Saint Cloud

Researchers are evaluating how well pre-treatment 68Ga-FAPI-46 PET/CT imaging can predict the histological response to neoadjuvant chemo-immunotherapy in patients with early-stage high-risk triple-negative breast cancer (TNBC). This prospective multicenter study focuses on female patients who have not yet been treated and are recommended to receive pembrolizumab combined with chemotherapy as their standard care. The study aims to improve understanding of treatment effectiveness using advanced imaging techniques before therapy begins. Participants will receive neoadjuvant treatment consisting of pembrolizumab 200 mg every three weeks combined first with four cycles of paclitaxel plus carboplatin, followed by four cycles of doxorubicin or epirubicin plus cyclophosphamide. After surgery, patients will continue adjuvant pembrolizumab for nine cycles or until cancer recurrence or unacceptable side effects occur. Each participant will undergo a 68Ga-FAPI-46 PET/CT scan before starting treatment, performed on the same machine as the 18F-FDG PET/CT scan and within 14 days prior to therapy. Throughout the study, researchers will monitor participants using scans and tissue analysis to assess histological response to treatment. They will measure the prediction accuracy through the area under the ROC curve at six months. Patient compliance, informed consent, and health insurance coverage are required for participation. Safety and treatment response will be carefully followed during and after the therapy period.

Researchers are studying a new treatment combination for adults with advanced breast cancer that is estrogen receptor positive, HER2 negative, and GRPR positive. The trial aims to find the recommended dose of the drug [177Lu]Lu-NeoB when given with ribociclib and fulvestrant to participants who have experienced early relapse after endocrine therapy or whose disease has progressed after endocrine therapy combined with a CDK4/6 inhibitor. This Phase 1 study includes a dose escalation part and a backfill part to assess safety, tolerability, and preliminary effectiveness. Participants will receive [177Lu]Lu-NeoB once every 28-day cycle for six cycles, ribociclib daily on days 1 to 21 of each cycle, and fulvestrant on specific days beginning at cycle 1. Pre- or perimenopausal women and men will also receive goserelin. The trial includes imaging with the radioactive agent [68Ga]Ga-NeoB at screening, possibly at cycle 2 day 15, and again 4 to 8 weeks after the last dose of [177Lu]Lu-NeoB to help locate cancer lesions. During the study, participants visit the clinic regularly for treatment, safety checks, and tumor assessments. Safety follow-up continues for 8 weeks after treatment ends, with extended monitoring every 12 to 24 weeks for up to 5 years to track side effects, adverse events, and treatment interruptions. Researchers will closely observe any dose-limiting toxicities and evaluate overall safety and effectiveness throughout the study period.

This research aims to evaluate the safety and effectiveness of BMS-986504, a selective PRMT5 inhibitor, when combined with Nab-paclitaxel and Gemcitabine, compared to a placebo combined with Nab-paclitaxel and Gemcitabine. The study focuses on participants with untreated metastatic Pancreatic Ductal Adenocarcinoma (PDAC) who have a specific genetic alteration called homozygous MTAP deletion. This is a randomized Phase 2/3 trial designed to explore treatment options for this patient population. Participants will be assigned to receive either BMS-986504 at specified doses on certain days along with Nab-paclitaxel and Gemcitabine, or a placebo with the same chemotherapy drugs. The treatments are given according to protocol schedules. Some participants may have received up to one cycle of Nab-paclitaxel and Gemcitabine before starting the study treatment, provided they did not experience disease progression or intolerable side effects. The initial cycle must be completed before randomization. During the study, researchers will monitor participants for progression-free survival and overall survival for up to three years after the last participant is randomized. Assessments include measuring tumor response using established criteria (RECIST v1.1). Participants will undergo evaluations to track safety, treatment effects, and disease status throughout the trial period.

Researchers are evaluating the effectiveness and safety of combining inavolisib with a cyclin-dependent kinase 4 and 6 inhibitor (CDK4/6i) and letrozole compared to placebo plus CDK4/6i and letrozole. This study focuses on participants with endocrine-sensitive PIK3CA-mutated hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer. It aims to assess treatment outcomes in the first-line setting for this specific breast cancer type. Participants will be assigned to receive either oral inavolisib once daily or a matching oral placebo once daily. All participants will also receive a CDK4/6 inhibitor on either Days 1-21 or Days 1-28 of each 28-day cycle, along with daily oral letrozole. This randomized, double-blind study will compare these two treatment combinations to monitor differences in disease progression and safety. Throughout the study, researchers will evaluate progression-free survival from the time of randomization until disease progression or death, up to 7 years. Participants will undergo assessments including tumor measurements by RECIST criteria, performance status evaluations, and monitoring of blood and organ function before treatment begins. Safety and efficacy will be closely observed during treatment, aiming to provide detailed long-term data on the study therapies.

