Cerritos

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 effectiveness and safety of zanidatamab combined with a physician's choice of chemotherapy compared to trastuzumab combined with chemotherapy in treating adults with metastatic HER2-positive breast cancer. This study focuses on participants whose cancer has progressed or who cannot tolerate previous treatment with trastuzumab deruxtecan (T-DXd). The study is a phase 3 randomized trial aiming to assess progression-free survival and other important outcomes such as patient-reported tolerability and physical functioning. Participants receive either zanidatamab or trastuzumab through intravenous infusion, alongside chemotherapy drugs chosen by their physician from eribulin, gemcitabine, vinorelbine (all intravenous), or oral capecitabine. The study includes detailed monitoring of drug safety and how the body processes zanidatamab. The treatments continue until disease progression or unacceptable side effects occur. During the study, participants undergo regular evaluations including scans to measure cancer progression according to RECIST guidelines. Researchers also monitor safety through laboratory tests and heart function assessments. Participants are followed for up to approximately 44 months to measure progression-free survival and overall treatment outcomes. Long-term follow-up and patient-reported outcomes help provide a complete understanding of the treatments' effects.

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).

This research aims to evaluate the safety and effectiveness of iza-bren, a bi-specific antibody-drug conjugate targeting EGFR and HER3 with a topoisomerase inhibitor, compared to the treatment of physician's choice (paclitaxel, nab-paclitaxel, carboplatin plus gemcitabine, or capecitabine). The study focuses on patients with previously untreated, locally advanced, recurrent inoperable, or metastatic triple-negative breast cancer (TNBC) or estrogen receptor (ER)-low, HER2-negative breast cancer who are not eligible for anti-PD(L)1 or endocrine therapies. The trial is conducted in two phases, phase 2 and phase 3, to thoroughly assess these treatments.

Researchers are evaluating the effectiveness and safety of pirtobrutinib (LOXO-305) compared to ibrutinib in adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The study includes participants who may have had prior treatment as well as treatment-nave participants with a specific genetic deletion (17p deletion). The study is a Phase 3, open-label, randomized trial designed to assess these treatments in different patient groups over varying durations. Participants receive either oral pirtobrutinib or oral ibrutinib. Part 1 compares these two drugs in participants with or without prior therapy, and participation can last up to six years. Part 2 focuses on pirtobrutinib alone in treatment-nave participants with 17p deletions, with participation lasting up to two years. The study carefully monitors responses to treatment, including complete and partial remissions. Throughout the study, participants undergo regular assessments to track their response to therapy, including measuring overall response rates from the start of treatment until disease progression or new treatments begin. Safety and organ function are monitored, and laboratory tests help evaluate blood counts and kidney function. The study aims to provide detailed information on how well the treatments work and their safety over the long term.

Researchers are evaluating zolbetuximab combined with pembrolizumab and chemotherapy in adults with locally advanced, unresectable, or metastatic stomach or gastroesophageal junction (GEJ) cancer. This study focuses on cancer cells that are HER2-negative but positive for the Claudin 18.2 protein and PD-L1, exploring how well zolbetuximab helps the immune system attack the tumor alongside immunotherapy and chemotherapy. The trial is a phase 3, randomized, double-blind study designed to compare the overall survival of participants receiving zolbetuximab with pembrolizumab and chemotherapy versus those receiving a placebo with pembrolizumab and chemotherapy. Participants receive study treatment in 6-week cycles, with zolbetuximab or placebo given by infusion every 2 or 3 weeks. Chemotherapy regimens include either CAPOX (capecitabine tablets and oxaliplatin infusion) or mFOLFOX6 (infusions of 5-fluorouracil, folinic acid, and oxaliplatin) administered on schedules matching the cycles. Pembrolizumab is infused every 3 or 6 weeks. Treatment continues until cancer worsens, is not tolerated, or another therapy is needed, with pembrolizumab given for up to 2 years. After initial cycles, some chemotherapy drugs are adjusted to only include oral capecitabine or certain infusions. During the study, participants visit the clinic for treatments, health checks, and scans to monitor cancer changes and side effects. Researchers also track medical problems related to the treatments and may collect tumor samples if cancer worsens. After stopping treatment, participants have follow-up visits and scans every 9 to 12 weeks, along with telephone check-ins every 3 months. The primary outcome measured is overall survival up to 72 months, with ongoing monitoring to evaluate safety and treatment effects.

