Chemotherapy (FID-007) for Cancer

Not currently recruiting at 2 trial locations

Overseen By Lorraine Martinez, RN

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Southern California

Must not be taking: Paclitaxel, Nab-paclitaxel, Warfarin, others

Disqualifiers: Hypersensitivity to paclitaxel, Heart failure, Active infection, others

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

Compensation: Varies

Number of Visits: 3

Duration: 28 days per cycle

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the optimal dose and understand the side effects of a new chemotherapy treatment called FID-007. FID-007 is a specialized form of the drug paclitaxel, designed to penetrate deeper into tumors while sparing normal cells. It targets individuals whose cancer has spread and does not respond to other treatments. Candidates may qualify if they have a solid tumor cancer that hasn’t responded to standard treatments and are not currently using paclitaxel as a first-line therapy. As a Phase 1 trial, this research focuses on understanding how FID-007 works in people, offering participants the opportunity to be among the first to receive this innovative treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must have finished any previous chemotherapy, radiotherapy, or targeted therapy at least 4 weeks before starting the trial.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that FID-007, a new type of chemotherapy, has undergone safety testing in people. The FDA has approved its drug master file, indicating a positive safety profile. Previous studies suggest that patients can manage the side effects of FID-007. This treatment delivers the drug paclitaxel in a special way to target tumors more directly, potentially reducing side effects. Although testing is still in the early stages, these findings suggest that FID-007 could be a safe option for people with cancer that has spread and hasn't responded to other treatments. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about FID-007 because it introduces a novel way to deliver paclitaxel, a well-known chemotherapy drug used to treat cancer. Unlike traditional treatments, which often involve direct infusions of paclitaxel, FID-007 uses PEOX-based polymer encapsulation. This innovative delivery method allows for a controlled release of the drug, potentially enhancing its effectiveness while minimizing side effects. By targeting cancer cells more precisely, FID-007 aims to improve patient outcomes and quality of life compared to standard chemotherapy options.

What evidence suggests that this treatment might be an effective treatment for cancer?

Research shows that FID-007, the investigational treatment in this trial, could effectively treat various advanced and difficult-to-treat cancers. Earlier studies found that FID-007 slowed or stopped tumor growth in cancers such as lung, stomach, breast, pancreatic, and ovarian cancer. This treatment uses paclitaxel, a common chemotherapy drug, encased in a special coating that targets tumors more precisely while sparing healthy cells. This method has enhanced the drug's ability to control tumor growth and reduced side effects. Overall, early evidence suggests that FID-007 might outperform traditional paclitaxel. ^{2 3 4 5 6}

Who Is on the Research Team?

Anthony El-Khoueiry, MD

Principal Investigator

University of Southern California

Are You a Good Fit for This Trial?

This trial is for adults with advanced solid tumors that have spread and don't respond to treatment. They must have acceptable blood counts, organ function, and a life expectancy of at least 3 months. Participants need measurable disease, no severe allergies to paclitaxel, no more than three prior chemotherapy treatments for advanced disease, and cannot be on certain anticoagulants or have serious heart conditions.

Inclusion Criteria

My kidney function is within the required range for the trial.

Hemoglobin ? 8 g/dL

I am a woman who can have children and my pregnancy test was negative.

Exclusion Criteria

I have brain metastasis but am stable after treatment and not on steroids.

I have had 3 or fewer chemotherapy treatments for my advanced disease.

I have never been treated with paclitaxel or nab-paclitaxel.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive FID-007 intravenously over 60 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

28 days per cycle

3 visits per cycle (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

• PEOX-based Polymer Encapsulated Paclitaxel FID-007

Trial Overview The study tests FID-007, a new form of the chemotherapy drug paclitaxel encapsulated in PEOX-based polymer which may target tumors more effectively while sparing normal cells. The trial aims to find the safest dose with the fewest side effects by gradually increasing doses among participants.

How Is the Trial Designed?

