Frankston

Researchers are evaluating if combining the medicines calderasib and subcutaneous pembrolizumab can more effectively treat people with non-small cell lung cancer NSCLC that has a KRAS G12C mutation. The study aims to find out whether patients receiving calderasib with pembrolizumab live longer without their cancer growing or spreading compared to those receiving pembrolizumab with chemotherapy. This is a Phase 3 clinical trial focusing on first-line treatment for advanced or metastatic nonsquamous NSCLC. Participants are assigned to one of two groups. One group receives subcutaneous pembrolizumab plus berahyaluronidase alfa every 6 weeks for up to 18 cycles about 2 years along with oral calderasib until treatment discontinuation criteria are met. The other group receives the same pembrolizumab and berahyaluronidase alfa regimen plus chemotherapy with pemetrexed and either carboplatin or cisplatin infusions during the early cycles. Treatment continues based on individual response and tolerability. During the study, participants will have regular visits for treatment and monitoring. Researchers will assess progression-free survival, overall survival, response rates, and quality of life using questionnaires and symptom scores over several years. Safety will be monitored through adverse event reporting. The trial lasts up to about 7 years with ongoing evaluation of health outcomes and side effects to understand the impact of these treatment combinations.

Researchers are studying the safety and initial effects of T3011, given directly into tumors, alone and combined with the intravenous drug pembrolizumab. This Phase 12a open-label study focuses on adults with advanced or metastatic solid tumors, including melanoma, head and neck squamous cell carcinoma HNSCC, sarcoma, cutaneous squamous cell carcinoma cSCC, and non-small cell lung cancer NSCLC. The study aims to find safe dose levels and assess how well these treatments are tolerated and work in these cancer types. The study involves several groups Phase 1 tests increasing doses of T3011 alone to determine a recommended dose. Phase 2a Part 1 evaluates T3011 alone in participants with melanoma, HNSCC, sarcoma, and cSCC. Phase 2a Part 2 studies T3011 with pembrolizumab in NSCLC patients. A rollover arm allows participants whose cancer progresses on T3011 alone to receive the combination treatment. T3011 is given as an intratumoral injection every two weeks, and pembrolizumab is given intravenously every three weeks when combined. Participants will have tumor biopsies, imaging, and laboratory tests to monitor safety, drug levels, and cancer response. Researchers will track side effects and measure outcomes like tumor response and survival for up to two years after the first dose. Safety and tolerability are closely followed throughout, with additional monitoring for immune responses and drug presence in bodily fluids. Participants may be followed for up to one year after their last treatment dose to assess overall survival and long-term effects.

Researchers are investigating whether sacituzumab tirumotecan alone or combined with other treatments can treat certain advanced or unresectable gastrointestinal cancers, including colorectal cancer, pancreatic ductal adenocarcinoma, and biliary tract cancer. The study aims to understand the safety and tolerability of sacituzumab tirumotecan and how well the cancer responds to these treatments. Participants will receive sacituzumab tirumotecan in different dose levels either combined with chemotherapy every two weeks in a 4-week cycle, alone every two weeks in a 4-week cycle, or combined with cisplatin and pembrolizumab in a 3-week cycle. Treatment continues until the cancer worsens or participants cannot tolerate it. Cisplatin is given up to approximately six months, and pembrolizumab is administered for up to about two years in the combination group. During the study, participants will have regular assessments to monitor safety, side effects, and how the cancer responds via imaging and clinical evaluation. Researchers will track dose-limiting toxicities, adverse events, treatment discontinuations due to side effects, and objective response rates. Additional measures include duration of response, progression-free survival, and overall survival, with monitoring lasting up to approximately 63 months.

Researchers are evaluating the safety, tolerability, and how the body processes HRS-3802 when used alone in patients with advanced malignant solid tumors. This phase I clinical study aims to better understand these factors in patients whose tumors have either not responded to standard treatments or for whom no effective standard treatments exist. The study is sponsored by Shandong Suncadia Medicine Co., Ltd. Participants will receive HRS-3802 as a single treatment. The study is open-label, meaning both participants and researchers know the treatment being given. The research includes monitoring for side effects and determining the maximum tolerated dose and recommended dose for future studies. Treatment effects will be assessed over several months, with follow-up evaluations up to two years for progression and response. During the study, participants will be monitored regularly for adverse events, dose-related toxicities, and tumor response using RECIST 1.1 criteria. Safety assessments will occur every four weeks, especially during the first 28 days of treatment. Researchers will also evaluate outcomes such as objective response rate, duration of response, and progression-free survival. Participants are expected to survive at least 12 weeks and will be followed for up to two years to assess treatment impact and safety.

