PTX-9908 Injection for patients with non-resectable liver cancer after TACE

Phase I/II Study of PTX-9908 Injection As an Inhibitor of Cancer Progression in Patients with Non-resectable Hepatocellular Carcinoma Following Transarterial Chemoembolization Treatment

This study is testing a new injection called PTX-9908 to see if it can help people with liver cancer who can't have surgery and have already had a certain type of chemotherapy.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 20 Years and up
• Sex: All
• Sponsor: TCM Biotech International Corp. (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (New Taipei City, Taiwan)
• Trial ID: NCT03812874 on ClinicalTrials.gov

What this trial studies

This multicenter Phase I/II study evaluates the safety and efficacy of PTX-9908 Injection in patients with non-resectable hepatocellular carcinoma (HCC) who have previously undergone transarterial chemoembolization (TACE). The study consists of an open-label dose escalation phase followed by a randomized placebo-controlled phase to assess the treatment's antitumor activity. Patients will receive PTX-9908 intravenously over a four-week period, with a follow-up phase to monitor outcomes. The study aims to determine the optimal dosing and overall effectiveness of the treatment.

Who should consider this trial

Good fit: Ideal candidates are adults with unresectable hepatocellular carcinoma who have recently completed TACE and meet specific health criteria.

Not a fit: Patients with resectable liver cancer or those who have not recovered adequately from TACE may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced liver cancer who have limited treatment choices.

How similar studies have performed: While similar approaches have been explored, this specific combination of PTX-9908 and TACE in this patient population is novel.

Eligibility criteria

Inclusion Criteria:

1. Unresectable hepatocellular carcinoma and at intermediate-stage HCC (BCLC stage B or Child-Pugh class A/B with large or multifocal HCC, no vascular invasion, or extrahepatic spread) with completed TACE procedure in 4 weeks before day 1 of study intervention infusion.
2. Recovered from TACE treatment and procedure related toxicities including ALT/AST and bilirubin within normal limit or reference numeric value (reference value is defined as the test value before TACE procedure).
3. ECOG (Eastern Cooperative Oncology Group) performance status \< 2.
4. Have adequate organ and marrow function as defined below:

   1. Absolute neutrophil count \> 1,200/µL
   2. Hemoglobin \> 9 g/dL
   3. Platelets \> 100,000/µL
   4. Total bilirubin \< 2 X ULN
5. Have adequate kidney function as estimated glomerular filtration rate (eGFR) \> 60 mL/min/1.73m2
6. A negative pregnancy test at screening. This applies to any female patient with childbearing potential.
7. Agree to use adequate contraception after signing informed consent form, during the duration of study participation and for at least 4-weeks after completion or withdrawal from the study. This applies to any female patient with childbearing potential and any male patient whose female partner has childbearing potential.

   Acceptable contraceptive methods include:
   1. Established use of oral, injected or implanted hormonal methods of contraception
   2. Placement of an intrauterine device (IUD) or intrauterine system (IUS)
   3. Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) \>=20 years of age. (Note: In Taiwan, age of majority recognized in law is 20 years of age)
8. \>=20 years of age. (Note: In Taiwan, age of majority recognized in law is 20 years of age)
9. Anticipated life expectancy of \>= 6 months at assessment during screening.
10. Ability to understand and have signed a written informed consent document.

Exclusion Criteria:

1. 1\. Patient with Child-Pugh B8-9.
2. Patient who has had anti-cancer therapy including surgery, radiotherapy, immunotherapy, or chemotherapy (except in TACE regimen) within 4 weeks prior to the screening visit.
3. Patient who has received any other investigational agents within 4 weeks prior to the screening visit.
4. Patient who has not recovered from the side effects of the earlier investigational agent or had anti-cancer therapy including surgery, radiotherapy, immunotherapy, or chemotherapy.
5. Patient with known brain metastases, leptomeningeal or epidural metastases (unless treated and well controlled for \>= 3 months).
6. Patient with prior history of co-malignancies, except for adequately treated carcinoma in situ of the cervix, ductal carcinoma in situ (DCIS) of the breast, and basal cell/squamous cell skin cancer.
7. Patient with history of myocardial infarction or uncontrolled cardiac dysfunction, or unstable arrhythmia or symptomatic peripheral arterial vascular disease.
8. Patient with history of positive serology for human immunodeficiency virus (HIV).
9. Patient with active, uncontrolled bacterial, viral, or fungal infections, which require systemic therapy.
10. Patient with poor liver function as indicated by serum bilirubin \> 2 mg/dL, Child-Pugh Class C, severe coagulopathy (INR \> 2) not correctable with vitamin K, or active hepatic encephalopathy.
11. Patient with known allergic reactions to biological agent or polypeptides similar to PTX-9908 Injection.
12. Woman who is pregnant or nursing.
13. Patient with concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the patient in this study.
14. Patient with unwillingness or inability to comply with the study protocol for any reason.
15. A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval \>480 milliseconds (ms) (CTCAE grade 1) using Frederica's QT correction formula
16. A history of additional risk factors for torsades de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
17. The use of concomitant medications that prolong the QT/QTc interval

Where this trial is running

New Taipei City, Taiwan

• National Taiwan University Hospital — New Taipei City, Taiwan, Taiwan (Recruiting)

Study contacts

• Principal investigator: Chien-Hung Chien-Hung, MD, PhD — National Taiwan University Hospital
• Study coordinator: Chien-Hung Chen, MD, PhD

Conditions Carcinoma, Hepatocellular