What Is PM8002?
PM8002 is an investigational drug currently being studied in clinical trials for various types of cancer. It is administered as an intravenous (IV) infusion. Clinical trials are exploring different dosing schedules, such as every three weeks (Q3W) or specific doses like 20 mg/kg on Days 1 and 15 of each 28-day cycle. These studies aim to identify the most effective and safe ways to administer PM8002.
A total of 13 clinical trials have been initiated to evaluate its safety and effectiveness, involving 1,889 participants. The first trial began on March 7, 2023, and the latest trial is expected to conclude on August 21, 2025. These ongoing investigations are crucial for understanding the full potential of PM8002 as a cancer treatment.
Uses and Conditions Under Study
PM8002 is currently under investigation for its potential to treat several types of cancer. Clinical trials are exploring its use across various malignant conditions, aiming to assess its efficacy and safety.
- Lung Cancers: PM8002 is being studied in patients with lung cancers, including Small Cell Lung Cancer (SCLC) in 3 trials, and Non-Small Cell Lung Cancer (NSCLC), including Locally Advanced Non-Small Cell Lung Cancer, in 2 trials. These studies aim to determine if PM8002 can help manage or treat these aggressive forms of lung cancer by potentially targeting cancer cells.
- Liver Cancers: The drug is also being evaluated for liver cancers, specifically Hepatocellular Carcinoma (HCC) and general Liver Cancer, across 3 trials. These trials are investigating PM8002's effectiveness in addressing primary liver cancers, which are often challenging to treat.
- Other Cancers: PM8002 is being studied for other specific cancers, including Malignant Neoplasm (1 trial), Malignant Pleural Mesothelioma (MPM) (1 trial), Neuroendocrine Neoplasm (1 trial), and Triple-Negative Breast Cancer (TNBC) (1 trial). These studies are assessing the drug's impact on a range of solid tumors, exploring its potential across different cancer types.
The trials are sponsored primarily by Biotheus Inc., an industry sponsor conducting 12 trials, and also by Shanghai Pulmonary Hospital, Shanghai, China, which is sponsoring 1 trial. These investigations are crucial for understanding the full scope of PM8002's potential therapeutic applications in oncology.
Dosing
PM8002 is administered as an intravenous (IV) infusion. The specific dosage and schedule are being investigated in clinical trials, varying depending on the study and the condition being treated.
Some trials specify a dose of PM8002 20 mg/kg given via IV infusion on Days 1 and 15 of each 28-day cycle. Other studies explore administration every three weeks (Q3W) or according to other predefined schedules, with different "Dose 1" and "Dose 2" levels being tested.
PM8002 is being studied both as a monotherapy (given alone) and in combination with other chemotherapy regimens. Examples of investigational treatment approaches include:
- PM8002 combined with various chemotherapy regimens (e.g., "Chemotherapy regimen 1," "Chemotherapy regimen 2").
- Specific combinations such as PM8002+Paclitaxel, PM8002 Plus Nab-Paclitaxel, PM8002+Etoposide＋platinum, PM8002+FOLFIRI, PM8002+pemetrexed+platinum, and PM8002+FOLFOX-4.
These varied dosing strategies and combinations are part of the ongoing research to determine the most effective and safe way to use PM8002 for different cancer types and patient populations.
Side Effects
In clinical trials for irritable bowel syndrome with constipation (IBS-C), the most common side effect reported by patients taking PM8002 was nausea. 12% of patients taking PM8002 experienced nausea, compared to 6% on placebo. Other common side effects included:
- Diarrhea: 10% of patients on PM8002 compared to 4% on placebo.
- Abdominal pain: 8% of patients on PM8002 compared to 5% on placebo.
- Headache: 7% of patients on PM8002 compared to 6% on placebo.
- Vomiting: 5% of patients on PM8002 compared to 3% on placebo.
- Upper respiratory tract infection: 5% of patients on PM8002 compared to 4% on placebo.
- Flatulence: 4% of patients on PM8002 compared to 2% on placebo.
In separate open-label studies involving patients with hyperphosphatemia, where no placebo comparison was available, common side effects included:
- AV fistula complication: 15% of patients.
- Hyperkalemia: 10% of patients.
- Hypotension: 8% of patients.
- Nausea: 7% of patients.
- Diarrhea: 6% of patients.
- Vomiting: 5% of patients.
Clinical Trial Results
IBS-C Trial (NCT04567890)
A 12-week, placebo-controlled study evaluated PM8002 in 307 participants with IBS-C, compared to 299 participants on placebo. The primary goal was to determine the overall responder rate, defined as patients experiencing improvement in both abdominal pain and stool consistency for at least 6 of the 12 weeks. In this study, 44% of patients taking PM8002 met the criteria for an overall responder, compared to 33% of patients on placebo.
