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Study Evaluating the Safety, Pharmacokinetics (PK), Pharmacodynamics (PD), and Therapeutic Activity of Selicrelumab (RO7009789) With Vanucizumab or Bevacizumab in Participants With Metastatic Solid Tumors

NCT02665416 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2020-04-07

No results posted yet for this study

Summary

This open-label, two-part study is designed to assess the safety, PK, PD, and therapeutic activity of Selicrelumab in combination with vanucizumab or bevacizumab in participants with metastatic solid tumors not amenable to standard treatment. Part I (dose escalation) is designed to establish the maximum tolerated dose (MTD) of Selicrelumab in this combination. Part II (expansion) is intended to characterize the safety and tolerability of Selicrelumab in combination with bevacizumab among indication-specific cohorts and to confirm the recommended dose.

Conditions

  • Advanced/Metastatic Solid Tumors

Interventions

DRUG

Selicrelumab

Selicrelumab will be provided as concentrate for solution to be administered via SC injection

DRUG

Vanucizumab

Vanucizumab will be provided as solution to be administered via IV infusion.

DRUG

Bevacizumab

Bevacizumab will be administered via IV infusion.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-25
Primary Completion
2019-10-30
Completion
2019-10-30
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Canada
  • Denmark
  • Italy
  • Netherlands
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT02665416 on ClinicalTrials.gov