OncoMatch/Clinical Trials/NCT05440708
A Study of TTI-101 as Monotherapy and in Combination in Participants With Locally Advanced or Metastatic, and Unresectable Hepatocellular Carcinoma
Is NCT05440708 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including TTI-101 and Pembrolizumab for hepatocellular carcinoma.
Treatment: TTI-101 · Pembrolizumab · Atezolizumab · Bevacizumab — The primary objectives of Cohort A Phase 1b are to evaluate the safety and tolerability of TTI-101 orally administered as a single agent to participants with locally advanced or metastatic, and unresectable Hepatocellular Carcinoma (HCC) and to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of TTI-101 as a single agent. The primary objectives of Cohort A Phase 2 are to evaluate the safety and tolerability of TTI-101 orally administered as a single agent at the RP2D to participants with locally advanced or metastatic, and unresectable HCC and to assess the preliminary efficacy of TTI-101 as a single agent in participants with locally advanced or metastatic, and unresectable HCC. The secondary objectives of Cohort A Phase 2 are to assess response, progression, survival, and pharmacokinetics. The primary objectives of Cohorts B and C Phase 1b are to evaluate the safety and tolerability of TTI-101 orally administered in combination with pembrolizumab therapy (Cohort B) and in combination with atezolizumab and bevacizumab therapy (Cohort C) to participants with locally advanced or metastatic, or unresectable HCC and to determine the MTD and/or RP2D of TTI-101 when used in combination with pembrolizumab therapy (Cohort B) and in combination with atezolizumab and bevacizumab therapy (Cohort C). The primary objectives of Cohorts B and C Phase 2 are to evaluate the safety and tolerability of TTI-101 orally administered in combination with pembrolizumab therapy (Cohort B) and in combination with atezolizumab and bevacizumab therapy (Cohort C) at the RP2D to participants with locally advanced or metastatic, and unresectable HCC and to assess the preliminary efficacy of TTI-101 in combination with pembrolizumab therapy (Cohort B) and in combination with atezolizumab and bevacizumab therapy (Cohort C) to participants with locally advanced or metastatic, and unresectable HCC. The secondary objectives of Cohorts B and C Phase 2 are to assess response, progression, survival, and pharmacokinetics.
Check if I qualifyExtracted eligibility criteria
Cancer type
Hepatocellular Carcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: STAT inhibitor
Previous treatment of the current malignancy with a signal transducer and activator of transcription (STAT) inhibitor.
Cannot have received: allogeneic stem cell or solid organ transplantation
Prior allogeneic stem cell or solid organ transplantation.
Lab requirements
Blood counts
ANC ≥1.5 × 10^9/L (1500/μL) without G-CSF support; Lymphocyte count ≥0.5 × 10^9/L (500/μL); Platelet count ≥75 × 10^9/L (75,000/μL) without transfusion; Hemoglobin ≥90 g/L (9 g/dL), may be transfused to meet criterion.
Kidney function
creatinine clearance ≥40 mL/min calculated using the Cockcroft-Gault formula, or 24-hour urine collection.
Liver function
AST, ALT, and alkaline phosphatase (ALP) ≤5 × ULN; Serum bilirubin ≤2 mg/dL; Serum albumin ≥28 g/L (2.8 g/dL); Child-Pugh class A or B7 within 7 days prior to enrollment.
Cardiac function
No significantly impaired cardiac function such as unstable angina pectoris, congestive heart failure with NYHA Class III or IV, myocardial infarction within the last 12 months, serious arrhythmia (including QTc prolongation of >450 ms for males and >470 ms for females and/or pacemaker), prior diagnosis of congenital long QT syndrome, or LVEF <50% on screening echocardiogram.
Has adequate hematologic and organ function as defined by the following local laboratory values at screening: ... Child-Pugh class A or B7 within 7 days prior to enrollment. Significantly impaired cardiac function such as unstable angina pectoris, congestive heart failure with New York Heart Association Class III or IV, myocardial infarction within the last 12 months prior to study entry; serious arrhythmia (including QTc prolongation of >450 ms for males and >470 ms for females and/or pacemaker) or prior diagnosis of congenital long QT syndrome or left ventricular ejection fraction <50% on screening echocardiogram.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- The Kirklin Clinic of University of Alabama Birmingham Hospital · Birmingham, Alabama
- University of California San Diego · La Jolla, California
- Norris Comprehensive Cancer Center · Los Angeles, California
- University of California Irvine Medical Center · Orange, California
- University of Colorado Hospital - Anschutz Medical Campus · Aurora, Colorado
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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