An Exploratory Study of the Folic Acid-tubulysin Conjugate EC1456 in Ovarian Cancer Subjects Undergoing Surgery
Status:
Completed
Trial end date:
2018-08-28
Target enrollment:
Participant gender:
Summary
This study looks to enroll subjects with ovarian cancer who will be having standard of care
surgery to remove ovarian cancer tumors. The main aim of this study is to be able to observe
how EC1456 has been taken in and broken down inside tumors. The effect of EC1456 on the tumor
will also be studied. This study will also help us compare the amount of EC1456 seen in
tumors and how the tumors are imaged by the 99mTc-etarfolatide single-photon emission
tomography (SPECT) or single-photon emission tomography with in-line x-ray computed
tomography (SPECT/CT).
All subjects will undergo a 99mTc-etarfolatide SPECT or SPECT/CT scan within 2 weeks prior to
EC1456 administration.
Individual subjects will then receive 1 of the following 2 doses of EC1456 pre-operatively:
- 4 mg/m2
- 8 mg/m2
EC1456 will be administered at 1 of the following 2 time points:
- <8 hours before planned surgery
- 48±4 hours before planned surgery
Blood will be collected for pharmacokinetic (PK) studies right after EC1456 dosing and again
right before surgery. At the time of surgery, tumor samples will be removed and sent to
Endocyte for analysis.
Phase:
Phase 1
Details
Lead Sponsor:
Endocyte
Treatments:
Folic Acid Sodium Pertechnetate Tc 99m Vitamin B Complex