Phase 1 Study of PYX-106 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, and Pharmacodynamics of PYX-106 in Subjects with Advanced Solid Tumors
IRAS ID
1007020
Contact name
Bin Zhang
Contact email
Sponsor organisation
Pyxis Oncology, Inc.
Eudract number
2022-002306-24
Research summary
This is a Phase 1, first-in-human (FIH), open-label, multicenter, non‑randomized, dose escalation study (referred to as Part 1 Dose Escalation) to evaluate the safety and tolerability of PYX-106 in participants with advanced solid tumours who have relapsed, been non-responsive, or have progressed with all available therapies, with a focus on those tumour types known to have expression of a specific protein called Siglec-15.
The participants in this study will have non-small cell lung cancer, breast cancer, endometrial cancer, thyroid cancer, kidney cancer, cholangiocarcinoma, bladder cancer, colorectal cancer, or head and neck squamous cell carcinoma. PYX-106 will be administered as an intravenous (IV) infusion initially every 2 weeks, for 14-day treatment cycles. Participants will be evaluated for disease assessment and response 6 weeks after Cycle 1 Day 1, 12 weeks after Cycle 1 Day 1, then every 8 weeks for the first year, and then every 12 weeks until their disease gets worse.
This study is for participants 18 years of age and older. Participants will be regularly examined by medical personnel, which include but are not limited to radiological tests (MRI, CT or PET, with or without contrast, depending on tumour type), blood tests, and heart monitor/scan, and involves tumour samples. Results will be recorded and shared with the National Health Authorities (to decide if this medication should be used in other patients) but no participant’s personal information will be disclosed.
A Dose Escalation Steering Committee will review the study data after completion of each cohort in Part 1 to ensure dose escalation decisions are appropriate and participant safety maintained.
A protocol amendment may be initiated to introduce a Part 2 Dose Expansion portion of the study. The design parameters will be determined by the data obtained during Part 1 Dose Escalation.
REC name
London - Brent Research Ethics Committee
REC reference
23/LO/0172
Date of REC Opinion
26 May 2023
REC opinion
Further Information Favourable Opinion