CompletedPhase 1

Safety Study of Pritumumab in Brain Cancer

United States15 participantsStarted 2021-02-22

Plain-language summary

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. Primary Objectives \- 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. Secondary Objectives * To determine pharmacokinetics and pharmacodynamics of Pritumumab * To identify preliminary signals of anti-tumor response to Pritumumab * To explore disease-related, patient-reported outcomes

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Ability to understand and the willingness to provide informed consent.
✓. Diagnosis
✓. Prior Therapy Has failed prior standard therapy including maximal safe surgical resection, radiation therapy (when appropriate for the specific cancer type), or systemic therapy or is intolerant of, or has refused other available therapies, but is still in need of therapy. No patients may receive Pritumumab prior to any surgery for their cerebral tumor
✓. Progression/Recurrence Has progression of brain cancer and measurable disease by magnetic resonance imaging (MRI) or computed tomography (CT) scan.
✓. Age Age ≥ 18 years.
✓. Performance Status Karnofsky Performance Status ≥ 60% (see Appendix A). Subjects must have a life expectancy of equal to or greater than 8 weeks.
✓. Organ and Marrow Function Requirements
✓. Contraception All fertile females and any man with a partner of child-bearing potential agrees to use adequate contraception which will include two of the following: hormonal or barrier method of birth control, or abstinence prior to study entry, for the duration of study participation, and for 30 days following completion of therapy.

Exclusion criteria

What they're measuring

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Timeframe: Up to 24 weeks

Trial details

NCT IDNCT04396717

SponsorNascent Biotech

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-01-06

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