Greenslopes

Researchers are evaluating MDNA11, a long-acting "beta-only" recombinant interleukin-2 designed to activate immune cells that attack cancer while minimizing stimulation of cells that suppress immunity. This Phase 1/2 open-label study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and early anti-tumor activity of MDNA11 alone or combined with pembrolizumab in patients with advanced or metastatic solid tumors. The study includes dose-escalation and dose-expansion parts for both monotherapy and combination therapy with pembrolizumab. MDNA11 is given intravenously every two weeks with doses ranging from 0.003 to 0.6 mg/kg for monotherapy, while dose ranges for combination therapy are also evaluated. Treatment continues until progression, withdrawal, or loss to follow-up, with tumor assessments by CT or MRI every 8 weeks. Participants will undergo regular imaging scans every 8 weeks to monitor tumor response and safety assessments throughout the 24-month study. Researchers will track recommended doses for expansion, treatment-related adverse events, and overall safety. The study involves up to 115 patients across multiple sites and includes long-term monitoring for up to 24 months.

Researchers are evaluating a new treatment called ifinatamab deruxtecan (I-DXd) for men with metastatic castration-resistant prostate cancer (mCRPC). This study compares I-DXd to chemotherapy to see if it helps people live longer overall and live longer without their cancer worsening. It is a Phase 3, open-label trial focused on patients who have progressed on prior therapies and have evidence of metastatic disease. Participants receive either I-DXd through an intravenous infusion every 3 weeks or docetaxel chemotherapy administered every 3 weeks. Prednisone tablets are also given daily as part of the treatment plan. Before each I-DXd dose, premedication is provided to help prevent nausea and vomiting using a combination of drugs such as corticosteroids and anti-nausea medicines. Treatment continues until disease progression, unacceptable side effects, or other reasons to stop. During the study, researchers monitor overall survival and how long patients live without their cancer progressing, for up to about 36 months. Participants undergo tumor tissue collection, scans, and assessments to track disease status and side effects. Safety is closely watched throughout treatment. The study includes men aged 18 and older with confirmed prostate cancer and metastatic disease who have previously received certain hormone therapies but no prior taxane chemotherapy for mCRPC.

Researchers are evaluating the safety and effectiveness of combining petosemtamab with pembrolizumab compared to pembrolizumab alone as a first treatment for people with recurrent or metastatic PD-L1 positive head and neck squamous cell carcinoma (HNSCC). This Phase 3, randomized, open-label study focuses on patients who have not received previous systemic therapy for incurable recurrent or metastatic disease, though prior therapy for locally advanced disease is allowed under certain conditions. The study excludes patients who have been treated with anti PD-(L)1 or anti-EGFR therapies except in specific cases. Participants will receive either the combination of petosemtamab plus pembrolizumab or pembrolizumab alone as their first-line treatment for this condition. The study includes detailed eligibility criteria based on tumor location, PD-L1 expression, health status, and prior treatments. Treatment effects will be observed over time with a focus on overall survival and tumor response rates measured according to standard criteria. During the study, participants will undergo assessments including tumor biopsies, imaging scans to measure disease progression, heart function tests, and evaluations of organ function. Safety and treatment response will be closely monitored up to approximately three years. The study also tracks overall survival and tumor response rate as primary outcomes, ensuring continuous follow-up and support throughout the trial period.

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.

This research aims to evaluate the safety and tolerability of increasing doses of ABT-301 combined with fixed doses of tislelizumab and bevacizumab in adults with proficient mismatch repair (pMMR)/non-microsatellite instability-high (non-MSI-H) colorectal cancer. The trial seeks to determine the maximum tolerated dose (MTD) and recommend a Phase 2 dose (RP2D) of ABT-301. The study includes patients with advanced or metastatic colorectal cancer who have undergone at least two prior systemic therapies. Participants receive ABT-301 orally once or twice daily in 21-day treatment cycles. Tislelizumab 200 mg and bevacizumab 7.5 mg/kg are administered by intravenous infusion on Day 1 of each cycle every three weeks. The study has two parts: Part 1 involves dose escalation to find the MTD and RP2D, while Part 2 evaluates two selected ABT-301 dosing regimens for safety, tolerability, and antitumor activity. Throughout the study, participants undergo regular assessments including imaging and laboratory tests to monitor tumor response, safety, and tolerability. The primary outcomes include safety, MTD determination, and efficacy measures such as progression-free survival. Participants are followed from screening to 90 days after the last dose in Part 1 and up to 28 months in Part 2, with ongoing monitoring of disease progression or survival.

Researchers are evaluating the effectiveness and safety of the drug BMS-986365 compared to the investigator's choice of therapy in men with metastatic castration-resistant prostate cancer. This Phase 3 study aims to measure the length of time participants live without radiographic disease progression, using established criteria for bone and soft tissue cancer progression. The study focuses on patients who have already been treated with androgen receptor pathway inhibitors and have metastatic prostate cancer confirmed by imaging. Participants will be randomly assigned to receive either one of two dose levels of BMS-986365 or the investigator's choice of treatment, which may include Docetaxel plus Prednisone/Prednisolone, Abiraterone plus Prednisone/Prednisolone, or Enzalutamide. The study has two parts: initially, participants are assigned to one of three groups including two BMS-986365 doses or comparator therapy, followed by a second part where they are randomized to either the selected BMS-986365 dose or the comparator treatment. During the study, participants will be monitored for disease progression through scans and evaluations using Response Evaluation Criteria in Solid Tumors and Prostate Cancer Clinical Trials Working Group criteria, with follow-up lasting up to four years. Safety and treatment effects will be assessed regularly, and participants' symptoms and quality of life will be closely observed. This long-term follow-up helps researchers understand the treatment's impact on cancer progression and patient well-being.

