BMX-001 + Paclitaxel for Ovarian Cancer

Overseen By Sara Penchev

Age: 18+

Sex: Female

Trial Phase: Phase 1 & 2

Sponsor: BioMimetix JV, LLC

Must not be taking: Corticosteroids, Anticancer therapy

Disqualifiers: Peripheral neuropathy, CNS metastases, Cardiac disease, others

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

Compensation: Varies

Number of Visits: 12

Duration: 48 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new combination of treatments for women with ovarian and endometrial cancers that have returned after previous therapies. It tests BMX-001, which may enhance the cancer-fighting effects of paclitaxel (a common chemotherapy drug) while reducing side effects such as nerve damage. Participants should have these types of recurrent cancers and have already undergone standard treatments. By studying BMX-001, researchers aim to improve cancer treatment and minimize unpleasant side effects. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

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

The trial protocol does not specify if you need to stop taking your current medications. However, you must wait at least 28 days after stopping any prior anticancer or hormonal therapy before starting the trial treatment.

Is there any evidence suggesting that BMX-001 + Paclitaxel is likely to be safe for humans?

Research has shown that BMX-001, when combined with paclitaxel (PTX), has shown promise in earlier studies. BMX-001 may reduce some side effects of PTX, such as nerve damage, while enhancing its cancer-fighting ability. In lab tests, this combination reduced cancer cell growth more effectively than PTX alone.

PTX has long been used to treat ovarian cancer and is known for its effectiveness, though it can cause nerve damage, a major concern. Previous studies have demonstrated that PTX is generally safe.

As this trial is in its early stages, the primary aim is to determine the safest dose of BMX-001 when used with PTX. The safety of the treatment is under careful observation and assessment. So far, no unexpected safety issues have arisen with BMX-001 in combination with PTX, but new information from this trial will provide further details. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for ovarian cancer?

Researchers are excited about BMX-001 + Paclitaxel for ovarian cancer because it introduces a novel combination approach to treatment. Unlike traditional chemotherapy options, which typically focus solely on attacking cancer cells, BMX-001 acts as an antioxidant that may protect healthy cells from damage caused by chemotherapy. This combination of BMX-001 and Paclitaxel not only targets cancer cells effectively but also potentially reduces side effects, making it a promising option for improving patient outcomes.

What evidence suggests that BMX-001 + Paclitaxel could be an effective treatment for ovarian cancer?

Studies have shown that BMX-001 can enhance the effectiveness of the cancer drug paclitaxel (PTX) while reducing the nerve damage PTX often causes. Paclitaxel, a common cancer treatment, can lead to serious nerve issues. BMX-001 protects nerves while still supporting PTX in fighting cancer cells. Specifically, early research demonstrated that BMX-001 reduced nerve damage caused by PTX, helping to prevent these nerve problems. This trial will evaluate the combination of BMX-001 and PTX, potentially improving treatment for patients with recurring ovarian and endometrial cancers by making the therapy more effective and less harmful. ^{4 5 6 7 8}

Who Is on the Research Team?

Angeles A. Secord

Principal Investigator

Duke Cancer Institute

James Crapo, MD

Principal Investigator

BioMimetix JV, LLC

Are You a Good Fit for This Trial?

This trial is for adults with advanced, recurrent, metastatic ovarian or endometrial cancer who have faced issues with chemotherapy resistance and nerve damage from previous treatments. Specific eligibility criteria are not provided but typically include factors like health status and prior treatment history.

Inclusion Criteria

My bone marrow is working well.

My liver is working well.

I can perform all my usual activities without assistance.

Exclusion Criteria

I have not had a serious infection requiring IV antibiotics or hospital stay in the last week.

I have moderate numbness or pain in my hands or feet.

I have a serious heart condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose-finding

Dose-finding stage to assess safety and dose-limiting toxicities of BMX-001 and PTX combination

8 weeks

Weekly visits for dose administration and monitoring

Treatment

Participants receive BMX-001 and PTX weekly to evaluate safety, tolerability, and efficacy

48 weeks

Weekly visits for treatment administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Every 12 weeks until disease progression or study termination

What Are the Treatments Tested in This Trial?

Interventions

• BMX-001
• Paclitaxel

Trial Overview The study tests BMX-001 in combination with the chemotherapy drug Paclitaxel (Taxol). It aims to find a safe dosage that enhances tumor control while reducing side effects, especially nerve damage caused by Taxol. The trial will also monitor how well tumors respond to this treatment combo.

How Is the Trial Designed?

Group I: BMX-001 + PTX Experimental Treatment 2 Interventions

All patients will be administered BMX-001 + PTX weekly on Days 1, 8, 15, and 22 of each 28 day cycle. BMX-001 is a SC injection while PTX is IV.

Who Is Running the Clinical Trial?

