Clinical trial · Interventional
A Multiple-Dose Study of RhuMab 2C4 and Docetaxel in the Treatment of Advanced Solid Tumors
A Phase Ib, Open-Label, Multicenter Study of the Safety and Pharmacokinetics of the Combination of RhuMab 2C4 (Omnitarg), a Recombinant Humanized Antibody to HER2, and Docetaxel (Taxotere) in Patients With Advanced 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 study will evaluate the safety, tolerability, and pharmacokinetics of the combination of rhuMab 2C4 (Perjeta) and docetaxel (Taxotere) in participants with advanced solid tumors that have progressed during or after standard therapy, or for which no standard therapy is available. Participants will be enrolled and evaluated for dose-limiting toxicities (DLTs) in escalating-dose cohorts in order to determine the maximum tolerated dose (MTD).
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 |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
| RhuMab 2C4 | Drug | Pertuzumab | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- RhuMab 2C4 + Docetaxel 100 mg/m^2 (Level 3)
- description
- Docetaxel will be administered via intravenous (IV) infusion on Day 1 of each 3-week cycle at a dose of 100 mg/m\^2 per day, and rhuMab 2C4 will be given on Day 1 of each 3-week cycle as a fixed-dose 420-mg IV infusion. For Cycle 1 only, rhuMab 2C4 administration will be delayed to Day 2 with an initial 840-mg loading dose. The incidence of DLTs will be used to guide intrapatient dose modification, as well as subsequent enrollment.
- interventionNames
- Drug: Docetaxel
- Drug: RhuMab 2C4
- type
- EXPERIMENTAL
- label
- RhuMab 2C4 + Docetaxel 60 mg/m^2 (Level 1)
- description
- Docetaxel will be administered via IV infusion on Day 1 of each 3-week cycle at a dose of 60 mg/m\^2 per day, and rhuMab 2C4 will be given on Day 1 of each 3-week cycle as a fixed-dose 420-mg IV infusion. For Cycle 1 only, rhuMab 2C4 administration will be delayed to Day 2 with an initial 840-mg loading dose. The incidence of DLTs will be used to guide intrapatient dose modification, as well as subsequent enrollment.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adults at least 18 years of age * Easter Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Life expectancy at least 12 weeks * Locally advanced or metastatic solid tumor with at least 1 measurable lesion, which has progressed during/after standard therapy * Human epidermal growth factor receptor 2 (HER2)-negative among participants with breast cancer * Negative pregnancy test or use of an adequate contraceptive method among women of childbearing potential * Adequate hematologic, hepatic, and renal function * Signed informed consent, histologically or cytologicall confirmed advanced solid tumor, adequate cardiac function as documented by LVEF \>50% by ECHO or MUGA Exclusion Criteria: * Clinical evidence of central nervous system (CNS) metastases * Prior chemotherapy, radiotherapy, or immunotherapy within 4 weeks, or hormone therapy within 2 weeks of study Day 1 * History of neuropathy Grade 2 or worse, or any unresolved residual chemotherapy effects * Prior HER2-active agents or docetaxel * Any investigational agent within 28 days of study drug * Prior cumulative doxorubicin dose greater than (\>) 360 mg/m\^2 or equivalent * Significant cardiovascular disease * Active/uncontrolled concurrent illness or infection- * Major surgery or trauma within 4 weeks of study Day 1
References
Publications (0)
Data not yet available