Lake Mary

Researchers are evaluating YL205, a drug given by intravenous infusion, in patients with advanced solid tumors. This multicenter, open-label phase III study in China aims to assess the safety, tolerability, pharmacokinetics how the drug moves through the body, and preliminary effectiveness of YL205. Eligible patients have advanced solid tumors that overexpress Napi2B and include cancers such as ovarian, non-squamous non-small cell lung, renal cell, and endometrial cancer. Participants receive YL205 as a lyophilized powder reconstituted for intravenous infusion at a dose of 160 mg per vial. Treatment is given once every three weeks in cycles, with dose levels adjusted during different study phases dose escalation phase Ia, dose expansion phase Ib, and cohort expansion phase II. The study evaluates at least two dose levels and the recommended phase 2 dose RP2D. Throughout approximately 36 months, participants are closely monitored for dose-limiting toxicities, treatment-emergent adverse events, and serious adverse events. Researchers assess tumor response using RECIST v1.1 criteria, including overall response rate, disease control rate, duration and depth of response, progression-free survival, and overall survival. Pharmacokinetic parameters like AUC, Cmax, and half-life are also measured. Patients undergo tumor sampling and radiological evaluations to track treatment effects and safety.

Researchers are conducting a Phase 1 study to evaluate BHV-1530 alone and in combination with cemiplimab in adults with advanced or metastatic solid tumors. This first-in-human, open-label trial aims to determine the safety, dosing, and potential benefits of BHV-1530 for patients whose cancer has progressed after standard treatments or who have no other available therapies. The study focuses on specific cancers including urothelial cancer, non-small cell lung cancer, and head and neck squamous cell carcinoma, especially those with certain genetic alterations. Participants will receive BHV-1530 as an intravenous infusion on Day 1 of each 21-day cycle, either alone or combined with cemiplimab given on the same schedule. The study includes dose escalation, expansion, and optimization phases to find the maximum tolerable dose and recommended dose range. Some groups may receive the drug alone, while others receive it combined with cemiplimab, with treatment continuing over multiple cycles as determined by the study protocol. During the trial, participants will have regular assessments to monitor safety and treatment effects, including tumor measurements according to RECIST 1.1 criteria and performance status evaluations. Researchers will collect tumor tissue samples, perform laboratory tests, and monitor drug levels in the blood. The main outcomes include determining optimal dosing, safety profile, and clinical benefit rates over an estimated 48 months. Participants health and response to treatment will be carefully followed throughout the study period.

Researchers are evaluating the drug FMC-376 in adults with advanced solid tumors that have a specific KRAS G12C mutation. This clinical trial is designed in three parts Phase 1A dose escalation, Phase 1B dose expansion, and Phase 2 cohort expansion, to study various dose levels in participants with these tumors. The trial focuses on tumors that are locally advanced, unresectable, or metastatic, including types like non-small cell lung cancer, colorectal cancer, and pancreatic cancer. Participants will receive FMC-376 orally as a daily capsule in 21-day cycles during the dose escalation, dose expansion, and cohort expansion phases. The study does not include placebo or blinded treatments. The trial aims to assess the safety, pharmacokinetics how the drug is absorbed and processed, and clinical activity of FMC-376 at multiple dose levels. During the study, participants will be monitored closely for dose-limiting toxicities within the first 21 days and adverse events for approximately 24 months. Researchers will measure drug levels in the blood, response rates, duration of response, disease control, progression-free survival, and overall survival. Participants will undergo regular assessments including laboratory tests and evaluations to track safety and treatment effects throughout the study period.

