Adelaide

Researchers are evaluating the safety of increasing doses of 131I-TLX101 given intravenously alongside standard care in patients newly diagnosed with glioblastoma, a type of brain tumor. This open-label, single-arm, multicenter Phase 1 study focuses on patients with histologically confirmed glioblastoma who have undergone surgery but not yet received systemic or radiation therapy. Participants receive ascending doses of 131I-IPA intravenously via infusion combined with the best standard of care, including planned chemoradiation therapy starting 3 to 6 weeks after surgery. The study monitors safety and dose-limiting toxicities over multiple dose levels to identify the recommended Phase 2 dose. During the 62-week study, participants undergo regular evaluations including clinical assessments, lab tests such as liver function, and monitoring for treatment-emergent adverse events. Researchers measure the incidence and severity of dose-limiting toxicities from the first dose until discharge after the second dose, along with overall safety and tolerability throughout the study period.

Researchers are investigating the safety, tolerability, distribution in the body, radiation dose, and early anti-tumor effects of 177Lu-RAD204, a radiolabeled antibody targeting PD-L1, in adults with certain advanced solid tumors that express PD-L1 or have specific genetic markers. This Phase 0/1, first-in-human study aims to find the recommended doses for future studies by evaluating both imaging and treatment doses in participants with cancers such as lung, breast, melanoma, head and neck, endometrial, and others with relevant mutations or markers. The study includes several periods: a screening period lasting up to 4 weeks, followed by a Phase 0 imaging period where a low dose of 177Lu-RAD204 is given to assess imaging quality, safety, and radiation exposure over about 2 weeks. After this, participants enter the Phase 1 treatment period involving dose escalation of the therapeutic 177Lu-RAD204 with cycles lasting 6 weeks. Participants may receive multiple cycles if they benefit clinically and have acceptable safety and organ radiation levels. Dose limiting toxicities are monitored for 6 weeks after the first treatment dose, with flexibility for altered schedules if needed. Throughout the study, participants undergo imaging scans, safety assessments, and dosimetry measurements to track how the drug moves and acts in the body. Researchers measure various outcomes including time activity curves, radiation dose, pharmacokinetics, and biokinetics over 72 hours, as well as safety and tolerability over 6 weeks. The study carefully monitors the recommended doses for future exploration, and participants may be followed for clinical benefit and adverse events during treatment cycles and follow-up periods.

Researchers are investigating treatments for women with recurrent endometrial cancer that expresses different levels of the HER2 protein. The study has two groups based on the tumor's HER2 score: Cohort 1 includes patients with HER2 IHC 1+ or 2+ who have previously received immune checkpoint inhibitors and platinum-based chemotherapy, while Cohort 2 includes patients with HER2 IHC 3+. The purpose is to compare the effectiveness and safety of the investigational drug BNT323 (also called DB-1303) against chemotherapy in Cohort 1 and to evaluate BNT323 alone in Cohort 2. The study also looks at how the drug affects the immune system, the body's handling of the drug, quality of life, and potential side effects. Participants in Cohort 1 are randomly assigned to receive either BNT323 via intravenous infusion or a chemotherapy drug chosen by the investigator (doxorubicin, paclitaxel, or docetaxel if paclitaxel is unsuitable). Treatment continues until the cancer progresses, unacceptable side effects occur, or the participant withdraws consent. Those in Cohort 2 receive BNT323 alone until disease progression or other discontinuation criteria are met. The study includes a screening period, a treatment period expected to last about six months, followed by safety monitoring, efficacy follow-up, and long-term survival follow-up lasting up to approximately 53 months. During the study, participants undergo regular assessments including imaging scans to measure tumor response by RECIST criteria, safety monitoring for adverse effects, and evaluations of quality of life. Researchers also study the pharmacokinetics of BNT323 and the immune response. The main outcomes measured are progression-free survival in Cohort 1 and objective response rate in Cohort 2. Safety follow-up ensures ongoing monitoring after treatment to evaluate longer-term effects and participant wellbeing.

