East Brunswick

Researchers are conducting a Phase 1B open-label dose escalation study to evaluate AV-380 in cancer patients experiencing cachexia, a condition involving severe weight loss and muscle wasting. AV-380 is a monoclonal antibody designed to bind to the growth differentiation factor 15 (GDF-15), a protein involved in cancer-related cachexia. The study aims to assess the safety, how the drug moves through and affects the body (pharmacokinetics and pharmacodynamics), and its potential immune response effects in patients actively receiving standard cancer treatments. Participants will receive increasing doses of AV-380 alongside their standard of care chemotherapy to determine appropriate dosing and monitor for any adverse effects. AV-380, a biological therapy, targets GDF-15 to potentially impact cachexia symptoms. The study involves treatment periods lasting up to four months, with careful observation during drug administration and follow-up visits. Throughout the study, participants will be closely monitored for adverse events, toxicity, and laboratory abnormalities from the time of enrollment through approximately 60 days after the last dose. Safety assessments and laboratory tests will be regularly conducted to evaluate the body's response to AV-380. The study involves active cancer patients with cachexia, with various evaluations to understand the drug's safety profile and effects over the study duration.

Researchers are conducting a first-in-human phase 1 study to evaluate MEN2312, a lysine acetyltransferase 6 (KAT6) inhibitor, in adults with advanced breast cancer. This study focuses on participants whose cancer has recurred locally or metastasized and who have limited treatment options after prior therapies. The trial aims to assess the safety and appropriate dosing of MEN2312, alone or combined with elacestrant, an oral drug also being studied. Participants will receive MEN2312 tablets orally, either as a single treatment or alongside elacestrant tablets. The study allows participants who have undergone up to six prior systemic therapies for advanced disease, including chemotherapy or antibody drug conjugates. The study involves careful selection of participants based on genetic alterations in their tumor tissue related to PIK3CA, AKT1, or PTEN genes. Throughout the trial, researchers will monitor participants for dose-limiting toxicity over the first 28 days and determine the recommended phase 2 dose by six months. Safety assessments, treatment response, and side effects will be tracked closely. Participation requires ongoing evaluations to measure how the participant's cancer responds and to ensure safety while receiving the study treatments.

The trial investigates the use of volrustomig in participants with unresected locally advanced head and neck squamous cell carcinoma (LA-HNSCC) who have not shown disease progression after receiving definitive concurrent chemoradiotherapy (cCRT). The study aims to evaluate the efficacy and safety of volrustomig compared to observation in this patient population. Participants have tumors that express PD-L1 and the study is conducted as a Phase III, randomized, open-label, multi-center global trial. Participants are assigned to receive either volrustomig as sequential therapy following cCRT or to an observation group. The treatment period involves monitoring participants who have completed definitive cCRT but remain unresected and have no evidence of metastatic disease. The study focuses on participants with Stage III, IVA, or IVB LA-HNSCC according to AJCC criteria, who have not undergone tumor resection before cCRT and have not been treated with radiotherapy alone. During the study, participants are regularly evaluated for progression-free survival, with follow-up lasting up to approximately 8 years to assess long-term outcomes. Researchers will monitor safety and disease progression closely. The overall participation duration includes screening, treatment or observation, and extended follow-up to capture both efficacy and safety data over time.

Researchers are evaluating the safety and effectiveness of combining durvalumab and domvanalimab compared to durvalumab plus placebo in adults with locally advanced (Stage III), unresectable non-small cell lung cancer (NSCLC) whose disease has not worsened after definitive platinum-based concurrent chemoradiation therapy. This Phase III, randomized, double-blind, placebo-controlled, international study involves multiple centers. Participants receive intravenous infusions of durvalumab and domvanalimab or durvalumab and placebo. The treatments are given after patients have completed concurrent platinum-based chemotherapy and radiation therapy with a total radiation dose of approximately 60 Gy. The study monitors patients over time to assess treatment effects and safety. During the study, participants undergo evaluations including tumor tissue analysis for PD-L1 status, performance status assessments, and monitoring of organ and marrow function. The main outcome measured is progression-free survival up to 8 years after randomization. Researchers also monitor for any adverse effects and disease progression throughout the study period.

Researchers are evaluating the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and early anti-tumor effects of increasing doses of EPI-326 in patients with locally advanced or metastatic head and neck squamous cell carcinoma (HNSCC) or epidermal growth factor receptor (EGFR)-mutant non-small cell lung cancer (NSCLC). This first-in-human, phase 1, open-label study involves multiple centers and focuses on patients whose tumors have documented EGFR mutations confirmed by molecular testing like next-generation sequencing (NGS). The study aims to establish the recommended dose and schedule for EPI-326 administration. EPI-326 is a tissue-selective bispecific antibody targeting EGFR-driven cancers. It is given as an intravenous (IV) infusion in the clinic. Patients will receive this treatment until their disease progresses, they experience unacceptable side effects, they choose to withdraw consent, or the study ends. The doses of EPI-326 will be increased gradually to assess how well patients tolerate the drug and to identify the best dosing regimen. Participants will be monitored for safety and tolerability of EPI-326 for up to three years. Researchers will assess how the drug behaves in the body (PK and PD) and evaluate its preliminary anti-tumor activity. Patients' overall health will be tracked, including performance status and organ function. The study will collect data on side effects and any disease progression during and after treatment to determine the drug's recommended dose and schedule.