Researchers are evaluating ASP3082, a drug given by intravenous infusion, in adults with advanced or metastatic solid tumors that have a specific mutation called KRAS G12D. This open-label Phase 1 study aims to check the safety and tolerability of ASP3082 alone or combined with other treatments like cetuximab, FOLFIRINOX, Nab-Paclitaxel plus gemcitabine, docetaxel, pembrolizumab, platinum-based chemotherapy, and NALIRIFOX. Participants have tumors that have not responded to or are ineligible for standard therapies. The study consists of two parts. In Part 1, small groups of participants receive escalating doses of ASP3082 alone or with cetuximab to find suitable doses. In Part 2, participants receive ASP3082 alone or combined with other study treatments at doses selected from Part 1. Treatments are given by infusion in cycles of 21 or 28 days. Participants continue treatment until intolerable side effects, disease progression, start of other cancer therapy, or withdrawal. Throughout the study, participants undergo regular monitoring for side effects, physical exams, lab tests, ECGs, and assessments of tumor response using standard criteria. Safety is tracked up to 48 months. Researchers collect tumor samples before and during treatment to study changes in the KRAS mutation. Participants overall health and performance status are also evaluated during the study, which may last several years depending on individual outcomes and treatment responses.

Researchers are evaluating the safety, toxicity, and pharmacokinetics of BTX-A51, alone and combined with fulvestrant, in people with advanced solid tumors and metastatic breast cancer that is estrogen receptor positive and HER2 negative. This phase 1, open-label study aims to find the safe dose levels and observe preliminary effects of the treatments in this patient group. The study includes multiple phases to carefully assess dosing and safety. The study has three phases. Phase 1a is a dose escalation phase where BTX-A51 is taken orally once daily on a schedule of 5 days on and 2 days off, in 28-day cycles. Dose levels increase sequentially to find the maximum tolerated dose. Phase 1b involves dose ranging of BTX-A51 alone in patients with specific breast cancer mutations, with dosing over 28 days. Phase 1c tests BTX-A51 combined with fulvestrant, an injection given on specific days within 28-day cycles, to evaluate combined safety. Participants will take BTX-A51 orally and may receive fulvestrant by injection if in the combination phase. Researchers will monitor adverse events, dose tolerance, and drug levels in the blood, collecting blood samples at specific times during treatment cycles. They will also assess response rates, duration of response, progression-free survival, and overall survival for up to two years after treatment. Safety follow-up continues for 30 days post-treatment, with options for continued access to BTX-A51 until disease progression or unacceptable toxicity.

Researchers are studying LY4050784, a drug being tested for safety, tolerability, and effectiveness in people with locally advanced or metastatic solid tumors that have a specific genetic alteration called SMARCA4 also known as BRG1. This study includes participants who have previously received, do not qualify for, or refuse standard treatments, or when no standard therapy is available. The trial is divided into two parts phase Ia, which focuses on finding the right dose, and phase Ib, which optimizes and expands the dose. The study may last up to about four years. Participants receive LY4050784 orally in different doses and combinations. Some receive LY4050784 alone, while others receive it combined with other anticancer drugs such as pembrolizumab, pemetrexed, cisplatin, carboplatin, paclitaxel, or nab-paclitaxel. The combinations are given in 21-day treatment cycles, continuing until certain criteria are met. The study includes evaluation of escalating doses and comparison of multiple doses during the dose-escalation and dose-expansion phases. During the trial, participants are monitored for side effects, how well they tolerate the treatment, and the drugs impact on their tumors. Researchers measure treatment-emergent adverse events, serious adverse events, and antitumor activity including response rates. They assess drug levels in the blood and how the body processes the drug. Regular safety and efficacy evaluations occur throughout the study, which may last up to approximately four years from the start. Participants overall health and tumor response are tracked closely during this time.

