Clayton

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 evaluating the safety and tolerability of MK-4716, a drug being studied alone or combined with other treatments in people with certain advanced or metastatic solid tumors that have KRAS alterations. This phase 1, open-label study includes participants with locally advanced unresectable or metastatic solid tumors or metastatic non-small cell lung cancer, focusing on those with measurable disease and specific prior treatment histories. Participants receive MK-4716 at varying dose levels and schedules as monotherapy or combined with Pembrolizumab or Cetuximab. MK-4716 is given orally, while Pembrolizumab and Cetuximab are administered intravenously. The study uses a parallel design with several experimental arms to assess different combinations and dosing. During the study, participants are monitored for dose-limiting toxicities up to about 28 days and for adverse events up to approximately four years. Researchers measure drug concentrations in the blood at designated timepoints, pharmacokinetics, and overall safety. Participants undergo regular evaluations to assess side effects, treatment tolerability, and disease status throughout the study period, which lasts until study completion in December 2030.

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 effectiveness and safety of an investigational drug called BNT323 also known as DB-1303 compared with standard chemotherapy in women with recurrent endometrial cancer. The study includes two groups based on the level of HER2 protein in the tumor Cohort 1 with HER2 levels 1 or 2 who have been previously treated with immune checkpoint inhibitors, and Cohort 2 with HER2 level 3. The study aims to understand how well BNT323 or chemotherapy controls cancer progression and how the drug affects patients immune response and quality of life. Participants in Cohort 1 will be randomly assigned to receive either BNT323 or chemotherapy drugs such as doxorubicin, paclitaxel, or docetaxel. In Cohort 2, participants will receive BNT323 alone. Treatments are given intravenously and continue until the cancer progresses, unacceptable side effects occur, or consent is withdrawn. The study includes screening, treatment, safety follow-up, efficacy follow-up, and a long-term survival follow-up lasting up to about 53 months. During the study, participants will undergo regular assessments including tumor evaluations, safety monitoring, and quality of life questionnaires. Researchers will measure progression-free survival in Cohort 1 and tumor response rate in Cohort 2. Safety is monitored by tracking adverse effects and drug levels in the body. Participants can expect to be followed for up to 53 months after treatment to assess long-term outcomes and survival.

Researchers are evaluating the safety and optimal dose of BNT329, an investigational drug, in people with advanced solid tumors that express the tumor marker CA19-9. The study also aims to assess how well BNT329 works by measuring participant responses and how long the tumor remains stable without growth or spread. Additionally, the study will examine how BNT329 moves through and affects the body. The trial includes up to four parts. Parts A and B focus on increasing doses to study safety and tolerability in participants with various advanced cancers expressing CA19-9 who have not responded well to previous treatments. Part C may be added if safety or effectiveness concerns arise, involving pre-dosing with a CA19-9 targeting antibody before BNT329. Part D tests two selected dose levels in participants with pancreatic ductal adenocarcinoma PDAC who have received prior treatment. Treatment is given as intravenous infusions every 2 or 3 weeks depending on the study part. Participants undergo screening, followed by treatment for up to two years, an end-of-treatment visit, two safety follow-ups, and a survival follow-up until death, withdrawal, or study end. Throughout the study, researchers monitor side effects, dose adjustments, tumor response, and survival. Blood samples will be collected to study drug levels and immune responses. Safety and effectiveness will be assessed up to 36 months from first dose.

Researchers are evaluating BG-C137, an antibody-drug conjugate targeting FGFR2b, in people with advanced solid tumors. This study aims to assess the safety, tolerability, how the drug moves and acts in the body, and early antitumor effects. It is a phase 1ab trial involving participants with tumors expressing FGFR2b or FGFR2 gene amplification who have received prior cancer treatments. The study is sponsored by BeOne Medicines and includes two main phases dose escalation and dose expansion. The trial has three parts Phase 1a evaluates increasing doses of BG-C137 alone and then in combination with other anticancer agents to establish safe dose levels. Phase 1b further explores the recommended dose in selected patient groups. BG-C137 and anticancer agents are given intravenously or orally depending on the treatment. Participants undergo dose escalation, safety expansions, and dose confirmations to determine the best dosing for further study. Participants will be monitored regularly for side effects and response to treatment for up to about two years. Assessments include measuring adverse events, drug levels in the blood, tumor response, and immune reactions to the drug. Safety follow-up visits occur after treatment ends. Researchers will measure outcomes such as maximum tolerated dose, overall response rate, disease control, and progression-free survival. The trial involves frequent visits for treatment and assessments throughout the study period.

