Greenslopes

Researchers are evaluating MDNA11, a long-acting beta-only recombinant interleukin-2 designed to activate immune cells that kill cancer while minimizing activation of immunosuppressive cells. This Phase 12 study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and early anti-tumor activity of MDNA11 alone or combined with the checkpoint inhibitor pembrolizumab in patients with advanced solid tumors. The study is conducted at multiple sites with regulatory and ethical approvals and includes about 115 patients. The trial has several parts dose escalation and expansion for MDNA11 monotherapy and for its combination with pembrolizumab. MDNA11 is given intravenously every two weeks with doses adjusted to find the recommended dose for expansion. Tumor assessments using CT or MRI scans happen every 8 weeks to monitor response until disease progression or other study-end criteria occur. Treatment may continue beyond progression under certain conditions. Participants undergo evaluations including tumor imaging, laboratory tests, and safety monitoring over up to 24 months. Researchers measure recommended dose levels, treatment-related adverse events, pharmacokinetics, immune response, and anti-tumor activity such as response rates and progression-free survival. Patients can withdraw anytime, and safety follow-up continues to understand MDNA11s effects alone and with pembrolizumab.

Researchers are studying metastatic castration-resistant prostate cancer mCRPC to find new treatment options. This trial evaluates if the study medicine ifinatamab deruxtecan I-DXd or MK-2400 helps people live longer overall and experience slower cancer growth or spread compared to chemotherapy. The study is a Phase 3 trial comparing I-DXd with standard chemotherapy for mCRPC patients. Participants are randomly assigned to receive either I-DXd at 12 mgkg every 3 weeks through intravenous infusion or docetaxel chemotherapy at 75 mgm2 every 3 weeks combined with daily prednisone pills. Treatment continues until the disease progresses, unacceptable side effects occur, or treatment is stopped for other reasons. Premedication is given before each dose of I-DXd to help prevent nausea and vomiting. During the study, participants will have regular visits for treatment and monitoring. Researchers will assess overall survival and radiographic progression-free survival for up to about 36 months. Additional measures include response rates, time to pain progression, PSA progression, and adverse events. The study tracks safety, treatment effects, and quality of life over a long follow-up period to better understand the potential benefits and risks of I-DXd compared to chemotherapy.

Researchers are investigating the effectiveness and safety of combining petosemtamab with pembrolizumab compared to pembrolizumab alone as first-line treatment for 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 and aims to improve treatment outcomes in this population. Participants will be randomly assigned to receive either the combination of petosemtamab plus pembrolizumab or pembrolizumab alone. The study excludes patients previously treated with anti PD-L1 or anti-EGFR therapies, with some exceptions for local treatments like cetuximab under specific conditions. The treatments will be administered as part of the trial, with researchers comparing the two approaches over the treatment period. During the study, participants will undergo regular evaluations including tumor assessments based on RECIST v1.1 criteria, health-related quality of life questionnaires, and safety monitoring for adverse events. The main outcomes measured include overall survival and objective response rate up to approximately three years. Additional assessments include progression-free survival, duration of response, and pharmacokinetics. These activities aim to provide comprehensive data on how well the treatments work and their safety profiles throughout the study period.

Researchers are evaluating HMBD-001, an anti-HER3 antibody, in combination with cetuximab with or without docetaxel for people with advanced squamous cell cancers. This Phase IbII, open-label, multi-center study focuses on various types of advanced or metastatic squamous cell carcinomas, including lung, head and neck, esophageal, cervical, cutaneous, and nasopharyngeal cancers. The study aims to assess the safety and effectiveness of these treatments in participants who have limited standard care options. Participants receive HMBD-001 intravenously once a week alongside cetuximab weekly, with or without docetaxel administered every three weeks. There are three treatment arms one with HMBD-001 plus docetaxel, one with HMBD-001 plus docetaxel and cetuximab both closed to recruitment, and one with HMBD-001 plus cetuximab. The trial evaluates different combinations to understand their effects on advanced squamous cell cancers. During the study, participants are monitored for adverse events and dose-limiting toxicities. Researchers track progression-free survival up to six months and measure tumor response using established criteria. Blood samples are collected to study the drugs behavior in the body and immune response. The study includes repeated treatment cycles and safety follow-up, with assessments continuing up to 48 months. Participants undergo tumor biopsies and organ function tests to ensure safety and gather comprehensive data.

Researchers are studying the safety, tolerability, and best dosing of a drug called ABT-301 combined with fixed doses of tislelizumab and bevacizumab in adults with a type of colorectal cancer called proficient mismatch repair pMMRnon-microsatellite instability-high non-MSI-H colorectal cancer. This study aims to find the highest safe dose of ABT-301 and the recommended dose for future studies while evaluating its effects in advanced or metastatic cases. Participants will take ABT-301 orally either once or twice daily in 21-day treatment cycles. Alongside ABT-301, participants will receive tislelizumab 200 mg and bevacizumab 7.5 mgkg via intravenous infusion on the first day of each 21-day cycle. The study has two parts a dose-escalation phase to identify safe dosing levels and a dose-optimization phase to further evaluate two selected doses for safety and activity against the cancer. During the study, participants will undergo regular assessments including measuring tumor response using RECIST criteria, monitoring safety and side effects, and pharmacokinetic and pharmacodynamic evaluations. These assessments occur from screening through treatment and up to 90 days after the last dose or until disease progression or death, lasting up to 28 months. The study monitors overall survival, progression-free survival, and duration of response to treatment.

