Locust Grove

Researchers are evaluating the effectiveness and safety of standard chemotherapy combined with bevacizumab, with or without the addition of INCA33890, as the first treatment option for patients with metastatic microsatellite stable colorectal cancer. This phase 3 randomized, double-blind study focuses on patients with stage IV colorectal adenocarcinoma that cannot be cured by surgery and who have not received prior systemic treatment for their metastatic disease. Participants will receive standard-of-care chemotherapy (FOLFOX) and bevacizumab both administered at protocol-defined doses. They will be randomly assigned to also receive either INCA33890 or a placebo, with dosing also defined by the study protocol. The treatments will be given as the initial therapy for metastatic disease, aiming to compare the outcomes between the groups receiving INCA33890 and those who do not. Throughout the study, participants will be monitored for progression-free survival for up to three years. Researchers will assess disease progression using measurable disease criteria and regularly evaluate participants' health status and organ function through laboratory tests. Safety and treatment response will be closely followed, with the goal of determining how well the treatments control the cancer without unacceptable side effects.

Researchers are conducting a global, multicenter, randomized, open-label Phase 2/3 trial to study the effects of Datopotamab Deruxtecan (Dato-DXd) combined with carboplatin or cisplatin versus gemcitabine combined with carboplatin or cisplatin. This study focuses on participants with locally advanced or metastatic urothelial carcinoma (la/mUC) who have experienced disease progression during or after treatment with enfortumab vedotin (EV) plus pembrolizumab. The research aims to assess preliminary efficacy, safety, and tolerability, and to identify the recommended Phase 3 dose (RP3D) based on Phase 2 results before proceeding to the Phase 3 portion. Dato-DXd will be given as an intravenous infusion every three weeks at a dose of 4 mg/kg or 6 mg/kg during Phase 2 or the RP3D during Phase 3. Carboplatin and cisplatin will also be administered intravenously every three weeks, with carboplatin dosed at AUC 4.5 or 5.0 mg·min/mL and cisplatin at 70 mg/m2. Gemcitabine will be given intravenously at 1000 mg/m2 on Days 1 and 8 of each three-week cycle. Participants eligible for cisplatin will receive it; those ineligible will receive carboplatin. The study starts with Phase 2 (Part A) to assess early outcomes and safety, then moves to Phase 3 (Part B) depending on those findings. Participants will be monitored for overall response rate, progression-free survival, and overall survival over periods up to 34 months in Phase 2 and 38 months in Phase 3. Assessments include radiographic evaluations to document disease progression or death. Safety and treatment tolerability will be closely observed throughout. Participants will provide tumor tissue samples for biomarker testing, and dosing will be tailored based on eligibility and investigator judgment. This comprehensive monitoring aims to evaluate the treatments' impact and patient outcomes over the study duration.