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A Study of PSB205 in Subjects With Advanced Solid Tumors

NCT03986606 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2020-11-25

No results posted yet for this study

Summary

This is an open-label, multicenter, Phase 1, ascending dose escalation study of PSB205 in subjects with advanced solid tumors. The study will be conducted in 2 parts. Part 1 of the study will be a dose escalation evaluation to determine the maximum tolerated dose (MTD) and to establish a recommended Phase 2 dose (RP2D) of PSB205. This study purpose is to describe the safety and tolerability, to assess Pharmacokinetics (PK) and immunogenicity, and to preliminarily assess the anti-tumor activity of PSB205 in subjects with solid tumors. Part 2 of the study will further evaluate the RP2D in 3 distinct tumor cohorts of approximately 12 subjects each.

Conditions

  • Neoplasm Malignant

Interventions

BIOLOGICAL

PSB205

PSB205 is a bi-functional product that has been engineered to contain two unique monoclonal antibodies.

Sponsors & Collaborators

  • Pharmaceutical Research Associates

    collaborator OTHER

  • Qilu Puget Sound Biotherapeutics (dba Sound Biologics)

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-05
Primary Completion
2021-02-28
Completion
2021-07-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03986606 on ClinicalTrials.gov