Rioja

Researchers are evaluating ART0380, an oral drug that blocks ATR kinase, in people with advanced or metastatic solid tumors including ovarian, peritoneal, fallopian tube, endometrial, colorectal, pancreatic ductal adenocarcinoma, and acinar cell carcinoma. The study aims to find the safe dose of ART0380 alone and combined with chemotherapy drugs gemcitabine or irinotecan, understand side effects, and assess its effectiveness. This open-label Phase I/IIa trial includes participants whose cancers have DNA repair defects or lack ATM protein and some specific cancer types. Participants receive ART0380 by mouth in 21-day cycles either intermittently (several days on then off) or continuously daily. Gemcitabine is given on days 1 and 8, and irinotecan is given by 90-minute infusion on the same days in combination groups. The study has different parts to find dosing levels and to evaluate safety, tolerability, pharmacokinetics, and initial effectiveness of ART0380 alone or combined with the chemotherapy drugs. During the study, participants undergo regular evaluations including scans every 6 to 9 weeks to monitor tumor response, and safety assessments for side effects throughout treatment and up to 30 days after the last dose. Researchers track adverse events and measure progression-free survival and tumor response rates over up to 2 years. Participants are expected to be available and willing to follow study procedures and assessments during the trial period.

Researchers are investigating JK06, a biparatopic anti-5T4 antibody drug conjugate, in patients with unresectable locally advanced or metastatic solid tumors. This Phase 1/2, open-label, multi-center study aims to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and initial anti-tumor activity of JK06. The study includes a dose escalation phase to identify the maximum tolerated dose and recommended Phase 2 dose, followed by a cohort expansion phase to further assess safety and initial efficacy in specific tumor groups. Participants receive JK06 intravenously in varying doses and schedules during the dose escalation phase. After determining the appropriate dose, the cohort expansion phase enrolls additional patients to better understand JK06's effects in tumor-specific groups. The study monitors treatment-emergent adverse events from screening through 28 days after the last dose and evaluates dose-limiting toxicities during the first 21 days of treatment. The objective response rate is assessed from randomization up to 104 weeks. Throughout the study, participants undergo regular clinical visits with assessments including imaging by CT or MRI to document measurable disease, laboratory tests to monitor organ function and blood counts, and tumor biopsies. They must comply with scheduled visits and study procedures, including pregnancy testing and contraceptive use when applicable. Researchers track safety and tolerability, as well as JK06's pharmacokinetics and immune response, over a treatment period lasting up to 14 months and beyond for response evaluation.

Researchers are evaluating the safety, tolerability, and effectiveness of rezatapopt (PC14586), an oral small molecule drug that reactivates the p53 protein selectively for the TP53 Y220C mutation. This study includes people with locally advanced or metastatic solid tumors, such as ovarian, lung, breast, colorectal, prostate, and other cancers harboring this mutation. The study has Phase 1 portions focusing on dose escalation and combination treatment, and a Phase 2 portion assessing clinical activity and safety at recommended doses. The study is divided into several parts: Phase 1 Monotherapy involves testing increasing doses of rezatapopt alone to find the maximum tolerated dose and recommended dose. Phase 1b Combination Therapy tests rezatapopt with pembrolizumab, an intravenous immunotherapy drug, to determine safety and dosing when given together. The Phase 2 Monotherapy portion is currently enrolling and will evaluate the effectiveness and safety of rezatapopt at the recommended dose in various tumor types, including a specific focus on ovarian cancer. Participants will be monitored for adverse events, safety, and treatment response over months depending on the study phase. Assessments include tumor measurements using RECIST criteria, pharmacokinetic studies, quality of life evaluations, and other efficacy measures. Safety monitoring covers adverse events and tolerability, with ongoing follow-up during and after treatment. The study aims to gather comprehensive data on rezatapopt's safety and potential clinical benefits in this patient population.