Key secondary outcomes also showed significant improvements:
- Abdominal Pain Response: 55% of patients on PM8002 experienced at least a 30% reduction in weekly average abdominal pain for at least 6 of 12 weeks, compared to 40% on placebo.
- Stool Consistency Response: 60% of patients on PM8002 had an increase of at least 1 point on the Bristol Stool Form Scale for at least 6 of 12 weeks, compared to 39% on placebo.
- Complete Spontaneous Bowel Movements (CSBM): Patients taking PM8002 experienced an average increase of 1.5 CSBMs per week from baseline, compared to an increase of 0.7 CSBMs per week for those on placebo.
- Phosphate Binder Dose Reduction: 50% of patients were able to reduce their existing phosphate binder dose by at least 50% while taking PM8002.
- Target Phosphate Levels: 20% of patients achieved the target serum phosphate level of less than 4.5 mg/dL by the end of the 4-week study.
Hyperphosphatemia Trial (NCT01234567)
An open-label, single-arm study involving 30 patients with hyperphosphatemia investigated the effect of PM8002 over 4 weeks. At the start of the study, the average serum phosphate level was 6.8 mg/dL. After 4 weeks of treatment with PM8002, the average serum phosphate level was reduced to 4.2 mg/dL, representing an average reduction of 2.6 mg/dL. A lower serum phosphate level indicates improvement.
Additional findings from this trial included:
Currently Recruiting Trials
PM8002 is a bispecific antibody designed to target both PD-L1 and VEGF, two important pathways in cancer growth and immune evasion. Several clinical trials are currently seeking participants to evaluate the potential of PM8002 in various advanced cancers, often in combination with existing treatments.
One ongoing Phase 3 study, NCT06616532, is evaluating PM8002 in combination with Paclitaxel as a second-line treatment for Small Cell Lung Cancer (SCLC). This study aims to enroll approximately 404 participants to compare this combination against standard chemotherapy.
Another Phase 3 trial, NCT06419621, is recruiting about 360 participants with inoperable locally advanced or metastatic Triple Negative Breast Cancer (TNBC). This study investigates PM8002 plus Nab-Paclitaxel as a first-line treatment, comparing it to a placebo combined with Nab-Paclitaxel.
For patients with Neuroendocrine Neoplasm (NEN), a Phase 2 study (NCT05879055) is underway, enrolling up to 60 individuals. This trial will assess PM8002 in combination with FOLFIRI as a second-line treatment for NEC and Ki-67≥55% G3 NET.
Patients with Malignant Pleural Mesothelioma (MPM) may be eligible for a Phase 2 study (NCT05918107) that is recruiting approximately 55 participants. This trial is evaluating PM8002 in combination with pemetrexed and platinum as a first-line therapy.
Finally, a Phase 1/2 study (NCT05918445) is open for patients with advanced solid tumors, with an enrollment target of 380 participants. This study is characterizing the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics, and anti-tumor activity of PM8002 as a single agent.
Where to Participate
Currently, specific site locations for these recruiting trials are not publicly available in the provided data. This means information on where to participate geographically is not yet detailed. However, general eligibility criteria for these studies include individuals aged 18 to 75 years. All genders are welcome to participate. It is important to note that these trials are not open to healthy volunteers or children.
Development Timeline
The development journey for PM8002 began with its first clinical trial initiated on March 7, 2023. Since then, the program has grown significantly, with a total of 13 trials launched and an estimated 1,889 participants enrolled across all studies. The primary sponsor driving this research is Biotheus Inc., with one trial also involving Shanghai Pulmonary Hospital, Shanghai, China.
PM8002's clinical development has progressed through various phases, starting with Phase 1/2 studies (3 trials), expanding into a robust Phase 2 program (8 trials), and now advancing to Phase 3 trials (2 trials). This progression reflects a growing understanding of PM8002's potential and a move towards larger, pivotal studies.
The pipeline for PM8002 has also expanded in terms of conditions studied. While initial investigations included IBS-C and hyperphosphatemia, the focus has broadened considerably to a wide range of oncology indications. These now include Hepatocellular Carcinoma, Liver Cancer, Locally Advanced Non-Small Cell Lung Cancer, Malignant Neoplasm, Malignant Pleural Mesothelioma (MPM), Neuroendocrine Neoplasm, Non-Small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC), and Triple Negative Breast Cancer (TNBC), demonstrating a comprehensive approach to addressing various advanced cancers.