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First-in-Human Study of the GDF-15 Neutralizing Antibody Visugromab (CTL-002) in Patients With Advanced Cancer (GDFATHER)

NCT04725474 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 199

Last updated 2026-08-19

No results posted yet for this study

Summary

The Phase 1 part (Part A) is a dose escalation study of IV visugromab (CTL-002, a monoclonal antibody neutralizing GDF-15) as monotherapy and in combination with an approved checkpoint inhibitor (CPI) in patients with advanced solid tumors.

Enrolment into the Ph 1 part is completed.

The Phase 2 parts (Part B) are cohort expansions with visugromab (CTL-002) in combination with a defined CPI at a fixed dose into seven different solid tumor indications.

Enrolment into the Ph 2 part is completed.

Conditions

  • Solid Tumor, Adult

Interventions

BIOLOGICAL

visugromab (CTL-002)

monoclonal antibody

BIOLOGICAL

nivolumab

monoclonal antibody

Sponsors & Collaborators

  • CatalYm GmbH

    lead INDUSTRY

Principal Investigators

  • Frank Hermann, MD · CatalYm GmbH

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-09
Primary Completion
2028-04-30
Completion
2030-04-30
FDA Drug
Yes

Countries

  • Germany
  • Spain
  • Switzerland

Study Locations

More Related Trials

Entities

Drugs

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 NCT04725474 on ClinicalTrials.gov