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, effectiveness, best dose, and how the body processes (pharmacokinetics) an investigational drug called BNT326. This study includes people with advanced solid tumors that are metastatic, recurrent, or have progressed after previous treatments. The investigation is divided into two parts: Part 1 tests BNT326 alone, and Part 2 studies BNT326 alone or combined with other immunotherapy drugs, including pumitamig (BNT327). Participants have specific tumor types like melanoma, non-small cell lung cancer, breast cancer, gastric cancer, colorectal cancer, and cervical cancer, among others. In Part 1, participants receive BNT326 by intravenous infusion in various groups based on cancer type and prior treatments. Part 2 involves BNT326 given alone or with pumitamig, also by intravenous infusion, in several defined cancer groups. Some groups are randomized to receive different dose levels or combinations to find the optimal treatment plan. The study includes a screening phase, treatment phase lasting up to 24 months or until progression or unacceptable side effects, a safety follow-up, efficacy follow-up, and long-term survival monitoring, totaling about 38 months for Part 1 and 48 months for Part 2. During the study, participants undergo regular assessments including measuring tumor response using RECIST criteria, monitoring for side effects and serious adverse events up to months after treatment ends, and measuring drug levels in the blood. Researchers track treatment interruptions or discontinuations due to side effects and evaluate dose-limiting toxicities. Tumor tissue samples are required before enrollment. Safety and effectiveness data are collected throughout treatment and follow-up periods to understand how well BNT326 works alone or combined and its safety profile.

Researchers are evaluating the safety, tolerability, and therapeutic effects of a combination treatment using BNT113 and pembrolizumab compared to pembrolizumab alone for patients with unresectable recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) that is positive for human papillomavirus 16 (HPV16+) and expresses the PD-L1 protein with a combined positive score of 1 or higher. This Phase II/III trial includes patients whose cancer cannot be treated with local therapies and who have not received prior systemic anticancer therapy for their current disease condition. The trial consists of two parts. Part A is a non-randomized Safety Run-In Phase to confirm the safety and tolerability of BNT113 combined with pembrolizumab at the selected dose. Part B is a randomized phase that compares BNT113 plus pembrolizumab against pembrolizumab alone as first-line treatment. Patients in Part A continue their treatment without randomization. Treatments are given by intravenous injection or infusion, and patients may receive either combination therapy or monotherapy for up to 24 months. There is also an optional pre-screening phase to test tumor samples for HPV16 DNA and PD-L1 expression before entering the main trial. Participants undergo regular assessments including tumor measurements based on RECIST 1.1 criteria confirmed by independent review. Researchers monitor treatment-emergent adverse events for up to 27 months in Part A and evaluate overall survival and progression-free survival for up to 48 months in Part B. Tumor tissue samples are collected before treatment to confirm eligibility. The study involves ongoing safety monitoring and efficacy evaluations throughout the treatment and follow-up periods.

Researchers are evaluating a combination treatment using BNT326 and BNT327 in adults with advanced or metastatic non-small cell lung cancer (NSCLC), including those with relapsed, progressive, or treatment-nafve disease. This multi-site, open-label study includes dose-finding and dose-expansion phases to investigate the safety, tolerability, and preliminary effectiveness of this combination therapy. The study targets patients whose tumors are advanced, metastatic, or recurrent with no curative treatment options available and includes participants with different genomic alterations. The study is divided into several parts: Part 1 is a dose escalation phase to find safe dose levels of BNT326 with BNT327; Part 2a expands the dose to further evaluate safety and initial efficacy; Part 2b focuses on dose optimization and understanding the contributions of each component. Participants receive intravenous infusions of BNT326 and BNT327, with some cohorts possibly receiving additional treatments such as pembrolizumab or standard chemotherapy. Treatment continues until disease progression, unacceptable side effects, withdrawal, or a maximum of 24 months. Dose levels for certain cohorts are determined based on earlier phase data, and some parts include randomization to different treatment groups. Participants undergo a screening period before starting treatment, followed by treatment, safety follow-up, efficacy follow-up, and long-term survival monitoring, totaling about 36 months. Researchers assess dose-limiting toxicities within the first 21 days of treatment and monitor adverse events, treatment interruptions, and objective response rates up to 36 months. Tumor measurements, safety labs, imaging, and patient health status are regularly evaluated. The study tracks tolerability and efficacy while ensuring participant safety throughout treatment and follow-up.

