East Melbourne

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 investigating new treatments for advanced ovarian cancer, specifically in patients who do not have homologous recombination deficiency (non-HRD positive). This Phase 3 study aims to assess whether maintenance treatment with sacituzumab tirumotecan (sac-TMT), alone or combined with bevacizumab, can improve progression-free survival compared to the current standard care after initial platinum-based chemotherapy and surgery. Participants receive sacituzumab tirumotecan through intravenous infusion at a dose of 4 mg/kg. Some also receive bevacizumab intravenously at 15 mg/kg as part of their maintenance treatment. Before sac-TMT infusion, participants are given prophylactic steroid mouthwash and recommended rescue medications including histamine-1 and histamine-2 receptor antagonists, acetaminophen or equivalent, and dexamethasone or equivalent. The study compares these treatments to standard care or observation following first-line chemotherapy. During the study, participants are monitored for progression-free survival for up to approximately 49 months. Researchers will assess how long participants live without their cancer getting worse. Throughout the trial, safety and response to treatment are evaluated. The study includes women aged 18 years and older who have completed surgery and first-line chemotherapy with specific responses and meet certain health criteria.

Researchers are evaluating AZD8421, a CDK2 inhibitor, alone and combined with other targeted anti-cancer drugs in female patients with ER+ HER2- advanced breast cancer and metastatic high-grade serous ovarian cancer. This Phase I/IIa study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary effectiveness of AZD8421. The study includes patients previously treated with CDK4/6 inhibitors or platinum-based chemotherapy, focusing on those with progressing metastatic or locoregionally recurrent disease. The study includes two main parts: AZD8421 monotherapy and combination therapy. Monotherapy evaluates AZD8421 alone to find the recommended Phase II dose in patients with advanced breast or ovarian cancer. Combination therapy tests AZD8421 with a CDK4/6 inhibitor (abemaciclib, ribociclib, or palbociclib) and camizestrant, an oral SERD, in breast cancer patients previously treated with CDK4/6 inhibitors. Treatment safety and drug behavior are closely monitored throughout. Participants will undergo assessments for dose limiting toxicities and adverse events from treatment start through an approximately 18-month safety follow-up. Researchers will also monitor laboratory tests, vital signs, ECGs, and reasons for stopping AZD8421 due to toxicity. The study requires measurable or assessable tumor lesions and performance status evaluations, ensuring patients meet specific health criteria. Total participation duration includes treatment and extended safety monitoring.

The purpose of this study is to assess the long-term safety and tolerability after an intravitreal injection (a shot of medicine into the eye) of JNJ-81201887 administered in parent clinical studies.

Researchers are evaluating the safety, tolerability, and how the body processes the drug DT-216P2 in patients with Friedreich's Ataxia (FA), a genetic condition. This phase 1/2 trial focuses on testing multiple increasing doses of DT-216P2 to better understand its effects in this patient group. Participants will receive DT-216P2 through subcutaneous (under the skin) and intravenous (into a vein) routes in a multiple ascending dose study design. The dosing schedule involves administering the drug in increasing amounts to assess safety and pharmacokinetics. The study is open-label, meaning both participants and researchers know the treatment being given. During the study, participants will be closely monitored for adverse events related to the treatment up to 12 weeks. Researchers will track safety outcomes and collect pharmacokinetic data to evaluate how the drug behaves in the body. The study includes careful screening, ongoing assessments, and adherence to contraception requirements. Participants aged 18 to 65 with genetically confirmed FA will be involved in this trial.

Researchers are evaluating the safety and effectiveness of belzupacap sarotalocan (bel-sar) compared to a sham control in patients with primary indeterminate lesions or small choroidal melanoma. This is a Phase 3 randomized, masked, controlled trial aiming to provide clear evidence on bel-sar's use in these eye conditions. The study focuses on patients without metastatic disease who have not previously been treated for their lesions, except possibly with photodynamic therapy. Participants receive bel-sar through a suprachoroidal injection using a specialized microinjector, followed by activation with an infrared laser. The control group undergoes similar procedures with sham devices and sham laser application to maintain masking. The trial is carefully designed to keep patients, assessors, and sponsors unaware of the treatment assignments to ensure unbiased results. Throughout the study, researchers will monitor the time it takes for tumors to progress, up to 65 weeks. Participants will undergo imaging and clinical evaluations to track safety and tumor status. The trial's structured follow-up includes assessments for any adverse effects and effectiveness of the treatment, helping to determine bel-sar's role in managing these eye tumors.

