West Valley City

Researchers are evaluating calderasib alone or combined with cetuximab to treat people with advanced solid tumors that have the KRAS G12C mutation, excluding colorectal cancer. This study aims to measure how many participants experience tumor shrinkage or disappearance and compare the responses between the two treatments. It is a phase 2, open-label trial focused on treatment safety and tolerability. Participants will receive calderasib orally with no set limit on treatment cycles. Some participants will also receive cetuximab via intravenous infusion every two weeks. Treatment continues until criteria for stopping the study intervention are met. The trial uses a randomized, parallel design to compare the two experimental arms. Throughout the study, participants will be monitored for tumor response, adverse events, and treatment discontinuations related to side effects. Researchers will also assess progression-free survival, duration of response, and overall survival up to about 76 months. The trial lasts until April 2032, with ongoing safety and efficacy evaluations during this period.

Researchers are exploring new treatments for women with relapsed high-grade serous ovarian cancer, which is a fast-growing cancer starting in ovarian cells, the lining of the belly, or fallopian tubes. The study evaluates raludotatug deruxtecan R-DXd, a type of antibody drug conjugate, combined with other therapies, to understand safety, tolerability, and cancer response. This includes women with platinum-sensitive and platinum-resistant recurrent ovarian cancer who have had prior treatments. The study has two parts Part 1 involves gradually increasing doses of R-DXd combined with chemotherapy drugs like carboplatin, paclitaxel, bevacizumab, or pembrolizumab to find a recommended dose. Part 2 uses this recommended dose to further assess treatment effects. Participants receive intravenous infusions every three weeks, with chemotherapy cycles lasting up to about four months and pembrolizumab up to two years. The combinations vary depending on cancer sensitivity and treatment history. Participants undergo regular treatment visits where cancer response and side effects are monitored. Tumor tissue samples are collected before treatment. Researchers track adverse events, dose-limiting toxicities, and how long the cancer responds to treatment. The study lasts up to approximately three years, allowing for long-term safety and effectiveness assessments, with ongoing evaluation of participants health throughout the trial.

Researchers are evaluating the safety, effectiveness, optimal dose, and behavior of an investigational drug called BNT326, alone or combined with other immunotherapy agents, in adults with advanced solid tumors. This study includes patients with tumors that have either spread metastatic, returned after treatment, or progressed despite previous therapies, across various cancer types such as melanoma, lung cancer, breast cancer, gastric cancer, colorectal cancer, and cervical cancer. Participants are divided into two parts Part 1 tests BNT326 alone in different tumor-specific groups, some with dose randomization to find optimal dosing. Part 2 evaluates BNT326 alone or combined with another investigational drug called pumitamig in several cancer types, with some groups receiving randomized doses and others non-randomized treatments. Treatments are given via intravenous infusion, with some oral medications combined in Part 1. The study includes dose escalation and randomization phases, and treatment can continue for up to 24 months or until disease progression or other reasons. During the study, participants undergo screening, treatment, safety follow-up, efficacy follow-up, and long-term survival monitoring phases. Researchers assess adverse events, treatment responses, disease progression, and drug behavior in the body using clinical evaluations and laboratory tests. Follow-up assessments occur up to approximately 38 months for Part 1 and 48 months for Part 2, with continued treatment possible for those benefiting from the therapy. The study aims to gather comprehensive data on safety, dosing, and effectiveness in this patient population.

Researchers are evaluating ALX2004, an antibody drug conjugate targeting EGFR, in adults with advanced or metastatic selected solid tumors including non-small cell lung cancer, head and neck squamous cell carcinoma, esophageal squamous cell carcinoma, and colorectal cancer. This Phase 1, open-label, multicenter study aims to find the appropriate dose and assess safety and response in participants who have previously received treatment for these cancers. The study is sponsored by ALX Oncology Inc. and plans to enroll up to 170 patients. The study includes three parts Phase 1a Dose Escalation with increasing doses of ALX2004 to find a safe dose, Phase 1a Dose Exploration where selected doses are further tested in specific tumor types, and Phase 1b Dose Expansion where the recommended dose is given to more patients. ALX2004 is given by intravenous infusion, and dosing is adjusted depending on the study phase and tumor type. Participants will have regular assessments including safety monitoring for dose limiting toxicities and adverse events, tumor response evaluations using RECIST criteria, and measurement of drug levels in the blood. Follow-up can last up to two years from the first dose. The study records outcomes like overall response rate, progression-free survival, and overall survival to understand ALX2004s effects. The total duration of participation depends on the treatment phase and follow-up period.

