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

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ClinicalTrials.gov Identifier: NCT04725474
Recruitment Status : Recruiting
First Posted : January 26, 2021
Last Update Posted : September 28, 2021
Sponsor:
Information provided by (Responsible Party):
CatalYm GmbH

Brief Summary:
Part A will be a dose escalation study of IV CTL002 (a monoclonal antibody neutralizing GDF-15) as monotherapy and in combination with an approved checkpoint inhibitor (CPI) in patients with advanced solid tumors. Part B will be a cohort expansion into up to five solid tumor indications.

Condition or disease Intervention/treatment Phase
Solid Tumor, Adult Biological: CTL-002 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 155 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients will be assigned to a dose level of CTL-002 at the time of their enrollment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, First-in-human (FIH), Two-part, Open-label Clinical Trial of Intravenous (IV) Administration of CTL-002 Given as Monotherapy and/or in Combination With an Anti-PD-1 Checkpoint Inhibitor in Subjects With Advanced-stage, Relapsed/Refractory Solid Tumors, That Relapsed Post or Were Refractory to a Prior Anti-PD-1/PD-L1 Therapy and Have Exhausted All Available Approved Standard Treatments or Are Not Eligible for Them Anymore (the "GDFATHER"-Trial: GDF-15 Antibody-mediaTed Effector Cell Relocation).
Actual Study Start Date : December 9, 2020
Estimated Primary Completion Date : May 31, 2023
Estimated Study Completion Date : May 31, 2025

Arm Intervention/treatment
Experimental: Part A: CTL-002 Monotherapy + Checkpoint Inhibitor Combination Dose Escalation
Up to five dose levels with CTL-002 administered as IV monotherapy and in combination with an checkpoint inhibitor
Biological: CTL-002
monoclonal antibody

Experimental: Part B: CTL-002 Monotherapy + Checkpoint Inhibitor combination
Up to 2 dose levels with CTL-002 in Part B (expansion)
Biological: CTL-002
monoclonal antibody




Primary Outcome Measures :
  1. Adverse Events (Parts A & B) [ Time Frame: min. 2 months ]
    Incidence of treatment emergent adverse events in monotherapy and/or combination therapy

  2. Determination of DLT and MTD (Part A) [ Time Frame: 28 days ]
    Assessment of toxicities in monotherapy and/or combination therapy per dose level

  3. Evaluation of clinical efficacy according RECIST (Part B) [ Time Frame: min. 6 weeks ]
    RECIST is measured every 6-8 weeks treatment


Secondary Outcome Measures :
  1. Cmax following the first dose of CTL-002 (Part A & B) [ Time Frame: 1 day ]
    PK parameter from serum CTL-002 levels

  2. AUC following the first dose of CTL-002 (Part A & B) [ Time Frame: 14 days ]
    PK parameter from serum CTL-002 levels

  3. Half-life of CTL-002 (Part A & B) [ Time Frame: min. 6 weeks ]
    PK parameter from serum CTL-002 levels

  4. Evaluation of treatment-emergent cytokine/chemokine concentrations (including TNF-a, IFN-g, IL-2, CXCL-9 and CXCL-10) (Part A & B) [ Time Frame: min. 6 weeks ]
    Measurement of concentration in peripheral blood

  5. Evaluation of clinical efficacy according RECIST (Part A) [ Time Frame: min. 6 weeks ]
    RECIST is measured every 6-8 weeks during treatment

  6. Evaluation of appetite [ Time Frame: min. 6 weeks ]
    Assessment of appetite via quality of life questionnaire

  7. Assessment of Body-Mass-Index (BMI) (kg/m2) [ Time Frame: min. 6 weeks ]
    Calculation of BMI in kg/m2 by combining measurement of body weight in kg and body height in cm

  8. Assessment of lumbar vertebra skeletal muscle index (L3SMI) (cm2/m2) [ Time Frame: min. 6 weeks ]
    Combining measurement of L3 vertebra skeletal muscle mass via computed tomography (CT) in cm2 and patient height (squared) in m2



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Main Inclusion Criteria:

  • 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
  • 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).
  • 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).

Main Exclusion Criteria:

  • 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 II-IV), any myocardial infarction/coronary event, CNS-ischemic event and any thromboembolic event at any time < 6 months prior to Screening.
  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04725474


Contacts
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Contact: Eugen Leo, MD, PhD, MBA / CMO +49 89 200066440 eugen.leo@catalym.com
Contact: Petra Fettes, PhD +49 89 200066440 petra.fettes@catalym.com

Locations
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Germany
Universitätsklinikum Essen, Westdeutsches Tumorzentrum, Innere Klinik und Poliklinik Recruiting
Essen, Germany, 45147
Universitätsklinikum Würzburg, Comprehensive Cancer Center Recruiting
Würzburg, Germany, 97078
Contact: Franziska Goerke    +49 931 201 409 ext 57    Goerke_f@ukw.de   
Contact: Julia Petzoldt- Weigel    +49 931 201 409 ext 59    Petzoldt_J@ukw.de   
Principal Investigator: Maria-Elisabeth Goebeler, Dr.         
Sub-Investigator: Ralf Bargou, Prof. Dr.         
Sub-Investigator: Cyrus Sayehli, Dr.         
Spain
Hospital Universitari Vall d'Hebron, Institute of Oncology Recruiting
Barcelona, Spain, 08035
Contact: Elena Garralda, Dr.       egarralda@vhio.net   
Principal Investigator: Elena Garralda Cabanas, Dr.         
START Madrid, Hospital Universitario HM Sanchinarro Recruiting
Madrid, Spain, 28050
Contact       emiliano.calvo@startmadrid.com   
Principal Investigator: Emiliano Calvo Aller, Prof. Dr.         
Clinica Universidad de Navarra, Unidad Central de Ensayos Clinicos Recruiting
Pamplona, Spain, 31008
Contact       eecc@unav.es   
Principal Investigator: Ignacio Melero Bermejo, Prof. Dr.         
Switzerland
University Hospital Zurich, Department of Dermatology Recruiting
Zurich, Switzerland, 9091
Contact: Reinhard Dummer, Prof. Dr.    +41 43 253 09 38    reinhard.dummer@usz.ch   
Principal Investigator: Reinhard Dummer, Prof. Dr.         
Sponsors and Collaborators
CatalYm GmbH
Investigators
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Study Director: Eugen Leo, MD, PhD, MBA CatylYm GmbH
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Responsible Party: CatalYm GmbH
ClinicalTrials.gov Identifier: NCT04725474    
Other Study ID Numbers: CTL-002-001
First Posted: January 26, 2021    Key Record Dates
Last Update Posted: September 28, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CatalYm GmbH:
CTL-002
GDF-15