NCT05388487

Tolerability and Safety of HF1K16 Injection in Patients With Refractory Solid Tumors

A Phase 1 Open-Label Dose-Escalation Study to Evaluate the Tolerability, DLT, Pharmacokinetics, and Preliminary Efficacy of HF1K16 in Patients With Refractory Solid Tumors

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: HighField Biopharmaceuticals Corporation · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

HF1K16 is an investigational pegylated liposome formulation of All-Trans Retinoic Acid (ATRA) for the induction of remission in patients with acute promyelocytic leukemia (APL) and for the treatment of solid tumors through targeting myeloid derived suppressor cells (MDSCs).

Detailed description

Myeloid Derived Suppressor Cells (MDSCs) play important roles in constituting the immune suppressive environment promoting cancer development and progression. While previous studies had shown that all-trans retinoic acid (ATRA) could induce MDSC differentiation and maturation, the very poor solubility and fast metabolism of the drug limited its applications as an immune-modulator for cancer immunotherapy HF1K16 is an investigational pegylated liposome formulation with great ATRA dose loading capacity and sustained drug release property. In preclinical studies, HF1K16 was shown to be able to remodel the host systemic immune homeostasis as well as modify tumor microenvironment (TME). It promotes MDSCs maturation into DCs and facilitates immune responses against cancer cells.

Conditions

• Solid Tumor, Adult

Interventions

Type	Name	Description
DRUG	HF1K16 /Arm 45 mg/m²	HF1K16 is a liposome suspension containing encapsulated ATRA. Drug concentration is 2mg/ml, and infusion should be completed between 60 minutes and 90 minutes
DRUG	HF1K16 /Arm 90 mg/m²	HF1K16 is a liposome suspension containing encapsulated ATRA. Drug concentration is 2mg/ml, and infusion should be completed between 60 minutes and 90 minutes
DRUG	HF1K16 /Arm 120 mg/m²	HF1K16 is a liposome suspension containing encapsulated ATRA. Drug concentration is 2mg/ml, and infusion should be completed between 60 minutes and 90 minutes
DRUG	HF1K16 /Arm 160 mg/m²	HF1K16 is a liposome suspension containing encapsulated ATRA. Drug concentration is 2mg/ml, and infusion should be completed between 60 minutes and 90 minutes
DRUG	HF1K16 /Arm 120 mg or 180 mg	HF1K16 is a liposome suspension containing encapsulated ATRA. Drug concentration is 2mg/ml, and infusion should be completed between 60 minutes and 90 minutes

Timeline

• Start date: 2022-02-16
• Primary completion: 2025-04-01
• Completion: 2025-11-01
• First posted: 2022-05-24
• Last updated: 2024-01-16

Locations

7 sites across 1 country: China

Regulatory

• FDA-regulated drug study