Researchers are evaluating the long-term safety and tolerability of KarXT in treating mania or mania with mixed features in adults with Bipolar-I disorder. This phase 3, open-label extension study aims to better understand how KarXT performs over an extended period in this population. The study includes participants who either completed previous double-blind placebo-controlled studies or are newly diagnosed with Bipolar-I disorder experiencing manic symptoms. Participants receive KarXT at specified doses on certain days, with some also taking therapeutic doses of Lithium, Valproate, or Lamotrigine as part of their treatment. The study does not mention a placebo group during this extension, focusing instead on monitoring the long-term effects of KarXT alone or in combination with these established therapies. During the study, participants are monitored for adverse events up to week 54 to assess safety. Evaluations include psychiatric assessments using scales such as the Young Mania Rating Scale and CGI-BP score at screening and baseline. Researchers will track treatment-emergent adverse events and overall tolerability throughout the study duration, which lasts up to 54 weeks for each participant.

Researchers are evaluating the safety and effectiveness of ibrutinib combined with venetoclax (I+V) and ibrutinib alone in people with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). This phase 2 study focuses on adjusting the ibrutinib dose either proactively or reactively based on side effects to find the best treatment approach. Participants will receive oral capsules of ibrutinib and, for some groups, oral tablets of venetoclax. The study includes different treatment groups to compare how these regimens work when ibrutinib dosing is modified in response to adverse events. Dosing schedules and adjustments will be closely monitored throughout the study. During the study, participants will undergo regular assessments including scans to measure lymph node size and other tests to track response and safety. Researchers will measure the best overall response rate for up to five years. Safety monitoring and follow-up will continue as needed to evaluate long-term outcomes and treatment tolerability.

Researchers are investigating the safety and effectiveness of KarXT in treating manic episodes in adults with Bipolar-I Disorder. This Phase 3 study focuses on individuals experiencing acute mania or mania with mixed features who require hospitalization. The study aims to compare KarXT with a placebo to see how well it reduces manic symptoms during a three-week inpatient period. Participants will be randomly assigned to receive either KarXT or a placebo at specified doses during the inpatient treatment phase. The study is double-blind, so neither the participants nor the researchers know who receives which treatment. The total study duration, including screening, treatment, and safety follow-up, will not exceed seven weeks. During the study, participants will be closely monitored through psychiatric evaluations and rating scales, including the Young Mania Rating Scale (YMRS) to measure changes in mania symptoms by week 3. Other assessments include the Clinical Global Impressions-Bipolar scale and safety evaluations. Researchers will track adherence, symptoms, and any side effects throughout the study period.

Researchers are evaluating the effectiveness and safety of standard chemotherapy combined with bevacizumab, with or without the addition of INCA33890, as the first treatment option for patients with metastatic microsatellite stable colorectal cancer. This phase 3 randomized, double-blind study focuses on patients with stage IV colorectal adenocarcinoma that cannot be cured by surgery and who have not received prior systemic treatment for their metastatic disease. Participants will receive standard-of-care chemotherapy (FOLFOX) and bevacizumab both administered at protocol-defined doses. They will be randomly assigned to also receive either INCA33890 or a placebo, with dosing also defined by the study protocol. The treatments will be given as the initial therapy for metastatic disease, aiming to compare the outcomes between the groups receiving INCA33890 and those who do not. Throughout the study, participants will be monitored for progression-free survival for up to three years. Researchers will assess disease progression using measurable disease criteria and regularly evaluate participants' health status and organ function through laboratory tests. Safety and treatment response will be closely followed, with the goal of determining how well the treatments control the cancer without unacceptable side effects.