelphia

London

  • Royal Marsden Hospital - Sutton

Trial Details

FieldValue
Enrollment Target 42 participants
Start Date 2024-05-24
Est. Completion 2027-12-31
Phase Phase 1
CDR-Life

1 total trials

What NCT06402201 shows while recruiting

NCT06402201 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower).

The record links to 1 condition, with Select Advanced Solid Tumors appearing as the primary indexed condition, and to 1 intervention - of which CDR404 is the first listed.

NCT06402201 lists 18 locations in 6 states (Other, Florida, Michigan).

Frequently Asked Questions

What is clinical trial NCT06402201 about?

NCT06402201 is a clinical study titled "First in Human Study of CDR404 in HLA-A*02:01 Participants With MAGE-A4 Expressing Solid Tumors". CDR404 is a highly potent and specific T-cell engaging bispecific and bivalent antibody designed for the treatment of cancers positive for the tumor-associated antigen melanoma-associated antigen 4 (MAGE-A4). This is a first-in-human study designed to evaluate the safety, tolerability, and prelimina...

What is the current status of trial NCT06402201?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2024-05-24. Estimated completion is 2027-12-31.

What conditions does trial NCT06402201 study?

This clinical trial studies the following conditions: Select Advanced Solid Tumors.

What interventions are being tested in trial NCT06402201?

The interventions under investigation include: CDR404 (BIOLOGICAL).

Who is sponsoring clinical trial NCT06402201?

This trial is sponsored by CDR-Life, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06402201 being conducted?

This trial has 18 study locations across Florida, Michigan, Oregon, Pennsylvania, London. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Select Advanced Solid Tumors

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 NCT06402201's enrollment target sits among peer trials

42 1106th of 2000 higher than 876 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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 NCT06402201, the US trial registry maintained by the National Library of Medicine. NCT06402201 (small enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.