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Study of ALE.C04 in Patients With Head and Neck Cancer

NCT06054477 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2025-02-17

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety profile of ALE.C04 monotherapy and in combination with pembrolizumab, to characterize pharmacokinetics profile of ALE.C04, recommended Phase II dose (RP2D) for ALE.C04 in combination with pembrolizumab and to assess anti-tumor activity of ALE.C04 in combination with pembrolizumab in patients with Head and Neck Cancer.

Conditions

Interventions

DRUG

ALE.C04

Q3W

DRUG

Pembrolizumab

200mg Q3W

Sponsors & Collaborators

  • Alentis Therapeutics AG

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-30
Primary Completion
2025-02-12
Completion
2025-02-12
FDA Drug
Yes

Countries

  • United States
  • Canada
  • France
  • Hong Kong
  • Italy
  • Singapore
  • Spain
  • Switzerland

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 NCT06054477 on ClinicalTrials.gov