A Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of TT125-802 in Subjects With Advanced Solid Tumors
Phase 1
Recruiting
- Conditions
- Advanced Solid TumorAdult Solid TumorAdult DiseaseCancerNSCLC
- Interventions
- Registration Number
- NCT06403436
- Lead Sponsor
- TOLREMO therapeutics AG
- Brief Summary
The purpose of this study is to test the safety and therapeutic effect of TT125-802 (single agent) in subjects with advanced solid tumors.
- Detailed Description
The purpose of this Phase 1, First-in-Human, Open-label Study is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of TT125-802 as single agent in subjects with advanced solid tumors.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
- Males and nonpregnant and non-breastfeeding females, aged ≥ 18 years of age at the time of signing the informed consent.
- Subjects with advanced solid tumors resistant or refractory to standard treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Measurable disease per RECIST 1.1 criteria.
- Adequate hematological function defined by absolute neutrophil count, ≥ 1.5 × 10^9/L, platelet count ≥ 100 × 10^9/L, and hemoglobin ≥ 9 g/dL, and without growth factor treatment or blood transfusion within 2 weeks before the study intervention start.
- Adequate hepatic function defined by total bilirubin level ≤ 1.5 × upper limit of normal (ULN), aspartate aminotransferase (AST) level ≤ 3 × ULN, and an alanine aminotransferase (ALT) level ≤ 3 × ULN.
- Adequate renal function defined by creatinine clearance > 60 mL/min according to the Cockcroft-Gault equation or creatinine levels <1.5 mg/dl.
- Adequate coagulation laboratory assessments, as follows: Prothrombin time (PT) or partial thromboplastin time (PTT) < 1.5 x upper limit of normal (ULN), or international normalized ratio (INR) < 1.5 or within target range if on prophylactic anticoagulation therapy.
- Life expectancy of > 3 months, in the opinion of the Investigator.
- Willing to adhere to contraception, egg and sperm donation, the fasting requirement, and other criteria as described in lifestyle restrictions
- Capable of giving signed informed consent.
Exclusion Criteria
- Clinically significant (i.e., active) uncontrolled intercurrent illness.
- Presence of brain metastases unless clinically stable.
- History or presence of malignancies unless curatively treated with no evidence of disease ≥ 2 years.
- Subjects with known human immunodeficiency virus and/or active viral hepatitis (B and/or C), and subjects on viral hepatitis B therapy are excluded. However, subjects with hepatitis C treated with curative therapy are not considered actively infected.
- Subject received a live vaccine within 30 days prior to the first dose of the study treatment administration.
- Serious gastrointestinal bleeding within 3 months, refractory nausea and vomiting, uncontrolled diarrhea, known malabsorption, significant small bowel resection or gastric bypass surgery, use of feeding tubes, other chronic gastrointestinal disease, and/or other situation that may preclude adequate absorption of oral medications.
- Subjects that have received a strong CYP3A4 inhibitor within 7 days prior to the first dose of TT125-802 or a strong CYP3A4 inducer within 14 days prior to the first dose of TT125-802.
- Hypersensitivity to the active substance or to any of the excipients of TT125-802.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description TT125-802 single agent TT125-802 -
- Primary Outcome Measures
Name Time Method Recommended Dose(s) for Expansion Day 1 to Day 21 Frequency and severity of adverse events (AEs) and serious adverse events (SAEs) Day 1 to approximately 16 weeks Frequency of dose interruptions and dose reductions Day 1 to approximately 16 weeks Incidence of dose-limiting toxicities (DLTs) Day 1 to Day 21
- Secondary Outcome Measures
Name Time Method Plasma concentration of TT125-802 in blood Day 1 to approximately 16 weeks Objective response rate (ORR) assessed by RECIST v1.1 Day 1 to approximately 16 weeks Duration of response (DOR) according to RECIST v1.1 Day 1 to approximately 16 weeks Progression-free survival (PFS) according to RECIST v1.1 Day 1 to approximately 16 weeks
Trial Locations
- Locations (5)
NEXT Oncology Barcelona
🇪🇸Barcelona, Spain
Vall d'Hebron Institute of Oncology
🇪🇸Barcelona, Spain
NEXT Oncology Madrid
🇪🇸Madrid, Spain
Ente Ospedaliero Cantonale
🇨🇭Bellinzona, Switzerland
Centre Hospitalier Universitaire Vaudois
🇨🇭Lausanne, Switzerland