Clinical trial · Interventional
A Study of 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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This open-label 2-arm study will assess the pharmacokinetics, pharmacodynamics, safety and efficacy of RO5429083 in patients with metastatic and/or locally advanced CD44-expressing malignant solid tumors. In Part A, cohorts of patients will receive RO5429083 intravenously at escalating doses. In Part B, patients will receive 89Zr-labelled RO5429083 in Cycles 1 and/or 2, followed by RO5429083. For all patients there will be an option to continue treatment with RO5429083 until disease progression or unacceptable toxicity occurs.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RO5429083 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A
- interventionNames
- Drug: RO5429083
- type
- EXPERIMENTAL
- label
- B
- interventionNames
- Drug: RO5429083
Primary outcomes (5)
- measure
- Arm A: Safety (Incidence of adverse events related to study drug)
- timeFrame
- Until disease progression or unacceptable toxicity (approximately 2 years)
- measure
- Arm A: Maximum tolerated dose of RO5429083
- timeFrame
- Until disease progression or unacceptable toxicity (approximately 2 years)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients, \>/= 18 years of age * 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: * 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
References
Publications (0)
Data not yet available