Study of EC0489 for the Treatment of Refractory or Metastatic Tumors

Endocyte

Status and phase

Completed

Phase 1

Conditions

Cancer

Treatments

Drug: EC20

Drug: EC0489, Injection

Study type

Interventional

Funder types

Industry

Identifiers

NCT00852189

EC-0489-01

Details and patient eligibility

About

This is a Phase 1 clinical trial evaluating the safety and tolerability of escalating doses of EC0489 in patients with refractory or metastatic tumors who have exhausted standard therapeutic options.

Full description

This is a Phase 1, dose escalation study of EC0489 administered by intravenous bolus (IV) during weeks 1 and 3 of a 4-week cycle in PART A and weekly on a 4-week cycle in PART B.

Both Parts are open to patients with refractory or metastatic cancer who have exhausted standard therapeutic options. EC0489 is a drug that is specifically designed to enter cells via a folate vitamin receptor. Experimental evidence shows that the target receptor is over-expressed in many human cancers. There are no previous human studies of EC0489; however, lab research (research in test tubes or animals) using EC0489 has shown activity against tumors in animals. This activity in animal models suggests that EC0489 may be useful as chemotherapy against human cancers. The primary objective of this study is to determine the safety and maximum tolerated dose of EC0489 given by intravenous bolus. The efficacy of treatment will also be measured.

Enrollment

65 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

18 years of age or older
Histological or cytological diagnosis of neoplasm
No effective standard therapeutic options
ECOG performance status of 0-2
≥ 4 weeks post therapeutic radiation or recovered (or returned to baseline) from any acute toxicity associated with prior cytotoxic therapy. Patients previously treated with non-cytotoxic therapy (e.g., EGFR, VGEF, etc.) and who have recovered from or have controlled drug-associated toxicity are allowed to enter the trial after a period consisting of 4 half-lives of the agent.
Negative serum pregnancy test for women of child-bearing potential within one week prior to treatment with investigational agents (99mTc-EC20 and EC0489)and willingness to practice contraceptive methods
Adequate bone marrow reserve, renal and hepatic function

Exclusion criteria

Concurrent malignancies
Women who are pregnant or breast-feeding
Evidence of symptomatic brain metastases
Receiving concomitant anticancer therapy (excluding supportive care)
Requires palliative radiotherapy at time of study entry
Requires antifolate therapy for comorbid conditions
Heart failure characterized as greater than NYHA Class I
History of myocardial infarct
Any of the following baseline echocardiogram findings: valvular lesions (stenosis or insufficiency) characterized as greater than moderate, systolic ventricular impairment characterized as greater than mild, left ventricular ejection fraction < 55%, any feature of the echocardiogram that would confound interpretation of the serial echocardiograms required by the protocol