Group I: Treatment (FID-007) Experimental Treatment 3 Interventions

Participants receive FID-007 IV over 60 minutes on days 1, 8 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Paclitaxel-loaded nanoparticles significantly reduced tumor weight and ascites volume in ovarian carcinoma xenografts in F344 rats, demonstrating effective tumor inhibition with weights of 4.55 g compared to 10.13 g in controls.

The nanoparticles also showed enhanced delivery to pelvic lymph nodes, with concentrations significantly higher than free paclitaxel, indicating a safe and effective lymphatic targeting mechanism for treating ovarian cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The inhibitory effect of paclitaxel nanoparticles on ovarian cancer xenografts and lymphatic targeting]. Lu, HX., Xu, CJ., Li, B., et al.[2017]

The amphiphilic block copolymer PEO-PBO effectively forms nanoparticles for delivering the cancer drug paclitaxel, with a size of approximately 92.71 nm, which is suitable for targeting tumors due to the enhanced permeability and retention effect.

PEO-PBO nanoparticles demonstrated superior pharmacokinetics, biodistribution, and tumor inhibition compared to the commonly used PEG-PDLLA, along with better biocompatibility and stability, indicating its potential as a promising drug delivery system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delivery of paclitaxel using nanoparticles composed of poly(ethylene oxide)-b-poly(butylene oxide) (PEO-PBO). Wang, L., Yao, J., Zhang, X., et al.[2018]

The study found that PTX-loaded polymeric micelles (PM/PTX) are more stable and safer than the conventional formulation (CrEL/EtOH/PTX), showing no hemolytic activity and reduced toxicity in healthy mice, particularly avoiding peripheral neuropathy.

PM/PTX demonstrated significantly higher antitumor activity, with an inhibition ratio approximately 1.5 times greater than CrEL/EtOH/PTX, indicating its potential as a more effective treatment for breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Encapsulating paclitaxel in polymeric nanomicelles increases antitumor activity and prevents peripheral neuropathy. Oda, CMR., Silva, JO., Fernandes, RS., et al.[2021]

A new formulation using 3rd generation taxoids with doubly amphiphilic poly(2-oxazoline)s (POx) significantly improves the solubility of these drugs, which are typically very hydrophobic, allowing for effective parenteral administration.

The selected taxoid SB-T-1214 showed one to two orders of magnitude greater activity against multidrug-resistant breast cancer cells compared to paclitaxel, and it effectively inhibited tumor growth in resistant models, outperforming both commercial paclitaxel and its traditional formulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Poly(2-oxazoline) based micelles with high capacity for 3rd generation taxoids: preparation, in vitro and in vivo evaluation. He, Z., Schulz, A., Wan, X., et al.[2019]

Increasing the amount of D-a-tocopheryl polyethylene glycol 1000 succinate (TPGS) in paclitaxel (PTX) nanocrystals transformed their shape from rod-like to stable spherical micelles, enhancing their cytotoxicity and cellular uptake in drug-resistant cancer cells.

Despite a faster clearance rate compared to Taxol, PTX/TPGS micelles showed improved accumulation in drug-resistant tumors, likely due to TPGS's ability to inhibit P-glycoprotein, which is responsible for drug resistance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Surfactant on Paclitaxel Nanocrystals: An In Vitro and In Vivo Study. Liu, H., Ma, Y., Liu, D., et al.[2019]

PTX-loaded PLGA nanoparticles (PTX-PLGA NPs) were developed as a drug carrier and showed enhanced antitumor effects against non-small-cell lung carcinoma (NSCLC) cells, particularly in promoting apoptosis and inhibiting cell migration and invasion.

