A Phase Ib/II Open-Label Multicenter Study Evaluating the Safety Activity And Pharmacokinetics of Divarasib in Combination with Other Anti-Cancer Therapies in Patients with Previously Untreated Advanced or Metastatic Non-Small Cell Lung Cancer with a KRAS G12C Mutation
A Phase Ib/II, Open-Label, Multicenter Study Evaluating the Safety, Activity, And Pharmacokinetics of Divarasib in Combination with Other Anti-Cancer Therapies in Patients with Previously Untreated Advanced or Metastatic Non-Small Cell Lung Cancer with a KRAS G12C Mutation
A Phase 1a/1b Trial of LY3962673 in Participants with KRAS G12D-Mutant Solid Tumors
This study is testing the tolerability, effectiveness, and potential for few side effects of the drug LY3962673 in patients with advanced solid tumors that have a KRAS G12D mutation, like pancreatic, colorectal, and lung cancer. In Phase 1a, the drug will be tested alone to see if it is well-tolerated and has few side effects. Some patients may receive different doses to check for side effects and how the drug works in the body. In Phase 1b, LY3962673 will be tested alone and with other standard treatments to find the best dose for these cancers. A committee will decide on dose increases based on the safety data.
A Phase 1b Study to Evaluate the Safety Tolerability and Preliminary Efficacy of ATP150/ATP152 VSV-GP154 and Ezabenlimab (BI 754091) in Patients with KRAS G12D/G12V Mutated Pancreatic Ductal Adenocarcinoma
This is an open-label, phase 1b study comprising two parts (safety and immunogenicity part and randomized efficacy part) to evaluate the safety, tolerability, preliminary efficacy, and immunogenicity of a heterologous prime-boost vaccine (protein and viral vector) strategy, in which approximately 90 patients with resected KRAS G12D/G12V mutated pancreatic cancer and colorectal cancer after (neo-) adjuvant chemotherapy or chemoradiotherapy will be enrolled in the following treatment parts of the study:Part 1 (Safety and Immunogenicity Part) – PDAC and CRC patientsPart 2 (Efficacy Part) – PDAC patients only
Dafna Bar-Sagi, PhD | NYU Langone Health
Dafna Bar-Sagi, PhD, is executive vice president and vice dean for science, chief scientific officer of NYU Langone and a professor of biochemistry.
SUNRAY-01 A Global Pivotal Study in Participants with KRAS G12C-Mutant Locally Advanced or Metastatic Non-Small Cell Lung Cancer Comparing FirstLine Treatment of LY3537982 and Pembrolizumab vs Placebo and Pembrolizumab in those with PD-L1 expression =50% or LY3537982 and Pembrolizumab Pemetrexed Platinum vs Placebo and Pembrolizumab Pemetrexed Platinum regardless of PD-L1 Expression
This study is testing two different treatments (LY3537982 in combination with pembrolizumab against a placebo combined with pembrolizumab) for a cancer called KRAS G12C-mutant NSCLC (non-small cell lung cancer). The study has two parts: Part A compares the treatments with one another for patients whose cancer has a marker called PD-L1 at a level of 50% or higher. Part B looks at the same treatments for patients with PD-L1 ranging from 0 to 100%. The decision about which part a patient joins depends on their doctor and what's best for treatment. Before joining, some patients might get one cycle of regular treatment if they really need it. The study also has two different doses of LY3537982 in combination with pembrolizumab, and they're trying to figure out the best amount, comparing different options to see which one works better. Overall, the study team is hoping to find better treatments for this type of lung cancer.
A Randomized Phase 2 Trial of Fruquintinib and TAS-102 as Compared to Fruquintinib in Patients with Refractory Advanced/Metastatic Microsatellite Stable Colorectal Cancer
This is a Phase 2 study testing whether a combination of TAS-102 and fruquintinib (a selective oral kinase inhibitor) is more effective and safer than fruquintinib alone in patients with advanced colorectal cancer that has spread from its primary location. TAS102 is a chemotherapy medication made of two different drugs that work by interfering with the cell cycle and DNA synthesis in cancer cells, killing the cancer cells. Patients will be randomly divided into two groups. One group will receive the combination of study medicines TAS-102 and fruquintinib, and the other group will receive Fruquintinib alone. Special scans will be done for all patients to check how their tumor size changes in response to the study medicines. Blood samples will be collected for all patients to monitor their overall well-being. The study team will examine and record the time interval for all patients from the start of treatment until their cancer comes back or worsens (progression-free survival). All patients will be closely monitored for potential side effects and safety concerns.
