Evaluating a new drug for 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

This study is testing a new drug called TT125-802 to see if it can help people with advanced solid tumors that haven't responded to other treatments.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: TOLREMO therapeutics AG (industry)
• Locations: 5 sites (Barcelona and 4 other locations)
• Trial ID: NCT06403436 on ClinicalTrials.gov

What this trial studies

This Phase 1, First-in-Human, Open-label study aims to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of TT125-802, a small molecule bromodomain inhibitor, in patients with advanced solid tumors. Participants will receive TT125-802 as a single agent to determine its therapeutic effects on tumors that are resistant or refractory to standard treatments. The study will involve measuring various health parameters and tumor responses to assess the drug's performance.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with advanced solid tumors that are resistant to standard treatments and have a performance status of 0 or 1.

Not a fit: Patients with solid tumors that are not advanced or those who have not exhausted standard treatment options may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors that have not responded to existing therapies.

How similar studies have performed: Other studies involving bromodomain inhibitors have shown promise, indicating potential for success with this novel approach.

Eligibility criteria

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.

Where this trial is running

Barcelona and 4 other locations

• NEXT Oncology Barcelona — Barcelona, Spain (RECRUITING)
• Vall d'Hebron Institute of Oncology — Barcelona, Spain (RECRUITING)
• NEXT Oncology Madrid — Madrid, Spain (RECRUITING)
• Ente Ospedaliero Cantonale — Bellinzona, Switzerland (RECRUITING)
• Centre Hospitalier Universitaire Vaudois — Lausanne, Switzerland (RECRUITING)

Study contacts

• Study coordinator: Silvio Costanzo, MSc

Conditions: Advanced Solid Tumor, Adult Solid Tumor, Adult Disease, Cancer, NSCLC, TOLREMO, Drug resistance, TT125-802