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THE-0504 in Patients With Solid Tumors

NCT07646106 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-06-12

No results posted yet for this study

Summary

Single-centre, open-label, dose escalation phase I clinical trial, designed to evaluate mainly the safety and tolerability of the antitumor drug THE-0504 in patients with different types of solid tumors.

Conditions

  • Small Cell Lung Cancer (SCLC)
  • Colorectal Carcinoma (CRC)
  • Gastric Cancer (GC)
  • Triple -Negative Breast Cancer
  • Pancreas Adenocarcinoma

Interventions

DRUG

THE-0504

THE-0504 will be administered intravenously according to the treatment regimen specified in the protocol.

Sponsors & Collaborators

  • Thena Biotech S.r.l.

    lead INDUSTRY

Principal Investigators

  • Gennaro Daniele · Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-13
Primary Completion
2027-05-01
Completion
2027-05-01

Countries

  • Italy

Study Locations

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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 NCT07646106 on ClinicalTrials.gov