A randomized phase II trial of adjuvant trastuzumab emtansine (T-DM1) followed by subcutaneous trastuzumab versus paclitaxel in combination with subcutaneous trastuzumab for Stage I HER2-positive breast cancer (ATEMPT 2.0)
This is a randomized phase II adjuvant study for women and men with Stage I HER2-positive invasive breast cancer. At least 500 eligible patients will be randomized 3:1 to trastuzumab emtansine (T-DM1), followed by subcutaneous (SC) trastuzumab (Herceptin Hylecta) (n = 375) or paclitaxel plus trastuzumab SC (TH) (n = 125). Patients may have any hormone receptor status, may be either pre- or post-menopausal, and must be systemic treatment-naïve for this cancer. HER-2 positivity will be confirmed by central testing in all patients. Patients will bestratified by Age (
A Phase 1a/1b Open-Label Study Evaluating the Safety Tolerability Pharmacokinetics and Efficacy of BBO-8520 in Subjects with Advanced KRASG12C Mutant Non-Small Cell Lung Cancer - the ONKORAS-101 Study
This is a Phase 1 study testing whether the new medicine BBO-8520 (a KRASG12C on/off inhibitor) is a safe and effective treatment option if given alone or together with another medicine called pembrolizumab (immunotherapy) for lung cancer patients whose tumors show changes in the KRAS gene. The study consist of two parts. In part 1, patients will be enrolled into one of five groups to receive the study medicine BBO-8520 alone. The study team will gradually increase the dose level of the study medicine for each group to find out the effective dose with fewer side effects. Some patients will be grouped to receive study medicine BBO-8520 together with pembrolizumab. In part 2, more patients will be included to receive the dose that was found to be effective while being safe. Patients who have previously received approved KRAS G12C inhibitors (ie, sotorasib and adagrasib) will be eligible. All patients will have blood samples taken to see how their bodies are handling the study medicines. The study team will have imaging scans taken for all patients to see how the study medicine is changing their tumor size. All patients will be closely monitored for side effects and safety concerns.
A phase II/III Study of Paclitaxel/Carboplatin alone or Combined with either Trastuzumab and Hyaluronidase-oysk (HERCEPTIN HYLECTA) or Pertuzumab Trastuzumab and Hyaluronidase-zzfx (PHESGO) in HER2 Positive Stage I-IV Endometrial Serous Carcinoma or Carcinosarcoma
This study is being done to answer the following question: Can we lower the chance of your endometrial cancer coming back and causing death by adding a drug or drugs that target HER2 proteins in addition to the usual combination of chemotherapy drugs that target HER2 proteins in addition to the usual combination of chemotherapy drugs?
A Phase 3 randomized open-label multicenter controlled study to evaluate the efficacy and safety of zanidatamab in combination with physician s choice chemotherapy compared to trastuzumab in combination with physician s choice chemotherapy for the treatment of participants with metastatic HER2-positive breast cancer who have progressed on or are intolerant to previous trastuzumab deruxtecan treatment
This study tests a new treatment called zanidatamab against a standard treatment called trastuzumab. Both treatments will be given with chemotherapy chosen by the doctor for patients with metastatic HER2-positive breast cancer who have not done well on or cannot tolerate a previous treatment called T-DXd. To join the study, patients need to have had at least two lines of HER2-directed therapies before. Patients will be checked for HER2-positive status before being enrolled, and randomization will happen once they meet all the study criteria. Patients will be assigned randomly to one of the two treatments, with groups based on their past treatments and where they live. They will receive their treatment in 21-day cycles until their disease gets worse, they decide to leave the study, or other reasons to stop occur. The study will keep a close watch on how effective the treatments are, with patients getting regular scans to check their health.