Canton

Researchers are evaluating intratumoral ONM-501 alone and in combination with cemiplimab, a PD-1 checkpoint inhibitor, in patients with advanced solid tumors and lymphomas. This phase 1, multicenter, open-label study aims to find the maximum tolerated dose, minimum effective dose, and recommended dose for expansion of ONM-501. The study includes patients whose tumors are advanced, nonresectable, or recurrent, and for whom no standard therapy is available. The trial has three parts: monotherapy dose escalation, combination therapy dose finding, and combination therapy dose expansion in specific tumor types. ONM-501 is given as intratumoral injections once weekly for three weeks followed by three weeks without treatment, in 21-day cycles. Cemiplimab is administered intravenously at 350 mg every three weeks during the combination phases. The dose escalation uses accelerated titration and a "Rolling 6" enrollment method to allow staggered patient entry. Participants will be closely monitored for treatment-emergent adverse events, dose-limiting toxicities, and serious adverse events for up to about 24 months. Assessments include physical exams, laboratory tests, and tumor measurements. The expansion phase will enroll patients into one to three indication-specific groups based on the recommended doses found. Safety and tolerability will be key outcomes throughout the study duration.

Researchers are evaluating the efficacy and safety of rilvegostomig compared to pembrolizumab as first-line treatments for patients with metastatic non-small cell lung cancer (mNSCLC) whose tumors have high PD-L1 expression. This Phase III, randomized, double-blind, and global study focuses on participants with stage IV mNSCLC who do not have certain genetic mutations or rearrangements and are eligible for systemic therapy. Participants receive either rilvegostomig or pembrolizumab intravenously on Day 1 of each 21-day cycle. The study compares these two biological treatments given as monotherapy. Both groups will be monitored over time to assess treatment impact and safety. Throughout the study, participants undergo evaluations including tumor measurements by CT or MRI, performance status assessments, and organ function tests. Researchers will measure overall survival and progression-free survival for up to approximately five years. Tumor samples are collected before treatment for central testing, and participants’ health and treatment responses are closely followed during the trial period.

Researchers are evaluating the safety and effectiveness of rilvegostomig compared to pembrolizumab, both combined with platinum-based doublet chemotherapy, as initial treatments for patients with metastatic non-squamous non-small cell lung cancer (mNSCLC) whose tumors express PD-L1. This Phase III, randomized, double-blind, global study focuses on patients whose tumors meet the PD-L1 expression threshold of 1% or higher and do not have certain genetic mutations or rearrangements that would require other targeted therapies. Participants receive either rilvegostomig or pembrolizumab intravenously on the first day of each 21-day treatment cycle. Both groups also receive platinum-based chemotherapy drugs such as carboplatin or cisplatin, administered intravenously up to four cycles, along with pemetrexed given intravenously on Day 1 of each cycle. The study monitors these treatments as first-line therapy for metastatic non-squamous NSCLC. During the study, participants undergo regular assessments including imaging scans to measure tumor size and response, as well as evaluations of organ and bone marrow function. Researchers track overall survival and progression-free survival for up to approximately five years. Safety is closely monitored throughout, and patients are followed long-term to assess outcomes related to treatment effectiveness and tolerability.

This is a Phase III, two-arm, randomized, double-blind, global, multicenter study assessing the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a first-line (1L) treatment for patients with squamous metastatic non-small cell lung cancer (mNSCLC) whose tumors express PD-L1 (tumor cells (TC) ≥ 1%).

Researchers are evaluating the long-term safety, tolerability, and lasting effects of ALKS 2680 tablets in adults aged 18 to 70 years with Narcolepsy Type 1, Narcolepsy Type 2, or Idiopathic Hypersomnia. This study continues from earlier trials and aims to monitor how well the treatment works and how safe it is over an extended period. Participants receive daily oral doses of ALKS 2680 tablets in varying strengths ranging from 4 mg to 18 mg. The study is an open-label, long-term extension, meaning all participants know they are receiving ALKS 2680 as they continue treatment after completing a prior parent study. The dose is administered once daily, and the study focuses on ongoing monitoring rather than comparing to a placebo. During the study, participants are regularly assessed for any treatment-emergent adverse events up to 100 weeks. Safety evaluations include clinical assessments, laboratory tests, and monitoring for any new health issues. Researchers track the ability to tolerate the medication and the durability of its effect on symptoms. This long-term follow-up helps ensure comprehensive understanding of the treatment's impact over time.

