Hackensack

Researchers are studying treatments for locally advanced or metastatic colorectal cancer mCRC that cannot be removed by surgery and has a specific KRAS G12C gene mutation. This trial aims to evaluate if adding the targeted therapies calderasib and cetuximab to the standard chemotherapy regimen mFOLFOX6 can provide better outcomes compared to mFOLFOX6 with or without bevacizumab. The study focuses on the safety and tolerability of these combinations and whether they can help people live longer without their cancer growing or spreading. Participants will be assigned to one of two groups. One group will receive calderasib orally, cetuximab every two weeks, and mFOLFOX6 chemotherapy including oxaliplatin, leucovorin or levofolinate calcium, and 5-fluorouracil every two weeks. The other group will receive mFOLFOX6 chemotherapy with or without bevacizumab every two weeks, based on the investigators decision. Treatments will continue until certain stopping criteria are met. During the study, participants will be monitored for side effects and treatment tolerance, with regular assessments of cancer progression. Researchers will measure outcomes such as dose-limiting toxicities, adverse events, progression-free survival, and overall survival. Quality of life will also be evaluated through questionnaires. The study may last up to several years, with monitoring continuing for safety and effectiveness throughout the treatment period and follow-up.

Researchers are investigating new treatments for extensive-stage small cell lung cancer ES-SCLC, a type of lung cancer that has spread widely within the lungs or to other parts of the body. This study evaluates the combination of two study medicines, gocatamig and I-DXd ifinatamab deruxtecan, with or without standard chemotherapy and immunotherapy. The research aims to understand the safety and tolerance of these combinations and whether they can shrink or eliminate tumors in people with ES-SCLC. Participants are assigned to one of several treatment groups. Some receive gocatamig and I-DXd during maintenance after completing standard chemotherapy and immunotherapy, while others receive these study medicines during both induction and maintenance phases. Additional groups receive gocatamig and I-DXd followed by gocatamig and atezolizumab, or standard treatment with carboplatin, etoposide, and atezolizumab followed by atezolizumab maintenance. Treatments are given intravenously and continue until disease progression or other study-specified criteria. During the study, participants will have regular assessments to monitor safety, side effects, and treatment response, including scans to measure tumor size and laboratory tests to evaluate drug levels and immune response. The study will track adverse events, treatment tolerability, and cancer control over up to approximately 58 months. Participants health status and responses to the treatments will be closely observed throughout this period, with periodic evaluations to understand long-term effects and outcomes.

Researchers are studying metastatic castration-resistant prostate cancer mCRPC to find new treatment options. This trial evaluates if the study medicine ifinatamab deruxtecan I-DXd or MK-2400 helps people live longer overall and experience slower cancer growth or spread compared to chemotherapy. The study is a Phase 3 trial comparing I-DXd with standard chemotherapy for mCRPC patients. Participants are randomly assigned to receive either I-DXd at 12 mgkg every 3 weeks through intravenous infusion or docetaxel chemotherapy at 75 mgm2 every 3 weeks combined with daily prednisone pills. Treatment continues until the disease progresses, unacceptable side effects occur, or treatment is stopped for other reasons. Premedication is given before each dose of I-DXd to help prevent nausea and vomiting. During the study, participants will have regular visits for treatment and monitoring. Researchers will assess overall survival and radiographic progression-free survival for up to about 36 months. Additional measures include response rates, time to pain progression, PSA progression, and adverse events. The study tracks safety, treatment effects, and quality of life over a long follow-up period to better understand the potential benefits and risks of I-DXd compared to chemotherapy.

