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

Main Inclusion Criteria:

• Signed and dated informed consent, and able to comply with the study procedures andany locally required authorization.

• Male or female aged ≥ 18 years.

• Relapsed/refractory patients with histologically or cytologically confirmeddiagnosis of advanced-stage or recurrent cancer (Germany-specific: and haveexhausted 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 tumorbiopsy (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 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) Grade IV, any myocardial infarction/coronary event, CNS-ischemic event andany thromboembolic event at any time < 6 months prior to Screening or presence ofany 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 colitiswhich are generally excluded or active autoimmunthyroiditis present < 6 months priorto 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 Bvirus (HBV), hepatitis C virus (HCV), tuberculosis (TB), or severe acute respiratorysyndrome coronavirus 2 (SARS-CoV-2).