Researchers are evaluating the safety and effectiveness of surovatamig, given alone or with other anticancer drugs, in people with mature B-cell blood cancers such as chronic lymphocytic leukemia, small lymphocytic lymphoma, mantle-cell lymphoma, large B-cell lymphoma, and B-cell non-Hodgkin lymphoma. This Phase 1/2 open-label study includes three substudies, each focusing on a specific type of these blood cancers. The study aims to understand how well surovatamig works and its safety profile in these patients. Participants will receive surovatamig either as a subcutaneous injection or intravenous infusion. Some participants may also receive other treatments like prednisone, rituximab, cyclophosphamide, vincristine, doxorubicin, or acalabrutinib according to standard care. The study involves an initial 28-day screening period, followed by a treatment phase where these medications are administered, and then a follow-up period to monitor outcomes. During the study, participants will undergo various assessments including monitoring for adverse events and serious side effects, with safety evaluations continuing for up to 6 years and 4 months. Researchers will also track dose-limiting toxicities during the first two months. The study involves regular evaluations of health status, treatment effects, and safety to better understand surovatamig's impact in these blood cancers.

Researchers are evaluating the effectiveness of camizestrant compared to standard endocrine therapy in patients with early breast cancer that is estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-). These patients have an intermediate or high risk of cancer recurrence and have already completed local treatments such as surgery and possibly chemotherapy, alongside at least 2 years and up to 5 years of standard adjuvant endocrine therapy. The study is a Phase III, open-label trial designed to assess outcomes over a long term. Participants will be randomly assigned to receive either camizestrant, an oral selective estrogen receptor degrader, or one of several standard endocrine therapies including tamoxifen, anastrozole, letrozole, or exemestane, administered according to local approved guidelines. The treatment duration for both groups is planned to last 60 months. Eligible patients may have previously used CDK4/6 inhibitors, and the study will specifically include those with intermediate or high risk of recurrence as determined by clinical and biological markers. During the study, participants will be monitored for up to 10 years from the last patient's randomization to evaluate invasive breast cancer-free survival. Additional outcomes include invasive disease-free survival, distant relapse-free survival, overall survival, safety, and clinical outcome assessments. The study involves ongoing assessments of health status, treatment effects, and safety to determine the long-term benefits and risks of camizestrant compared to standard therapies.

The trial investigates the progression-free survival benefit of duvelisib monotherapy compared to the investigator's choice of gemcitabine or bendamustine in adults with relapsed or refractory nodal T cell lymphoma exhibiting the T follicular helper (TFH) phenotype. This phase 3, open-label, randomized controlled study focuses on participants whose disease has returned or not responded after at least one prior systemic cytotoxic therapy and who have measurable disease according to established criteria. Participants will be assigned to receive either oral duvelisib capsules or an intravenous solution of gemcitabine or bendamustine, based on investigator choice. The study treatments are given as monotherapy. The trial is multicenter and open-label, meaning both participants and researchers know which treatment is being given. Throughout the study, participants will be monitored for progression-free survival, as evaluated by an Independent Review Committee, for up to three years. Researchers will assess disease status and treatment effects using standardized criteria. Safety and treatment adherence will also be observed during the study period.

Researchers are evaluating the safety and anti-cancer activity of NX-5948, an oral Bruton's Tyrosine Kinase (BTK) degrader, in adults with advanced B-cell malignancies. This Phase 1a/1b open-label study focuses on patients with relapsed or refractory B-cell cancers who have received prior therapies and for whom no other beneficial treatments are known. The study includes multiple types of B-cell cancers such as Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL), Diffuse Large B-cell Lymphoma (DLBCL), Mantle Cell Lymphoma (MCL), and others, including those with central nervous system involvement. In Phase 1a, the study escalates doses of NX-5948 to assess its safety and tolerability in patients with various B-cell malignancies who have specific prior treatment histories. Phase 1b Part 1 expands safety and evaluates anti-tumor activity at selected doses across up to 17 patient groups with different B-cell cancers. Part 2 further explores anti-tumor effects in an additional group of CLL/SLL patients at the selected dose. Treatment involves oral administration of NX-5948, with patients possibly randomized to different dose levels to find the optimal dosing. Participants will undergo regular assessments including monitoring for side effects, tumor response evaluations through clinical and laboratory tests, and tracking of adverse events over months to years. Key measures include dose-limiting toxicities, overall response rates, and safety outcomes such as serious adverse events and treatment discontinuations. The study aims to establish maximum tolerated doses and long-term safety while observing the drug's activity against B-cell cancers over up to six years of follow-up.

Researchers are evaluating the safety and effectiveness of Raludotatug Deruxtecan (R-DXd) in people with platinum-resistant, high-grade ovarian, primary peritoneal, or fallopian tube cancer. This study includes two parts: Phase 2 to find the best dose based on safety and response, and Phase 3 to compare R-DXd with the investigator's choice of chemotherapy. R-DXd is an antibody-drug conjugate that targets CDH6, a protein overexpressed in tumor cells. Participants will receive R-DXd through intravenous infusions. In Phase 2 (Part A), the dose will be optimized, and biopsies will be collected before and during treatment if possible. In Phase 3 (Part B), participants will be randomly assigned to receive either R-DXd or chemotherapy chosen by their doctor, which may include paclitaxel, topotecan, or PLD, all given by IV infusion. The study monitors treatment effects up to 18 months in Phase 2 and up to 26 months in Phase 3. During the study, participants will have regular scans and assessments to measure tumor response and progression-free survival. Researchers will monitor safety and organ function through lab tests and performance status evaluations. Participants must be willing to follow the study visits and procedures, which include biopsy samples in Phase 2 and imaging assessments to evaluate treatment response. The study aims to provide detailed information about how well R-DXd works and its safety in this patient group.

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.