Lake Mary

This study is a multicenter, open-label, phase I/II study of YL205 in China to evaluate the safety, tolerability, PK characteristics and preliminary efficacy of YL205 in the following selected patients with advanced solid tumors.

Researchers are conducting a Phase 1, first in human, open-label, multicenter study to evaluate BHV-1530 in adult participants with advanced or metastatic solid tumors. This study focuses on patients who have progressed after or are intolerant to standard treatments, including specific cancers such as urothelial cancer, non-small cell lung cancer, and head and neck squamous cell carcinoma, with or without certain FGFR3 alterations. The purpose is to assess safety, dosing, and potential expansion for later trials in these advanced cancer types. BHV-1530 will be given as an intravenous infusion on Day 1 of each 21-day treatment cycle. The study includes dose-escalation, dose-expansion (backfill), and dose-confirmation cohorts to determine the recommended dose and evaluate safety. Participants will receive repeated cycles of therapy, and dosing adjustments will be based on observed effects and tolerability. The treatment period is expected to last up to approximately 48 months, covering the full study duration. Participants will be closely monitored through regular assessments including tumor measurements by RECIST 1.1 criteria, laboratory tests, vital signs, and performance status evaluations. Researchers will track adverse events throughout the study to evaluate safety and tolerability. Additional evaluations include liver and kidney function tests, hematologic status, and pregnancy tests for women of childbearing potential. The primary outcomes measured are the number of patients experiencing adverse events and determining the optimal BHV-1530 dose for future studies.

Researchers are evaluating FMC-376 in adults with advanced solid tumors that have a specific KRAS G12C mutation. This trial aims to assess the safety, pharmacokinetics, and clinical effects of FMC-376 in patients whose tumors are locally advanced, unresectable, or metastatic. The study is conducted in three parts: Phase 1A (dose escalation), Phase 1B (dose expansion), and Phase 2 (cohort expansion), focusing on multiple dose levels in this patient population. Participants will receive FMC-376 as an oral capsule taken daily. The study explores different dosing schedules across the phases to determine optimal dosing and further evaluate the treatment's effects. The study is open-label, meaning both researchers and participants know which treatment is being administered. During the study, participants will be closely monitored for adverse events and dose limiting toxicities up to 21 days, with safety assessments continuing for approximately 24 months. Researchers will also assess pharmacokinetics and clinical activity of FMC-376. Participants must meet certain health and function criteria before and during the study to ensure safety and reliable results.

Researchers are evaluating the safety and tolerability of ASP3082 in adults with advanced solid tumors that have a specific KRAS G12D mutation. This open-label Phase 1 study includes patients with locally advanced or metastatic solid tumors who have received prior standard therapies or are ineligible for them. The study is conducted in two parts to identify suitable doses of ASP3082 alone or combined with cetuximab. In Part 1, small groups of participants receive escalating doses of ASP3082 alone or with cetuximab through intravenous infusion. A medical panel reviews safety data after each group to decide on dose escalation. In Part 2, participants receive ASP3082 alone or with other study treatments, including various chemotherapy drugs, also by infusion. Treatments are given in cycles lasting 21 or 28 days and continue until intolerable side effects, disease progression, new treatments, or participant withdrawal. Participants will undergo regular assessments including physical exams, laboratory tests, ECGs, and performance status evaluations to monitor safety and treatment effects for up to 48 months. Researchers will track adverse events, dose-limiting toxicities, and overall health status throughout the study. Participants must provide tumor samples and may have biopsies during treatment. The study involves ongoing monitoring to assess the impact and safety of ASP3082 over time.

Researchers are evaluating the safety, toxicity, pharmacokinetics, and preliminary effectiveness 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 multicenter, open-label, nonrandomized study is conducted in three phases to find safe dose levels and to assess the impact of the treatments on these cancers. The study begins with Phase 1a, where the dose of BTX-A51 is gradually increased to find the maximum tolerated dose or recommended Phase 2 dose. BTX-A51 is given orally once daily on a schedule of 5 days on and 2 days off, with each treatment cycle lasting 28 days. In Phase 1b, up to 40 participants receive BTX-A51 alone at two dose levels to evaluate safety and preliminary effects. Phase 1c tests the combination of BTX-A51 with fulvestrant at two dose levels to assess safety and tolerability, also in 28-day cycles. Participants will be closely monitored throughout the study. Researchers will track any side effects starting from the first dose and for 30 days after the last dose of BTX-A51 alone or with fulvestrant. They will also determine the maximum tolerated dose by observing dose-limiting toxicities during the first 28-day cycle. Subjects may continue receiving BTX-A51 until their disease progresses or unacceptable side effects occur. The study includes regular assessments to measure safety, drug effects, and participant health over the treatment period.

Researchers are evaluating the safety, tolerability, and effectiveness of the study drug LY4050784, alone or combined with other anticancer agents, in participants with locally advanced or metastatic solid tumors that have a SMARCA4 (BRG1) alteration. These participants have either previously received standard treatments, are not suitable for those treatments, or there are no standard therapies available. The study is designed as an open-label, multicenter Phase 1 trial lasting up to approximately 4 years. The study consists of two parts: Phase 1a, which involves dose escalation to find the maximum tolerated dose and recommended Phase 2 dose of LY4050784; and Phase 1b, which includes dose optimization and dose expansion to assess safety, tolerability, and antitumor activity of LY4050784 alone or in combination with other intravenous anticancer drugs such as Pembrolizumab, Cisplatin, Carboplatin, Pemetrexed, Paclitaxel, and Nab paclitaxel. LY4050784 is taken orally. Participants may receive treatment in different cohorts depending on their tumor type and treatment history. During the study, participants will be closely monitored for treatment-emergent adverse events, serious adverse events, and overall response to therapy over up to 4 years. Researchers will evaluate the maximum tolerated dose, safety, and antitumor activity of LY4050784. Assessments will include physical exams, performance status evaluations, and disease measurements using standard criteria. The study aims to confirm optimal dosing and understand the drug's effects alone and in combination with other therapies.

