A Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of TT125-802 in Subjects With Advanced Solid Tumors
NCT ID: NCT06403436
Last Updated: 2025-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
50 participants
INTERVENTIONAL
2023-11-07
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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TT125-802 single agent
TT125-802
TT125-802 administered orally
Interventions
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TT125-802
TT125-802 administered orally
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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TOLREMO therapeutics AG
INDUSTRY
Responsible Party
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Locations
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Sarah Cannon Research Institute Oncology Partners
Nashville, Tennessee, United States
NEXT Oncology Virginia
Fairfax, Virginia, United States
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
Countries
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Central Contacts
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Facility Contacts
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Deepak Bhamidipati, MD
Role: primary
Alexander I Spira, MD
Role: primary
Elena Garralda, MD
Role: primary
Irene Braña, MD
Role: primary
Valentina Boni, MD
Role: primary
Ilaria Colombo, MD
Role: primary
Krisztian Homicsko, MD
Role: primary
Other Identifiers
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TT-CSP-001
Identifier Type: -
Identifier Source: org_study_id