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

• Status: Recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: HighField Biopharmaceuticals Corporation
• Collaborator: Tigermed Consulting Co., Ltd

Criteria

Inclusion Criteria:

1, Willing and able to provide the test of informed consent in writing. 2. Male or female, age > 18 years and < = 75 years. 3. The subjects had to be diagnosed by histology and/or cytology with locally advanced or metastatic solid tumor. There is no effective standard of care or the patient is intolerant to the standard therapy.

4. According to the definition of RECIST 1.1, participants must have at least one measurable lesion.

5, Eastern group (ECOG) tumor physical state to 0 or 1. 6, Expected lifetime > 12 weeks. 7, Men or women of childbearing age must agree to adopt effective contraception after signing the informed consent form until 180 days after the end of the study. Premenopausal women or those within 2 years after menopause are included.

Exclusion Criteria:

1, Patients received systemic antitumor therapy, including chemotherapy, radiotherapy, biologic therapy, endocrine therapy, or immunotherapy within 3 weeks prior to the first dose, except for the following: Nitrosoureas or mitomycin C within 6 weeks; Oral fluorouracils and small molecule drugs within 2 weeks or within 5 half-life periods of the drug (whichever is longer); Antitumour traditional Chinese medicine within 2 weeks.

2.Adverse effects of previous anti-tumor therapy have not recovered to CTCAE 5.0 grade rating of ≤ grade 1 (except for toxicity judged by the investigator be of no safety risk, such as alopecia, grade 2 peripheral neurotoxicity, etc.) 3.Patients received other unlisted clinical trial drugs or treatments within 28 days prior to the first dose.

4.Taken vitamin A or any vitamin A derivatives within 7 days prior to the first dose.

5, Past history of deep vein thrombosis or pulmonary embolism. 6, Evidence that there is poor control of thyroid diseases, or diseases of the retina.

7. Patients have symptomatic central nervous system (CNS) metastases, meningeal metastases, or a primary CNS tumor that is associated with progressive neurological symptoms. Except that the brain metastases are shown to be stable judged by imaging examination within 4 weeks.

8. Evidences of serious or uncontrolled systemic disease (for example: instability or decompensated respiratory disease, liver or kidney disease) 9. Serious liver and kidney function damage; 10. Has clinical significance of cardiovascular disease; 11. Have known immune inhibitory disease or human immunodeficiency virus (HIV) infection.

12. Patients with severe osteoporosis or bone metastasis, and serum 25 - light で vitamin D values is less than 50 nmol/L 13. Active hepatitis (Hepatitis B: HBsAg-positive and HBV-DNA ≥ 500 cps/mL or 200 IU/mLL; HCV RNA-positive).

14. Persons with known hypersensitivity to any of the active ingredients or excipients or a history of atopic allergic reactions.

15. The pregnancy test positive (blood beta human chorionic gonadotropin - HCG [B] test positive) or lactationWomen.

16. Researchers believe that patients with combined disease may affect the compliance.

17, Participants not willing to or fail to follow the procedure.