Researchers are studying advanced prostate cancer by evaluating combinations of investigational drugs JNJ-87189401 and JNJ-78278343, along with other treatments such as apalutamide, lutetium Lu-177 vipivotide tetraxetan, and JNJ-101556143. The study aims to identify recommended dosing regimens and assess the safety of these combinations in different parts of the trial, including dose escalation and safety evaluation phases. Participants in Part 1 will receive escalating doses of JNJ-78278343 and JNJ-87189401 to find the best dosing for Phase 2. Parts 2A and 2B will treat participants with the selected dosing regimen, while Part 2C will add apalutamide to the combination. Part 3 assesses safety when combining the drugs with standard lutetium Lu-177 vipivotide tetraxetan treatment, and Part 4 evaluates safety with the addition of JNJ-101556143. Throughout the study, participants will be closely monitored for dose-limiting toxicities and adverse events for up to nearly five years. Researchers will measure drug levels in the blood, immune responses, tumor responses, progression-free survival, and prostate-specific antigen levels. The study involves multiple treatment phases with ongoing safety assessments and long-term follow-up to understand how these drug combinations affect advanced prostate cancer.

Researchers are evaluating the safety, tolerability, and effectiveness of combining Imzokitug with Pumitamig and Platinum-Doublet Chemotherapy PDCT compared to Pumitamig and PDCT alone. The study focuses on adults with locally advanced or metastatic non-small cell lung cancer NSCLC who have not received previous systemic therapy for advanced or metastatic disease. This is a Phase 2 interventional trial assessing first-line treatments for this condition. Participants will receive either the combination of Imzokitug, Pumitamig, and PDCT or Pumitamig with PDCT alone. Treatment involves specified doses given on certain days, with tumor tissue samples required for analysis. The study is randomized and parallel in design, with multiple experimental arms. The primary treatment period extends up to approximately four years, during which the response to therapy will be closely monitored. Throughout the trial, participants will undergo evaluations including tumor assessments using RECIST v1.1 criteria to measure objective response rates. Safety will be monitored by documenting adverse events, serious adverse events, and treatment-related effects up to 90 days after the last treatment. Researchers will also track progression-free survival, overall survival, duration of response, and time to recurrence during the study and follow-up periods. The trial is sponsored by Bristol-Myers Squibb and aims to collect comprehensive data over several years.

Researchers are evaluating BMS-986365 compared to the investigators choice of therapy in men with Metastatic Castration-resistant Prostate Cancer. This phase 3, randomized trial aims to assess how well BMS-986365 works and how safe it is, focusing on radiographic progression-free survival. The study includes participants who have previously been treated with androgen receptor pathway inhibitors and have metastatic prostate cancer confirmed by imaging. Participants are randomized into groups receiving either one of two dose levels of BMS-986365 or an active comparator treatment chosen by the investigator, which includes either Docetaxel plus PrednisonePrednisolone or Enzalutamide or Abiraterone plus PrednisonePrednisolone. The study has two parts Part 1 compares the different doses and comparator arms, while Part 2 focuses on the selected BMS-986365 dose versus the investigators choice. Dosing schedules are specified but not detailed here. During the study, participants undergo regular assessments including imaging scans to evaluate cancer progression, pain and symptom questionnaires, blood tests, electrocardiograms, and monitoring for adverse events. Outcomes measured include progression-free survival, overall survival, response rates, pain progression, and quality of life changes. The study may last up to 4 years, with ongoing safety and efficacy evaluations throughout this time.

Researchers are evaluating the efficacy and safety of pegozafermin in adults with compensated cirrhosis caused by metabolic dysfunction-associated steatohepatitis MASH, previously known as nonalcoholic steatohepatitis NASH. This study focuses on participants with biopsy-confirmed advanced liver fibrosis stage F4 due to MASH. The research aims to understand how pegozafermin affects liver health over time compared to a placebo. Participants will receive either pegozafermin or a matched placebo through subcutaneous injections. The study follows a randomized, parallel design with quadruple masking to ensure unbiased results. The treatment period extends up to 24 months, with additional long-term follow-up lasting up to five years to assess disease progression and liver fibrosis regression. During the study, participants will undergo various assessments including measurements of liver fibrosis, disease progression through clinical events, and liver function tests such as alanine aminotransferase ALT levels. Tools like Enhanced Liver Fibrosis ELF score and FibroScan Vibration-controlled Transient Elastography VCTE will be used to monitor liver condition up to 60 months. Safety and efficacy will be closely monitored throughout the study period, which may last up to seven years in total.

Researchers are evaluating a modified interleukin-2 fusion protein called IOV-3001 in adults with previously treated, unresectable or metastatic melanoma who will receive lifileucel. This Phase 12, open-label study aims to understand the safety, tolerability, and appropriate dosing of IOV-3001, which incorporates a modified form of aldesleukin into the antibody palivizumab. The trial includes participants with melanoma that has progressed after certain prior therapies and focuses on both cutaneous and uveal melanoma under specific conditions. Participants will receive IOV-3001 as a single intravenous infusion administered in a hospital setting. The Phase 1 portion has two parts in Part 1, IOV-3001 is given before the lifileucel treatment regimen in Part 2, it is given after lifileucel instead of aldesleukin. Dose escalation will occur in participants with unresectable or metastatic melanoma to determine the recommended dose for Phase 2. During the study, participants will be closely monitored for safety and pharmacokinetics up to 30 days after dosing, with longer-term follow-up to assess immune response, overall and progression-free survival, and response rates for up to 5 years. Researchers will evaluate treatment effects using radiographic assessments, immune profiles, and disease progression measures. Safety follow-up and data collection will continue after treatment to better understand the therapys impact and persistence.