Rioja

Researchers are evaluating ART0380, a new oral drug that targets ATR kinase, in adults with advanced or metastatic solid tumors, including ovarian, peritoneal, fallopian tube, endometrial, colorectal, pancreatic, and acinar cell cancers. This open-label Phase IIIa study aims to find the recommended safe dose of ART0380 alone and combined with gemcitabine or irinotecan, understand side effects, and assess early signs of effectiveness. Participants will receive ART0380 either alone or in combination with gemcitabine or irinotecan in 21-day treatment cycles. ART0380 dosing schedules include intermittent or continuous oral administration. Gemcitabine is given on Days 1 and 8, and irinotecan is given as a 90-minute infusion on Days 1 and 8. The study has multiple parts evaluating different dosing regimens and patient groups, including dose escalation and dose expansion cohorts, with some participants randomized to receive combination therapy or gemcitabine alone. During the study, participants will undergo regular assessments including imaging scans to measure tumor response, blood tests for safety and pharmacokinetics, and tumor marker evaluations over several months. Researchers will monitor side effects from the treatments and measure outcomes such as maximum tolerated dose, progression-free survival, response rates, and overall survival. The study includes follow-up for up to 24 months to observe long-term effects.

Researchers are studying ATTR-01, an experimental drug made from a modified common cold virus designed to infect and multiply only in cancer cells. This virus carries an immune therapy drug aimed at helping a participants own immune system target cancer. The trial includes a phase 1 dose escalation and expansion to find the best dose, marking the first time ATTR-01 will be given to humans. If an optimal dose is found, further study sub-protocols will evaluate its potential to treat select epithelial solid tumors. Participants receive ATTR-01 through intravenous injection. The study starts with a phase 1 segment focusing on dose finding and safety. If successful, additional phases may be added to further assess the drugs effect on cancer. The trial includes one experimental group receiving ATTR-01, with no placebo or control group. Expanded access to ATTR-01 outside the trial is not available. During the study, participants will have evaluations including tumor measurements by RECIST version 1.1 criteria, biopsies before and after treatment, and assessments of organ function and immune response. Researchers will monitor safety by tracking adverse events and will measure outcomes like tumor response, disease control, progression-free survival, and overall survival at 1, 2, and 5 years. The trial also evaluates viral persistence and immunogenicity. Participants are expected to comply with hygiene measures to prevent virus spread, and the study follows them for up to several years.

Researchers are evaluating JK06, a biparatopic anti-5T4 antibody drug conjugate, in patients with unresectable locally advanced or metastatic solid tumors. This Phase 12, open-label study aims to assess the safety, tolerability, pharmacokinetics, immunogenicity, and initial anti-tumor activity of JK06. The study includes dose escalation to find the maximum tolerated dose and recommended Phase 2 dose, followed by dose expansion in specific tumor groups to further evaluate safety and early efficacy. Participants receive JK06 intravenously in cycles of 21 days. The dose escalation phase involves increasing doses to identify the optimal dose, while the cohort expansion phase uses this dose to treat tumor-specific groups. The study is randomized without masking and includes multiple centers. Treatment continues through these phases to collect detailed safety and response data. During the study, participants will have regular assessments including tumor measurement by CT or MRI scans, laboratory tests to monitor blood counts and organ function, and evaluations of adverse events. Researchers will track dose-limiting toxicities, pharmacokinetics, immune response, and tumor response over up to 104 weeks. Participants are monitored for safety up to 28 days after the last dose, and long-term outcomes such as progression-free survival and duration of response are also recorded.

Researchers are evaluating the safety, tolerability, pharmacokinetics, and effectiveness of PC14586 rezatapopt, an oral small molecule that reactivates the p53 protein selectively for the TP53 Y220C mutation. This Phase 12 open-label study includes patients with locally advanced or metastatic solid tumors harboring this mutation. The study aims to find the best dose, assess treatment response rates, and monitor quality of life in various cancer types, including ovarian, lung, breast, and endometrial cancers. The study consists of multiple parts Phase 1 monotherapy dose escalation to find the maximum tolerated dose and recommended Phase 2 dose RP2D of rezatapopt Phase 1b combination therapy evaluating rezatapopt with pembrolizumab and Phase 2 dose expansion cohorts where participants receive daily oral rezatapopt at the RP2D, either alone or combined with pembrolizumab. Participants receive pembrolizumab intravenously every three weeks when in the combination group, and rezatapopt is taken daily with food. Participants will undergo regular monitoring including safety assessments, blood tests to study drug levels, and imaging scans to measure tumor response using RECIST criteria. Researchers will track adverse events, response rates, progression-free survival, overall survival, and quality of life over several months. The total study duration varies by phase but includes up to 34 months of treatment for Phase 2 and ongoing follow-up for safety and efficacy evaluation.