A Phase 1 interventional study of IGN002 in NHL, sponsored by Spectrum Pharmaceuticals, Inc. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-11.
Sponsored by Spectrum Pharmaceuticals, Inc · Phase 1, Interventional, and Treatment
This is a Phase 1 multi-center, open-label study that allows subjects who derived clinical benefit after completing IGN002 treatment in the Spectrum sponsored IGN002-101 study to continue treatment with IGN002. Subjects who completed the IGN002-101 study, tolerated IGN002 treatment, and did not experience progressive disease (PD) are eligible to participate in this study.
In this extension study, IGN002 study drug will initially be administered at the same dose level and schedule that the subject was receiving at the conclusion of the Spectrum sponsored IGN002-101 study. If additional safety and PK data from another Spectrum sponsored IGN002 study support a higher dose level that is deemed safe and well tolerated by the Safety Review Committee (SRC), the dose of IGN002 may be increased within a given subject. However, dose levels of IGN002 in this extension study may not exceed the maximum tolerated dose (MTD). In addition, the dose for a given subject may be lowered per Investigator discretion. Each treatment cycle comprises a total of 8 doses of IGN002 administered at weekly intervals.
Subjects will be evaluated at the study clinic before each dose of IGN002. At each study visit, standard of care assessments will be performed, which will include physical examination, measurement of vital signs, documentation of adverse events (AEs) and concomitant medications, and laboratory analyses of blood and urine. Radiological assessments will be performed at the end of each 8-week cycle. Tumor status will be assessed by comparison to the subject's baseline tumor status, as determined in the separate study, IGN002-101, or tumor nadir, if the subject has demonstrated response.
Reasons for subject withdrawal include PD in subjects not deriving clinical benefit from IGN002 therapy or clinically significant IGN002-related AEs. If a subject discontinues the study for any reason, an early termination (ET) visit will be conducted 30 (±3) days after the last dose of IGN002. This visit will include physical examination, vital sign measurements, laboratory analyses of blood and urine, and documentation of AEs and concomitant medications.
Spectrum Pharmaceuticals, Inc is the lead sponsor of 59 studies on the registry; 1 is open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 12 (71%) have results posted.
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Exclusion Criteria:
IGN002 study drug will initially be administered at the same dose level and schedule that the subject was receiving at the conclusion of the other Spectrum sponsored IGN002 study, IGN002-101.
Biological: IGN002
IGN002 is a monoclonal antibody fusion protein
To evaluate the incidence of adverse events following multiple doses of IGN002 administered weekly as an IV infusion to subjects with refractory NHL
Adverse Event collection and assessment will be done to assess the safety and tolerability of IGN002
Time frame: An average of 1 year.
Duration of response to IGN002 using the Lugano Classification for NHL
Lugano Classification Criteria for NHL will be used to assess the duration of response to IGN002
Time frame: Through study completion, an average of 1 year.
Overall response rate of the therapeutic agent in NHL patients.
Overall response rate following IGN002 treatment will be assessed
Time frame: Through study completion, an average of 1 year.
Plan to share: No
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This study is withdrawn, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Spectrum Pharmaceuticals, Inc