A Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of TT125-802 in Subjects With Advanced Solid Tumors

Launched by TOLREMO THERAPEUTICS AG · May 3, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called TT125-802 for adults with advanced solid tumors, which are types of cancer that have spread or do not respond to standard treatments. The main goal of the study is to evaluate how safe TT125-802 is and how well it works against these tumors. The trial is currently looking for participants aged 18 and older who have advanced cancer that has not improved with other therapies. To be eligible, individuals need to have measurable cancer, good overall health, and certain blood test results.

Participants in this trial can expect to receive the TT125-802 treatment and will be monitored closely for any side effects and how their cancer responds. They will need to follow some specific guidelines, such as avoiding certain medications and maintaining health check-ups. It's important for potential participants to understand that this is an early-stage study, so while they may benefit from the treatment, it is also a chance to help researchers learn more about fighting advanced solid tumors.

Gender

ALL

Eligibility criteria

• 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.