Researchers are investigating if intismeran autogene combined with pembrolizumab can prevent advanced melanoma from growing or spreading. Advanced melanoma is skin cancer that has spread to other parts of the body and cannot be removed with surgery. The study aims to see if people receiving intismeran autogene with pembrolizumab live longer without their cancer worsening than those receiving placebo with pembrolizumab. This is a phase 2 clinical trial evaluating these treatments in people with first-line advanced melanoma. Participants will receive either intismeran autogene or placebo via intramuscular injection every 3 weeks for up to 9 doses about 27 weeks. All participants will also receive pembrolizumab by intravenous infusion every 6 weeks for up to 17 doses, totaling around 2 years of treatment or until their disease progresses or they stop the treatment. The study compares the experimental combination to a placebo plus pembrolizumab to better understand the effects of intismeran autogene. During the study, participants will have regular assessments to measure how long they live without the cancer growing or spreading, as well as overall response and survival up to 6 years. Researchers will monitor side effects and reasons for stopping therapy for up to 2 years. Participants will undergo scans and tumor tissue analysis for biomarker studies. The trial includes a randomized design with triple masking and aims to enroll adults aged 18 and older with advanced melanoma.

Researchers are investigating new treatment options for breast cancer that is hormone receptor-positive HR and human epidermal growth factor receptor 2-negative HER2-, specifically for cases that are unresectable locally advanced or metastatic. This type of breast cancer involves cancer cells that depend on hormones like estrogen or progesterone and have low HER2 protein levels. The study focuses on comparing the effects of patritumab deruxtecan against chemotherapy or trastuzumab deruxtecan in patients whose cancer has progressed despite prior treatments. Participants receive either patritumab deruxtecan through intravenous infusions every three weeks for about 13 months or a treatment chosen by their physician, which may include various chemotherapy drugs or trastuzumab deruxtecan, administered according to specific schedules for up to 13 months. The study is randomized and open-label, meaning participants are randomly assigned to one of the treatment groups, and both the patients and researchers know which treatment is given. Throughout the study, participants undergo regular assessments to monitor cancer progression and overall survival for up to approximately 85 months. Researchers evaluate tumor response, duration of response, and changes in quality of life using standardized questionnaires. Safety is carefully monitored by recording adverse events and treatment discontinuations. The goal is to understand if patritumab deruxtecan can improve outcomes compared to current treatment options.

Researchers are investigating new treatments for high-risk, early-stage breast cancer, specifically targeting two types triple-negative breast cancer TNBC and hormone receptor-low positiveHER2-negative breast cancer. These cancers are characterized by low or no HER2 protein and low hormone receptor presence. The study aims to evaluate if adding sacituzumab tirumotecan sac-TMT to pembrolizumab and chemotherapy can better reduce cancer cells in tumors and lymph nodes and improve the length of time patients live without cancer progression compared to pembrolizumab with chemotherapy alone. Participants in this trial receive one of two treatment plans. One group gets sacituzumab tirumotecan intravenously every two weeks plus pembrolizumab every three weeks for 12 weeks, followed by pembrolizumab with carboplatin and paclitaxel for another 12 weeks. After 3 to 6 weeks, surgery and optional radiation therapy take place, followed by pembrolizumab for about 28 weeks. Participants with remaining disease may receive additional treatments chosen by their doctors, including olaparib, capecitabine, doxorubicin, epirubicin, or cyclophosphamide. The other group receives chemotherapy drugs carboplatin and paclitaxel with pembrolizumab initially, then pembrolizumab with cyclophosphamide and doxorubicin or epirubicin, followed by surgery, optional radiation, and pembrolizumab for about 28 weeks, with similar additional options for residual disease. During the study, participants undergo core needle biopsies, receive intravenous infusions of study drugs, and have surgery and possible radiation therapy. Researchers assess outcomes such as the percentage of participants with no detectable cancer cells at surgery pathological complete response, event-free survival up to about 92 months, and overall survival up to nearly 10 years. Quality of life and side effects are monitored through questionnaires and adverse event tracking. The study lasts several years, with various assessments throughout treatment and follow-up periods to gather comprehensive data on treatment effects and safety.

