A Dose Optimization Study for L19TNF in Combination With Lomustine in Patients With Glioblastoma at Progression or Recurrence

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The trial aims to collect safety, efficacy, exposure, dose- response, pharmacokinetic and pharmacodynamic information of the combination of L19TNF and lomustine at different dose levels in patients with Glioblastoma at progression or recurrence

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Male or female, age ≥18.

• Patients with histologically confirmed glioblastoma per 2021 WHO classification progression according to RANO criteria.

• For operated patients, the histological report must document glioblastoma recurrence and a new MRI will need to be done at 3-5 weeks after surgery (directly before study treatment start). Study treatment will need to start minimum 4 weeks after surgery.

• MGMT promotor status known.

• Karnofsky Performance Status (KPS) ≥ 60%.

• Documented negative test for HIV-HBV-HCV. For HBV serology, the determination of HbsAg and anti-HbcAg Ab is required. In patients with serology documenting previous exposure to HBV, negative serum HBV-DNA is required (HBV-DNA is not required for patients with documented vaccination report). For HCV, HCV-RNA or HCV antibody test is required. Subjects with a positive test for HCV antibody but no detection of HCV-RNA indicating no current infection are eligible.

• Female patients: female patients must be either documented not Women Of Childbearing Potential (WOCBP)\* or must have a negative pregnancy test within 14 days of starting treatment.

• Additionally WOCBP must agree to use, from the screening to 6 months following the last study drug administration, highly effective contraception methods, as defined by the Recommendations for contraception and pregnancy testing in clinical trials issued by the Head of Medicine Agencies' Clinical Trial Facilitation Group (www.hma.eu/ctfg.html) and which include, for instance, progesterone-only or combined (estrogen- and progesterone-containing) hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone-releasing systems, bilateral tubal occlusion or vasectomized partner.

• Male patients: male subjects able to father children must agree to use two acceptable methods of contraception throughout the study and until 6 months after last study drug administration (e.g. condom with spermicidal gel). Double-barrier contraception is required.

• Personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.

⁃ Willingness and ability to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures.

‣ Women of childbearing potential (WOCBP) are defined as females who have experienced menarche, are not postmenopausal (12 months with no menses without an alternative medical cause) and are not permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral oophorectomy, or bilateral salpingectomy).

Locations
United States
Illinois
Northwestern Memorial Hospital
NOT_YET_RECRUITING
Chicago
Massachusetts
Beth Israel Deaconess Medical Center (BIDMC)
NOT_YET_RECRUITING
Boston
Dana-Farber Cancer Institute (DFCI)
RECRUITING
Boston
Massachusetts General Hospital (MGH)
NOT_YET_RECRUITING
Boston
New York
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
NOT_YET_RECRUITING
Philadelphia
UPMC Hillman Cancer Center
RECRUITING
Pittsburgh
Virginia
University of Virginia (UVA)
NOT_YET_RECRUITING
Charlottesville
Contact Information
Primary
Teresa Hemmerle, PhD
regulatory@philogen.com
+390577017816
Backup
Marco Taras
regulatory@philogen.com
+390577017816
Time Frame
Start Date: 2024-05-22
Estimated Completion Date: 2026-06
Participants
Target number of participants: 90
Treatments
Experimental: Arm A
Patients will be treated with L19TNF on Days 1, 3 and 5, and on Days 22, 24 and 26 and Lomustine on Day 1 (in the evening after L19TNF infusion) of a 42-day cycle for up to a maximum of 6 cycles.
Experimental: Arm B
Patients will be treated with on Days 1, 3 and 5, and on Days 22, 24 and 26 and Lomustine on Day 1 (in the evening after L19TNF infusion) of a 42-day cycle for up to a maximum of 6 cycles
Experimental: Arm C
Patients will be treated with L19TNF on Days 1, 3 and 5, and on Days 22, 24 and 26 and Lomustine on Day 1 (in the evening after L19TNF infusion) of a 42-day cycle for up to a maximum of 6 cycles.
Experimental: Arm D
Patients will be treated with L19TNF on Days 1, 3 and 5, and on Days 22, 24 and 26 and Lomustine on Day 1 (in the evening after L19TNF infusion) of a 42-day cycle for up to a maximum of 6 cycles.
Experimental: Arm E
Patients will be treated with L19TNF on Days 1, 3 and 5, and on Days 22, 24 and 26 and Lomustine on Day 1 (in the evening after L19TNF infusion) of a 42-day cycle for up to a maximum of 6 cycles.
Experimental: Arm F
Patients will be treated with L19TNF on Days 1, 3 and 5, and on Days 22, 24 and 26 and Lomustine on Day 1 (in the evening after L19TNF infusion) of a 42-day cycle for up to a maximum of 6 cycles.
Sponsors
Leads: Philogen S.p.A.

This content was sourced from clinicaltrials.gov