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Anti-tumor antibiotic

L19TNF + Doxorubicin for Soft Tissue Sarcoma (DOXO75 Trial)

Phase 1
Waitlist Available
Research Sponsored by Philogen S.p.A.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3, 6, 9, 12 and 18 months
Awards & highlights

DOXO75 Trial Summary

This trial is testing a new cancer drug to see if it is safe to use with an existing cancer drug.

Who is the study for?
Adults aged 18-85 with advanced soft tissue sarcoma, excluding Kaposi's sarcoma and GIST, who haven't had certain prior treatments or have uncontrolled diseases. They must not be pregnant, agree to use effective contraception, have a measurable lesion by CT scan per RECIST criteria, an ECOG ≤ 2, and a life expectancy of at least 3 months.Check my eligibility
What is being tested?
The trial is testing the safety of combining L19TNF with doxorubicin in patients with soft tissue sarcoma. The goal is to find the best dose of doxorubicin that can be safely used alongside L19TNF.See study design
What are the potential side effects?
Potential side effects may include those commonly associated with chemotherapy such as nausea, fatigue, increased risk of infection due to low blood cell counts; specific risks related to L19TNF are not detailed but could involve reactions similar to other immune-targeting therapies.

DOXO75 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3, 6, 9, 12 and 18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3, 6, 9, 12 and 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Blood pressure
Calculation of the body surface area (BSA)
ECOG performance status
+7 more
Secondary outcome measures
Efficacy of L19TNF in combination with doxorubicin: Disease Control Rate
Efficacy of L19TNF in combination with doxorubicin: Overall response rate
HAFA measurement
+3 more

DOXO75 Trial Design

1Treatment groups
Experimental Treatment
Group I: Arm L19TNF + DOXOExperimental Treatment2 Interventions
Patients will be treated with: doxorubicin 75 mg/m2 i.v. on day 1 of each 21-day cycle; L19TNF 13 µg/kg i.v. on day 1, 3 and 5 of each 21-day cycle
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
L19TNF
2019
Completed Phase 2
~20

Find a Location

Who is running the clinical trial?

Philogen S.p.A.Lead Sponsor
38 Previous Clinical Trials
2,338 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Dose Finding Study of L19TNF and Doxorubicin in Patients With STS
2019. "Dose Finding Study of L19TNF and Doxorubicin in Patients With STS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04032964.
~0 spots leftby Dec 2024
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