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

Cancer Clinical Trial

— TT-CSP-001  

Official title:

A Phase 1, First-in-Human, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of TT125-802 in Subjects With Advanced Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06403436
• Other study ID #: TT-CSP-001
• Status: Recruiting
• Phase: Phase 1
• Start date: November 7, 2023
• Est. completion date: December 2025

Study information

• Verified date: June 2024
• Source: TOLREMO therapeutics AG
• Contact: Silvio Costanzo, MSc
• Phone: +41616382333
• Email: clinical[@]tolremo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adult Disease
• Adult Solid Tumor
• Advanced Solid Tumor
• Cancer
• Neoplasms

Intervention

Drug:
• TT125-802
TT125-802 administered orally

Locations

Country	Name	City	State
Spain	Hospital Vall d'Hebrón	Barcelona
Spain	NEXT Oncology	Barcelona
Spain	NEXT Madrid	Madrid
Switzerland	Ente Ospedaliero Cantonale	Bellinzona
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
TOLREMO therapeutics AG

Countries where clinical trial is conducted

Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency and severity of adverse events (AEs) and serious adverse events (SAEs)		Day 1 to approximately 16 weeks
Primary	Frequency of dose interruptions and dose reductions		Day 1 to approximately 16 weeks
Primary	Incidence of dose-limiting toxicities (DLTs)		Day 1 to Day 21
Primary	Recommended Dose(s) for Expansion		Day 1 to Day 21
Secondary	Plasma concentration of TT125-802 in blood		Day 1 to approximately 16 weeks
Secondary	Objective response rate (ORR) assessed by RECIST v1.1		Day 1 to approximately 16 weeks
Secondary	Duration of response (DOR) according to RECIST v1.1		Day 1 to approximately 16 weeks
Secondary	Progression-free survival (PFS) according to RECIST v1.1		Day 1 to approximately 16 weeks