BP1001-A + Paclitaxel for Solid Tumors

Recruiting at 3 trial locations

Overseen By Brian Forbes

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Bio-Path Holdings, Inc.

Must not be taking: Investigational agents

Disqualifiers: CNS disease, Cardiac events, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called BP1001-A for individuals with advanced solid tumors that have returned or do not respond to standard treatments. The first part of the trial aims to find the safest dose of BP1001-A when used alone. Subsequently, the study will assess the safety and effectiveness of BP1001-A in combination with a chemotherapy drug called paclitaxel. Individuals with certain types of ovarian or endometrial tumors who do not respond to other treatments might be suitable candidates. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop my current medications for the trial?

The trial requires that any hormonal therapy directed at the malignant tumor be stopped at least two weeks before starting BP1001-A. Other prior therapies for the tumor must be stopped at least four weeks before the first dose of BP1001-A. Hormone replacement therapy and stable hormonal therapy for prostate, ovarian, or breast cancer can continue.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that BP1001-A is being tested to find the safest dose for treating solid tumors. Earlier studies have determined how much of the drug can be given without causing serious side effects. These studies aim to find the highest dose that remains safe for patients.

Paclitaxel, a drug commonly used in cancer treatment, is also being tested with BP1001-A. Paclitaxel has been used for many years and is generally safe when patients take medication beforehand to prevent allergic reactions. However, it can cause side effects like low white blood cell counts, increasing the risk of infections.

In summary, BP1001-A is still in the early stages of safety testing, while paclitaxel is well-known and generally safe with precautions. Prospective trial participants should consult their doctor to understand the potential risks and benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for solid tumors, which typically include chemotherapy and radiation, BP1001-A is a novel therapeutic that targets specific molecular pathways involved in tumor growth. Researchers are excited about BP1001-A because it may enhance the effectiveness of existing chemotherapy drugs, like paclitaxel, by disrupting cancer cell survival mechanisms at a molecular level. This could potentially lead to more effective tumor shrinkage with possibly fewer side effects.

What evidence suggests that BP1001-A might be an effective treatment for solid tumors?

Research has shown that BP1001-A alone has potential in treating solid tumors. In early results, the first patient treated experienced a 15% reduction in tumor size. Another patient who received a higher dose saw a significant decrease in tumor size, and their disease remained stable. In this trial, some participants will receive BP1001-A monotherapy.

Other participants will receive a combination of BP1001-A with paclitaxel, a well-known cancer drug. Paclitaxel has already been used successfully for advanced cancers like ovarian and breast cancer. This trial studies the combination to improve outcomes for hard-to-treat solid tumors. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

Adults (≥18 years) with advanced or recurrent solid tumors, such as ovarian, endometrial, fallopian tube cancer, who have no other beneficial treatments available. They must be willing to undergo biopsies and have a life expectancy >3 months. Participants need an ECOG score of 0 or 1 and adequate organ function. Women must not be pregnant and agree to birth control; men also need to use contraception.

Inclusion Criteria

I am willing to have biopsies before and, if needed, after treatment.

My cancer can be measured and has a specific area that can be evaluated.

My ovarian cancer is of a specific cell type.

Exclusion Criteria

You have had a severe allergic reaction to paclitaxel or docetaxel in the past.

I have no lasting side effects worse than mild from previous treatments.

I have HIV with a specific CD4+ T-cell count or active hepatitis B/C.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Determine the safety and maximum tolerated dose (MTD) or maximum administered dose (MAD) of BP1001-A as a single agent

4-8 weeks

Dose Expansion

Determine the safety, toxicity, and response of BP1001-A in combination with paclitaxel

4-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• BP1001-A

Trial Overview The trial is testing BP1001-A alone and combined with paclitaxel in patients with certain solid tumors. It's in phase I where they first find the safest dose for BP1001-A by itself, then see how it works together with paclitaxel regarding safety, toxicity response.

How Is the Trial Designed?

Group I: BP1001-A monotherapy Experimental Treatment 1 Intervention

Dose escalation of BP1001-A monotherapy

Group II: BP1001-A and Paclitaxel Experimental Treatment 1 Intervention

Dose expansion of selected dose of BP1001-A with paclitaxel

Who Is Running the Clinical Trial?

Bio-Path Holdings, Inc.

Lead Sponsor

Trials

6

Recruited

300+

Published Research Related to This Trial

Paclitaxel and docetaxel are effective antitumor agents that work by stabilizing microtubules, leading to cell death, but they have different pharmacokinetic profiles; paclitaxel has nonlinear plasma clearance while docetaxel has linear disposition, affecting how their concentrations change with dosage.

Both drugs require premedication to manage side effects, with paclitaxel needing corticosteroids and antihistamines, while docetaxel only requires corticosteroids; their toxic effects differ, with paclitaxel primarily causing neutropenia and peripheral neuropathy, and docetaxel leading to myelosuppression and fluid retention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Taxanes: an overview of the pharmacokinetics and pharmacodynamics. Vaishampayan, U., Parchment, RE., Jasti, BR., et al.[2023]

Paclitaxel, a novel antineoplastic drug, has shown significant effectiveness in treating advanced cancers such as ovarian, breast, non-small cell lung cancer, and head and neck cancer, with a potential to become a first-line treatment when combined with platinum for advanced ovarian cancer.

