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A Multiple Ascending Dose Study of R1507 in Patients With Advanced Solid Tumors.

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Roche

Status and phase

Completed
Phase 1

Conditions

Neoplasms

Treatments

Drug: RG1507

Study type

Interventional

Funder types

Industry

Identifiers

NCT00400361
BO19373

Details and patient eligibility

About

This study will determine the maximum tolerated dose and pharmacokinetic profile of R1507 in patients with metastatic or locally advanced malignant solid tumors, non-Hodgkin's lymphoma or Hodgkin's lymphoma. Groups of patients will be sequentially enrolled to receive ascending doses of R1507 either weekly or three-weekly by intravenous infusion. The starting dose of 1mg/kg iv for each dosing regimen will be escalated in subsequent groups of patients after a satisfactory assessment of safety, tolerability and pharmacokinetics of the previous dose. The anticipated time on study treatment is until disease progression or dose-limiting toxicity, and the target sample size is <100 individuals.

Enrollment

98 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • adult patients, >=18 years of age;
  • solid neoplasm, non-Hodgkin's lymphoma or Hodgkin's lymphoma;
  • metastatic or locally advanced disease, not curable by any currently available treatment.

Exclusion criteria

  • severe, uncontrolled systemic disease;
  • patients who require treatment with glucocorticoids or immunosuppressive treatment within last 6 months;
  • patients with diabetes mellitus.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

98 participants in 1 patient group

1
Experimental group
Treatment:
Drug: RG1507

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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