Wilson

Researchers are conducting a Phase 1/2a trial to assess the safety and tolerability of DB-1303/BNT323 in people with advanced solid tumors that express HER2. The study focuses on patients with HER2-positive or HER2-expressing malignant solid tumors that are advanced, unresectable, recurrent, or metastatic, and have not responded to standard treatments or have no available standard treatments. This multicenter, open-label study includes an initial dose-escalation phase followed by a dose expansion phase to explore safety, tolerability, and preliminary efficacy of the treatment.

Researchers are evaluating the anti-tumor activity of amivantamab combined with pembrolizumab and carboplatin compared to pembrolizumab, 5-fluorouracil (5-FU), and platinum therapy (carboplatin or cisplatin) in participants with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). This trial focuses on participants who have not received prior systemic treatment in the recurrent/metastatic setting. HNSCC is a type of cancer affecting the outer tissue layer of the mouth and throat and other head and neck regions. Participants will receive either amivantamab added to pembrolizumab and carboplatin or the standard care regimen of pembrolizumab, 5-FU, and a platinum agent (carboplatin or cisplatin). 5-FU will be given as an infusion over a 4-day period. The study is a phase 3, randomized, open-label, multicenter trial comparing these treatment combinations. During the study, researchers will monitor overall survival and the objective response rate using standard tumor evaluation criteria for up to about 3 years and 7 months. Participants will undergo assessments to measure disease response, including imaging and other evaluations, to track how well the treatments work. Safety and side effects will also be monitored throughout the trial period.

The primary purpose of the study is to assess how well amivantamab in combination with lazertinib or in combination with chemotherapy works (antitumor activity) in participants with epidermal growth factor receptor mutated (EGFRm) non-small cell lung cancer (NSCLC; that is one of the major types of lung cancer).

Researchers are evaluating the effectiveness and safety of adding Tersolisib (LY4064809/STX-478) to other anti-cancer drugs as the first treatment for adults with advanced hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer. This phase 3 study focuses on participants whose cancer has a specific genetic change called a PIK3CA mutation and who have not received prior treatment for advanced breast cancer. The study aims to understand how well this treatment combination works and its safety over time. Participants will receive Tersolisib or a placebo, combined with a CDK4/6 inhibitor (Ribociclib, Palbociclib, or Abemaciclib) and endocrine therapy (Anastrozole, Letrozole, Exemestane, or Fulvestrant). All drugs are given orally except for Fulvestrant, which is given by injection into the muscle. The study includes two parts: Part 1 allows participants who have had up to two prior treatments for advanced breast cancer, including chemotherapy; Part 2 includes those with no prior treatment for advanced disease and classifies them as endocrine sensitive or resistant based on their cancer history. During the study, participants will be regularly assessed for cancer response, progression-free survival, and side effects. Researchers will monitor measurable disease or bone involvement and track overall response rates, including complete or partial tumor shrinkage. The study will continue as long as the treatment is helping without causing unbearable side effects. Follow-up may last up to five years to observe long-term outcomes and safety.

Researchers are evaluating the effectiveness and safety of BMS-986489, a fixed-dose combination of atigotatug and nivolumab, compared to durvalumab in participants with limited-stage small-cell lung cancer (LS-SCLC). This Phase 2, open-label, randomized study focuses on consolidation therapy following standard chemoradiotherapy in participants without disease progression. Atigotatug is a novel antibody targeting fuc-GM1 on tumor cells, and when combined with nivolumab, an immune checkpoint inhibitor, it may enhance antitumor effects. Participants will be randomly assigned to receive either BMS-986489 or durvalumab as consolidation therapy. Both treatments are given as intravenous infusions once every 4 weeks for up to 2 years. Before randomization, participants must have completed concurrent chemotherapy (including platinum and etoposide) and radiotherapy without progression. Prophylactic cranial irradiation may be given before starting study treatment, following institutional guidelines. During the study, participants will be monitored regularly for overall survival up to 5 years from randomization, with assessments every 8 to 12 weeks depending on treatment status. Researchers will evaluate safety and efficacy through clinical examinations, imaging scans, laboratory tests, and adverse event monitoring. Participants are expected to follow contraceptive guidelines and maintain follow-up visits as outlined in the protocol.

Researchers are evaluating the effectiveness of trastuzumab deruxtecan (T-DXd) in patients with HER2-positive (IHC 3+) locally advanced, unresectable, or metastatic solid tumors in the United States. The study focuses on patients who have already received prior systemic treatment for metastatic or advanced disease and have no satisfactory alternative treatment options. This observational study aims to capture real-world outcomes in a diverse patient population excluding those with breast, colorectal, non-small cell lung, gastric/gastroesophageal junction cancers, and hematological malignancies. Participants will receive trastuzumab deruxtecan monotherapy as prescribed in routine clinical practice following the FDA label. The study will be conducted across approximately 30 sites including community oncology practices, hospital systems, and academic medical centers, enrolling about 100 patients. Treatment will be observed in a real-world setting without intervention on dosing or administration by the study team. During the study, researchers will collect information on tumor response rates and how long patients respond to treatment, following participants for up to 2.5 years after enrollment. Additional outcomes include time to stopping treatment and time to starting subsequent treatments. Data will be gathered from medical records and clinical assessments to understand the treatment’s impact in everyday clinical use, ensuring thorough safety and effectiveness monitoring throughout the study period.