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.

This trial is designed for adults diagnosed with metastatic pancreatic ductal adenocarcinoma PDAC who have not yet received systemic treatment for their advanced cancer and have a good performance status. The study evaluates pumitamig, an investigational drug, in combination with chemotherapy to assess its safety and effectiveness. This phase II trial plans to explore different chemotherapy regimens combined with pumitamig to understand their impact on the disease.

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 evaluating the safety and effectiveness of VS-7375, an oral drug that targets the KRAS G12D mutation, in patients with advanced solid tumors that have this specific mutation. The study includes patients with pancreatic ductal adenocarcinoma, non-small cell lung cancer, colorectal cancer, and other solid tumors harboring the KRAS G12D mutation. The trial is a Phase 12, open-label study sponsored by Verastem, Inc., aiming to find suitable doses and understand the drugs impact alone and in combination with other therapies. The study has several parts dose escalation to find the best dose of VS-7375 alone and combined with cetuximab, carboplatinpemetrexedpembrolizumab, or gemcitabine-based therapies and dose expansion to evaluate the effectiveness of these treatments at the recommended doses. Treatment cycles last 21 or 28 days, and combinations are tailored for different tumor types and patient groups, including older adults. Cetuximab is an antibody targeting EGFR, while other drugs used are chemotherapy or immunotherapy agents. Participants will have regular assessments to monitor safety, side effects, and how well the treatments work over up to 2.5 years. These include measuring disease response using standard criteria, monitoring adverse events, and evaluating drug levels in the body. The study tracks tolerability and side effects during treatment and continues follow-up after treatment ends. Participants must meet specific health and tumor criteria and agree to use contraception during the study.

Researchers are evaluating HLX48, an EGFRc-MET bispecific antibody-drug conjugate, in patients with advanced or metastatic solid tumors. This open-label phase I clinical trial aims to assess the safety, tolerability, and pharmacokinetic profile of HLX48 given at increasing doses. The trial uses a 33 dose escalation design to carefully study the effects and side effects of HLX48 in this patient population. Participants will receive HLX48 via intravenous infusion at one of six preset dose levels. The dose-limiting toxicity DLT observation period lasts for 3 weeks after the first dose, during which the Safety Review Committee reviews safety data to decide on dose escalation or cohort expansion. New dose groups may be added based on safety, tolerability, pharmacokinetics, immunogenicity, and efficacy data. Those who withdraw early for reasons unrelated to toxicity may be replaced. Throughout the study, participants will undergo evaluations including tumor measurements by RECIST v1.1, ECOG performance status assessments, and laboratory tests to confirm organ function. Safety monitoring includes dose-limiting toxicity and maximum tolerated dose assessments within the first cycle of treatment. Secondary outcomes such as response rates, survival, and antibody development will be tracked for up to 24 months. Participants are followed closely during and after treatment to collect comprehensive data on HLX48s effects.

Researchers are evaluating the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor effects of AK138D1 in adults with advanced solid tumors. This first-in-human, open-label Phase I trial includes patients whose tumors are resistant or intolerant to standard treatments, aiming to better understand this new drugs potential. The study includes two parts dose escalation to find the maximum tolerated dose and dose expansion to determine the recommended dose for further research. Participants will receive AK138D1 through intravenous infusions at pre-determined dose levels based on their study group. The first part focuses on gradually increasing doses to identify safe limits, while the second part treats more patients with the recommended dose to further assess safety and early effectiveness. This process helps define appropriate dosing for future studies. During the trial, participants will undergo regular monitoring for side effects and dose-related toxicities for up to two years. Researchers will perform scans and measurements to track tumor response using standard criteria and collect blood samples to study drug levels, immune reactions, and survival outcomes. The study also tracks how long participants respond to treatment and how long they live without disease progression, providing a comprehensive view of safety and preliminary benefits over time.