NCT03382340

IMX-110 in Patients With Advanced Solid Tumors

A Phase 1/2a Open-Label, Dose-Escalation/Dose-Expansion Safety, Tolerability and Pharmacokinetic Study of IMX-110 in Patients With Advanced Solid Tumors

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Immix Biopharma Australia Pty Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase 1 is an open-label, multi-center dose escalation/dose expansion study designed to assess the safety, tolerability and pharmacokinetics (PK) for the recommended phase 2 dose (RP2D) of IMX-110. The RP2D will be evaluated in a further dose expansion Phase 2a study submitted.

Conditions

• Solid Tumor, Adult
• Advanced Solid Tumors
• Pancreatic Cancer
• Breast Cancer
• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	Imx-110	a nanoparticle encapsulating a Stat3/NF-kB/poly-tyrosine kinase inhibitor and low-dose doxorubicin

Timeline

• Start date: 2018-02-15
• Primary completion: 2023-10-31
• Completion: 2023-12-31
• First posted: 2017-12-22
• Last updated: 2023-09-28

Locations

2 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study