Open-Label Multicenter 2-Arm Phase I Study of RO5429083 with Dose-Escalation and Extension Cohorts, and Imaging Cohorts with RO5429083 and 89Zr-labeled RO5429083, in Patients with Metastatic and/or Locally Advanced, CD44-Expressing, Malignant Solid Tumors

Open-Label Multicenter 2-Arm Phase I Study of RO5429083 with Dose-Escalation and Extension Cohorts, and Imaging Cohorts with RO5429083 and 89Zr-labeled RO5429083, in Patients with Metastatic and/or Locally Advanced, CD44-Expressing, Malignant Solid Tumors - BP25385

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON39242

Enrollment

Registered

2011-03-21

Start date

2011-06-07

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

different types of malignant tumors solid tumors

Interventions

Arm A will be a multi-center standard *3+3* design and will consist of cohorts of a minimum of 3 patients which will be sequentially enrolled in one of the dose levels of RO5429083 administered intr

1 cycle = 2 weeks) schedule. Dose-escalation will be based on the safety evaluation of patients after two cycles (q2W x 2) at each dose level Arm B: 89Zr-labeled RO5429083 will be administered intr

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Adult patients, >/= 18 years of age;- Metastatic and/or locally advanced malignant CD44-expressing solid tumors (Arm A);- Histologically confirmed metastatic and/or locally advanced malignant CD44-expressing solid tumors ;- Patients with disease progression on standard therapy, or have tumors that are not curable by standard therapy;- Life expectancy of over 12 weeks

Exclusion criteria

Exclusion criteria: - Concurrent therapy with any other investigational drug;- Known or suspected CNS metastases including leptomeningeal metastases;- Active bleeding, bleeding diathesis or history of coagulation disorder;- Uncontrolled diabetes mellitus;- Active or uncontrolled infections;- Patients with HIV infections;- Patients with poorly controlled hypertension

Design outcomes

Primary

Measure	Time frame
Arm A-Dose Escalation Cohort Primary Objectives * To describe the pharmacokinetics (PK) and safety profiles (including the maximum tolerated dose (MTD) or Optimal Biological Dose) of escalating doses of RO5429083 in patients with metastatic and/or locally advanced malignant CD44-expressing solid tumors. Arm A-Extension Cohort Primary Objectives • To investigate the Tumor Growth Control Rate (TGCR): complete response (CR), partial response (PR), and stable disease (SD). • To describe the safety profile of RO5429083 in patients with metastatic and/or locally advanced malignant CD44-expressing solid tumors. • To determine the recommended Phase II dose. Arm B: Imaging Study with 89Zr labeled RO5429083 Primary Objectives • To evaluate the in vivo biodistribution and organ pharmacokinetics of 89Zr labeled RO5429083 in patients with CD44-expressing solid tumors.	—

Measure

Time frame

Arm A-Dose Escalation Cohort Primary Objectives * To describe the pharmacokinetics (PK) and safety profiles (including the maximum tolerated dose (MTD) or Optimal Biological Dose) of escalating doses of RO5429083 in patients with metastatic and/or locally advanced malignant CD44-expressing solid tumors. Arm A-Extension Cohort Primary Objectives • To investigate the Tumor Growth Control Rate (TGCR): complete response (CR), partial response (PR), and stable disease (SD). • To describe the safety profile of RO5429083 in patients with metastatic and/or locally advanced malignant CD44-expressing solid tumors. • To determine the recommended Phase II dose. Arm B: Imaging Study with 89Zr labeled RO5429083 Primary Objectives • To evaluate the in vivo biodistribution and organ pharmacokinetics of 89Zr labeled RO5429083 in patients with CD44-expressing solid tumors.

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Secondary

Measure	Time frame
Arm A-Dose Escalation Cohort Secondary Objectives • To determine the recommended dose (RD) for RO5429083 for the extension cohort. • To describe the anti-tumor activity of RO5429083. • To describe the pharmacodynamic effects of RO5429083 in skin biopsies, whole blood samples and tumor biopsies. Arm A-Extension Cohort Secondary Objectives • To describe the anti-tumor activity of RO5429083 using: o Objective Response Rate (ORR) o Duration of Response o Progression Free Survival • To describe the PK profile of RO5429083. • To describe the pharmacodynamic effects of RO5429083 in skin biopsies, whole blood samples and tumor biopsies. Arm B: Imaging Study with 89Zr labeled RO5429083 Secondary Objectives • To explore target saturation and correlate with pharmacological effect.	—

Measure

Time frame

Arm A-Dose Escalation Cohort Secondary Objectives • To determine the recommended dose (RD) for RO5429083 for the extension cohort. • To describe the anti-tumor activity of RO5429083. • To describe the pharmacodynamic effects of RO5429083 in skin biopsies, whole blood samples and tumor biopsies. Arm A-Extension Cohort Secondary Objectives • To describe the anti-tumor activity of RO5429083 using: o Objective Response Rate (ORR) o Duration of Response o Progression Free Survival • To describe the PK profile of RO5429083. • To describe the pharmacodynamic effects of RO5429083 in skin biopsies, whole blood samples and tumor biopsies. Arm B: Imaging Study with 89Zr labeled RO5429083 Secondary Objectives • To explore target saturation and correlate with pharmacological effect.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)