Researchers are evaluating the safety and tolerability of low-dose lenalidomide given continuously under the skin (subcutaneous infusion) combined with dexamethasone and a proteasome inhibitor in patients with multiple myeloma. This Phase 1/2 trial aims to understand how the drug behaves in the body, as well as its effects on disease markers like response rate and progression-free survival. The study also explores the impact of this treatment on patient-reported symptoms and quality of life. Participants receive low-dose lenalidomide continuously by subcutaneous infusion alongside dexamethasone and a proteasome inhibitor such as bortezomib. An oral lenalidomide treatment serves as an active control. The study is designed to monitor treatment over 12 months, focusing on safety, dose-limiting toxicities, and pharmacokinetic profiles at steady blood concentrations. Throughout the study, participants undergo regular assessments including monitoring for side effects, blood tests to measure drug levels and biomarkers, and evaluations of treatment response such as complete or partial remission rates. Safety is closely tracked by recording adverse events and toxicities. The study also measures progression-free survival and duration of response to assess treatment effectiveness over the year-long period.

Researchers are evaluating whether adding navtemadlin to ruxolitinib treatment provides more clinical benefit than ruxolitinib alone for patients with Myelofibrosis who have not responded well to ruxolitinib alone. This Phase 3, randomized, double-blind study focuses on patients with Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis. Participants must be JAK inhibitor-naive and have a suboptimal response to ruxolitinib treatment during the initial run-in period. During the study, all subjects start by receiving ruxolitinib alone in a run-in period. Those showing a suboptimal response are then randomly assigned in a 2:1 ratio to receive either navtemadlin or a navtemadlin placebo as an add-on to their ongoing ruxolitinib treatment. The study is blinded, so neither the participants nor the doctors know who is receiving the navtemadlin or placebo. Navtemadlin is an investigational MDM2 inhibitor, while ruxolitinib is a janus kinase 1/2 inhibitor. Participants are involved in assessments to compare spleen volume reduction and total symptom score reduction between the two treatment groups over 24 weeks. Researchers monitor safety and efficacy through clinical evaluations, symptom tracking, and laboratory tests. The study includes screening for performance status, blast counts, and TP53 wild-type status, ensuring participants meet specific health criteria before randomization.

Researchers are evaluating overall survival in patients with advanced metastatic or locally recurrent breast cancer who have no approved treatment alternatives. This Phase 3, multicenter, randomized, open-label study compares the Bria-IMT regimen combined with the checkpoint inhibitor Retifanlimab against treatment chosen by patients or physicians. The study also aims to assess the activity of the Bria-IMT regimen alone compared to its combination with the checkpoint inhibitor. Participants are initially randomized equally into three groups: Bria-IMT plus Retifanlimab, treatment of physician's choice (TPC), and Bria-IMT alone. After enrollment of 150 patients, the monotherapy group is discontinued, allowing crossover to combination therapy if needed, with subsequent randomization continuing between combination therapy and TPC. Treatment cycles for Bria-IMT with or without Retifanlimab occur every three weeks, including cyclophosphamide given 2-3 days before SV-BR-1-GM inoculations, SV-BR-1-GM administered intradermally, interferon injections at inoculation sites, and Retifanlimab infusions timed consistently each cycle. TPC is given according to standard care at each site using approved drugs including chemotherapy and targeted agents. Participants undergo imaging assessments every six weeks twice, then every eight weeks during treatment if disease is stable and no major safety issues arise. Safety and overall survival will be monitored up to 60 months. Eligibility requires confirmation of advanced breast cancer with prior therapies failed, and participants must have an ECOG performance status of 0 to 2 with expected survival of at least four months. The study includes comprehensive assessments, treatment monitoring, and long-term follow-up to evaluate outcomes and safety.

Researchers are evaluating whether a new medicine called PF-08634404 combined with chemotherapy is more effective than the current standard treatment, pembrolizumab with chemotherapy, for adults with locally advanced or metastatic non-small cell lung cancer (NSCLC). This Phase 3 study focuses on adults 18 years and older with squamous or non-squamous NSCLC who are not candidates for surgery or curative chemoradiotherapy and have not received prior treatment for advanced disease. The study excludes participants with known actionable genomic alterations and aims to compare overall survival and progression-free survival over approximately 39 and 32 months, respectively. Participants are assigned to two parts based on their tumor type: squamous NSCLC patients in Part 1 and non-squamous NSCLC patients in Part 2. Within each part, participants are randomly assigned to receive either the experimental treatment PF-08634404 or the control treatment pembrolizumab, each combined with a chemotherapy regimen tailored to tumor type. Treatments are given via intravenous infusions in cycles, followed by maintenance therapy with either monotherapy or combination therapy depending on the study part. Treatment continues as long as it is beneficial and side effects remain manageable. During the study, participants will have regular visits for treatment administration and health evaluations. Cancer response will be monitored with tests every 6 weeks for the first 48 weeks and then every 12 weeks afterward. Researchers will assess overall survival and progression-free survival, ensuring thorough monitoring of participants' health and treatment effects throughout the study period.