Researchers are evaluating the safety, appropriate dosing, and early effectiveness of [177Lu]Lu-SN201, a radiolabeled nanomedicine, in adults with advanced solid tumors who have no standard treatment options. This first-in-human study aims to find the maximum tolerated dose and understand the drug's safety, tolerability, pharmacokinetics, and dosimetry in patients with recurrent, locally advanced, metastatic, or refractory solid cancers. The study includes both Phase I and Phase IIa components. Participants will receive [177Lu]Lu-SN201 through a slow intravenous infusion on the first day of each treatment cycle. They may receive up to three cycles spaced approximately six weeks apart, with some flexibility for delays. The initial treatment cycle requires an overnight hospital stay for observation. Imaging techniques such as whole-body planar scans and SPECT/CT will be used after dosing to monitor how the drug spreads and is processed in the body. Disease response will be evaluated using CT or MRI scans according to standardized criteria. If participants continue to subsequent cycles, their eligibility and drug supply will be reassessed within 17 days before treatment. Throughout the study, participants will undergo regular assessments including adverse event monitoring, medication reviews, and imaging scans on multiple days after dosing to evaluate biodistribution and dosimetry. Safety and clinical benefits in different tumor groups will be tracked over 24 to 48 months, including evaluating dose-limiting toxicities and serious adverse events. The total treatment duration can last up to about 22 weeks, with follow-up to measure treatment effects and safety over several years.

Researchers are evaluating the safety of aerosolized RSP-1502 in people with cystic fibrosis who have chronic lung infections caused by Pseudomonas aeruginosa. This phase 1b/2a study compares different doses of RSP-1502 to an active control, aiming to find the maximum tolerated dose (MTD) and assess safety outcomes. Participants must meet specific lung function and infection criteria to join the study. The study involves administering RSP-1502 or an active control solution by inhalation using a nebulizer for 14 days. RSP-1502 contains tobramycin and CaEDTA in a sterile solution, while the active control is a tobramycin inhalation solution. After dose escalation to identify the MTD, a dose expansion phase compares the MTD of RSP-1502 to the active control for another 14 days. Participants will then be followed for 14 days after treatment ends. Participants will have their lung function tested with spirometry and undergo electrocardiograms on specific days during treatment. Researchers will monitor for any treatment-related adverse events and serious adverse events throughout the 28-day treatment and follow-up period. They will also track pulmonary exacerbations and other safety measures. The total participation includes dosing and a 14-day follow-up after treatment completion.

Researchers are evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of a drug called TT5 in healthy volunteers and surgical patients. This first-in-human, phase 1 study is double-blind, randomized, and placebo-controlled, involving both single and multiple ascending doses. The trial aims to understand how TT5 behaves in the body and its psychological effects in different participant groups. The study is organized into three parts: Part A involves single ascending doses in healthy volunteers with up to 5 dose levels; Part B includes multiple ascending doses over 7 days in healthy volunteers with up to 3 dose levels; Part C studies surgical patients receiving up to 4 doses of TT5 on the same day. Both TT5 and a placebo vehicle are administered intravenously according to the dosing schedule. Participants will be closely monitored for adverse events, changes in physical exams, vital signs, and lab tests during the dosing periods (Day 1 to Day 8 for single dose cohorts and Day 1 to Day 14 for multiple dose cohorts). Psychological responses are assessed using the Bond and Lader Visual Analog Scale. Safety, drug levels, and biological markers will be evaluated, with follow-ups throughout the study period lasting up to two weeks for each dosing cohort.