Clinical trial · Interventional
Study of the Safety and Tolerability of IV Infused PG545 in Patients With Advanced Solid Tumours
An Open-label, Multi-centre Phase I Study of the Safety and Tolerability of IV Infused PG545 in Patients With Advanced Solid Tumours
NCT02042781CI-TRIAL-00029840completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This Phase Ia study aims to establish the maximum tolerated dose of once-weekly IV infused PG545 and to evaluate its safety in subjects with advanced solid tumours. In addition, the study will explore whether PG545 exposure results in changes to chemicals produced by the body that are associated with cancer growth and spread.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumours | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PG545 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PG545
- description
- Once weekly, one hour IV infusion of PG545.
- interventionNames
- Drug: PG545
Primary outcomes (1)
- measure
- Determination of maximum tolerated dose (MTD) of PG545
- timeFrame
- Evaluated at the end of initial 28-day cycle
- description
- The MTD will be determined by assessing dose limiting toxicities at the end of the first month's treatment. Dose escalation and de-escalation will continue until an MTD is identified. Each cohort of patients will receive weekly doses at a single dose level for the duration of the study.
Secondary outcomes (3)
- measure
- Number of adverse events by cohort
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \>=18 years. * Histological or cytological documentation of non hematologic, malignant solid tumour. * Have failed at least one previous therapeutic regimen. * LIfe expectancy \>= 12 weeks. * ECOG performance status 0 or 1. * Written, signed and dated informed consent. * Able and willing to meet all protocol-required treatments, investigations and visits. * Have adequate organ function. Exclusion Criteria: * Clinically significant non-malignant disease. * Active CNS metastases. * Subjects with uncontrolled diabetes. * History of clinically significant adverse drug reaction to heparin or other anti-coagulant agents * Concomitant use of aspirin (\> 150 mg/day), NSAIDs (except COX-2 selective inhibitors), vitamin K antagonists (other than low-dose), heparin within two weeks prior to randomisation, or other anti-platelet drugs. * History of severe allergic, anaphylactic or other significant adverse reaction to radiographic contrast media. * Known seropositivity to the human immunodeficiency vies (HIV) * Women who are pregnant or breast feeding * Women of child-bearing potential and male subjects who are partners of women of child bearing potential who are unable or unwilling to use effective means of contraception. * Subjects who have received an investigational agent within 28 days prior to Cycle 1 Day 1.
References
Publications (1)
- DERIVEDHammond E, Haynes NM, Cullinane C, Brennan TV, Bampton D, Handley P, Karoli T, Lanksheer F, Lin L, Yang Y, Dredge K. Immunomodulatory activities of pixatimod: emerging nonclinical and clinical data, and its potential utility in combination with PD-1 inhibitors. J Immunother Cancer. 2018 Jun 14;6(1):54. doi: 10.1186/s40425-018-0363-5. PMID 29898788