Status:
ACTIVE_NOT_RECRUITING
First-in-Human Study of the GDF-15 Neutralizing Antibody Visugromab (CTL-002) in Patients With Advanced Cancer (GDFATHER)
Lead Sponsor:
CatalYm GmbH
Conditions:
Solid Tumor, Adult
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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)...
Eligibility Criteria
Inclusion
- Main
- 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).
- Main
Exclusion
- 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).
Key Trial Info
Start Date :
December 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2027
Estimated Enrollment :
274 Patients enrolled
Trial Details
Trial ID
NCT04725474
Start Date
December 9 2020
End Date
October 31 2027
Last Update
August 9 2024
Active Locations (13)
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1
Universitätsklinikum Essen, Westdeutsches Tumorzentrum, Innere Klinik und Poliklinik
Essen, Germany, 45147
2
Universitätsklinikum Frankfurt, Medizinische Klinik I
Frankfurt am Main, Germany, 60590
3
Universitätsklinikum Würzburg, Comprehensive Cancer Center
Würzburg, Germany, 97078
4
Next Oncology, Phase I Unit. IOB - Hospital Quironsalud
Barcelona, Spain, 08023