Researchers are conducting a first-in-human, Phase I clinical trial to evaluate the safety and tolerability of three investigational drugs: AZD2284, AZD2287, and AZD2275 in men with metastatic castration-resistant prostate cancer. The study aims to find the optimal dosing regimen and assess how the drugs distribute in the body, as well as to explore the safety and potential effectiveness of escalating doses of AZD2284 based on initial findings. The trial is divided into two parts: Part A focuses on imaging to determine the best dosing approach for AZD2287, with or without pre-administration of AZD2275 to improve drug distribution. Part B involves dose escalation of AZD2284 to evaluate safety, tolerability, and possible efficacy, followed by expansion cohorts to further explore AZD2284's effects. Participants will receive these investigational drugs during the respective study parts. Participants will undergo various assessments including imaging scans (SPECT/CT and planar images), laboratory tests, and evaluations of adverse events and dose limiting toxicities over different timeframes up to 5 years for long-term monitoring. Researchers will measure drug absorption, organ and tumor uptake, and safety outcomes. The total study duration includes monitoring for side effects and treatment responses to better understand the investigational drugs' impact.

Researchers are evaluating the safety, tolerability, and effectiveness of up to three doses of KIO-301 given by injections into both eyes every six weeks in adults with late-stage retinitis pigmentosa (RP). This study includes patients with no light perception or low vision and is a Phase II, controlled study designed to better understand how this treatment may work in advanced RP cases. Participants diagnosed with non-syndromic RP, including Usher's Syndrome Type II, are eligible to join. Participants will receive either 50 micrograms or 100 micrograms of KIO-301, or a placebo consisting of sterile saline or balanced salt solution, administered by intravitreal injection. The treatment period lasts 12 weeks with injections every six weeks, followed by a 12-week follow-up for safety and efficacy evaluations. Those who received placebo may opt to join an open-label extension lasting an additional 24 weeks for further observation. During the study, participants will attend visits every three weeks for pharmacokinetic, safety, tolerability, and efficacy assessments. The total main study duration can be up to 30 weeks, including a screening period of up to 45 days. Researchers will monitor vision using specialized tests, track side effects, and analyze the body's response to the drug. Safety and tolerability will be closely followed from baseline through 12 weeks after the last injection.

This research evaluates the safety, tolerability, and effectiveness of a single intravitreal injection of SAR446597 in people with Geographic Atrophy (GA) caused by Age-related Macular Degeneration (AMD). It is a Phase 1/2, two-part, multicenter study focusing on participants aged 60 years and older who have this eye condition. The study aims to assess the impact of this treatment on GA over a long period. Participants receive a one-time injection of SAR446597 directly into the eye, or a sham injection during Part II of the study. The core study phase lasts about two years for each participant, followed by an Extended Follow-Up (EFU) phase that continues for three more years to monitor long-term safety and effects. During the study, researchers monitor for ocular and non-ocular treatment-emergent adverse events and serious adverse events from Day 1 through Week 104. Participants undergo regular assessments of their eye health and vision, including visual acuity and lesion size evaluations. The total participation includes the core phase and extended follow-up, ensuring thorough observation of treatment safety and tolerability over five years.

Researchers are evaluating the safety, tolerability, pharmacokinetics, and preliminary effectiveness of mosunetuzumab (Lunsumio) alone in adults with relapsed or refractory chronic lymphocytic leukemia (CLL). The study also includes participants who are currently progressing on a Bruton tyrosine kinase inhibitor (BTKi) and need additional therapy; these participants may continue their BTKi during screening and early treatment. An additional group of non-US participants will be studied to assess mosunetuzumab combined with venetoclax, a B-cell lymphoma 2 (BCL2) inhibitor, to explore the combined treatment effects. Participants will receive subcutaneous mosunetuzumab as the main treatment. Those in the combination group will take daily oral venetoclax. Intravenous tocilizumab is available to manage cytokine release syndrome if it occurs. Treatment schedules include cycles of mosunetuzumab administration, with some participants continuing their BTKi during the first two cycles. The study includes up to approximately 12 months of monitoring for dose-limiting toxicities in some groups and up to 24 months for the combination treatment group. Throughout the study, participants will undergo evaluations including safety assessments, pharmacokinetic blood tests, and clinical monitoring for side effects and treatment responses. Researchers will track the rate of dose-limiting toxicities over time to understand treatment safety. Women of childbearing potential and men must follow strict contraceptive guidelines during and after treatment. Overall participation may last up to two years depending on the treatment arm, with close observation to ensure participant safety and treatment adherence.