Grand Rapids

Researchers are studying 177Lu-BetaBart, a 177Lu-labeled anti-B7-H3 monoclonal antibody, to understand its safety, how it moves and distributes in the body, and its preliminary effectiveness against certain solid tumors. This study focuses on patients aged 18 and older with relapsed or refractory locally advanced, inoperable, or metastatic solid tumors including castration-resistant prostate cancer, colorectal cancer, various lung cancers, head and neck squamous cell carcinoma, ovarian, cervical, endometrial, triple negative breast, and esophageal squamous cell carcinoma. The trial has two phases to evaluate safety and early anti-tumor activity, using advanced study designs to identify appropriate dosing and response rates. The study involves two main phases: Phase 1 is a dose escalation phase where participants receive intravenous infusions of 177Lu-BetaBart every 6 weeks to determine the maximum tolerated dose and recommended dose for Phase 2. Phase 2a is a dose expansion phase conducted at the recommended dose to further assess safety and early anti-tumor effects. Each phase includes a screening period, treatment and imaging period, and a safety and long-term follow-up period. Participants will undergo various assessments including imaging scans and laboratory tests to monitor disease progression, treatment safety, and biological responses over periods up to 6 weeks for Phase 1 and up to 30 weeks for Phase 2a. Researchers will track adverse events, dose recommendations, and measure tumor activity using biochemical markers and imaging. Long-term safety and treatment effects will be followed after the treatment periods to gather comprehensive clinical data.

Researchers are evaluating 64Cu-LNTH-1363S, a radiolabeled FAP inhibitor, in patients with sarcomas or gastrointestinal tract cancers. This multicenter, open-label Phase 1/2a study aims to assess the safety and tolerability of the agent, establish dosimetry, and identify the optimal imaging dose and timing. The study also compares the imaging biodistribution of 64Cu-LNTH-1363S with FAP expression measured by immunohistochemistry in tumor tissues. The study is divided into two parts. Part 1 involves six patients with metastatic sarcomas receiving a single dose of approximately 8 ± 1 mCi of 64Cu-LNTH-1363S, followed by serial PET/CT scans at multiple timepoints on the intervention day to determine biodistribution and optimal imaging parameters. Part 2 includes twenty patients with non-metastatic, operable sarcomas or gastrointestinal cancers planned for surgery within 60 days. These patients undergo imaging with the agent, and tissue samples collected during surgery are analyzed for FAP expression. Both parts monitor cardiac safety through ECG assessments. Participants will go through screening up to 14 days before intervention, receive the imaging dose on one day, and have safety follow-ups for 1 to 7 days depending on the study part. Assessments include serial PET/CT imaging at specified timepoints post-dose, tumor tissue sampling for immunohistochemistry, and cardiac monitoring for changes in heart rate and QT intervals. Part 2 extends up to 10 to 11 weeks to cover the surgical tissue collection period. The study measures biodistribution, dose optimization, correlation with FAP expression, and cardiac safety throughout the participation period.

Researchers are studying the safety and effectiveness of 67Cu-SAR-bisPSMA in men with metastatic castrate resistant prostate cancer that expresses PSMA. This Phase I/IIa trial focuses on participants whose cancer has progressed despite androgen deprivation therapy and prior treatments with androgen receptor pathway inhibitors. The study aims to understand how the drug distributes in the body, determine safe dosing levels, and evaluate treatment responses over several years. Participants receive two drugs: 64Cu-SAR-bisPSMA for imaging and dosimetry, and 67Cu-SAR-bisPSMA for treatment. The study includes a dose escalation phase to find the maximum tolerated or feasible dose of a single 67Cu-SAR-bisPSMA dose over 8 weeks, followed by a recommended dosing phase with two doses over 14 weeks. Imaging with PET/CT scans using 64Cu-SAR-bisPSMA helps model dosimetry for the therapeutic 67Cu-SAR-bisPSMA. The treatment is given under close monitoring to assess safety and response. During the study, participants undergo PET/CT scans, blood tests, ECGs, and vital sign monitoring at various times up to 5 years to track drug distribution, treatment effects on prostate specific antigen levels, radiographic cancer response, and any side effects. Safety is closely followed through laboratory results and adverse event reporting. Participants are monitored for long-term tolerability and treatment outcomes, with study involvement lasting up to five years.

Researchers are studying whether calderasib alone or combined with cetuximab can treat advanced solid tumors in people who have the KRAS G12C mutation. This phase 2, open-label trial aims to find out how many participants respond to these treatments and to compare their safety and tolerability. Participants receive calderasib by mouth and cetuximab through intravenous infusion. The study includes people with locally advanced or metastatic solid tumors other than colorectal cancer, who have already undergone standard treatments. The trial monitors response and side effects over time as participants receive either calderasib alone or in combination with cetuximab. During the study, participants undergo regular assessments to measure tumor response and track any side effects or adverse events. Researchers record how many people experience treatment-related side effects and how many stop treatment due to these effects. The study follows participants for up to approximately 76 months to assess long-term outcomes and safety.