BioMimetix JV, LLC

Lead Sponsor

Trials

11

Recruited

700+

Published Research Related to This Trial

Paclitaxel is a cytotoxic drug that belongs to the taxane group and is specifically approved for treating metastatic ovarian carcinoma after standard platinum-based therapies have not been effective.

It represents a new treatment option for patients with advanced ovarian cancer, providing an alternative when traditional therapies fail.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paclitaxel for ovarian cancer. [2015]

Paclitaxel demonstrated a 22% objective response rate in women with platinum-refractory ovarian cancer, indicating it can be an effective treatment option for this challenging condition.

While the treatment had an acceptable safety profile, with leukopenia being the most common severe toxicity (78% of patients), there were also treatment-related deaths (1.5%), highlighting the need for careful monitoring during therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paclitaxel for platinum-refractory ovarian cancer: results from the first 1,000 patients registered to National Cancer Institute Treatment Referral Center 9103. Trimble, EL., Adams, JD., Vena, D., et al.[2017]

Paclitaxel has been established as an effective treatment for newly diagnosed ovarian cancer patients, leading to its incorporation into primary chemotherapy regimens, particularly in combination with cisplatin as the new standard in the U.S.

Ongoing clinical trials are exploring various strategies to optimize paclitaxel-based chemotherapy, including comparisons of different platinum-based drugs and infusion schedules, as well as evaluating high-dose therapies with stem cell support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chemotherapy of advanced ovarian cancer: current status and future directions. Ozols, RF., Vermorken, JB.[2015]

Cytoreductive surgery followed by platinum-based chemotherapy, particularly with carboplatin, remains the standard treatment for advanced epithelial ovarian cancer, but most patients are not cured, highlighting the need for improved therapies.

Paclitaxel, a novel agent effective in platinum-resistant ovarian cancer, is being tested in combination with platinum compounds in clinical trials for previously untreated patients, aiming to enhance treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of ovarian cancer: current status. Ozols, RF.[2015]

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]

Inhibiting Src family and Abl kinases using siRNAs or dasatinib significantly enhances the sensitivity of ovarian cancer cells to paclitaxel, as demonstrated in both cell cultures and HEY xenograft models.

The mechanism involves the induction of p27(Kip1), which promotes apoptosis by suppressing Bcl-2 and Cdk1 expression, leading to increased effectiveness of paclitaxel treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of p27(Kip1) in dasatinib-enhanced paclitaxel cytotoxicity in human ovarian cancer cells. Le, XF., Mao, W., He, G., et al.[2021]

Citations

1. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/537139

BMX-001 + Paclitaxel in Adult Patients With Advanced ... The study focuses on BMX-001, a redox-active manganese metalloporphyrin compound that uniquely combines the ability to enhance anti-tumor efficacy and protect ...

2. ctv.veeva.com ctv.veeva.com/study/bmx-001-paclitaxel-in-adult-patients-with-advanced-recurrent-metastatic-ovarian-or-endometrial-c

BMX-001 + Paclitaxel in Adult Patients With Advanced ... This clinical trial is a proof-of-concept Phase 1/2 study aimed at establishing the recommended Phase 2 dose (RP2D) of BMX-001 when administered ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04661696

Efficacy and Safety of Paclitaxel (Albumin-bound) ... CSPC OUYI PHARMACEUTICAL CO., LTD has successfully developed Paclitaxel (Albumin-Bound) and the bioequivalence test results show good consistency with Abraxane.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40900760/

Suppression of Paclitaxel-Induced Neuropathy and ... Data revealed a significant ability of BMX-001 to suppress peripheral neuropathy and neuroinflammation. Importantly, while protecting peripheral ...

5. withpower.com withpower.com/trial/phase-2-endometrial-cancer-endometrial-neoplasm-3-2025-989f3

BMX-001 + Paclitaxel for Ovarian Cancer This trial is for adults with advanced, recurrent, metastatic ovarian or endometrial cancer who have faced issues with chemotherapy resistance and nerve damage ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06620029

BMX-001 + Paclitaxel in Adult Patients With Advanced ... The goal is to determine if BMX-001 can be safely administered at increasing doses while enhancing both the efficacy of treatment as well as diminishing ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12389141/

Therapeutic Potential of BMX-001 for Preventing ... In ovarian cancer models, co-treatment with BMX-001 and PTX significantly reduced the cell viability of CAOV2 cells compared to PTX alone ...

8. nrgoncology.org nrgoncology.org/Home/News/Post/adding-bmx-001-to-the-usual-chemoradiation-therapy-for-patients-with-head-and-neck-cancer-nrg-cc013

Adding BMX-001 to the Usual Chemoradiation Therapy for ... This phase 2 trial will compare the incidence of severe oral mucositis (SOM) between BMX-001 and placebo.