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

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

NCT ID: NCT06403436

Condition: Advanced Solid Tumor
Adult Solid Tumor
Adult Disease
Cancer

Conditions: Official terms:
Neoplasms

Conditions: Keywords:
TOLREMO
Drug resistance
TT125-802
Small molecule

Study type: Interventional

Study phase: Phase 1

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: TT125-802
Description: TT125-802 administered orally
Arm group label: TT125-802 single agent

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.

Criteria for 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 an estimated glomerular filtration rate > 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: NEXT Oncology

Address:
City: Barcelona
Zip: 08023
Country: Spain

Status: Recruiting

Contact:
Last name: Elena Garralda, MD

Facility:
Name: Hospital Vall d'Hebrón

Address:
City: Barcelona
Zip: 08035
Country: Spain

Status: Recruiting

Contact:
Last name: Irene Braña, MD

Facility:
Name: NEXT Madrid

Address:
City: Madrid
Zip: 28223
Country: Spain

Status: Recruiting

Contact:
Last name: Valentina Boni, MD

Facility:
Name: Ente Ospedaliero Cantonale

Address:
City: Bellinzona
Zip: 6500
Country: Switzerland

Status: Recruiting

Contact:
Last name: Ilaria Colombo, MD

Facility:
Name: Centre Hospitalier Universitaire Vaudois

Address:
City: Lausanne
Zip: 1890
Country: Switzerland

Status: Recruiting

Contact:
Last name: Krisztian Homicsko, MD

Start date: November 7, 2023

Completion date: December 2025

Lead sponsor:
Agency: TOLREMO therapeutics AG
Agency class: Industry

Source: TOLREMO therapeutics AG

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06403436