Researchers are evaluating the safety, tolerability, and early effectiveness of oral Alintegimod alone, followed by its combination with ipilimumab, and then nivolumab monotherapy in patients with locally advanced or metastatic cancers. This Phase 1b/2a study focuses on patients who have received one or more prior therapies and includes tumor types such as melanoma, pleural mesothelioma, renal cell carcinoma, MSI-high or mismatch repair-deficient colorectal cancer, hepatocellular carcinoma, and non-small cell lung cancer without certain genomic tumor aberrations. The study aims to assess treatment-related adverse events and define recommended phase two doses over 18 months. The initial part of the study (Phase 1b) involves dose escalation of oral Alintegimod provided as softgel capsules. This is followed by combination therapy with intravenous ipilimumab. After completing Alintegimod plus ipilimumab treatment, all patients receive intravenous nivolumab monotherapy cycles to continue treatment up to 12 months unless disease progression or toxicity occurs. The study also includes a blinded, randomized, multi-cohort Phase 2a to compare combination versus reference regimens, which will begin near the end of Phase 1b. Participants will undergo safety and tolerability assessments, including monitoring for treatment-related adverse events using CTCAE version 5.0 over one year. Blood samples will be collected for research, and disease status will be monitored using standard RECIST criteria. Laboratory tests will evaluate blood counts, renal and liver function, and other relevant parameters. The study also tracks adherence and manages safety through regular evaluations, with a total participation period of up to 18 months to define doses and treatment effectiveness.

Researchers are evaluating the safety, tolerability, and early effectiveness of EIK1004 (IMP1707), a PARP1 selective inhibitor, in adults with advanced solid tumors including recurrent advanced or metastatic breast cancer, ovarian cancer, metastatic castrate resistant prostate cancer, and pancreatic cancer. Participants must have specific harmful or suspected harmful mutations in certain homologous recombination repair genes. This study is a combined Phase 1 and Phase 2 trial. The study has two parts: dose escalation and dose optimization. In the dose escalation phase, researchers aim to find the highest dose that participants can tolerate or the maximum achievable dose of EIK1004. During the dose optimization phase, selected doses will be further studied to assess safety, tolerability, how the drug moves and acts in the body, and its anti-tumor effects. EIK1004 is given as a monotherapy, meaning it is the only treatment given. Participants will undergo evaluations including assessments of organ function, disease status using criteria like RECIST1.1 and tumor markers such as CA125 or PSA, and monitoring for side effects. Safety will be tracked by recording dose-limiting toxicities and any adverse or serious adverse events up to one month after the last dose. The study includes follow-up for safety and tolerability, with participants expected to have a life expectancy of at least 12 weeks. Female and male participants of childbearing potential must use effective contraception during the study and for six months after the last dose.

Researchers are evaluating the safety and effectiveness of Raludotatug Deruxtecan (R-DXd) in people with platinum-resistant, high-grade ovarian, primary peritoneal, or fallopian tube cancer. This study includes two parts: Phase 2 to find the best dose based on safety and response, and Phase 3 to compare R-DXd with the investigator's choice of chemotherapy. R-DXd is an antibody-drug conjugate that targets CDH6, a protein overexpressed in tumor cells. Participants will receive R-DXd through intravenous infusions. In Phase 2 (Part A), the dose will be optimized, and biopsies will be collected before and during treatment if possible. In Phase 3 (Part B), participants will be randomly assigned to receive either R-DXd or chemotherapy chosen by their doctor, which may include paclitaxel, topotecan, or PLD, all given by IV infusion. The study monitors treatment effects up to 18 months in Phase 2 and up to 26 months in Phase 3. During the study, participants will have regular scans and assessments to measure tumor response and progression-free survival. Researchers will monitor safety and organ function through lab tests and performance status evaluations. Participants must be willing to follow the study visits and procedures, which include biopsy samples in Phase 2 and imaging assessments to evaluate treatment response. The study aims to provide detailed information about how well R-DXd works and its safety in this patient group.

Researchers are conducting a Phase I/II open-label study to assess the safety, how the body processes it, and early effects of the investigational drug GDC-7035. The study focuses on adults with advanced or metastatic solid tumors that have a specific genetic change called the KRAS G12D mutation. This trial aims to explore GDC-7035 both alone and alongside other cancer treatments to better understand its potential in this group of patients. The study includes two treatment groups: one receiving only GDC-7035 and another receiving GDC-7035 combined with other anti-cancer therapies. Both groups will undergo dose escalation and expansion phases, where doses are carefully increased and then given at defined levels as per the study plan. This approach helps determine the appropriate dosing and evaluates how the drug works when used alone or with other treatments. Participants will be monitored over time for any side effects, including those severe enough to limit dosing, using a standardized grading scale. The study will track how many participants experience adverse events and dose-limiting toxicities over a four-year period. Safety assessments, drug level measurements, and activity evaluations will be conducted throughout the trial to gather comprehensive information on the treatment effects and participant well-being.