Researchers are evaluating the combination of BNT324, a B7-H3 antibody-drug conjugate, with BNT327, a bispecific antibody targeting PD-L1 and VEGF, in participants with advanced, metastatic, or relapsed small cell lung cancer SCLC and non-small cell lung cancer NSCLC. This multi-part study aims to find safe doses, optimize treatment, assess preliminary effects, and confirm clinical efficacy in different lung cancer groups. The study includes participants with confirmed lung cancer who have measurable disease and meet specific health criteria. Participants will receive intravenous infusions of BNT324 combined with BNT327 in a dose escalation design to establish two recommended dose levels RP2D and RP2D-1. The study has two parts Part 1 focuses on dose finding in NSCLC and SCLC Part 2 compares these doses in treatment-naive and relapsed lung cancer cohorts, with some randomized groups. Additional participants may join at the optimal dose to further evaluate safety and effectiveness. Participants will undergo screening, followed by treatment, safety follow-up, and long-term survival monitoring. Researchers will assess dose-limiting toxicities, adverse events, treatment interruptions, and response rates using standardized criteria. Outcomes include objective response rate, disease control, progression-free survival, duration of response, and overall survival, with evaluations continuing up to 87 months. Safety is closely monitored during and after treatment, and participants health status is regularly assessed.

Researchers are evaluating a culturally-tailored home-based physical activity program designed for Hispanic or LatinoLatina adolescent and young adult childhood cancer survivors. These survivors may face long-term effects like weight gain, fatigue, and reduced physical fitness after cancer treatment. The study aims to see if this culturally-relevant program can help increase physical activity and improve overall health compared to using a Fitbit tracker alone. The study has two stages. In Stage 1, 20 Latinx survivors participate in developing the intervention using Fitbit trackers, text messages, social media support, wearable activity devices, and interviews over 9 months. In Stage 2, 170 survivors who do not meet physical activity guidelines are randomized to either the intervention group, which includes Fitbit use, weekly goal-setting, peer support via social media and Zoom meetings, and optional activity partners, or a control group that only uses Fitbit trackers for 12 weeks. The intervention includes an intensive phase with weekly sessions followed by a 4-week maintenance phase. Participants will wear Fitbit trackers daily and engage in goal-setting, peer discussions, and physical activity reminders. Researchers will measure moderate to vigorous physical activity, sedentary time, and health-related quality of life over 12 weeks. Additional evaluations include physiological markers of heart and metabolic health and qualitative interviews to improve the program. The study lasts through the intervention phases with ongoing monitoring and support for participants.

Researchers are studying BG-C0979, a drug being evaluated alone or combined with tislelizumab in adults with advanced solid tumors. The study includes early phases to test safety, dosage, how the drug moves in the body, and initial anti-tumor effects. Participants have advanced, metastatic, or unresectable tumors, with some having prior treatments and others being treatment-naive depending on the study phase. Participants receive BG-C0979 through intravenous infusion in different doses during Phase 1a dose escalation and safety expansion. Later, Phase 1b includes dose optimization and expansion of BG-C0979 alone, as well as combination therapy with tislelizumab for select tumor types. The study evaluates increasing doses, determines recommended doses for future studies, and compares monotherapy with combination therapy. Participants undergo regular assessments including tumor measurements using RECIST criteria, performance status evaluation, blood tests, and monitoring for side effects over up to 24 months. Researchers track how the drug is processed in the body, adverse events, tumor response, progression, and survival. This includes frequent safety and laboratory monitoring during treatment to understand tolerability and impact on tumors.

Researchers are evaluating the safety, tolerability, and preliminary effectiveness of IMP1734, a PARP1 selective inhibitor, in people with advanced solid tumors. This study includes patients with breast cancer, metastatic prostate cancer, ovarian cancer, and other solid tumors who have previously received certain treatments. The goal is to find an optimal dose for future clinical development by studying how the drug affects the body and how the body processes it. The study has two parts Part 1 involves gradually increasing doses of IMP1734 given as a daily oral tablet to identify the highest safe dose or maximum achievable dose. This includes testing the drug alone and in combination with other treatments for specific cancers like metastatic prostate, ovarian, and breast cancer. Part 2 focuses on refining the dose to find the best amount for future studies. Treatment can last up to three years after the first dose. Participants will be monitored closely with assessments of side effects, blood tests to study drug levels and effects, and evaluations of tumor response using standard criteria. Safety monitoring continues up to 30 days after the last dose. Researchers measure how well the drug is tolerated and its impact on the cancer over time. The total participation may extend up to three years, with ongoing evaluations during this period.