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A Phase 1, Open-Label, Non-randomized, Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TL32711 in Adults With Refractory Solid Tumors or Lymphoma

Phase 1
18 Years
Not Enrolling

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Trial Information

A Phase 1, Open-Label, Non-randomized, Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TL32711 in Adults With Refractory Solid Tumors or Lymphoma

The purpose of this Phase 1 open-label, non-randomized dose escalation study is to determine
the maximum tolerated dose (MTD) and characterize the safety and tolerability of TL32711
when administered as a 30 minute intravenous infusion once weekly for three weeks per
repeated 4 week intervals in subjects with refractory solid tumors or lymphoma.
Additionally study will assess anti-tumor activity, pharmacokinetics, and exploratory
biomarkers as a measurement of pharmacodynamic effects.


Inclusion Criteria:

- Advanced metastatic or unresectable malignancy that is refractory to currently
available standard therapies or no effective therapy exists. The subject's
malignancy must be confirmed by prior pathologic study.

- Evaluable disease (measurable or non-measurable) by Response Evaluation Criteria in
Solid Tumors (RECIST, Version 1.1) or Revised Response Criteria for Malignant
Lymphoma (2007).

- Life expectancy greater than 3 months.

- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.

- Adequate renal function, defined as serum creatinine ≤ 1.5 X upper limit of normal
(ULN), or calculated creatinine clearance ≥ 60 ml/min.

- Adequate hepatic function, defined as aspartate aminotransferase (AST) and alanine
aminotransferase (ALT) levels ≤ 3 X ULN and total bilirubin < 1.5 X ULN.

- Adequate bone marrow function, defined as absolute neutrophil (ANC) ≥ 1,500/mm3 (≥1.5
X106/L), platelet count ≥ 75,000/mm3 (≥ 75 X106/L), and hemoglobin ≥ 10 mg/dL in the
absence of transfusion.

Key Exclusion Criteria:

- Recent anti-cancer treatment defined as:

- Standard or investigational anti-cancer therapy within 4 weeks prior to first
dose of TL32711. Exception: continued hormonal interventions for sensitive

- Radiation therapy within 2 weeks prior to the first dose of TL32711.

- Clinically significant pulmonary illness resulting in Grade ≥ 2 hypoxia (National
Cancer Institute Common Terminology criteria for Adverse Events [NCI CTCAE, v4]) or
any requirement for supplemental oxygen, or pulse oximetry less than 90% saturation
on room air.

- Symptomatic or uncontrolled brain metastases requiring current treatment (less than
4 weeks from last cranial radiation or 2 weeks from last steroids).

- Impaired cardiac function or clinically significant cardiac disease.

- Ongoing auto-immune disease or with history of an auto-immune disease within the past
5 years. Auto-immune disease include but are not limited to systemic lupus
erythematosis, scleroderma, rheumatoid arthritis, psoriasis, psoriatic arthritis,
ulcerative colitis and regional enteritis (Crohn's disease).

- Systemic or chronic topical corticosteroids or immunosuppressive therapy within 4
weeks prior to study entry or anticipated need of systemic corticosteroids or
immunosuppressive therapy during study participation.

- Skin lesions of Grade ≥ 2 severity (NCI CTCAE v4), except alopecia.

- Lack of recovery of prior adverse events to Grade ≤1 severity (NCI CTCAE v 4) (except
alopecia or neuropathy) due to medications administered prior to the first dose of

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Define the MTD

Outcome Time Frame:

4 weeks (Cycle 1)

Safety Issue:


Principal Investigator

Ravi Amaravadi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pennsylvania, Abramson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

November 2009

Completion Date:

March 2013

Related Keywords:

  • Cancer
  • Lymphoma



Roswell Park Cancer InstituteBuffalo, New York  14263
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
University of Pennsylvania Abramson Cancer CenterPhiladelphia, Pennsylvania  19104