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A Phase I/IIa Study of EF-009 in Patients With Pancreatic Cancer

ConditionPancreatic Cancer
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorEverfront Biotech Co., Ltd.

About this trial

This study is a multi center, open-label, dose escalation, Phase I/IIa study of EF-009 in up to 30 patients with borderline resectable and unresectable pancreatic cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female or male, age ≥ 18 years old

Subject has cytological, histological, or pathological confirmation of pancreatic cancer Note: All histologic subtype(s) of exocrine and endocrine pancreatic cancer are eligible to enroll in the study

no distant metastases;

venous involvement of the superior mesenteric vein (SMV)/portal vein (PV) with or without impingement and narrowing of the lumen;

Disqualifiers

Subjects who have participated in other investigational studies within 4 weeks prior to receive EF-009

Subjects with known or suspected hypersensitivity to EF-009 or the excipient

Subject not eligible for resection without significantly affecting vital function

Subjects with distant metastasis or recurrence of pancreatic cancer

Trial design

Design model

Single group

Treatments tested in this trial

  • EF-009

    Drug

    Subjects who meet the eligibility criteria will have completed following evaluations and assessments before receiving treatment: a) review of medical and medication history; b) physical examination, vital signs and documentation of ECOG; c) ECG; d) routine serum biochemical, hematologic, urine pregnancy (if applicable) and urine laboratory assessments; and e) evaluation of European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 score. On Day 0, subjects will undergo EF-009 wafer implantation via laparoscopy

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: EF-009Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Maximum Tolerated Dose (MTD)

Phase I

Time frame
21 days
2

Overall survival

Phase IIa

Time frame
2 years

Secondary outcomes

1

Progression Free Survival

Time frame
2 years
2

Proportion of subjects underwent pancreatic resection surgery after the EF-009 wafer implantation

Time frame
2 years
3

Time to pancreatic resection surgery after the EF-009 wafer implantation

Time frame
2 years
4

Objective response rate

Time frame
2 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Everfront Biotech Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: