A Multiple Ascending Dose Study of R1507 in Children and Adolescents With Advanced Solid Tumors.

Multiple Ascending Dose (MAD) Study of the IGF-1R Antagonist R1507 Administered as an Intravenous Infusion in Pediatric Patients With Advanced Solid Tumors.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00560144

Enrollment

Registered

2007-11-19

Start date

2007-12-31

Completion date

2011-12-31

Last updated

2016-11-01

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

Conditions

Neoplasms

Brief summary

This 3 arm study will determine the dose of R1507 which will achieve a mean drug exposure in children and adolescents with advanced solid tumors equivalent to the exposure achieved in adults at the recommended dose of 9mg/kg/week. It will also determine the maximum tolerated dose (if appropriate) and the pharmacokinetic profile of R1507. Groups of patients will be sequentially enrolled in one of up to 3 dose levels (3,9mg/kg or a PK-derived dose, not to exceed 16 mg/kg) of R1507 administered weekly by intravenous infusion.An expanded cohort of patients will be enrolled at the optimal dose/MTD. The anticipated time on study treatment is until disease progression or dose limiting toxicity, and the target sample size is \<100 individuals.

Interventions

DRUGRG1507

3mg/kg iv weekly

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

2 Years to 17 Years

Healthy volunteers

Inclusion criteria

* pediatric patients aged 2-17 years of age; * histologically confirmed solid tumors; * cancer which has relapsed after, or failed to respond to, curative therapy, or no other potentially curative treatment options available.

Exclusion criteria

* treatment with corticosteroids within past 2 weeks; * current or past use of anti-IGF-1R antibodies; * current treatment with immunosuppressive agents; * patients with diabetes mellitus; * known HIV or hepatitis B or C; * hypersensitivity to any of the components of R1507 or to monoclonal antibodies.

Design outcomes

Primary

Measure	Time frame
Serum drug exposure level equivalent to exposure in adults at adult recommended dose.	Throughout study

Secondary

Measure	Time frame
MTD (AEs, laboratory parameters)	Throughout study

Countries

United States

Outcome results

None listed

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