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Clinical Trial 20266

Cancer Type: Malignant Hematology
Study Type: Treatment
NCT#: NCT02663518

Phase: Phase I
Prinicipal Investigator: Lubomir Sokol

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Overview

Study Title

A Phase 1a/1b Dose Escalation and Expansion Trial of TTI-621, a Novel Biologic Targeting CD47, in Subjects with Relapsed or Refractory Hematologic Malignancies and Selected Solid Tumors

Summary

This is a trial of TTI-621 in subjects with relapsed or refractory hematologic malignancies and selected solid tumors.

Objective

The primary objective of the escalation phase of the study is to characterize the safety profile and dose-limiting toxicities (DLT) of TTI-621 in order to identify the maximum tolerated dose (MTD) in subjects with advanced relapsed or refractory lymphomas. The primary objective of the expansion phase of the study is to further characterize the safety of TTI-621 in an expanded number of primary hematologic malignancies and selected solid tumors and to evaluate the safety of individual subject TTI-621 dose intensification. The primary objective of the dose optimization phase is to further evaluate the safety and tolerability of TTI-621 at dose levels higher than the initially recommended phase 1b dose of 0.2 mg/kg (as determined during phase 1a dose escalation) and the MTD and/or recommended phase 2 dose will be re-assessed per revised DLT criteria following a 3+3 dose escalation schema. The DLT criteria are revised based on the totality of safety data collected thus far from the phase 1a and 1b dose expansion phase of the study. The starting dose for this further dose evaluation will be the highest dose of TTI-621 evaluated (0.5 mg/kg) during phase 1b dose expansion following dose intensification regimens permissible per protocol (Part 3).

Treatments

Therapies

Medications

TTI-621 ()

Inclusion Criteria

  • Advanced measurable malignancy
  • Adequate hematologic status
  • Relapsed or are refractory following at least 2 prior systemic therapeutic attempts (1 prior systemic attempt for PTCL). For CTCL, extracorporal photochemotherapy (ECP) will be considered a systemic therapy. Local radiation and topical agents are not systemic therapies.
  • Adequate coagulation function
  • Adequate hepatic function
  • Adequate renal function

  • Exclusion Criteria

  • Known, current central nervous system disease involvement or untreated brain metastases
  • Allogeneic transplant within 30 days prior to the planned start of treatment or subjects with active graft-vs-host disease with the exception of Grade 1 skin involvement
  • History of hemolytic anemia or bleeding diathesis

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