Researchers are evaluating the effectiveness and safety of pegozafermin in adults aged 18 to 75 years who have compensated cirrhosis caused by metabolic dysfunction-associated steatohepatitis (MASH), previously known as nonalcoholic steatohepatitis (NASH). Participants in this phase 3 study must have biopsy-confirmed advanced liver fibrosis (stage F4) due to MASH and meet specific metabolic health criteria. The study aims to understand how well pegozafermin can help improve liver fibrosis and delay disease progression over time. Participants will receive either pegozafermin or a placebo through subcutaneous injections. The study will monitor participants over a long period, up to five years, to observe changes in liver fibrosis and any clinical events related to disease progression. The treatment is given to those with compensated cirrhosis, meaning their liver is damaged but still functioning, and the study carefully evaluates the safety and potential benefits of pegozafermin in this group. Throughout the study, participants will undergo regular assessments to track liver health, including fibrosis regression and timing of disease progression. Researchers will use clinical events and laboratory tests to measure outcomes from the start of the study through 24 months and up to five years. Safety and health will be monitored closely, ensuring any side effects or complications are identified promptly. This comprehensive follow-up helps provide detailed information on the long-term effects of the treatment and participants' liver condition.

Researchers are investigating a modified interleukin-2 fusion protein called IOV-3001 in adults with advanced melanoma that cannot be removed by surgery or has spread to other parts of the body. This study includes participants with melanoma that has been previously treated and focuses on those receiving lifileucel, a cell therapy. The trial is an open-label Phase 1/2 study exploring the safety, tolerability, and dosing of IOV-3001. During the Phase 1 portion, participants will be divided into two parts: Part 1 involves receiving IOV-3001 before lifileucel treatment, while Part 2 involves receiving IOV-3001 after lifileucel instead of aldesleukin. IOV-3001 is given as a single intravenous infusion in a hospital setting. The study will monitor the effects of these treatment sequences to determine the recommended dose for the next phase. Participants will undergo assessments including safety and tolerability evaluations up to 30 days following treatment. Researchers will also track recovery from prior cancer treatment side effects and disease progression. The study includes regular monitoring of physical health and response to therapy, with a focus on participants' performance status and measurable disease lesions. Overall, the trial aims to gather important information on IOV-3001's role in treating advanced melanoma when combined with lifileucel therapy.

Researchers are evaluating the safety, pharmacokinetics, and preliminary effectiveness of NST-628, an oral tablet, in adults with advanced solid tumors that have mutations or dependence on the MAPK pathway. This two-part Phase 1 study focuses on patients who have exhausted standard treatment options. The study aims to determine the recommended dose for expansion and to assess tumor response rates in these patients. The study consists of two parts: Part A involves dose escalation, where patients receive increasing daily doses of NST-628 in 28-day cycles to find the maximum tolerated dose and recommended dose for expansion. Part B expands the study to up to six cohorts of about 30 participants each, focusing on specific MAPK pathway mutant solid tumors at the recommended dose. This expansion will help define safety and potential benefits, with the possibility to adjust dosing based on findings. Participants will be monitored throughout the study, which lasts about one year on average. Researchers will evaluate safety by tracking adverse effects and determine tumor response rates. Required assessments include tumor tissue analysis and disease measurement by standard tools. Participants must have adequate organ function and performance status, and will provide informed consent. Safety monitoring continues through study completion to gather comprehensive data on NST-628's effects.

Researchers are evaluating the study medicine elranatamab alone and in combination with daratumumab for people with relapsed or refractory multiple myeloma who have received prior treatments including lenalidomide and a proteasome inhibitor. The study aims to compare elranatamab to a combination therapy of daratumumab, pomalidomide, and dexamethasone, while also assessing the safety and activity of elranatamab with daratumumab. This is an open-label, phase 3 randomized trial involving multiple centers. The study includes three parts. Part 1 evaluates the safety and activity of different doses of elranatamab combined with daratumumab. In Part 2, participants are randomly assigned to receive either elranatamab alone, elranatamab with daratumumab, or the combination of daratumumab, pomalidomide, and dexamethasone. Part 3 investigates the effect of increased infection protection measures in participants treated with elranatamab alone or with daratumumab. All drugs are given by either subcutaneous injection or orally depending on the medication. Participants will receive study treatment until their disease worsens, unacceptable side effects occur, or they decide to stop. Researchers will monitor safety by tracking dose limiting toxicities during the first 42 days after starting elranatamab and treatment-emergent adverse events during the first 84 days. Progression-free survival will be assessed up to 51 months after randomization. Throughout the study, participants will undergo regular assessments to evaluate treatment safety and effectiveness.