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

RECRUITINGPHASE1

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

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

NCT06403436•TOLREMO therapeutics AG

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+1 more criteria

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.

Locations (7)

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

Key Dates

Start Date

November 7, 2023

Primary Completion Date

August 1, 2026

Completion Date

December 1, 2026

Last Updated

October 9, 2025

Enrollment

ESTIMATED participants

Conditions

Advanced Solid TumorAdult Solid TumorAdult DiseaseCancerNSCLCEGFRKRAS G12CSquamous Cell Lung Cancer

Interventions

TT125-802

DRUG

Contacts

Silvio Costanzo, MSc

CONTACT

+41616382333 clinical@tolremo.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 9, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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