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New treatment option for Soft-tissue Sarcoma
Official title Trial of Single Protein Encapsulated Doxorubicin, SPEDOX-6 in Advanced Malignancies
ClinicalTrials.gov ID: NCT07064018
What this study is testing
What is Spedox-6?
Spedox-6 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for soft-tissue sarcoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 anthracyclines.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- people ≥ 18 years at the first screening examination/visit.
- people 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 relative to normal tissue including: STS, TNBC, cervical cancer, NSCLC, ovarian cancer, and KRAS...
- Disease that is considered measurable by RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
You likely can't join if
- Patients with cancers with known driver mutations for which there are known and effective targeted therapies that have not received those therapies...
- Unstable angina pectoris, angioplasty, cardiac stenting, or myocardial infarction 6 months before study entry.
- Untreated metastases to the Central Nervous System (CNS).
- Have received any prior doxorubicin or anthracycline equivalent.
- Previous radiation to the mediastinal or pericardial area.
- A known allergy to albumin.
See the full eligibility criteria
- people ≥ 18 years at the first screening examination/visit.
- people 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 relative to normal tissue including: STS, TNBC, cervical cancer, NSCLC, ovarian cancer, and KRAS mutated pancreatic ductal adenocarcinoma without requirement for...
- Disease that is considered measurable by RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Life expectancy of at least 12 weeks.
- Human Immunodeficiency Virus (HIV)-positive trial participants should be on established antiretroviral therapy (ART) for at least four weeks and have an HIV viral load less than 400 copies/mL prior to enrollment.
- Left ventricular ejection fraction \> 50%.
- Adequate organ function: (Hb ≥10 g/dL, ANC ≥1,000/µL3, and platelets ≥100,000/µL3), serum bilirubin ≤.5x the institutional upper limit of normal (ULN) (unless known Gilbert's disease), Aspartate Aminotransferase (AST)...
- For patients with known Gilbert's disease, serum unconjugated bilirubin must be \< 4 mg/dL.
- Patient must have washed out of prior chemotherapy (at least 3 weeks from last end of therapy), radiotherapy (at least 4 weeks from last end of therapy), immunotherapy (at least 4 weeks from last end of therapy), other...
- Recovery from toxicities of prior therapy. Toxicities should have recovered to CTCAE grade ≤ 1 or baseline with exception of alopecia.
- Females of reproductive potential must have had a negative pregnancy test performed within 7 days prior to the start of treatment. Additionally, female people of reproductive potential should agree to use effective...
- For males of reproductive potential: vasectomy or highly effective contraception (e.g., condoms, abstinence) during the study and for an additional 6 months after the last dose of SPEDOX-6.
- Patients with cancers with known driver mutations for which there are known and effective targeted therapies that have not received those therapies, but are able to. If a patient has received appropriate targeted...
- Unstable angina pectoris, angioplasty, cardiac stenting, or myocardial infarction 6 months before study entry.
- Untreated metastases to the Central Nervous System (CNS).
- Have received any prior doxorubicin or anthracycline equivalent.
- Previous radiation to the mediastinal or pericardial area.
- A known allergy to albumin.
- HIV infection with CD4+ count \< 350 cells/µL or Acquired Immunodeficiency (AIDS)-defining opportunistic infection in previous 12 months.
- Pregnant (positive serum or urine pregnancy test) or lactating.
- Previous treatment with an investigational agent or the non-approved use of a drug or device withing 4 weeks of study entry.
- Uncontrolled diabetes mellitus.
- Patients who require concomitant use of strong inhibitors or inducers of CYP3A4, CYP2D6 or P-glycoprotein (P-gp).
The study team makes the final eligibility decision.
Where it's taking place
- Orange, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Orange, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.