Frankston

Researchers are evaluating the safety and preliminary effectiveness of T3011, a treatment given directly into tumors, alone and combined with pembrolizumab, an intravenous medication, in adults with advanced or metastatic solid tumors. This Phase 1/2a open-label study focuses on several types of cancers including melanoma, head and neck squamous cell carcinoma, sarcoma, cutaneous squamous cell carcinoma, and non-small cell lung cancer. The study aims to find the best dose of T3011 and understand its safety when used alone or with pembrolizumab. The study begins with a Phase 1 dose escalation to test increasing doses of T3011 using a 3+3 design. After determining the recommended dose, Phase 2a Part 1 will evaluate T3011 alone in different cancer types across multiple arms, while Phase 2a Part 2 will assess the combination of T3011 with pembrolizumab in participants with metastatic non-small cell lung cancer. T3011 is given as an intratumoral injection up to 4mL every two weeks, and pembrolizumab is given intravenously every three weeks when combined. A rollover arm allows participants whose disease progresses on T3011 alone to receive the combination treatment. Participants will be closely monitored for safety and treatment effects for up to two years from the first dose of T3011. Assessments include tumor measurements, biopsies, laboratory tests, and evaluation of adverse effects. The study records the tolerability of escalating doses and the combination treatment, tracking disease progression and response. Participants must attend scheduled visits for injections, monitoring, and evaluations throughout the study period.

Researchers are investigating sacituzumab tirumotecan (MK-2870) alone or combined with other treatments to treat certain gastrointestinal cancers. These include colorectal cancer that cannot be removed by surgery or has spread, advanced pancreatic ductal adenocarcinoma, and biliary tract cancer. The study aims to understand the safety and tolerability of sacituzumab tirumotecan and measure how many participants respond to the treatment by having their cancer shrink or disappear. Participants may receive sacituzumab tirumotecan by intravenous infusion alone or with other anticancer drugs such as fluorouracil (5-FU), leucovorin or levoleucovorin, cisplatin, and pembrolizumab. Rescue medications like diphenhydramine, H2 receptor antagonists, acetaminophen, dexamethasone, and a steroid mouthwash are given to prevent infusion reactions and oral side effects. Supportive care treatments for side effects, including antidiarrheal and antiemetic agents, are allowed throughout the study. During the study, researchers monitor participants for dose-limiting toxicities within about 4 weeks and track adverse events, treatment discontinuations, and tumor response over up to approximately 63 months. Assessments include safety evaluations and measuring cancer response using standardized criteria. This long-term follow-up helps evaluate both the effectiveness and safety of the treatments being studied.

Researchers are evaluating the safety, tolerability, and how the body processes HRS-3802 when given alone to patients with advanced malignant solid tumors. This Phase 1 clinical trial focuses on patients who have not responded to standard treatments or for whom no effective standard treatments exist. The study aims to understand how well patients tolerate HRS-3802 and to collect important safety and dosage information. Participants will receive HRS-3802 as a monotherapy. The study is open-label and single-arm, meaning all participants receive the investigational drug without a comparison group. The treatment period includes monitoring for dose-limiting toxicities during the first 28 days, with assessments at 3 weeks for maximum tolerated dose and recommended Phase II dose. The treatment and monitoring occur over an average duration of 5 months, with safety evaluations every 4 weeks after treatment starts. During the study, participants will be regularly assessed for side effects and how severe these are, using various tests and clinical evaluations. Researchers will collect data on adverse events, dose tolerability, and pharmacokinetics of HRS-3802. Participants will also undergo laboratory tests, physical examinations, and follow-up visits to monitor their health and treatment effects. The total involvement time in the study is around five months, with careful safety oversight throughout.

Researchers are evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of IMP1734, a PARP1 selective inhibitor, in participants with advanced solid tumors. The study aims to assess preliminary efficacy and find the best dosing for future clinical development. This first-in-human trial is conducted in two parts, focusing on patients with recurrent, advanced, or metastatic solid tumors including metastatic prostate, ovarian, breast, and other solid tumors with specific genetic mutations. The trial has two main phases: Part 1 involves dose escalation of IMP1734 as a monotherapy to determine the maximum tolerated or achievable dose in solid tumors. Part 2 focuses on dose optimization to select the optimal dose for further clinical use. Treatment involves oral administration of IMP1734, with dose escalation steps and combination dose escalations in specific cancers like metastatic prostate cancer, ovarian, and breast cancer. Participants will undergo regular assessments to monitor safety through adverse event tracking, pharmacokinetic and pharmacodynamic evaluations, and tumor response measurements using criteria like RECIST1.1, CA125, or PSA. The study includes monitoring for serious adverse events from consent until 30 plus 7 days after the last dose. Dose-limiting toxicities are assessed during the first treatment cycle. Participants are expected to have adequate organ function, a life expectancy of at least 12 weeks, and will be followed closely during the trial to evaluate the drug's safety and potential anti-tumor activity.

Researchers are evaluating the safety and effectiveness of VS-7375, a selective oral KRAS G12D inhibitor, alone and combined with other cancer treatments in patients with advanced solid tumors carrying the KRAS G12D mutation. This Phase 1/2 study focuses on solid tumors including pancreatic ductal adenocarcinoma, non-small cell lung cancer, and colorectal cancer, aiming to better understand treatment effects in this specific genetic context. Participants may receive VS-7375 either by itself or combined with other therapies such as cetuximab, carboplatin plus pemetrexed plus pembrolizumab, gemcitabine alone, or gemcitabine with nab-paclitaxel. The study includes multiple parts: dose escalation to find maximum tolerated or feasible doses, evaluation of anticancer activity over up to 2.5 years, and combination regimens with a treatment period averaging 9 months. Treatment cycles are typically 21 or 28 days long depending on the study part. During the study, participants will be closely monitored for safety, side effects, and treatment response using standard criteria. Researchers will track adverse events, tolerability, and preliminary anticancer effects over months to years. Assessments include evaluations at each treatment cycle and follow-up visits to understand the best dosing and combination strategies. Participants must meet specific health and disease criteria to join and will be followed throughout treatment and observation periods.

