SPEDOX-6 for Cancer

Overseen By Chao Family Comprehensive Cancer Center University of California, Irvine

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of California, Irvine

Must be taking: Antiretroviral therapy

Must not be taking: CYP3A4 inhibitors

Disqualifiers: Driver mutations, CNS metastases, others

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

Compensation: Varies

Number of Visits: 6

Duration: 18 weeks

67 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the optimal dose of SPEDOX-6, a new treatment for challenging cancers such as soft-tissue sarcoma and triple-negative breast cancer. It evaluates SPEDOX-6's effectiveness in patients whose cancer has not responded to at least two prior treatments and who have not received anthracyclines (a type of chemotherapy). Potential candidates include individuals with advanced cancers like those mentioned, whose previous treatments have failed. The trial tests various doses to identify the most effective and safest option. As a Phase 1 trial, this research seeks to understand how SPEDOX-6 functions in people, offering participants the chance to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial requires a washout period (time without taking certain medications) of at least 3 weeks for chemotherapy and 4 weeks for radiotherapy, immunotherapy, other targeted therapies, or surgery. Additionally, you cannot use strong inhibitors or inducers of CYP3A4, CYP2D6, or P-glycoprotein (types of enzymes and proteins that affect drug metabolism).

Is there any evidence suggesting that SPEDOX-6 is likely to be safe for humans?

Research has shown that SPEDOX-6 has promising safety results. Studies have found that SPEDOX-6 is less harmful to heart cells than traditional treatments like doxorubicin, a common chemotherapy drug. In lab tests, SPEDOX-6 killed cancer cells while being gentler on heart cells. This suggests it might cause fewer heart-related side effects while still effectively fighting cancer.

The FDA has granted SPEDOX-6 an orphan drug designation, indicating some confidence in its safety for specific conditions, although more testing is needed. As this treatment is in an early-phase trial, researchers continue to learn about any possible side effects and how well people can tolerate it. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for cancer?

Researchers are excited about SPEDOX-6 because it targets cancer cells in a unique way. Unlike traditional chemotherapy options that broadly attack dividing cells, SPEDOX-6 is designed to be more selective, potentially reducing harm to healthy cells. Additionally, SPEDOX-6 is combined with Filgrastim or Pegfilgrastim, which helps boost white blood cell counts, possibly leading to fewer side effects like infections. This combination and targeted approach may offer a more effective and tolerable treatment option for cancer patients.

What evidence suggests that SPEDOX-6 might be an effective treatment for cancer?

Research has shown that SPEDOX-6 could effectively treat various cancers, such as breast cancer and sarcomas. It functions similarly to doxorubicin, a common chemotherapy drug, but with a reduced risk of heart damage, a typical side effect. Studies in mice found that SPEDOX-6 targets fast-growing cancer cells and reduces tumor growth more effectively than some current treatments. Its protein coating facilitates easier entry into cancer cells and minimizes harm to healthy cells. This trial will explore various dose levels of SPEDOX-6, with some arms also including Filgrastim or Pegfilgrastim to support treatment. Although still under investigation, early results suggest promising potential for success. ^{1 2 3 6 7}

Who Is on the Research Team?

Warren Chow, MD

Principal Investigator

Chao Family Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with advanced cancers like soft-tissue sarcoma, triple-negative breast cancer, non-small cell lung cancer, cervical and ovarian cancers, or KRAS mutant pancreatic ductal adenocarcinoma. Participants must not have been treated with anthracyclines before.

Inclusion Criteria

Disease must be considered measurable by RECIST v1.1.

Life expectancy must be at least 12 weeks.

Left ventricular ejection fraction must be > 50%.

Exclusion Criteria

A known allergy to albumin is an exclusion criterion.

HIV infection with CD4+ count < 350 cells/µL or Acquired Immunodeficiency (AIDS)-defining opportunistic infection in the previous 12 months is an exclusion criterion.

Pregnant or lactating individuals are excluded.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive SPEDOX-6 chemotherapy on day 1 of each 21-day cycle, for a total of 6 cycles

18 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

What Are the Treatments Tested in This Trial?

Interventions

• SPEDOX-6

Trial Overview The study tests SPEDOX-6's safe dosage in patients with specific advanced cancers. It's a Phase 1b/IIa trial that gradually increases doses to find the recommended amount for Phase II trials. Pegfilgrastim and Filgrastim are also used to support treatment.

How Is the Trial Designed?

Group I: Phase 1b Dose Level 8 - Spedox-6 + Filgrastim/Pegfilgrastim Experimental Treatment 3 Interventions

Spedox-6, 310 mg/m2, Chemotherapy single agent systemic, received on day 1 of each 21 day cycle, for a total of 6 cycles. Filgrastim or Pegfilgrastin, injected subcutaneously or intravenously, received according to Institutional standard.