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 conducting a Phase I/II, multi-site, open-label study to evaluate the safety, effectiveness, and optimal dosing of the investigational treatments BNT323 combined with BNT327 in adults with advanced breast cancer. This includes those with hormone receptor-positive or negative types, HER2-positive, HER2-low, HER2-ultralow, HER2-null breast cancer, or triple-negative breast cancer. The study aims to understand how these treatments work alone and together in this patient population. The study has two parts: Part 1 involves dose escalation where participants with chemotherapy-pretreated advanced breast cancer receive BNT323 and BNT327 together to find the recommended Phase 2 dose. Part 2 is an expansion phase that tests the safety and effectiveness of the chosen dose, including randomized comparisons of combination therapy at different doses and monotherapies. Participants may be assigned to one of four treatment arms, with dosing administered via intravenous infusion. Participants will be monitored for dose-limiting toxicities during the first 21 days of treatment, as well as adverse events up to 90 days after the last dose. Tumor response will be assessed for up to 36 months. Evaluations include heart function tests, tumor imaging, safety assessments, and tracking of side effects. The study carefully monitors treatment safety, effectiveness, and participant health throughout the trial duration.

Researchers are evaluating the safety and effectiveness of new treatments called BNT314 and BNT327 combined with chemotherapy for people with metastatic colorectal cancer (mCRC) that is microsatellite stable or mismatch repair proficient (MSS/pMMR). This study includes participants who did not respond well to their first chemotherapy treatment and aims to find the right dose and assess how well these treatments work together to shrink tumors or slow their growth. The study includes multiple phases to test safety, dosing, and treatment benefits. The study has three parts: Part A focuses on safety and dose escalation of BNT314 with BNT327; Part B tests the safety and optimal dose of BNT314 combined with BNT327 and standard chemotherapy; and Part C compares the combination treatment with standard chemotherapy alone to see if it improves outcomes. Treatments are given by intravenous infusion or oral methods depending on the drug. Participants receive treatment until their disease worsens, they cannot tolerate the therapy, or the study ends, with an average treatment duration of 6 to 10 months. Participants will be screened, treated, and followed up for safety and long-term survival. Researchers will regularly monitor for side effects, treatment response, and disease progression using scans and laboratory tests. The study includes a safety follow-up period and a long-term survival follow-up that can last up to 57 months, with committees overseeing participant safety throughout the trial.

Researchers are evaluating the safety, effectiveness, best dose, and how the body processes (pharmacokinetics) an investigational drug called BNT326. This study includes people with advanced solid tumors that are metastatic, recurrent, or have progressed after previous treatments. The investigation is divided into two parts: Part 1 tests BNT326 alone, and Part 2 studies BNT326 alone or combined with other immunotherapy drugs, including pumitamig (BNT327). Participants have specific tumor types like melanoma, non-small cell lung cancer, breast cancer, gastric cancer, colorectal cancer, and cervical cancer, among others. In Part 1, participants receive BNT326 by intravenous infusion in various groups based on cancer type and prior treatments. Part 2 involves BNT326 given alone or with pumitamig, also by intravenous infusion, in several defined cancer groups. Some groups are randomized to receive different dose levels or combinations to find the optimal treatment plan. The study includes a screening phase, treatment phase lasting up to 24 months or until progression or unacceptable side effects, a safety follow-up, efficacy follow-up, and long-term survival monitoring, totaling about 38 months for Part 1 and 48 months for Part 2. During the study, participants undergo regular assessments including measuring tumor response using RECIST criteria, monitoring for side effects and serious adverse events up to months after treatment ends, and measuring drug levels in the blood. Researchers track treatment interruptions or discontinuations due to side effects and evaluate dose-limiting toxicities. Tumor tissue samples are required before enrollment. Safety and effectiveness data are collected throughout treatment and follow-up periods to understand how well BNT326 works alone or combined and its safety profile.

Researchers are looking for new ways to treat neovascular age-related macular degeneration (NVAMD). Available standard (usual) treatments for NVAMD, such as aflibercept, may not work for every person. Researchers want to learn if a trial medicine called tiespectus (also called MK-8748 or EYE201) can treat NVAMD. The goal of this trial is to learn if tiespectus works as well as aflibercept to treat NVAMD.

This research aims to learn about the safety and dosing of COM503, a drug being studied alone or combined with zimberelimab, in people with advanced solid tumors. It is a first-in-human Phase 1 clinical trial focused on participants with advanced or recurrent metastatic solid malignancies who have progressed despite standard treatments. The study seeks to assess safety, tolerability, and determine the best doses for future research. Participants will receive COM503 either alone or together with zimberelimab through intravenous infusions. The trial has two parts: dose escalation to find the maximum tolerated or administered dose, and dose expansion to further evaluate safety and dosing at identified levels. Both treatments are given as infusions, and the study monitors how well participants tolerate these therapies. During the study, participants will have their tumors measured by CT or MRI scans and will be closely monitored for safety from the first dose until 90 days after the last dose or start of a new cancer therapy. Researchers will evaluate side effects, tolerability, and other safety outcomes. Participation involves regular assessments and follow-up to understand the effects of COM503 alone or with zimberelimab in advanced cancer settings.