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JOURNAL ONKOLOGIE – STUDIE
GDFATHER

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

Rekrutierend

NCT-Nummer:
NCT04725474

Studienbeginn:
Dezember 2020

Letztes Update:
26.01.2021

Wirkstoff:
CTL-002

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 1

Sponsor:
CatalYm GmbH

Collaborator:
-

Studienleiter

Eugen Leo, MD, PhD, MBA
Study Director
CatylYm GmbH

Kontakt

Studienlocations
(3 von 6)

Universitätsklinikum Essen, Westdeutsches Tumorzentrum, Innere Klinik und Poliklinik
45147 Essen
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps
Universitätsklinikum Würzburg, Comprehensive Cancer Center
97078 Würzburg
(Bayern)
GermanyNoch nicht rekrutierend» Google-Maps
Hospital Universitari Vall d'Hebron, Institute of Oncology
08035 Barcelona
SpainNoch nicht rekrutierend» Google-Maps
START Madrid, Hospital Universitario HM Sanchinarro
28050 Madrid
SpainRekrutierend» Google-Maps
Clinica Universidad de Navarra, Unidad Central de Ensayos Clinicos
31008 Pamplona
SpainRekrutierend» Google-Maps
University Hospital Zurich, Department of Dermatology
9091 Zurich
SwitzerlandNoch nicht rekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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).

Studien-Rationale

Primary outcome:

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:

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

Studien-Arme

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

Geprüfte Regime

  • CTL-002:
    monoclonal antibody

Quelle: ClinicalTrials.gov


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