Phase 1 Study of PYX-201 in Solid Tumors
Research type
Research Study
Full title
A First-in-Human, Open-label, Multicenter, Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of PYX-201 in Participants with Advanced Solid Tumors
IRAS ID
1006893
Contact name
Bin Zhang
Contact email
Sponsor organisation
Pyxis Oncology, Inc.
Eudract number
2022-002284-30
Research summary
Pyxis Oncology, Inc., is running a clinical research study to see if a test medicine, not yet approved for market, named PYX-201, will help in the treatment of people with advanced solid tumours who have relapsed (i.e., the cancer has come back), been non-responsive to treatment, or have progressed with all available therapies.
This will be the first-in-human, dose escalation (i.e., a progressive increase in the dose levels) , clinical study of PYX-201 and will aim to include 45 participants from the United States and Europe with advanced solid tumours.
The study will have several groups of participants who will receive PYX-201 at different doses. In the first group, participants will receive 0.3 mg/kg of PYX-201. The doses of the following groups will be based on how previous groups respond. The maximum possible dose that will be given is 8 mg/kg.
The primary aim of the study is to determine the recommended dose(s) of PYX-201 for participants with advanced) solid tumours. The secondary aim, is to study how PYX-201 behaves in the body (characterise the PK profile), to study the preliminary antitumor activity of PYX-201 treatment (how well the study treatment works) and to evaluate the immunogenicity of PYX-201 (whether the study treatment causes the body to produce antibodies against the study treatment).
It is estimated that this part of the study (Part 1, dose escalation) will last for a maximum of 3 years, and a part 2 may be started to explore a selected dose in a larger patient population (dose expansion).
REC name
West of Scotland REC 1
REC reference
23/WS/0017
Date of REC Opinion
16 Mar 2023
REC opinion
Further Information Favourable Opinion