Dr Kim on Ongoing and Planned Research in HCC at Moffitt Cancer Center

Richard Kim, MD, service chief, Medical Gastrointestinal Oncology, senior member, Department of Gastrointestinal Oncology, Moffitt Cancer Center; professor, oncology, the University of South Florida College of Medicine, discusses ongoing and planned research at Moffitt Cancer Center in patients with hepatocellular carcinoma (HCC).

Although there is a plethora of approved TKI and immunotherapy agents in the HCC treatment armamentarium, there are still ample opportunities for novel drug development, Kim begins. Presently, Moffitt Cancer Center is pioneering the use of an agent designed to target the STAT3 pathway, he states. An ongoing phase 1b/2 trial (NCT05440708) is evaluating the efficacy of the STAT3 inhibitor, TTI-101, as a standalone agent in the refractory setting, Kim notes. Additionally, investigators are exploring its potential in combination with atezolizumab (Tecentriq) plus bevacizumab (Avastin) in the first-line setting, he adds.

The primary objective for cohort A of the phase 1b portion is evaluating the safety and tolerability of single-agent TTI-101. Additionally, the study aims to determine the maximum tolerated dose (MTD) or the recommended phase 2 dose (RP2D) of TTI-101 as a single agent. In the phase 2 portion of the study, the focus is on assessing the safety, tolerability, and preliminary efficacy of TTI-101 as a single agent at the RP2D in cohort A; key secondary objectives including response, progression, survival, and pharmacokinetics.

For cohorts B and C in the dose-expansion phase of the study, the primary objective is to evaluate the safety and tolerability of TTI-101 in combination with pembrolizumab (cohort B)or with atezolizumab and bevacizumab (cohort C) for patients with HCC. The primary goals of cohorts B and C in the phase 2 portion remain consistent, focusing on the safety, tolerability, and preliminary efficacy of these combinations for participants with locally advanced or metastatic, unresectable HCC.

STAT3 inhibitors are also being investigated in combination with pembrolizumab (Keytruda) for patients who have experienced progression on immunotherapy in the second line, he continues. Kim states that this signifies a commitment to exploring diverse drug classes to enhance current therapeutic approaches in HCC.