While PTX-PLGA NPs initially had weaker effects than free PTX at shorter time points (12 and 24 hours), they demonstrated stronger inhibition of NSCLC cell activity at 48 and 72 hours, indicating their potential for sustained drug release and improved therapeutic efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study on the Mechanism of Action of Paclitaxel-Loaded Polylactic-co-glycolic Acid Nanoparticles in Non-Small-Cell Lung Carcinoma Cells. Zuo, Y., Shen, W., Wang, L., et al.[2023]

The phase I study of PNU166945, a polymer-conjugated derivative of paclitaxel, involved 12 patients with refractory solid tumors and showed that it could be administered safely without dose-limiting toxicities up to 196 mg/m², with mild hematologic toxicity.

While one patient experienced a partial response and the pharmacokinetics of PNU166945 were linear, the study was halted due to severe neurotoxicity observed in rat studies, indicating potential safety concerns that differ from standard paclitaxel formulations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I clinical and pharmacokinetic study of PNU166945, a novel water-soluble polymer-conjugated prodrug of paclitaxel. Meerum Terwogt, JM., ten Bokkel Huinink, WW., Schellens, JH., et al.[2019]

Intraperitoneal (i.p.) administration of paclitaxel formulated as PTX-30W significantly reduced metastatic nodules and tumor volume in a gastric cancer model, leading to prolonged survival compared to conventional PTX dissolved in Cremophor EL.

PTX-30W showed higher drug accumulation in peritoneal tumors and preferentially targeted hypovascular areas, suggesting it may be a more effective treatment for peritoneal malignancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraperitoneal administration of paclitaxel solubilized with poly(2-methacryloxyethyl phosphorylcholine-co n-butyl methacrylate) for peritoneal dissemination of gastric cancer. Soma, D., Kitayama, J., Konno, T., et al.[2022]

The synthesized PEO-b-PCL copolymers with paclitaxel (PTX) side groups showed limited drug release (5.0% at pH 7.4 and 6.7% at pH 5.0) over 72 hours, indicating a controlled release mechanism that may be beneficial for targeted therapy.

While the cytotoxicity of the PEO-b-P(CL-PTX) particles against cancer cells increased over time, it was still significantly lower than that of free PTX, suggesting that while the copolymer can solubilize PTX, its effectiveness in killing cancer cells may require further optimization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel self-associating poly(ethylene oxide)-b-poly(epsilon-caprolactone) based drug conjugates and nano-containers for paclitaxel delivery. Shahin, M., Lavasanifar, A.[2018]

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.6042

Efficacy from the phase 1 study of FID-007, a novel ... Taxanes in this setting have historically demonstrated response rates around 14-27%. FID-007 (FID) consists of paclitaxel encapsulated in a ...

2. jitc.bmj.com jitc.bmj.com/content/11/Suppl_2/A1812

782-B FID-007: nanoencapsulated paclitaxel derived from ... Taken together, this example demonstrates the proof of concept for PEOX polymer based nano-drug delivery platform which can be broadly applied ...

3. asco.org asco.org/abstracts-presentations/ABSTRACT416054

A phase 1 dose escalation/expansion study of FID-007 ... In xenograft studies, FID reduced or limited tumor growth in multiple tumor types including lung, gastric, breast, pancreatic, and ovarian cancer. Preclinically ...

4. ascopubs.org ascopubs.org/doi/10.1200/jco.2013.31.15_suppl.e13538

Evaluation of the toxicity and efficacy of paclitaxel ... Conclusions: Encapsulation with PEOX-based polymers reduced the toxicity and significantly improved the efficacy of paclitaxel in controlling tumor growth in ...

5. withpower.com withpower.com/trial/phase-1-neoplasms-4-2018-9beb8

Chemotherapy (FID-007) for Cancer · Info for Participants Research shows that using nanoparticles to deliver paclitaxel, like in FID-007, can improve how the drug targets tumors and enhances its ability to stop tumor ...

6. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2018-00758

FID-007 in Treating Participants with Advanced Solid Tumors This phase I trial studies the side effects and best dose of PEOX-based polymer encapsulated paclitaxel FID-007 (FID-007) in treating participants with ...