Phase 1/2 Study of PBI-200 in Subjects with NTRK-Fusion-Positive Advanced or Metastatic Solid Tumors
Research type
Research Study
Full title
A Phase 1/2 Study of PBI-200 in Subjects with NTRK-Fusion-Positive Advanced or Metastatic Solid Tumors
IRAS ID
1005229
Contact name
Jordan Leef
Contact email
Sponsor organisation
Pyramid Biosciences, Inc.
Eudract number
2021-001029-32
Clinicaltrials.gov Identifier
Research summary
This research is involving patients with cancer that is considered advanced and/or has spread to other parts of the body. Patients have received treatment for cancer but it has come back or has worsened following that treatment. During the study patients will receive treatment with a drug (PBI-200) that has not been approved yet. PBI-200 is a drug to block these growth signals from certain abnormal proteins in cancer cells. This study is being done to evaluate the safety and potential usefulness of PBI-200 in patients with certain cancers. The study will be conducted in 2 parts. The goal of Phase 1 is to determine the safety and side effects of PBI-200 and to determine the best dose of PBI-200 to be used for further study. During Phase 1, groups of approximately 1 to 6 patients will enroll in the study, one group at a time. The first patient will receive the lowest dose. If PBI-200 does not cause severe side effects in this patient, then the next group of patients (probably 1 – 3 patients) will receive a higher dose. The doses will continue to increase for each new group of patients until some patients have severe side effects that require the dose to be lowered to a safer dose. The dose increase may also be stopped early, before severe side effects occur, if a lower dose is found that is shrinking research participants’ tumors. In Phase 2, patients will receive the best dose of PBI-200 as determined in Phase 1. The goal of Phase 2 is to test if PBI-200 is active against cancers. Taking part in this study may make health better or worse or have little effect on health. The Sponsor of this study is Pyramid Biosciences, Inc., a pharmaceutical company. Pyramid will fund this study.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
22/SC/0431
Date of REC Opinion
6 Jan 2023
REC opinion
Further Information Favourable Opinion