Group II: Phase 1b Dose Level 7 - Spedox-6 + Filgrastim/Pegfilgrastim Experimental Treatment 3 Interventions

Spedox-6, 250 mg/m2, Chemotherapy single agent systemic, received on day 1 of each 21 day cycle, for a total of 6 cycles. Filgrastim or Pegfilgrastin, injected subcutaneously or intravenously, received according to Institutional standard.

Group III: Phase 1b Dose Level 6 - Spedox-6 + Filgrastim/Pegfilgrastim Experimental Treatment 3 Interventions

Spedox-6, 200 mg/m2, Chemotherapy single agent systemic, received on day 1 of each 21 day cycle, for a total of 6 cycles. Filgrastim or Pegfilgrastin, injected subcutaneously or intravenously, received according to Institutional standard.

Group IV: Phase 1b Dose Level 5 - Spedox-6 + Filgrastim/Pegfilgrastim Experimental Treatment 3 Interventions

Spedox-6, 160 mg/m2, Chemotherapy single agent systemic, received on day 1 of each 21 day cycle, for a total of 6 cycles. Filgrastim or Pegfilgrastin, injected subcutaneously or intravenously, received according to Institutional standard.

Group V: Phase 1b Dose Level 4 - Spedox-6 + Filgrastim/Pegfilgrastim Experimental Treatment 3 Interventions

Spedox-6, 120 mg/m2, Chemotherapy single agent systemic, received on day 1 of each 21 day cycle, for a total of 6 cycles. Filgrastim or Pegfilgrastin, injected subcutaneously or intravenously, received according to Institutional standard.

Group VI: Phase 1b Dose Level 3 - Spedox-6 + Filgrastim/Pegfilgrastim Experimental Treatment 3 Interventions

Spedox-6, 80 mg/m2, Chemotherapy single agent systemic, received on day 1 of each 21 day cycle, for a total of 6 cycles. Filgrastim or Pegfilgrastin, injected subcutaneously or intravenously, received according to Institutional standard.

Group VII: Phase 1b Dose Level 2 - Spedox-6 + Filgrastim/Pegfilgrastim Experimental Treatment 3 Interventions

Spedox-6, 40 mg/m2, Chemotherapy single agent systemic, received on day 1 of each 21 day cycle, for a total of 6 cycles. Filgrastim or Pegfilgrastin, injected subcutaneously or intravenously, received according to Institutional standard.

Group VIII: Phase 1b Dose Level 1 - Spedox-6 Experimental Treatment 1 Intervention

Spedox-6, 20 mg/m2, Chemotherapy single agent systemic, received on day 1 of each 21 day cycle, for a total of 6 cycles.

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials

580

Recruited

4,943,000+

Sunstate Biosciences LLC

Industry Sponsor

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10656302/

Protein-encapsulated doxorubicin reduces cardiotoxicity in ... We demonstrate that SPEDOX-6 retains the anticancer efficacy of UF DOX, while minimizing its cardiotoxicity. Human breast cancer and ...

2. mdpi.com mdpi.com/2072-6694/17/5/881

Targeted Treatment of Sarcomas by Single Protein ... Combined with a study on MB-MDA-231 (medium FcRn), SPEDOX-6's antitumor efficacy displays an inverse relationship with FcRn levels in three tumor mouse models, ...

3. ecancer.org ecancer.org/en/news/23638-stem-cells-used-to-target-cancer-treatment-protect-heart-cells

Stem cells used to target cancer treatment, protect heart cells The new formulation called SPEDOX-6 increased the drug's likelihood of being taken up by fast-dividing cells such as cancer cells while also ...

4. researchgate.net researchgate.net/figure/SPEDOX-6-PK-study-and-DOX-level-measurement-in-mouse-heart-tissues-a-Comparison-of_fig3_344638074

SPEDOX‐6 PK study and DOX level measurement in ... The data indicates that SPESN38-5 by IV at 55 mg/kg is more effective in suppressing HCT-116 tumor growth with lower systemic toxicity compared to irinotecan at ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT07064018/trial-of-single-protein-encapsulated-doxorubicin-spedox-6-in-advanced-malignancies?activelyRecruiting=false&page=984&id=29&slug=breast-cancer

Trial of Single Protein Encapsulated Doxorubicin, SPEDOX ... This is a Phase 1b/IIa dose escalation clinical trial determining the recommended phase II dose of SPEDOX-6 in subjects with advanced, ...

6. breastcancertrials.org breastcancertrials.org/bct_nation/mts/mtsResult.seam?zip=94107&searchTerm1=NCT07064018

MTS Trials - BreastCancerTrials.org Purpose: To study the safety, effects (good and bad), and anti-cancer activity of single protein encapsulated doxorubicin (SPEDOX-6) chemotherapy.

7. medicalxpress.com medicalxpress.com/news/2023-08-spedox-cancer-treatment-heart-cells.pdf

Using SPEDOX-6 to provide targeted cancer treatment and ... This data confirms that SPEDOX-6 is less toxic to heart cells while preserving its anticancer activity. A clinical trial is currently being ...