Researchers are evaluating BG-C0902, a new antibody-drug conjugate targeting the epidermal growth factor receptor EGFR and mesenchymal-epithelial transition MET in people with advanced solid tumors. This first-in-human Phase 1a1b study aims to assess the safety, tolerability, how the drug behaves in the body pharmacokinetics and pharmacodynamics, and early signs of its ability to fight tumors. The study is sponsored by BeOne Medicines and includes two phases dose escalation and safety expansion Phase 1a and dose expansion Phase 1b. Participants will receive BG-C0902 through intravenous infusion in doses that increase over time during Phase 1a to find the recommended dose for further study. In Phase 1b, this recommended dose will be tested in selected tumor types. The study does not use randomization or blinding and involves sequential patient groups receiving the drug alone or in combination with other treatments. During the study, participants will undergo evaluations for adverse events, dose limiting toxicities, and tumor responses over approximately two years. Researchers will monitor blood levels of the drug and related antibodies, assess tumor changes using standard criteria, and check overall health status. Safety and effectiveness measurements will be collected regularly, with follow-up to understand how well participants respond and tolerate the treatment over time.

Researchers are evaluating IBI354, a recombinant anti-HER2 monoclonal antibody-camptothecin derivative conjugate, in people with locally advanced unresectable or metastatic solid tumors. This Phase 12, open-label, multicenter study aims to assess the safety, tolerability, and dose-limiting toxicities to find the maximum tolerated or administered dose and the recommended Phase 2 dose of IBI354. The study also explores the drugs effectiveness and safety in this patient population. Participants receive sequential doses of IBI354 through a single-arm treatment plan. The study includes a Phase 1a dose escalation period to determine safety and dosing limits, followed by Phase 1b2 periods focusing on selected solid tumors expressing HER2. Treatment schedules and dosing details are designed to monitor tolerability and explore efficacy outcomes over time. During the study, participants undergo various assessments including monitoring for adverse events, dose-limiting toxicities within the first 21 days of treatment, and evaluation of objective response rate, duration of response, progression-free survival, and overall survival for up to two years. Safety evaluations continue up to 30 days after the last dose. Participants provide written informed consent and undergo cardiac function monitoring before treatment, with ongoing evaluations throughout their participation, which lasts as long as the study and follow-up periods continue.

Researchers are evaluating BDC-4182, an immune stimulating antibody conjugate, in people with advanced gastric and gastroesophageal cancers. This first-in-human dose escalation study aims to assess the safety and tolerability of BDC-4182 and to find the recommended dose for Phase 2. Participants have cancers that are metastatic or unresectable and have usually undergone prior standard treatments or are intolerant to them. Participants receive escalating doses of BDC-4182 until the maximum tolerated dose is found. Additional participants may join backfill cohorts at cleared dose levels to collect more safety data, followed by an expansion phase at the recommended dose. BDC-4182 consists of an anti-claudin 18.2 monoclonal antibody linked to a TLR 78 dual agonist, given as a single agent. During the study, participants have safety assessments including adverse event monitoring for about two years, with dose-limiting toxicities evaluated within 21 days of treatment. Effectiveness measures like tumor response rates, duration of response, disease control, progression-free and overall survival, and pharmacokinetics of the drug are tracked for up to four years. Biopsies or archival tumor samples are collected, and organ function is monitored. Participation lasts through dose escalation and expansion phases with ongoing safety and outcome evaluations.