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

NCT04725474 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: CTL-002-001
• Study Type: interventional
• Target: 263
• Locations: 3 countries
• Sites: 13

Brief 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.

Conditions

Solid Tumor, Adult

Keywords

CTL-002; GDF-15; visugromab

Outcome Measures

Primary Outcomes (3)

• Adverse Events (Parts A & B)

  Incidence of treatment emergent adverse events in monotherapy and/or combination therapy

  min. 2 months

• Determination of DLT and MTD (Part A)

  Assessment of toxicities in monotherapy and/or combination therapy per dose level

  28 days

• Evaluation of clinical efficacy according RECIST (Part B)

  RECIST is measured every 6-8 weeks treatment

  min. 6 weeks

Secondary Outcomes (8)

• Cmax following the first dose of CTL-002 (Part A & B)

  1 day

• AUC following the first dose of CTL-002 (Part A & B)

  14 days

• Half-life of CTL-002 (Part A & B)

  min. 6 weeks

• Evaluation of treatment-emergent cytokine/chemokine concentrations (Part A & B)

  min. 6 weeks

• Evaluation of clinical efficacy according RECIST (Part A)

  min. 6 weeks

Study Arms (2)

Phase 1 (Part A; dose escalation): CTL-002 Monotherapy + Checkpoint Inhibitor Combination

EXPERIMENTAL

Up to 5 dose levels with visugromab (CTL-002) administered as IV monotherapy and in combination with a CPI

Biological: visugromab (CTL-002)

Phase 2 (Part B; expansion): visugromab (CTL-002) + Checkpoint Inhibitor Combination

EXPERIMENTAL

At defined dose level(s) with visugromab (CTL-002)

Biological: visugromab (CTL-002)

Interventions

visugromab (CTL-002) BIOLOGICAL

monoclonal antibody

Phase 1 (Part A; dose escalation): CTL-002 Monotherapy + Checkpoint Inhibitor Combination; Phase 2 (Part B; expansion): visugromab (CTL-002) + Checkpoint Inhibitor Combination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed and dated informed consent, and able to comply with the study procedures and any locally required authorization.
• Male or female aged ≥ 18 years.
• Relapsed/refractory patients with histologically or cytologically confirmed diagnosis of advanced-stage or recurrent cancer (Germany-specific: and have exhausted all standard of care treatments or are not eligible for such treatments)
• Progressed on/relapsed after at least one prior anti-PD-1/PD-L1 treatment
• Biopsy-accessible tumor lesions and willing to undergo triple sequential tumor biopsy (Part A) and dual biopsy (Part B, only for selected cohorts).
• At least 1 radiologically measurable lesion per RECIST V1.1/imRECIST (Part B).
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
• Life expectancy \> 3 months as assessed by the Investigator.
• Adequate organ function (bone marrow, hepatic, renal function and coagulation).

You may not qualify if:

• Pregnant or breastfeeding.
• Any tumor-directed therapy within 21 days before study treatment.
• Treatment with investigational agent within 21 days before study treatment.
• Radiotherapy within 14 days before study treatment.
• Pre-existing arrhythmia, uncontrolled angina pectoris, uncontrolled heart failure (NYHA) Grade IV, any myocardial infarction/coronary event, CNS-ischemic event and any thromboembolic event at any time \< 6 months prior to Screening or presence of any uncontrolled heart failure NYHA Grade III or higher.
• Left ventricular ejection fraction (LVEF) \< 50% measured by echocardiogram or MUGA.
• QTcF \> 450 ms for men or \> 470 ms for women.
• Any active autoimmune requiring systemic immunosuppressive treatments. .
• Any history of non-infectious pneumonitis \< 6 months prior to Screening.
• Any active inflammatory bowel disease such as Crohn's disease or ulcerative colitis which are generally excluded or active autoimmunthyroiditis present \< 6 months prior to Screening.
• History of CNS disease such as stroke, seizure, encephalitis, or multiple sclerosis (\< 6 months prior to Screening).
• Evidence for active infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), tuberculosis (TB), or severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

Sponsors & Collaborators

• CatalYm GmbH: lead

Study Sites (13)

Universitätsklinikum Essen, Westdeutsches Tumorzentrum, Innere Klinik und Poliklinik

Essen, 45147, Germany

Location

Universitätsklinikum Frankfurt, Medizinische Klinik I

Frankfurt am Main, 60590, Germany

Location

Universitätsklinikum Würzburg, Comprehensive Cancer Center

Würzburg, 97078, Germany

Location

Next Oncology, Phase I Unit. IOB - Hospital Quironsalud

Barcelona, 08023, Spain

Location

Hospital Universitari Vall d'Hebron, Institute of Oncology

Barcelona, 08035, Spain

Location

ICMDiM, Hospital Clinic

Barcelona, 08036, Spain

Location

ICO Hospitalet, Hospital Duran i Reynals

Barcelona, 08908, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

START Madrid, Hospital Universitario HM Sanchinarro

Madrid, 28050, Spain

Location

Clinica Universidad de Navarra, Unidad Central de Ensayos Clinicos

Pamplona, 31008, Spain

Location

University Hospital Basel, Department for Medical Oncology

Basel, 4031, Switzerland

Location

Kantonsspital St. Gallen, Clinic for Medical Oncology & Hematology

Sankt Gallen, 9007, Switzerland

Location

University Hospital Zurich, Department of Dermatology

Zurich, 9091, Switzerland

Location

Study Officials

• Sujata Rao, MD

  CatylYm GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients will be assigned to a dose level of CTL-002 (Part A) or an expansion cohort (Part B) at the time of their enrollment

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: January 26, 2021
• Study Start: December 9, 2020
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2030
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (7); DE (3); CH (3)