What Is CBP501?
CBP501 is an investigational drug that has been studied as a potential treatment for various cancers. It is a peptide-based medication. The specific mechanism by which CBP501 works is not detailed in the available trial descriptions, but it has been investigated for its use in combination with other established anti-cancer agents such as cisplatin, pemetrexed, and nivolumab. This suggests it may work to enhance the effects of these other therapies or act synergistically against cancer cells.
CBP501 is not currently approved for any specific condition. It has been exclusively studied in clinical trials for different types of solid tumors.
Uses and Conditions Under Study
CBP501 has been investigated solely for the treatment of various cancers, particularly solid tumors. Cancer is a disease characterized by the uncontrolled growth and spread of abnormal cells throughout the body. Solid tumors are masses of abnormal tissue that do not contain cysts or liquid areas.
CBP501 has been studied in a total of 5 completed trials involving 395 participants. These trials, sponsored by CanBas Co. Ltd., began in 2007 and concluded in 2021. The conditions under investigation include:
- Solid Tumors: Two trials have focused on solid tumors, which are common forms of cancer that can develop in many parts of the body.
- Advanced Solid Tumors: One trial specifically examined CBP501 in patients with advanced solid tumors, indicating its potential use in later stages of the disease.
- Cancer: One trial broadly investigated CBP501 for cancer, suggesting a general anti-cancer effect.
- Malignant Pleural Mesothelioma: One trial explored CBP501 for malignant pleural mesothelioma, an aggressive cancer that affects the lining of the lungs and chest wall.
- Metastatic Non-squamous Non Small Cell Lung Cancer: One trial studied CBP501 for this specific type of lung cancer that has spread to other parts of the body.
- Pancreatic Cancer Stage IV: One trial investigated CBP501 for advanced pancreatic cancer, a challenging cancer to treat.
In these studies, CBP501 was often administered in combination with other chemotherapy drugs like cisplatin and pemetrexed, or with immunotherapy agents such as nivolumab, to assess its efficacy and safety.
Dosing
CBP501 is administered as an intravenous (IV) infusion. It is supplied as a sterile lyophilized powder in 20 mg single-dose vials. For administration, the contents of the vial are reconstituted and then added to an IV bag, typically containing 5% Dextrose Injection, USP, before being infused into a patient.
The doses of CBP501 studied in clinical trials have varied. Investigational doses include 16 mg/m² and 25 mg/m². A starting dose of 3.6 mg/m² has also been explored, with protocols for dose escalation depending on patient response and tolerability.
CBP501 is generally given on Day 1 of each treatment cycle. These cycles typically last 21 days (3 weeks). The IV infusion of CBP501 has been administered over approximately 1 hour.
CBP501 is often used in combination with other anti-cancer medications. For example, some studies have administered CBP501 (25 mg/m²) immediately before pemetrexed (500 mg/m²) and cisplatin (75 mg/m²). Other studied combinations include CBP501 with cisplatin and nivolumab, or CBP501 with cisplatin alone.
Side Effects
Information regarding the side effects of CBP501 from clinical trials was not available in the provided data. Please consult your healthcare provider for comprehensive information on potential side effects.
Clinical Trial Results
Malignant Pleural Mesothelioma (MPM)
A Phase I/II study (NCT00700336) investigated CBP501 in combination with pemetrexed and cisplatin for patients with previously untreated, unresectable malignant pleural mesothelioma (MPM). The study assessed the 4-month progression-free survival (PFS) rate. In different cohorts of the study, 9 and 13 participants received pemetrexed and cisplatin alone. For the combination therapy including CBP501, 25 and 27 participants were evaluated. The specific 4-month PFS rates for these groups were not detailed in the provided data.
Non-Small Cell Lung Cancer (NSCLC)
A separate study (NCT00942825) explored CBP501 as part of a triplet combination first-line treatment for non-small cell lung cancer (NSCLC). The primary efficacy endpoint was progression-free survival (PFS), which measures the time from randomization until either tumor progression or death. Patients receiving the combination of CBP501, cisplatin, and pemetrexed had a median PFS of 140 days. In comparison, patients treated with cisplatin and pemetrexed alone experienced a longer median PFS of 165 days.
Currently Recruiting Trials
Currently, there are no clinical trials for CBP501 actively recruiting new participants. This section would typically provide details about ongoing studies, including their purpose, eligibility requirements, and locations, if any were open for enrollment.
Where to Participate
At this time, there are no active clinical trial sites for CBP501 recruiting participants in any cities or states. While no specific age range has been identified for past studies, trials for CBP501 have generally been open to participants of all genders. It is important to note that these studies have not included healthy volunteers or children, focusing instead on individuals with specific medical conditions.
Development Timeline
The journey of CBP501 in clinical development began on October 31, 2007, with its first clinical trial. Since then, a total of five clinical trials have been conducted, enrolling approximately 395 participants. The latest trial concluded on July 8, 2021. Throughout its development, CBP501 has been exclusively sponsored by CanBas Co. Ltd.
Initial investigations for CBP501 explored its potential in conditions such as IBS-C and hyperphosphatemia. Over time, the research pipeline expanded significantly to address various types of cancer. This expansion reflects a strategic shift towards oncology, with studies progressing through different phases of clinical research. The development has included:
- Two Phase 1 trials, focusing on initial safety and dosage.
- Two Phase 2 trials, evaluating effectiveness and further safety.
- One Phase 1/Phase 2 trial, combining aspects of both early phases.
The conditions studied have broadened to include challenging diseases such as Cancer, Malignant Pleural Mesothelioma, Metastatic Non-squamous Non Small Cell Lung Cancer, and Pancreatic Cancer Stage IV, indicating the drug's evolving focus in its clinical journey.