Clinical trial · Interventional
A Phase 1 Study of IMGN289 in Adult Patients With EGFR-positive Solid Tumors
A Phase 1, Multi-center, Open-label Study of IMGN289 Administered Intravenously in Adult Patients With EGFR-positive Solid Tumors
NCT01963715CI-TRIAL-00019306terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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 is a Phase 1, first-in-human study to determine the recommended dose of IMGN289 in adult patients with advanced EGFR-positive tumors.
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 |
|---|---|---|---|
| EGFR Positive Solid Tumors | Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IMGN289 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- EGFR+ Solid Tumor
- description
- EGFR+ Solid Tumor
- interventionNames
- Drug: IMGN289
Primary outcomes (1)
- measure
- Number of participants with dose limiting toxicities
- timeFrame
- Up to 2 years
Secondary outcomes (5)
- measure
- Number of participants with adverse events
- timeFrame
- Up to 2 years
- measure
- Area under the plasma concentration versus time curve
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years old at time of consent * Diagnosed with a solid tumor that has progressed despite standard therapy or for which no standard effective or curative options exist or are suitable * EGFR-positive tumor expression * Adequate blood and organ function * Must agree to use contraception while on study and for 12 weeks after the last dose of IMGN289 as applicable * Must be willing and able to sign informed consent and follow the study schedule and other protocol requirements Exclusion Criteria: * Other anti-cancer treatment during the study * Symptomatic brain metastases * Other clinically significant disease as defined by the protocol * Chronic skin condition that requires prescribed oral or intravenous treatment * History of severe rash that required discontinuation of prior EGFR targeted therapy * Receiving therapeutic doses of warfarin or heparin for anti-coagulation * Known diagnosis of HIV or active viral hepatitis * Women who are pregnant or breast feeding
References
Publications (0)
Data not yet available
No reference posted for this study.