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Clinical Trials associated with PF-07934040A Phase 1 Open-Label Study of PF-07934040 as a Single Agent and in Combination With Other Targeted Agents in Participants With Advanced Solid Tumors Harboring Mutations in the KRAS Gene
The purpose of this study is to learn about the safety and effects of the study medicine alone or when given together with other anti-cancer therapies. This study also aims to find the best dose.
This study is seeking participants who have solid tumors (a mass of abnormal cells that forms a lump or growth in the body) that:
* are advanced (cancer that doesn't disappear or stay away with treatment) and
* have a KRAS gene mutation (a change in the DNA of the KRAS gene that can cause cells to grow in very high numbers).
This includes (but limited to) the following cancer types:
Non-Small Cell Lung Cancer (NSCLC): It's a type of lung cancer where the cells grow slowly but often spread to other parts of the body.
Colorectal Cancer (CRC): This is a disease where cells in the colon (a part of large intestine) or rectum grow out of control.
Pancreatic ductal adenocarcinoma (PDAC): This is a cancer that starts in the ducts of the pancreas but can spread quickly to other parts of the body. Pancreas is a long, flat gland that lies in the abdomen behind the stomach. Pancreas creates enzymes that help with digestion. It also makes hormones that can help control your blood sugar levels.
All participants in this study will take the study medication (PF-07934040) as pill by mouth twice a day repeating for 21-day or 28-day cycles.
Depending on which part of the study participants are enrolled into they will receive the study medication (PF-07934040 alone or in combination with other anti-cancer medications). These anti-cancer medications will be given in the study clinic by intravenous (IV) that is directly injected into the veins at various times (depending on the treatment) during the 21-day or 28-day cycle.
Participants can continue to take the study medication (PF-07934040) and the combination anti-cancer therapy until their cancer is no longer responding.
The study will look at the experiences of people receiving the study medicines. This will help see if the study medicines are safe and effective.
Participants will be involved in this study for up to 4 years. During this time, they will come into the clinic between 1 to 4 times in each 21-day or 28-day cycle. After they have stopped taking the study medication (at about at 2 years) they will be followed for another two years to see how they are doing.
/ Not yet recruitingPhase 1 一项在携带 KRAS 基因突变的晚期实体瘤研究参与者中评估 PF-07934040 单药治疗以及与其他靶向药物联合治疗的 I 期开放性研究
[Translation] A Phase I open-label study evaluating PF-07934040 as monotherapy and in combination with other targeted agents in participants with advanced solid tumors harboring KRAS mutations
剂量递增主要目的:在KRAS突变肿瘤研究参与者的连续队列中评估递增给药剂量的PF-07934040的安全性和耐受性,以估计MTDm/RDEm并选择I期扩展剂量。剂量扩展主要目的:评估PF-07934040在携带KRAS突变的PDAC、mCRC和NSCLC (2-3L)研究参与者中的安全性和耐受性以及初步抗肿瘤活性。评估PF-07934040与吉西他滨和白蛋白结合型紫杉醇联合治疗在携带KRAS突变的转移性PDAC肿瘤(1L)研究参与者中的安全性和耐受性以及初步抗肿瘤活性。评价PF-07934040与西妥昔单抗联合治疗在携带KRAS突变的转移性CRC肿瘤 (2L) 研究参与者中的安全性和耐受性以及初步抗肿瘤活性。评价PF-07934040与FOLFOX和贝伐珠单抗联合治疗在携带 KRAS突变的转移性 CRC (1L) 研究参与者中安全性和耐受性以及初步抗肿瘤活性。评价 PF-07934040 与帕博利珠单抗联合治疗(联用或不联用含铂化疗)在携带 KRAS 突变的转移性NSCLC (1L) 研究参与者中的安全性和耐受性以及初步抗肿瘤活性。
[Translation] Dose EscalationPrimary Objectives: To evaluate the safety and tolerability of escalating doses of PF-07934040 in consecutive cohorts of study participants with KRAS mutant tumors to estimate the MTDm/RDEm and select a Phase I expansion dose.Dose ExpansionPrimary Objectives: To evaluate the safety and tolerability and preliminary anti-tumor activity of PF-07934040 in study participants with KRAS mutant PDAC, mCRC, and NSCLC (2-3L). To evaluate the safety and tolerability and preliminary anti-tumor activity of PF-07934040 in combination with gemcitabine and nab-paclitaxel in study participants with metastatic PDAC tumors with KRAS mutations (1L). To evaluate the safety and tolerability and preliminary anti-tumor activity of PF-07934040 in combination with cetuximab in study participants with metastatic CRC tumors with KRAS mutations (2L). To evaluate the safety, tolerability, and preliminary anti-tumor activity of PF-07934040 in combination with FOLFOX and bevacizumab in study participants with metastatic CRC (1L) harboring KRAS mutations. To evaluate the safety, tolerability, and preliminary anti-tumor activity of PF-07934040 in combination with pembrolizumab (with or without platinum-based chemotherapy) in study participants with metastatic NSCLC (1L) harboring KRAS mutations.
100 Clinical Results associated with PF-07934040
100 Translational Medicine associated with PF-07934040
100 Patents (Medical) associated with PF-07934040
100 Deals associated with PF-07934040