Researchers are conducting a first-in-human, open-label Phase I study to assess the safety, tolerability, pharmacokinetics, immune response, and early antitumor effects of AK138D1 in adults with advanced solid tumors. The study focuses on individuals whose cancer is locally advanced or metastatic and resistant or intolerant to standard treatments. The trial consists of two main parts: a dose-escalation stage to find the maximum tolerated or maximum administered dose, and a dose-expansion stage to determine the recommended dose for further study. Participants receive AK138D1 through intravenous infusion according to their assigned dosing plan. During the study, participants will be monitored for adverse events and dose-limiting toxicities for up to approximately two years. Researchers will also assess tumor response using measurable lesions, organ function, and overall health status. The total involvement includes signing consent, regular assessments, and safety follow-up to evaluate the drug's effects and tolerability.

Researchers are investigating new treatment options for adults with advanced solid tumors that have a KRASG12C mutation. This mutation causes cancer cells to grow, and while the drug sotorasib is approved to target these cancer cells, it usually works only for a limited time before the cancer grows again. The study is testing BAY3498264, a drug designed to block a protein called SOS1 that works with KRAS, hoping this will enhance the effects of sotorasib by providing a longer or stronger response. This is a first-in-human Phase 1 study focusing on the safety and best dosing of BAY3498264 when combined with sotorasib. Participants will first take BAY3498264 alone for seven days, then receive it together with sotorasib in repeated 21-day cycles. Sotorasib is given daily at a standard approved dose alongside BAY3498264. Treatment will continue as long as it benefits participants without causing severe side effects, or until the cancer progresses, or if the participant or doctor decides to stop. The study consists of three parts: dose escalation, backfill, and expansion to determine safe dosing and to monitor effects. Throughout the study, participants will have blood and urine samples collected and undergo imaging scans such as CT, PET, MRI, and X-rays. Their heart health will be checked using ECGs. Researchers will closely monitor safety by tracking any side effects, serious adverse events, drug levels in the blood, and any toxicities during the first treatment cycle. The study will last approximately three years to assess the maximum tolerated dose and overall safety of the drug combination.

Researchers are investigating HMBD-001, an anti-HER3 antibody, in combination with cetuximab with or without docetaxel in participants who have advanced squamous cell cancers. This Phase Ib/II open-label study aims to evaluate the safety, tolerability, and efficacy of these treatments in multiple centers. The study includes participants with various advanced squamous cell carcinomas, such as lung, head and neck, esophageal, cervical, cutaneous, and nasopharyngeal cancers. Participants receive HMBD-001 intravenously once weekly alongside cetuximab weekly, which may include a loading dose on the first day of treatment. Some participants also receive docetaxel every three weeks at a dose of 60 or 75 mg/m². The study has multiple arms where treatments are given according to the participant's cancer type and prior therapies. Tumor biopsies and other assessments are part of the study requirements. During the study, participants are closely monitored for adverse events from consent until 30 days after their last dose. Safety is assessed, including dose-limiting toxicities during the first 21-day cycle. Researchers also evaluate progression-free survival for up to six months. Participants undergo regular evaluations, including tumor measurements and health assessments, to understand treatment effects and safety. The study duration varies depending on treatment response and follow-up periods.

Researchers are evaluating the safety and effectiveness of HLX22 combined with trastuzumab and chemotherapy as the first treatment for patients with HER2-positive locally advanced or metastatic adenocarcinoma of the gastric or gastroesophageal junction. This phase 2, double-blind, randomized, and multiregional study compares this combination against trastuzumab and chemotherapy with or without pembrolizumab. The study aims to measure how well the treatments work in controlling the disease and improving survival for up to five years. Participants will be randomly assigned to one of two groups. One group receives HLX22 at 15 mg/kg every three weeks along with trastuzumab, chemotherapy (XELOX regimen), and possibly a placebo for pembrolizumab. The other group receives a placebo for HLX22 plus trastuzumab, chemotherapy (XELOX), and possibly pembrolizumab every three weeks. Treatment continues until the disease worsens, unacceptable side effects occur, withdrawal of consent, or other protocol-specified reasons. Throughout the study, participants will undergo regular assessments including tumor scans reviewed by an independent committee to evaluate progression-free survival and overall survival over up to five years. Other evaluations include safety monitoring and organ function tests. The study tracks how long patients live without disease progression and overall survival, aiming to better understand the benefits and risks of HLX22 combined with current standard treatments.

Researchers are evaluating ziltivekimab as a treatment for people living with heart failure and inflammation. This Phase 3 study compares ziltivekimab to a placebo in participants with heart failure who have mild to preserved ejection fraction and systemic inflammation. The study aims to assess the effect of ziltivekimab on cardiovascular death, heart failure hospitalization, or urgent heart failure visits over a period of up to 4 years. Participants will receive monthly injections of either ziltivekimab or a placebo using a pre-filled syringe or a pen-injector. The study medication is administered subcutaneously once a month for up to 4 years. The trial includes up to 20 clinic visits during which participants will be monitored and assessed. During the study, participants will use a study app on their phone to record all injections and complete questionnaires. Researchers will monitor participants for key outcomes like cardiovascular events and heart failure episodes from the time of randomization until the end of the study. Safety and health status will be regularly evaluated throughout the study period, which may last up to 48 months.