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A Study of MNRP1685A in Patients With Locally Advanced or Metastatic Solid Tumors

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00747734
Enrollment
35
Registered
2008-09-05
Start date
2008-09-30
Completion date
Unknown
Last updated
2011-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid Cancers

Keywords

Neuropilin-1, NRP1, anti-NRP1, anti-angiogenic

Brief summary

This is a Phase I, first-in-human, open-label, dose-escalation study of MNRP1685A administered by IV infusion every 3 weeks in patients with locally advanced or metastatic solid tumors for whom standard therapy either does not exist or has proven to be ineffective or intolerable. This study will be conducted at up to three study centers in the United States.

Interventions

Escalating intravenous dose

Sponsors

Genentech, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Incidence and nature of dose-limiting toxicities (DLTs)Length of study

Secondary

MeasureTime frame
Total exposure (AUC)Length of study
Maximum and minimum serum concentrationsLength of study
ClearanceLength of study
Volume of distributionLength of study

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026