Safety Study of Pritumumab in Brain Cancer
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|ClinicalTrials.gov Identifier: NCT04396717|
Recruitment Status : Recruiting
First Posted : May 21, 2020
Last Update Posted : September 2, 2021
Pritumumab is a human IgG1 kappa antibody that binds to a malignant tumor associated antigen, ecto domain-vimentin (EDV) which is expressed in a variety of tumor cells. Pritumumab was shown to have relatively high reactivity with brain cancer cell lines, while no reactivity was demonstrated with normal neurons, astrocytes or fetal cerebral cells. Pritumumab has notable antibody-dependent cellular cytotoxicity (ADCC), brain tumor penetration and antitumor activity in nude mouse human xenograft models.
- To determine the safety and/or tolerability and the recommended Phase 2 dose (RP2D) of escalating, intravenously (IV) administered Pritumumab doses in patients with recurrent gliomas or with brain metastases.
- To determine pharmacokinetics and pharmacodynamics of Pritumumab
- To identify preliminary signals of anti-tumor response to Pritumumab
- To explore disease-related, patient-reported outcomes
|Condition or disease||Intervention/treatment||Phase|
|Malignant Primary Brain Tumors Brain Metastases, Adult||Biological: Pritumumab||Phase 1|
This is an open-label, Phase 1, outpatient, dose escalation study of Pritumumab in patients with brain cancer who have failed prior therapy and have no other available options. In the first part of the study, escalating doses of Pritumumab of 1.6, 4.8, 8.0, 12.0, and 16.2 mg/kg will be administered in a sequential, safety-driven manner to eligible patients according to standard 3+3 scheme, as an 1-hour IV infusion on Days 1, 8, 15, and 22 of each 28-day treatment cycle. The dose levels may be modified upon obtained results. Once the maximum tolerated dose (MTD) is determined, an expansion cohort including 6-12 patients in selected tumor type at a dose equal or below to MTD is planned to determine the recommended Phase 2 dose (RP2D). A total of 42 patients may be administered with Pritumumab in this study.
Patients will be treated with Pritumumab for a maximum of 6 cycles or until cancer progression or unacceptable toxicity. Patients will be followed after treatment completion every four months or until death or lost to follow-up. Standard clinical, laboratory and functional assessments will be employed to monitor for safety, tolerability and tumor response, including blood sampling for clinical biochemistries, pharmacokinetics, CSF and tissue samples, at frequency specified by the protocol. Patient-reported outcomes will also be assessed.
|Study Type :||Interventional|
|Estimated Enrollment :||42 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||Open label, non-randomized, 3+3 dose escalation to determine MTD, followed by exoansion to 6-12 patients to determine RP2D. Subjects will continue study treatment until progressive disease or unacceptable toxicity. Follow-up will occur until death or lost to follow-up.|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1, Sequential Cohort, Open-Label, Dose-Escalation Study of the Safety and CNS Exposure of Pritumumab in Patients With Brain Cancer|
|Actual Study Start Date :||March 18, 2021|
|Estimated Primary Completion Date :||January 30, 2023|
|Estimated Study Completion Date :||June 30, 2023|
Dose Escalation phase (3+3 patients):
Pritumumab administered sequentially as 1-hour IV infusion, on Day 1, 8, and 22 of each 28-day treatment cycle at: 1.6 mg/kg, 4.8 mg/kg, 8.0 mg/kg, 12.0 mg/kg, and 16.2 mg/kg, for a maximum of 6 cycles or progression or unacceptable toxicity.
Expansion phase (6-12 patients): Pritumumab administered as 1-hour IV infusion, on Day 1, 8, and 22 of each 28-day treatment cycle at or below MTD for a maximum of 6 cycles or progression or unacceptable toxicity.
Pritumumab IgG1 human monoclonal antibody
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: Up to 24 weeks ]Number of participants with treatment-related adverse events as assessed by NCI-CTCAE v.5.0 during first 24 weeks of treatment
- Intra-cranial Objective Response Rate [ Time Frame: 2 months ]Intra-cranial objective response rate at 2 months as assessed by the Response Assessment in Neuro-oncology (RANO) criteria
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04396717
|Contact: Deborah Fridman, PSD, RNfirstname.lastname@example.org|
|United States, California|
|Hoag Memorial Hospital Presbyterian||Recruiting|
|Newport Beach, California, United States, 92663|
|Contact: Deborah Fridman 949-764-4430 email@example.com|
|Principal Investigator:||Jose A. Carrillo, MD||One Hoag Drive Newport Beach, CA 92663, United States|