A Study With L19TNF in Combination With Lomustine in Patients With Glioblastoma at Progression or… (NCT06336291) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Study With L19TNF in Combination With Lomustine in Patients With Glioblastoma at Progression or Recurrence
United States90 participantsStarted 2024-05-22
Plain-language 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
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
✓. 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.
Exclusion criteria
✕. Inability to undergo contrast-enhanced MRI.
What they're measuring
1
Adverse Events
Timeframe: From the screening, throughout the study, until demonstration of confirmed disease progression, treatment begins with another anti-cancer agent or surgery, or for a minimum of 12 months
2
Serious Adverse Events
Timeframe: From the screening, throughout the study, until demonstration of confirmed disease progression, treatment begins with another anti-cancer agent or surgery, or for a minimum of 12 months
3
Unacceptable Toxicity
Timeframe: From the start of treatment up to 3 months
4
DILI assessment
Timeframe: From the screening, throughout the study, until demonstration of confirmed disease progression, treatment begins with another anti-cancer agent or surgery, or for a minimum of 12 months
5
Survival
Timeframe: From enrollment to death from any cause, for a minimum of 12 months
. Anti-cancer treatment with radiation therapy, chemotherapy, targeted therapies, immunotherapy, hormones, tumor treating fields or other antitumor therapies within 4 weeks prior to study treatment start.
✕. Subjects who participated in an investigational drug or device study within 4 weeks prior to study treatment start.
✕. Grade ≥ 4 myelotoxicity with previous treatment of alkylating agents (e.g., TMZ, CCNU).
✕. Previous treatment with Bevacizumab.
✕. Previous treatment with L19TNF.
✕. Previous treatment in the PH-L19TNFCCNU-02/20 study.
✕. Known history of allergy to TNF, any excipient in the study medication or any other intravenously administered human proteins/peptides/antibodies.