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

NCT06403436 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: TT-CSP-001
• Study Type: interventional
• Target: 50
• Locations: 3 countries
• Sites: 7

Brief 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.

Conditions

Advanced Solid Tumor; Adult Solid Tumor; Adult Disease; Cancer; NSCLC; EGFR; Squamous Cell Lung Cancer; KRAS G12C

Keywords

TOLREMO; Drug resistance; TT125-802; Small molecule; Bromodomain inhibitor; NSCLC

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• 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

Study Arms (1)

TT125-802 single agent

EXPERIMENTAL

Drug: TT125-802

Interventions

TT125-802 DRUG

TT125-802 administered orally

TT125-802 single agent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• TOLREMO therapeutics AG: lead

Study Sites (7)

Sarah Cannon Research Institute Oncology Partners

Nashville, Tennessee, 37203, United States

Location

NEXT Oncology Virginia

Fairfax, Virginia, 22031, United States

Location

NEXT Oncology Barcelona

Barcelona, 08023, Spain

Location

Vall d'Hebron Institute of Oncology

Barcelona, 08035, Spain

Location

NEXT Oncology Madrid

Madrid, 28223, Spain

Location

Ente Ospedaliero Cantonale

Bellinzona, 6500, Switzerland

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, 1890, Switzerland

Location

MeSH Terms

Conditions

Disease; Neoplasms

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2024
• First Posted: May 7, 2024
• Study Start: November 7, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (2); US (2); ES (3)