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Sym004 in Patients With Advanced Solid Tumors

NCT01117428 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 111

Last updated 2018-10-15

Study results available
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Summary

This trial is designed as a multi-centre, open label, dose-escalation, phase I trial and consists of five parts.

Conditions

Interventions

DRUG

Sym004

In part A, patients in all dose cohorts will continue weekly treatment with the assigned dose of Sym004 until disease progression. In Part B, patients will continue weekly treatment with the tolerated dose of Sym004 until disease progression. In Part C, patients will receive weekly doses of Sym004 at the dose level below 12 mg/kg i.e. 9 mg/kg until disease progression. In Part D and E, patients will receive doses of Sym004 administered every 2 weeks at dose level 12 mg/kg and 18 mg/kg, respectively until disease progression. In Part F, patients will receive a single loading dose of 9 mg/kg followed by weekly doses of 6 mg/kg.

Sponsors & Collaborators

  • Symphogen A/S

    lead INDUSTRY

Principal Investigators

  • Josep Tabernero, MD, PhD · Vall d´Hebron University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2015-02-28
Completion
2015-05-31
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01117428 on ClinicalTrials.gov