SPEDOX-6 for Advanced Malignancies

Trial of Single Protein Encapsulated Doxorubicin, SPEDOX-6 in Advanced Malignancies

Recruiting Phase 1 Phase 2 Interventional Study
Soft-tissue Sarcoma Triple Negative Breast Cancer Non-small Cell Lung Cancer Cervical Cancer Ovarian Cancer KRAS Mutation-Related Tumors
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
67 (estimated)
Sponsor
University of California, Irvine · Other
Who this trial is looking for

This trial is looking for adults with advanced cancers that have not responded to previous treatments. Participants will receive a new medication called SPEDOX-6 to see how well it works.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am at least 18 years old.
  • I have advanced solid tumors that have not responded to at least two previous therapies.
  • I have certain types of cancer like soft-tissue sarcoma or triple-negative breast cancer.
  • My cancer can be measured.
  • I have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  • I expect to live for at least 12 more weeks.
  • I am HIV-positive and on effective treatment with a low viral load.
  • I have proper organ function tests.

You may not be able to join if

  • I have had heart problems like a heart attack in the last 6 months.
  • I have untreated brain metastases.
  • I have received doxorubicin or similar medications before.
  • I have had radiation to the chest area.
  • I know I am allergic to albumin.
  • I am pregnant or breastfeeding.
  • I have uncontrolled diabetes.
  • I have not had a break from previous treatments as required.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
This is a Phase 1b/IIa dose escalation clinical trial determining the recommended phase II dose of SPEDOX-6 in subjects with advanced, therapy-refractory soft-tissue sarcoma (STS); triple-negative breast cancer (TNBC); Non-small cell lung cancer (NSCLC); cervical cancer; ovarian cancer; KRAS mutant pancreatic ductal adenocarcinoma. These are subjects who have not previously been treated with anthr…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Subjects ≥ 18 years at the first screening examination/visit. * Subjects with advanced histologically or cytologically confirmed solid tumors (see below) refractory to or relapse from at least two previous therapies. * Tumor types expected to express lower levels of FcRn relat…
Contacts

Chao Family Comprehensive Cancer Center University of California, Irvine

1-877-827-8839

ucstudy@uci.edu

CONTACT

University of California Irvine Medical Center

CONTACT