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A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacology of MNRP1685A, a Human IgG1 Antibody, Administered Intravenously in Patients With Locally Advanced or Metastatic Solid Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
Solid Cancers

Thank you

Trial Information

A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacology of MNRP1685A, a Human IgG1 Antibody, Administered Intravenously in Patients With Locally Advanced or Metastatic Solid Tumors


Inclusion Criteria:



- Age ≥ 18 years

- Incurable, locally advanced, or metastatic solid malignancy that has progressed on,
or failed to respond to, at least one prior regimen

- Evaluable or measurable disease per RECIST (in certain circumstances, prostate or
ovarian cancer patients with non-measurable disease)

Exclusion Criteria:

- Inadequate hematologic or organ function

- Anti-cancer therapy within 4 weeks prior to initiation of study treatment

- Recent history of or current clinically significant gastrointestinal, cardiovascular
or pulmonary disorders

- Any condition requiring full-dose anticoagulants, such as warfarin, heparin, or
thrombolytics, or a filter of the inferior vena cava

- Active infection or autoimmune disease

- Known human immunodeficiency virus (HIV) infection

- Pregnancy or breast feeding

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence and nature of dose-limiting toxicities (DLTs)

Outcome Time Frame:

Length of study

Safety Issue:

No

Principal Investigator

Rainer Brachmann, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Food and Drug Administration

Study ID:

ANP4509g

NCT ID:

NCT00747734

Start Date:

September 2008

Completion Date:

Related Keywords:

  • Solid Cancers
  • Neuropilin-1
  • NRP1
  • anti-NRP1
  • anti-angiogenic

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