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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

Tracking Information
First Submitted Date  ICMJE January 14, 2021
First Posted Date  ICMJE January 26, 2021
Last Update Posted Date September 28, 2021
Actual Study Start Date  ICMJE December 9, 2020
Estimated Primary Completion Date May 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2021)
  • Adverse Events (Parts A & B) [ Time Frame: min. 2 months ]
    Incidence of treatment emergent adverse events in monotherapy and/or combination therapy
  • Determination of DLT and MTD (Part A) [ Time Frame: 28 days ]
    Assessment of toxicities in monotherapy and/or combination therapy per dose level
  • Evaluation of clinical efficacy according RECIST (Part B) [ Time Frame: min. 6 weeks ]
    RECIST is measured every 6-8 weeks treatment
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2021)
  • Cmax following the first dose of CTL-002 (Part A & B) [ Time Frame: 1 day ]
    PK parameter from serum CTL-002 levels
  • AUC following the first dose of CTL-002 (Part A & B) [ Time Frame: 14 days ]
    PK parameter from serum CTL-002 levels
  • Half-life of CTL-002 (Part A & B) [ Time Frame: min. 6 weeks ]
    PK parameter from serum CTL-002 levels
  • 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
  • Evaluation of clinical efficacy according RECIST (Part A) [ Time Frame: min. 6 weeks ]
    RECIST is measured every 6-8 weeks during treatment
  • Evaluation of appetite [ Time Frame: min. 6 weeks ]
    Assessment of appetite via quality of life questionnaire
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE First-in-Human Study of the GDF-15 Neutralizing Antibody CTL-002 in Patients With Advanced Cancer (GDFATHER)
Official Title  ICMJE 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).
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE 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
Condition  ICMJE Solid Tumor, Adult
Intervention  ICMJE Biological: CTL-002
monoclonal antibody
Study Arms  ICMJE
  • 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
    Intervention: Biological: CTL-002
  • Experimental: Part B: CTL-002 Monotherapy + Checkpoint Inhibitor combination
    Up to 2 dose levels with CTL-002 in Part B (expansion)
    Intervention: Biological: CTL-002
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 25, 2021)
155
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 31, 2025
Estimated Primary Completion Date May 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Germany,   Spain,   Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04725474
Other Study ID Numbers  ICMJE CTL-002-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party CatalYm GmbH
Study Sponsor  ICMJE CatalYm GmbH
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Eugen Leo, MD, PhD, MBA CatylYm GmbH
PRS Account CatalYm GmbH
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP