A Phase 1/2, first-in-human, two-part, open-label clinical trial of intravenous 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.
- Conditions
- ADVANCED-STAGE, RELAPSED/REFRACTORY SOLID TUMORSMedDRA version: 21.1Level: LLTClassification code: 10065252Term: Solid tumor Class: 10029104Therapeutic area: Diseases [C] - Neoplasms [C04]Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- CTIS2024-512575-12-00
- Lead Sponsor
- CatalYm GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 199
Provide signed and dated informed consent. For Part A only: signed pre-screening consent for subjects that undergo pre-screening procedures or collection of historical data prior to informed consent procedure., Life expectancy > 3 months as assessed by the Investigator., Adequate organ function: a. Bone marrow function: hemoglobin = 9.0 g/dL (equal to 5.59 mmol/L); platelet count = 100 × 10^9 /L; leukocyte count = 2.5 × 10^9 /L. b. Hepatic function: AST and ALT = 2 × upper limit of normal (ULN) (3 × ULN in the case of liver metastases); bilirubin = 1.5 × ULN (2 × ULN in case of liver metastases/subjects with Gilbert’s disease). c. Renal function: serum creatinine < 1.5 × ULN and/or creatinine clearance = 50 ml/min (Cockcroft-Gault equation). d. Coagulation: no evidence for clinically relevant hypo- or hypercoagulability or presence of thrombosis/thrombotic event as per D-Dimer, antithrombin III (ATIII), prothrombin time (PT)/international normalized ratio (INR), and activated partial thromboplastin time (aPTT) analysis and treating physician’s assessment. Note: D-Dimer elevation by itself does not preclude inclusion if no clinical evidence of thrombosis is present., All toxicities related to prior radiotherapy, chemotherapy, and any type of immunotherapy or other anti-cancer therapy, or surgical procedure must have recovered to Grade = 1 based on NCICTCAE v5.0, except alopecia (any grade), and Grade 2 peripheral sensory neuropathy, and AEs that are clinically not considered as significant in this context and/or are stable on supportive therapy., If subject has type II diabetes and receives metformin, metformin has to be replaced with other antidiabetic(s) prior to start of study treatment (at minimum 7 days prior to study baseline GDF-15 measurement) and for the whole study treatment duration, Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to CTL-002 treatment. If a pregnancy test is not performed within 7 days of dosing with CTL-002, a repeat test must be performed prior to Day 1 dosing. Women of childbearing potential are defined as sexually mature women without prior hysterectomy or who have had any evidence of menses in the past 12 months. However, women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, anti-estrogens, or ovarian suppression., All subjects, male and female, who are not surgically sterilized or postmenopausal as defined above, and subjects’ partners of childbearing potential must agree to use highly effective methods of contraception” during the study and for at least 5 months (5 times the predicted half-life of CTL-002 in humans) after the last dose of CTL-002. Highly effective methods of contraception” are combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation, progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner, or sexual abstinence. The double-barrier method (synthetic condoms, diaphragm, or cervical cap with spermicidal foam, cream or gel), periodic abstinence (such as calendar, symptothermal, or post-ovulation), withdrawal (coitus interruptus), lactational amenorrhea method and spermicide only are NOT acceptable as highly effective methods
Pregnant or breastfeeding., 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 autoimmune thyroiditis present < 6 months prior to Screening., Type I diabetes., History of CNS disease such as stroke, seizure, encephalitis, or multiple sclerosis (< 6 months prior to Screening)., Any history of motor neuron disorder or disease that affects motor neuron function., Ongoing immune-related AEs (irAEs) and/or AEs = Grade 2 not resolved from previous therapies except vitiligo, stable peripheral sensory neuropathy up to Grade 2, hair loss, and stable endocrinopathies with substitutive hormone therapy., Active allergy requiring systemic treatment (with the exception of histamine H1 receptor blocker treatment) or active infections requiring systemic anti-infectious therapy., History of or clinical evidence of CNS primary tumors or metastases including leptomeningeal metastases, unless they have been previously treated, demonstrated no progression at least for 3 months before Screening, are asymptomatic and have had no requirement for steroids or enzyme inducing anticonvulsants in the last 14 days before Screening – subjects with suspected brain metastases at Screening should undergo a CT/MRI of the brain prior to study entry., Systemic steroids at a daily dose of > 10 mg of prednisolone, > 2 mg of dexamethasone or equivalent, except non-systemic (inhaled, topical, nasal), for the last 28 days and ongoing., Subjects with rapidly progressing disease (as per Investigator assessment), which may predispose to inability to tolerate treatment and/or study procedure., Has received any tumor-directed therapy within 21 days before start of study treatment., Major surgery within last 4 weeks prior to Screening., Known/expected hypersensitivity against CTL-002 and/or anti-PD-1/PD-L1 agents or their ingredients or previously had a severe hypersensitivity (= Grade 3) reaction to treatment with monoclonal antibodies (including pembrolizumab, nivolumab, cemiplimab etc.) and/or any of their excipients, 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) as per adequate testing performed, Dementia or altered mental status that would prohibit informed consent., Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory abnormality giving reasonable suspicion of a disease or condition that in the opinion of the Investigator would contraindicate the use of an investigational drug., Receipt of any organ transplantation, including hematopoietic cell transplantation, but with the exception of transplants that do not require immunosuppression (e.g., corneal transplant, hair transplant)., Paraneoplastic syndrome (PNS) of autoimmune nature, requiring systemic treatment (systemic steroids or immunosuppressive agents) or a clinical symptomatology suggesting worsening of PNS., Vaccine administration within 4 weeks of investigational drug administration (exception: coronavirus disease 2019 [COVID-19] vaccination). Vaccination with live vaccines while on trial is prohibited. Administration of inactivated vaccines like inactivated influenza vaccines or RNA vaccines is allowed, including COVID-19., Known active drug or alcohol ab
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method