Mount Pleasant

Researchers are investigating ATG-037 alone and in combination with Pembrolizumab for patients with locally advanced or metastatic solid tumors. This Phase I, multi-center, open-label, dose-finding study aims to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of these treatments. The study includes patients with unresectable Stage III or IV melanoma who have progressed after prior immune checkpoint inhibitor therapy, excluding mucosal and uveal melanoma types. The study consists of two parts: Part I involves oral administration of ATG-037 once daily on day -2, followed by twice daily from cycle 1 day 1, with a 21-day treatment cycle. After two cycles of ATG-037 monotherapy, eligible participants receive combination therapy with ATG-037 and Pembrolizumab 200 mg every three weeks for up to approximately two years. In Part II, ATG-037 and Pembrolizumab are administered starting from cycle 1. The study plans to enroll 39-51 subjects for dose escalation in Part 1, up to 18 subjects in Part 2 dose escalation, and 24-34 subjects per dose expansion cohort. Participants will be monitored for adverse events, dose-limiting toxicities, maximum tolerated dose, and recommended phase 2 dose over up to 21 days and one year after the last dose. Assessments include safety monitoring, pharmacokinetic and pharmacodynamic testing, and preliminary efficacy evaluations. The study requires participants to have adequate organ function and an ECOG performance status of 0 or 1, with contraceptive measures for females and barrier contraception for males during and after treatment.

Researchers are studying patritumab deruxtecan (MK-1022) as a treatment for certain advanced gastrointestinal cancers, including colorectal cancer, biliary tract cancer, hepatocellular carcinoma, and gastroesophageal cancer. These cancers have spread or cannot be surgically removed. The study aims to understand the safety, tolerability, and effectiveness of this treatment, especially how many patients experience tumor shrinkage or disappearance. Participants will receive patritumab deruxtecan through intravenous infusion. The study includes both Phase 1 and Phase 2 stages to evaluate safety and how well the treatment works. Patients who have already undergone prior therapy for their cancer and have recovered from any side effects will be enrolled. During the study, researchers will monitor participants for dose-limiting toxicities within 21 days, track any adverse events over about 44 months, and observe if participants stop treatment due to side effects. The main outcome also includes measuring the objective response rate, or how many patients' tumors respond to the treatment. Safety and efficacy will be carefully assessed throughout the trial.