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

TOLREMO therapeutics AG

Status and phase

Enrolling

Phase 1

Conditions

EGFR

Squamous Cell Lung Cancer

Advanced Solid Tumor

KRAS G12C

Cancer

Adult Solid Tumor

Adult Disease

NSCLC

Treatments

Drug: TT125-802

Study type

Interventional

Funder types

Industry

Identifiers

NCT06403436

TT-CSP-001

Details and patient eligibility

About

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

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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
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.