Researchers are studying MEN2312, a lysine acetyltransferase 6 KAT6 inhibitor, in adults with advanced breast cancer that is not curable. This first-in-human, phase 1 study evaluates MEN2312 alone and in combination with elacestrant to understand its safety and determine the best dose. Participants have specific genetic alterations in their tumors and have received prior endocrine therapy and cyclin-dependent kinase 4 and 6 inhibitor treatment. Participants will be randomly assigned to receive either MEN2312 by itself or MEN2312 combined with elacestrant, both given as oral tablets. The study follows a sequential design and aims to identify dose-limiting toxicities and recommend the phase 2 dose over several months of treatment. This includes monitoring drug levels in the body and how the body processes the medications. During the study, participants will have regular assessments to monitor side effects, tumor response, and overall health. These include evaluating the number of dose-limiting toxicities within the first 28 days and tracking response rates, progression-free survival, and overall survival for up to nine months after treatment ends. Researchers will also measure drug concentration and excretion to better understand the treatment effects and safety over time.

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.

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 conducting a Phase 1a1b open-label study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of PLN-101095 combined with pembrolizumab in adults with advanced or metastatic solid tumors. Participants must have tumors for which pembrolizumab is indicated and must show disease progression or relapse after at least three months of pembrolizumab treatment. The study includes consecutive dose-escalation and dose-expansion cohorts to explore different dosing levels and tumor types. The study has two main parts Part 1 uses a Bayesian optimal interval design for dose escalation with accelerated titration to test increasing doses of PLN-101095 combined with pembrolizumab, while Part 2 uses Simons two-stage design for dose expansion. Doses of PLN-101095 range from 250 mg twice daily up to 2000 mg twice daily or 1000 mg three times daily, given in combination with pembrolizumab administered intravenously every three weeks. Participants in expansion cohorts include those with non-small cell lung cancer, clear cell renal cell carcinoma, or tumor mutational burden-high solid tumors, receiving PLN-101095 as monotherapy or combined with pembrolizumab. Participants will be monitored for safety and tolerability from first dose through 16 weeks after treatment ends, and anti-tumor activity will be measured from first dose until disease progression or death. Pharmacokinetics of PLN-101095 will be assessed at specified time points. The study evaluates participants measurable lesions and organ function, with follow-up assessments for adverse events and treatment response. The total duration varies depending on treatment response and tolerability, with ongoing monitoring throughout the study period.

Researchers are evaluating IAM1363, an investigational drug, in a Phase 11b open-label study involving participants with advanced cancers that have HER2 alterations. The study aims to assess the safety and early effects of IAM1363 in these patients, including those with brain metastases. This trial includes multiple parts focusing on dose escalation, dose optimization, expansion in specific tumor types, and combination with other anti-cancer treatments. The study has four parts Part 1 involves escalating doses of IAM1363 as a monotherapy to find the maximum tolerated dose. Part 2 optimizes the dose based on safety and preliminary efficacy results. Part 3 expands to tumor-specific groups using the selected dose. Part 4 studies IAM1363 combined with other cancer drugs. Treatments are given orally in 14- or 21-day cycles. Participants will undergo evaluations including monitoring for dose-limiting toxicities, adverse events, and laboratory abnormalities. Researchers will measure responses in tumors and the central nervous system, pharmacokinetics, and treatment modifications. Follow-up will continue through study completion, estimated at about 46 months. Safety is closely monitored during and after treatment, with assessments of heart function and other clinical measures.

Researchers are evaluating BHV-1510, a Trop-2 directed antibody-drug conjugate, alone and combined with cemiplimab in adults with previously treated, advanced solid tumors that are incurable or have no standard therapies left. This Phase 12 open-label study aims to assess safety, tolerability, and preliminary effectiveness in this population, including determination of recommended doses and maximum tolerated doses of BHV-1510. The study includes two parts Phase 1 dose escalation to test BHV-1510 alone and with cemiplimab, and Phase 2 dose expansion to further assess response rates and safety. BHV-1510 is given intravenously on various schedules, including every 2 or 3 weeks, sometimes with cemiplimab infusions every 3 weeks. The combination dosing regimens vary, with cemiplimab given at 350 mg on Day 1 or Day 1 and Day 8 every 3 weeks. Participants will undergo regular safety assessments, including monitoring adverse events and laboratory tests. Researchers will measure BHV-1510 levels in blood and evaluate tumor response using imaging and standard criteria. The study may last up to about 47 months, with ongoing follow-up to assess duration of response, progression-free survival, overall survival, and other clinical outcomes. Safety and tolerability will be closely monitored throughout the study.