Neoplasms

Blood and Lymph Conditions

All Conditions

Immune System Diseases

Symptoms and General Pathology

Rare Diseases

Leukemia

Leukemia, Lymphoid

Lymphoma

Leukemia, Lymphocytic, Chronic, B-Cell

Leukemia, Prolymphocytic

Leukemia, Hairy Cell

Chronic Graft Versus Host Disease

Lymphosarcoma

Chronic Lymphocytic Leukemia

Hairy Cell Leukemia

All Drugs and Chemicals

Mitogens

AGS67E

Immunoconjugates

Immunologic Factors

Participants will receive 0.05 milligram per kilogram (mg/kg) AGS67E without growth factor (GF) by intravenous infusion once every three weeks.

Participants will receive 0.1 mg/kg AGS67E without GF by intravenous infusion once every three weeks.

Participants will receive 0.3 mg/kg AGS67E without GF by intravenous infusion once every three weeks.

Participants will receive 0.6 mg/kg AGS67E without GF by intravenous infusion once every three weeks.

Participants will receive 0.9 mg/kg AGS67E without GF by intravenous infusion once every three weeks.

Participants will receive 1.2 mg/kg AGS67E without GF by intravenous infusion once every three weeks.

Participants will receive 1.2 mg/kg AGS67E with GF by intravenous infusion once every three weeks.

Participants will receive 1.5 mg/kg AGS67E with GF by intravenous infusion once every three weeks.

Participants will receive 1.8 mg/kg AGS67E with GF by intravenous infusion once every three weeks.

Associate Medical Director

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of AGS67E both without and with myeloid growth factor (GF) in subjects with refractory or relapsed lymphoid malignancies. Immunogenicity and anticancer activity of AGS67E will also be assessed.

The dose escalation study will have two parts:

1. Dose Escalation of AGS67E without myeloid growth factor (GF)
2. Dose Escalation of AGS67E with myeloid growth factor (GF)

Subjects will be enrolled sequentially into dose cohorts starting with AGS67E without GF.

All subjects will receive a single 30 minute intravenous (IV) infusion of AGS67E once every three weeks. Subjects will continue treatment until disease progression, intolerability of AGS67E, investigator decision or consent withdrawal.

This dose escalation will first determine the maximum tolerated dose (MTD) of AGS67E without GF and then determine the MTD of AGS67E with GF. Once an MTD has been established, the study may enroll subjects into respective expansion cohorts of 12 subjects each at doses recommended by the data review team (DRT) (expansion cohort without GF and/or expansion cohort with GF).

During dose escalation, the Data Review Team will review cumulative unaudited data on an interim basis to review subject safety, recommend exploring additional doses and/or schedules, or the expansion of existing cohorts.

A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Escalating Doses of AGS67E Given as Monotherapy in Subjects With Refractory or Relapsed Lymphoid Malignancies

A Phase 1 Study Evaluating Safety, Tolerability, and Pharmacokinetics of Escalating Doses of AGS67E Given as Monotherapy in Subjects With Refractory or Relapsed Lymphoid Malignancies

Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

Tumor response is defined as either a complete response (CR) or partial response (PR)

ORR for a cohort is defined as the percentage of subjects who experience a best response of either complete response (CR) or partial response (PR) in that cohort.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Escalating Doses of AGS67E Given as Monotherapy in Subjects With Refractory or Relapsed Lymphoid Malignancies	NCT02175433	Relapsed Lympho... Refractory Lymp...	AGS67E	18 Years -	Astellas Pharma Inc
A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Escalating Doses of AGS67E Given as Monotherapy in Subjects With Refractory or Relapsed Lymphoid Malignancies	NCT02175433	Relapsed Lympho... Refractory Lymp...	AGS67E	18 Years -	Astellas Pharma Inc

Spots Global Cancer Trial Database for pharmacokinetics of ags67e