While initial hypersensitivity reactions posed challenges, current premedication strategies have reduced these side effects to less than 3%, although neutropenia remains a major dose-limiting adverse effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paclitaxel (Taxol): a review of its antitumor activity in clinical studies Minireview. Hájek, R., Vorlicek, J., Slavik, M.[2015]

Paclitaxel is an effective chemotherapy drug that works by stabilizing microtubules, which interrupts cell division, and has shown significant activity against advanced ovarian, breast, and lung cancers in clinical trials.

While paclitaxel is effective, it has notable side effects, particularly neutropenia, which limits dosage, and other adverse effects like hypersensitivity and neurotoxicity, necessitating careful monitoring of blood cell counts during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paclitaxel: a new antineoplastic agent for refractory ovarian cancer. Gregory, RE., DeLisa, AF.[2015]

Paclitaxel has shown significant efficacy in treating various cancers, with response rates of 24%-30% in platinum refractory ovarian cancer and up to 62% in untreated advanced breast cancer, indicating its potential as a key chemotherapy agent.

The drug's unique mechanism of action, along with its ability to be combined with other therapies, suggests it can be effectively used in early-stage disease and has demonstrated superiority over standard treatments in ovarian and lung cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paclitaxel (Taxol®): A new natural product with major anticancer activity. De Furia, MD.[2012]

In a study involving 64 pediatric patients with recurrent or refractory solid tumors, nab-Paclitaxel was found to have a tolerable safety profile, with the maximum tolerated dose (MTD) not reached, but 240 mg/m2 was selected as the recommended phase II dose due to its pharmacokinetics and antitumor activity.

Efficacy results showed that at doses of 210 mg/m2 and above, there were complete and partial responses in a small percentage of patients, with 22% achieving stable disease, indicating potential effectiveness in treating certain pediatric solid tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I results of a phase I/II study of weekly nab-paclitaxel in paediatric patients with recurrent/refractory solid tumours: A collaboration with innovative therapies for children with cancer. Moreno, L., Casanova, M., Chisholm, JC., et al.[2019]

Paclitaxel has shown significant efficacy as a salvage therapy for various advanced cancers, including non-small cell lung cancer (NSCLC), ovarian, breast, and head and neck cancers, particularly in heavily pretreated patients who did not respond to previous treatments.

Ongoing studies are focused on optimizing paclitaxel's use in combination with other drugs and determining its role in primary therapy, as well as addressing unresolved issues related to its dosage, infusion length, and associated toxicities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Update on the antitumor activity of paclitaxel in clinical trials. Rowinsky, EK.[2017]

In a study of 42 metastatic breast cancer patients who had previously been treated with taxanes, nab-paclitaxel demonstrated a 23.8% overall response rate, indicating significant antitumor activity despite prior treatment failures.

Nab-paclitaxel was well tolerated, with most treatment-related side effects being mild to moderate, suggesting a manageable safety profile for patients with advanced disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective study on nanoparticle albumin-bound paclitaxel in advanced breast cancer: clinical results and biological observations in taxane-pretreated patients. Fabi, A., Giannarelli, D., Malaguti, P., et al.[2022]

In a study of 15 patients with advanced breast cancer resistant to anthracyclines, paclitaxel administered via a 3-hour intravenous infusion showed an overall response rate of 47%, with three complete responses and four partial responses.

The treatment was generally well-tolerated, with common side effects like neutropenia and hair loss, but these were not clinically concerning, suggesting that higher doses of paclitaxel could be safely explored in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paclitaxel (Taxol) efficacy in patients with advanced breast cancer resistant to anthracyclines. Gianni, L., Capri, G., Munzone, E., et al.[2015]

In a phase II study involving 25 patients with metastatic breast cancer, paclitaxel demonstrated significant efficacy, with 14 patients achieving a major response and a median survival time of 20 months.

Paclitaxel remains effective even in patients who have undergone multiple prior chemotherapy regimens, including those resistant to anthracyclines, although combination therapies can lead to serious side effects like neutropenic fever and neuropathy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The University of Texas M.D. Anderson Cancer Center experience with paclitaxel in breast cancer. Hortobagyi, GN., Holmes, FA., Ibrahim, N., et al.[2015]

Combination therapies using paclitaxel with other antineoplastic agents show promise for treating metastatic breast cancer, but optimal dosing and scheduling remain unclear, which complicates their development.

Unexpected toxic interactions between paclitaxel and other drugs have been observed, highlighting the need for careful evaluation of combination therapies in clinical trials before they are used outside of research settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paclitaxel combination therapy in the treatment of metastatic breast cancer: a review. Holmes, FA.[2015]

In a trial involving 158 HER2-negative metastatic breast cancer patients, cabazitaxel did not significantly improve progression-free survival compared to weekly paclitaxel, with median PFS of 6.7 months for cabazitaxel versus 5.8 months for paclitaxel.

