PARP Inhibitor

Researchers are evaluating SPR1020, a new selective PARP1 inhibitor, in adults with advanced solid tumors who have limited treatment options. This open-label, multicenter study aims to assess the safety, tolerability, pharmacokinetic profile, and preliminary antitumor activity of SPR1020. The drug is designed to target tumors with BRCA mutations or homologous recombination repair gene alterations, potentially offering improved safety and effectiveness compared to earlier PARP inhibitors, especially for patients with brain metastases. SPR1020 is given orally once daily in 21-day treatment cycles. The study has two main parts: a Phase I dose-escalation and backfill segment to determine the optimal dose and evaluate safety, followed by a Phase II dose-expansion portion to further assess the drug at the recommended dose. Various dose levels from 25 mg to 250 mg per day are being studied. Participants receive the study drug until disease progression or other reasons for treatment end, with the possibility of dose adjustments as needed. Participants will undergo regular monitoring including safety assessments, pharmacokinetic sampling up to about 189 days, and tumor response evaluations using standard criteria. Adverse events will be tracked from the first dose through 30 days after the last dose or until new anti-tumor therapy begins, for up to one year. The study includes frequent lab tests and requires tumor and blood samples for genetic testing. Overall participation can last up to one year, with careful follow-up to evaluate both efficacy and safety outcomes.

Researchers are evaluating the safety and effectiveness of combining radioactive particles with the drug fluzoparib to treat advanced, inoperable soft tissue sarcoma. This phase II clinical trial focuses on patients with measurable tumors that cannot be surgically removed, aiming to understand how well this combination works in controlling the disease. Participants receive implantation of radioactive iodine-125 seeds followed by oral doses of fluzoparib at 150 mg twice daily after meals, starting 48 hours after the implantation. Fluzoparib is given continuously for 2 months per cycle, with tumor assessments monthly during the first cycle. Depending on tumor response, additional particle implantations (up to three) may be given, with medication pauses before surgeries and continuation after surgery until 6 months after the last implantation. The maximum treatment duration with fluzoparib is one year. Throughout the study, patients undergo regular tumor evaluations using CT or MRI scans and monitoring for side effects. Key outcomes include the objective response rate after 12 months, progression-free survival at multiple time points, overall survival rates, and safety events. Patients who experience intolerable side effects, disease progression, or choose to stop treatment enter a survival follow-up phase. The total participation may extend until study completion in December 2028.

Researchers are studying an experimental drug called VB15010, a PARP1 inhibitor, to see if it is safe, tolerable, and has anti-cancer effects in patients with advanced solid tumors. This phase I/II clinical trial focuses on adults aged 18 to 75 who have progressive cancer confirmed by tissue tests and specific gene mutations related to DNA repair. Participants will receive VB15010 tablets as a monotherapy. This oral drug is given in cycles of 28 days, and researchers will carefully monitor the safety, side effects, and the drug's behavior in the body. The study will track dose-limiting toxicities during the first cycle and observe the drug's maximum blood concentration over about one year. The trial includes patients with various advanced cancers, including breast, prostate, ovarian, pancreatic, biliary, and colorectal cancers. During the study, participants will undergo evaluations for adverse events and serious side effects from the time they consent until 30 days after their last dose. Researchers will also assess tumor response in prostate cancer patients and monitor pharmacokinetics and pharmacodynamics throughout treatment. The total participation time and follow-up will vary depending on individual response, with safety and efficacy measured regularly. The trial is sponsored by Zhejiang Yangli Pharmaceutical Technology Co., Ltd.

Researchers are evaluating whether a supportive telehealth program called REVITALIZE can reduce fatigue and its impact on daily life for adult women with ovarian cancer who are taking PARP inhibitors. This Phase 3 randomized trial compares the REVITALIZE intervention to receiving educational materials about cancer survivorship and fatigue management. The study is funded by the National Cancer Institute and involves about 240 participants. Participants will be randomly assigned to one of two groups. The REVITALIZE group will have eight weekly one-on-one coaching sessions plus two booster sessions conducted via Zoom, focusing on fatigue education, Acceptance and Commitment Therapy skills, and behavior changes. The other group will receive specialized educational materials on managing fatigue. Both groups will use a wireless pill bottle to track their PARP inhibitor medication. Participants will complete questionnaires at enrollment and at 8, 13, 20, and 28 weeks to measure fatigue interference, fatigue severity, sleep disturbance, quality of life, emotional distress, and medication adherence. The primary outcome is the change in fatigue interference score from baseline to 20 weeks. The study duration is about seven months, during which participants will be monitored for adherence and outcomes using surveys and pill bottle data.

Radiation therapy is an important part of treating breast cancer, especially as newer drug treatments like HER2 inhibitors, CDK4/6 inhibitors, PARP inhibitors, capecitabine, and PD1 inhibitors have improved outcomes for specific groups of patients. Many patients need both radiation and ongoing drug therapy, but it is unclear if these treatments should be given at the same time. This research aims to assess the safety of giving radiation alongside these newer systemic therapies for breast cancer patients aged 18 to 70. Participants will receive radiation to the chest wall or breast area, with or without nearby lymph nodes. Alongside radiation, they will be given one of several systemic treatments including capecitabine, HER2 inhibitors (such as trastuzumab and pertuzumab), CDK4/6 inhibitors, PARP inhibitors, or immune checkpoint inhibitors like pembrolizumab. All treatments will be administered concurrently to evaluate combined safety. The study is non-randomized and monitors patients receiving these combined therapies. During the study, participants are closely monitored for side effects, especially severe events graded as 3 or higher. Assessments occur weekly during radiation, then at 4 and 12 weeks after radiation ends, with additional checks if serious symptoms arise within three months post-radiation. Researchers record any adverse events to understand treatment safety. The study is sponsored by the Cancer Institute and Hospital, Chinese Academy of Medical Sciences, and will run until January 2027.

Researchers are evaluating a combination of vismodegib and atezolizumab in patients with platinum resistant ovarian, fallopian tube, or primary peritoneal cancer. This study focuses on patients whose disease progressed within six months after platinum-based chemotherapy, a group with limited treatment options and poor prognosis. The trial aims to explore new therapeutic candidates due to low response rates to existing single-agent therapies and the high mortality associated with advanced disease stages. Participants will receive a fixed daily dose of 150 mg vismodegib orally and 1200 mg of atezolizumab intravenously every three weeks in 21-day cycles. The combination targets the hedgehog signaling pathway and immune checkpoint PD-L1 to potentially improve treatment outcomes. The study includes a phase II clinical trial setting, with treatment and monitoring extending up to 36 months. During the trial, participants will undergo safety assessments focused on dose limiting toxicities and measurements of tumor response using standardized criteria over up to three years. Researchers will monitor overall survival and progression-free survival, along with immune-related response rates. Patients will provide tumor samples for biomarker research and complete laboratory tests to confirm eligibility and monitor health status throughout the study.