Researchers are evaluating the effects, safety, and response to the medicine zasocitinib in children and teenagers aged 4 to under 18 years who have moderate-to-severe plaque psoriasis. The study is designed in two parts, with Part A including both children and teenagers and Part B including only children. Initially, only teenagers meeting the study criteria can join, with children joining later after more data is collected from other studies. In Part A, participants are randomly assigned to receive either zasocitinib or a placebo for the first 16 weeks, after which all receive zasocitinib for the rest of the study. Participants in Part B receive zasocitinib throughout. The treatment period lasts up to 208 weeks, followed by a 4-week safety follow-up. Both drug and matching placebo are used, and the study is conducted at multiple centers. Participants will attend multiple visits to the study site over a total duration of up to 4 years and 2 months, including a screening period of up to 35 days. Researchers will assess improvements in psoriasis severity using measures like the Static Physician's Global Assessment and Psoriasis Area and Severity Index at week 16. In Part B, they will also study how the body absorbs and processes zasocitinib by measuring drug levels at specific times. Safety and tolerability will be monitored throughout the study.

Researchers are conducting a multi-center, open-label Phase 1 clinical trial to study the drug ZG006 in adults with small cell lung cancer who have not responded to or cannot tolerate existing standard treatments. The trial aims to find the highest safe dose and recommended dose for future studies while assessing the drug's safety, tolerability, and how it behaves in the body. Participants must have a tumor tissue sample showing DLL3 expression and a performance status of 0 or 1. ZG006 will be given through an intravenous infusion. The study uses a dose escalation design called "3+3" to determine the maximum tolerated dose and recommended phase 2 dose. This process helps identify the best dose to use in further research. Participants will receive treatment and be monitored closely for side effects, laboratory changes, and adverse events over approximately two years. During the study, participants will undergo regular assessments including safety monitoring for dose-limiting toxicities, adverse events, and serious adverse events. Outcomes measured include tolerability, safety, and pharmacokinetics of ZG006. Participants will be followed for up to two years to evaluate laboratory results and overall treatment effects. Female and male participants must agree to use reliable contraception during treatment and for six months after the last dose. The total study duration depends on individual treatment and follow-up schedules.

Researchers are evaluating CTIM-76, a Claudin-6 directed bispecific antibody, in a Phase 1a/1b open-label study involving people with platinum-refractory or resistant ovarian cancer and other advanced CLDN6-positive solid tumors such as testicular and endometrial cancers. The study aims to assess the safety, tolerability, and effectiveness of CTIM-76, as well as to identify the best dose for further testing. This first-in-human trial includes a dose escalation phase and a dose expansion phase to explore treatment responses and side effects. In the Phase 1a dose escalation phase, participants receive CTIM-76 once weekly on days 1, 8, 15, and 22 of each 28-day cycle. Participants continue treatment until disease progression, unacceptable side effects, or a decision to stop treatment. The Phase 1b dose expansion phase will test CTIM-76 at one or two dose levels or schedules in groups of about 20 participants each, focusing on ovarian, testicular, or endometrial cancer. The recommended dose for further study will be selected based on safety, drug levels, biological effects, and early signs of benefit. Participants will be closely monitored for safety and treatment effects throughout the study. Researchers will assess dose-limiting toxicities up to 28 days after the first dose and measure overall response rates up to 24 months. Evaluations include tumor measurements using RECIST 1.1 criteria, organ function tests, and regular health assessments. The study requires participants to have a good performance status and a minimum life expectancy, with ongoing review to ensure safety and treatment suitability.

Researchers are evaluating IM-1021, an antibody-drug conjugate, in a Phase 1 study for participants with advanced cancer, including advanced B-cell lymphomas and advanced solid tumors. The study aims to assess the safety, tolerability, pharmacokinetics, and initial anti-tumor activity of IM-1021. It focuses on patients who have relapsed or are refractory to prior therapies and includes various lymphoma subtypes and solid tumor types such as pancreatic cancer, non-squamous non-small cell lung cancer, malignant mesothelioma, epithelial ovarian cancer, triple-negative breast cancer, and liposarcoma. The study has two parts: Part A is a dose escalation phase to find safe and tolerable doses and schedules of IM-1021 given intravenously on an intermittent basis. Part B is an expansion phase to further evaluate safety and tolerability at recommended doses in specific disease cohorts. Alternative dosing schedules may also be studied. IM-1021 is given intravenously during these phases, and the study includes multiple cancer indications. Participants will be monitored for safety and side effects from the first dose until 37 days after the last dose. Researchers will collect data on adverse events and determine recommended doses for future studies. Eligibility evaluations include performance status, organ function, and measurable disease assessments. The total participation duration includes treatment and follow-up for safety and tolerability, with assessments guided by cancer response criteria relevant to each tumor type.

Researchers are conducting a Phase 1/2a trial to assess the safety and tolerability of DB-1303/BNT323 in people with advanced solid tumors that express HER2. The study focuses on patients with HER2-positive or HER2-expressing malignant solid tumors that are advanced, unresectable, recurrent, or metastatic, and have not responded to standard treatments or have no available standard treatments. This multicenter, open-label study includes an initial dose-escalation phase followed by a dose expansion phase to explore safety, tolerability, and preliminary efficacy of the treatment.