Researchers are evaluating oral Alintegimod 7HP349 alone and in combination with ipilimumab, followed by nivolumab monotherapy, in patients with locally advanced or metastatic cancers who have received one or more prior therapies. This open-label Phase Ib dose escalation study is followed by a blinded, randomized multi-cohort Phase 2a comparison of combination versus reference regimens, aiming to assess safety, tolerability, and preliminary efficacy. Participants will receive Alintegimod monotherapy in escalating doses for one cycle, then Alintegimod combined with ipilimumab for four cycles, followed by nivolumab monotherapy for eleven cycles. Alintegimod is given orally as softgel capsules, while ipilimumab and nivolumab are administered intravenously. The treatment continues until the end of the study period, lasting 12 months, unless disease progression or toxicity requires early termination. Throughout the study, participants will undergo assessments including adverse event monitoring, pharmacokinetic testing, and tumor response evaluations using RECIST criteria. Researchers will measure treatment-related side effects, drug levels in the blood, progression-free survival, and overall response rates. Safety will be closely monitored over 18 months, with participants expected to attend regular visits for clinical evaluations and laboratory tests during the study duration.

Researchers are evaluating the safety, tolerability, and preliminary effectiveness of EIK1004 IMP1707, a PARP1 selective inhibitor, in adults with advanced solid tumors including recurrent advancedmetastatic breast cancer, ovarian cancer, metastatic castrate resistant prostate cancer mCRPC, and pancreatic cancer. These participants must have mutations in select homologous recombination repair HRR genes. The study is a Phase 12 open-label trial sponsored by Eikon Therapeutics. The study has two parts dose escalation and dose optimization. In the dose escalation phase, participants receive escalating oral doses of EIK1004 daily except during a single-dose period to find the highest tolerated or achievable dose. The dose optimization phase further evaluates safety, tolerability, how the drug moves and acts in the body, and anti-tumor effects at selected doses. Participants will be monitored closely with assessments including adverse event tracking up to one month after the last dose, and pharmacokinetic evaluations up to three years. The main outcomes include the number of participants experiencing dose-limiting toxicities and other adverse events. Participants must have evaluable disease and meet specific health and organ function requirements. The total study participation duration varies, with follow-up extending up to three years for some measures.

Researchers are evaluating the safety and effectiveness of Raludotatug Deruxtecan R-DXd in adults with platinum-resistant, high-grade ovarian, primary peritoneal, or fallopian tube cancer. This study includes a Phase 2 dose-optimization part to find the best dose based on safety and effectiveness, followed by a Phase 3 part comparing R-DXd to chemotherapy chosen by the investigator. The study targets tumors that overexpress CDH6, a protein that R-DXd specifically binds to. Participants are randomly assigned to receive intravenous R-DXd at various doses every three weeks or an investigators choice of chemotherapy drugs including paclitaxel, pegylated liposomal doxorubicin, or topotecan. The Phase 2 portion focuses on determining the optimal dose, while the Phase 3 portion compares the recommended dose with standard chemotherapy. Treatments are given through IV infusions according to the assigned group. During the study, participants undergo scheduled visits for drug administration, safety monitoring, and evaluations including imaging scans to assess tumor response. Researchers measure outcomes such as objective response rate, progression-free survival, overall survival, duration of response, symptom changes, and pharmacokinetics over periods up to 40 months. Safety is closely monitored through adverse event tracking and laboratory tests, with participants followed until the studys completion in 2030.

Researchers are studying GDC-7035, a drug being tested alone and with other anti-cancer treatments in adults with advanced or metastatic solid tumors that have a KRAS G12D mutation. This Phase III trial aims to assess the safety, how the drug moves through the body, and its initial effects in this patient group. The study is open-label and conducted at multiple centers with dose escalation and expansion phases. Participants receive GDC-7035 either as a single agent or combined with other anti-cancer therapies. The study follows a dose-escalation approach where doses are increased to find safe and effective levels. Both treatment arms involve protocol-defined dosing of GDC-7035, given sequentially. The trial includes a dose expansion phase to further evaluate the drugs effects at selected doses. During the study, participants will be closely monitored for adverse events and dose-limiting toxicities using standardized criteria over four years. Blood and plasma samples will be collected at specific times to analyze drug concentrations, including comparisons of dosing with or without food. Researchers will measure tumor response rates, duration of response, and progression-free survival. The total study period extends up to the primary completion date in May 2028, with ongoing safety and activity assessments.