NCT04733183

Efficacy and Safety of L19TNF in Previously Treated Patients with Advanced Stage or Metastatic Soft-tissue Sarcoma

A Randomized Study to Investigate the Efficacy and Safety of the Tumor-targeting Human Antibody-cytokine Fusion Protein L19TNF in Previously Treated Patients with Advanced Stage or Metastatic Soft-tissue Sarcoma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 98 (estimated)
• Sponsor: Philogen S.p.A. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Open label, randomized, controlled phase II study preceded by a safety run-in part in subjects with advanced or metastatic soft-tissue sarcoma.

Detailed description

Open label, randomized, controlled phase II study preceded by a safety run-in part in subjects with advanced or metastatic soft-tissue sarcoma. * Safety Run-in Part: Six (6) patients will be treated with 1000 mg/m2 dacarbazine (DTIC) on Day 1 every 3 weeks plus 13 µg/kg L19TNF on Days 1, 3 and 5 every 3 weeks to test for safety of the combination. Should unacceptable toxicities occur in ≥ 2 patients during an observation period from Day 1 to Day 21 (first cycle), enrollment will be stopped at this dose level and 6 patients will be treated sequentially with DTIC at 850 mg/m2 on Day 1 every 3 weeks plus 13 µg/kg L19TNF on Days 1, 3 and 5 every 3 weeks. * Tumor Activity Evaluation Part Approximately 86 patients will be enrolled and parallel assigned in a 1:1 fashion to one of two different arms, as follows: * Arm 1: Patients will receive DTIC on Day 1 every 3 weeks plus L19TNF on Days 1, 3 and 5 every 3 weeks. * Arm 2: Patients will receive DTIC on Day 1 every 3 weeks. During the conduct of the study, detailed safety parameters will be routinely reviewed by the DSMB.

Conditions

• Soft Tissue Sarcoma

Interventions

Type	Name	Description
DRUG	Dacarbazine	Dacarbazine (DTIC), 1000 mg/m2 or 850 mg/m2 on Day 1 of every 21-day cycle (based on results and DSMB evaluation in the safety run-in part of the study)
DRUG	onfekafusp alfa	L19TNF, 13 μg/kg, on Day 1, 3, and 5 of every 21-day cycle for a maximum of 6 induction cycles. Patients experiencing apparent or real benefit with minimal or acceptable toxicity from the first 6 cycles of treatment, can receive, at investigator's discretion, maintenance treatment of 13 μg/kg, on Day 1 every 21-day

Timeline

• Start date: 2020-08-28
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2021-02-01
• Last updated: 2025-01-27

Locations

23 sites across 5 countries: France, Germany, Italy, Poland, Spain