A Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of TT125-802 in Subjects With Advanced Solid Tumors (TT-CSP-001)

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

The purpose of this study is to test the safety and therapeutic effect of TT125-802 (single agent) in subjects with advanced solid tumors.

Study Overview

• Status: Active, not recruiting
• Conditions: Cancer; Adult Solid Tumor; NSCLC; Advanced Solid Tumor; Adult Disease; Squamous Cell Lung Cancer; EGFR; KRAS G12C
• Intervention / Treatment: Drug: TT125-802

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 1

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08035
    • Vall d'Hebron Institute of Oncology
  • Barcelona, Spain, 08023
    • Next Oncology Barcelona
  • Madrid, Spain, 28223
    • Next Oncology Madrid
• Switzerland
  • Bellinzona, Switzerland, 6500
    • Ente Ospedaliero Cantonale
  • Lausanne, Switzerland, 1890
    • Centre Hospitalier Universitaire Vaudois
• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Sarah Cannon Research Institute Oncology Partners
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • NEXT Oncology Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TT125-802 single agent	Drug: TT125-802; TT125-802 administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Frequency and severity of adverse events (AEs) and serious adverse events (SAEs)	Day 1 to approximately 16 weeks
Frequency of dose interruptions and dose reductions	Day 1 to approximately 16 weeks
Incidence of dose-limiting toxicities (DLTs)	Day 1 to Day 21
Recommended Dose(s) for Expansion	Day 1 to Day 21

Secondary Outcome Measures

Outcome Measure	Time Frame
Plasma concentration of TT125-802 in blood	Day 1 to approximately 16 weeks
Objective response rate (ORR) assessed by RECIST v1.1	Day 1 to approximately 16 weeks
Duration of response (DOR) according to RECIST v1.1	Day 1 to approximately 16 weeks
Progression-free survival (PFS) according to RECIST v1.1	Day 1 to approximately 16 weeks

Collaborators and Investigators

• Sponsor: TOLREMO therapeutics AG

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: April 12, 2024
• First Submitted That Met QC Criteria: May 3, 2024
• First Posted (Actual): May 7, 2024

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: NSCLC; Drug resistance; Small molecule; TOLREMO; TT125-802; Bromodomain inhibitor
• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms; Disease
• Other Study ID Numbers: TT-CSP-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No