Researchers are evaluating zanidatamab combined with chemotherapy to treat people with early-stage HER2-positive breast cancer. This Phase 2 study focuses on patients with Stage II or III invasive breast carcinoma that is confirmed to be HER2-positive. The purpose is to assess the safety and effectiveness of this combination treatment before surgery. Participants receive zanidatamab and chemotherapy drugs such as paclitaxel, docetaxel, carboplatin, trastuzumab, and pertuzumab, all administered intravenously. After completing neoadjuvant therapy, participants agree to undergo either a mastectomy or breast-conserving surgery. The study is open-label and conducted at multiple centers. During the study, researchers monitor the participants' response by measuring the number who achieve a pathological complete response within 8 months. They also ensure participants have adequate organ function, track heart function with imaging, and evaluate treatment safety. Participants are regularly assessed to support study goals and monitor any side effects.

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 comparing how long participants with KRAS/NRAS and BRAF wild-type recurrent, unresectable, or metastatic colorectal cancer remain disease-free and their overall survival time when treated with two different regimens. This phase 3 study focuses on patients who have previously received chemotherapy. The study aims to evaluate progression-free survival and overall survival in participants receiving amivantamab plus FOLFIRI versus cetuximab or bevacizumab plus FOLFIRI. The study involves two treatment groups: one receiving amivantamab combined with chemotherapy drugs 5-fluorouracil, leucovorin calcium or levoleucovorin, and irinotecan (FOLFIRI), and the other receiving either cetuximab or bevacizumab with the same chemotherapy regimen. Participants will be randomly assigned to one of these treatment arms. The treatments will be administered according to protocol to assess their effects on the cancer. Participants will be monitored for up to 2 years and 1 month to measure progression-free survival through blinded independent central review and followed for overall survival for up to 4 years and 4 months. The study includes assessments of tumor response, safety, and other clinical evaluations. Tissue samples and detailed clinical data will also be collected. This comprehensive monitoring will help determine the comparative effectiveness of the treatment options over time.

This trial is focused on adults with KRAS/NRAS and BRAF wild-type unresectable or metastatic left-sided colorectal cancer. It compares the length of time participants remain free from disease progression when treated with amivantamab combined with chemotherapy regimens (mFOLFOX6 or FOLFIRI) versus cetuximab combined with the same chemotherapy regimens. The study is a randomized, open-label Phase 3 clinical trial designed to evaluate progression-free survival over a period of up to 4 years and 2 months. Participants receive either amivantamab with chemotherapy drugs including 5-fluorouracil, leucovorin calcium or levoleucovorin, oxaliplatin, or irinotecan hydrochloride, or cetuximab with the same chemotherapy regimens (mFOLFOX6 or FOLFIRI). Treatments are administered as first-line therapy for their colorectal cancer. The trial assesses how these treatments affect disease progression and survival. During the study, participants will be monitored regularly through assessments and evaluations to measure progression-free survival. Researchers will gather data via blinded independent central review to ensure unbiased assessment of disease status. Participants are followed up for safety and treatment efficacy over the study duration, which may last over four years.

Researchers are evaluating the safety and effectiveness of ifinatamab deruxtecan (I-DXd) combined with the immune checkpoint inhibitor atezolizumab, with or without carboplatin, in adults with extensive stage-small cell lung cancer (ES-SCLC). This study includes two parts: Part A, a Phase 1b safety run-in phase, and Part B, a Phase 2 dose optimization phase. The main goal is to assess treatment-related side effects and determine the best dose of I-DXd in these combination therapies for first-line treatment. The study has two cohorts: Cohort 1 includes participants receiving I-DXd as maintenance therapy after initial induction treatment with carboplatin, etoposide, and atezolizumab; Cohort 2 includes participants receiving I-DXd during both induction and maintenance phases without prior ES-SCLC treatment. All study drugs, including I-DXd, atezolizumab, and carboplatin, are given intravenously. Participants will receive treatments in cycles of 21 days, with specific dosing and combination regimens evaluated during the study. Participants will undergo regular assessments including monitoring for dose-limiting toxicities and any treatment-emergent adverse events from the start of treatment up to 37 months. Safety evaluations, laboratory tests, imaging, and other study procedures will be conducted according to the protocol. The study aims to closely observe how participants tolerate the treatments and to collect important data on side effects and overall safety throughout the study period.