Cabazitaxel was associated with a significantly lower risk of peripheral neuropathy (16.5% vs 54.5% for paclitaxel) and better quality of life scores, indicating it may be a more tolerable option for patients despite similar overall efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Concept: A randomised multicentre trial of first line chemotherapy comparing three weekly cabazitaxel versus weekly paclitaxel in HER2 negative metastatic breast cancer. Bahl, A., Wilson, W., Ball, J., et al.[2022]

In a study of 30 women with advanced breast cancer, the combination of doxorubicin and paclitaxel resulted in a high overall response rate of 83%, with 24% achieving complete remission, indicating strong efficacy for this treatment regimen.

However, the treatment was associated with significant toxicities, including neutropenia and cardiotoxicity, with 50% of patients experiencing reduced heart function and 20% developing congestive heart failure, highlighting the need for careful monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined doxorubicin and paclitaxel in advanced breast cancer: effective and cardiotoxic. Gehl, J., Boesgaard, M., Paaske, T., et al.[2020]

In a study of 32 breast cancer patients who had previously failed high-dose chemotherapy, paclitaxel, either alone or combined with epirubicin, showed a 55% overall response rate after 3 courses and a 57% response rate after 6 courses, indicating its efficacy as a salvage treatment.

The median survival for patients receiving these treatments was 27.5 months, although the main side effects were hematologic, including significant neutropenia in 25% of patients, highlighting the need for careful monitoring and management of toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Salvage treatment with epirubicin and/or paclitaxel in metastatic breast cancer patients relapsed after high-dose chemotherapy with peripheral blood progenitor cells. Tartarone, A., Sirotovà, Z., Aieta, M., et al.[2022]

Paclitaxel is a highly effective chemotherapeutic agent that works by promoting the polymerization of tubulin, disrupting cell division and leading to cell death, and it is effective against various tumor types including breast, ovarian, and lung cancers.

However, patients may experience significant toxicities such as hypersensitivity reactions and neurotoxicity, which can vary based on the dosage and treatment schedule, and some tumors may develop resistance to the drug through changes in tubulin structure or increased drug efflux.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paclitaxel in cancer therapy. Mekhail, TM., Markman, M.[2019]

The combination therapy of bevacizumab and paclitaxel (BP regimen) showed a median time to treatment failure of 6.2 months and a median overall survival of 15.4 months in a study of 90 Japanese patients with metastatic breast cancer, indicating its efficacy in real-world settings.

While the BP regimen was generally well tolerated, 31.1% of patients required a dose reduction of paclitaxel, particularly those starting at the higher dose of 90 mg/m2, highlighting the need for careful dose management to minimize adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Real-World Retrospective Cohort Study of Combined Therapy with Bevacizumab and Paclitaxel in Japanese Patients with Metastatic Breast Cancer. Yamada, H., Inoue, K., Nagai, SE., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04196257

Study Details | NCT04196257 | BP1001-A in Patients With ... This is a phase I, open-label, study of BP1001-A in participants with advanced or recurrent solid tumors. The dose escalation phase will determine the ...

2. clin.larvol.com clin.larvol.com/trial-detail/NCT04196257

BP1001-A in Patients With Advanced or Recurrent Solid ... Important trial with advanced or recurrent solid tumors, including ovarian and uterine, pancreatic and breast cancer with initial cohort completion and data ...

3. withpower.com withpower.com/trial/phase-1-fallopian-tube-neoplasms-7-2021-19ccc

BP1001-A + Paclitaxel for Solid Tumors Paclitaxel, a novel antineoplastic drug, has shown significant effectiveness in treating advanced cancers such as ovarian, breast, non-small cell lung cancer, ...

4. nasdaq.com nasdaq.com/articles/bio-path-holdings-reports-positive-progress-phase-1-1b-bp1001-clinical-trial-solid-tumors

Bio-Path Holdings Reports Positive Progress in Phase 1/1b ... Successful treatment of the first solid tumor patient in the Phase 1/1b BP1001-A clinical trial, demonstrating a 15% tumor reduction after six ...

5. synapse.patsnap.com synapse.patsnap.com/article/bio-path-holdings-reports-strong-response-to-bp1001-a-in-solid-tumor-patients

Bio-Path Holdings Reports Strong Response to BP1001-A ... The first patient treated with a higher dose of 90 mg/m2 showed significant tumor reduction and maintained stable disease status.

6. cancer.gov cancer.gov/clinicaltrials/NCI-2022-07163

BP1001-A in Patients With Advanced or Recurrent Solid ... The dose escalation phase will determine the safety and the maximum tolerated dose (MTD) or maximum administered dose (MAD) of BP1001-A as a single agent. After ...

7. biopathholdings.com biopathholdings.com/wp-content/uploads/2023/07/BP1001-A_Solid_Tumor_Completion_o_First_Dose_Cohort-v2.pdf

Advancing to Second Cohort of Phase 1/1b Clinical Trial ... The Phase 1b portion of the study will commence after successful completion of BP1001-A monotherapy cohorts and will assess the safety and ...