Clinical trial · Interventional
A Study of LY3164530 in Participants With Cancer
A Phase 1 Study of LY3164530, a Bispecific Antibody Targeting Mesenchymal-Epithelial Transition Factor (MET) and Epidermal Growth Factor Receptor (EGFR), in Patients With Advanced or Metastatic Cancer
NCT02221882CI-TRIAL-00041268completedPhase 1Results postedClinicalTrials.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)
The main purpose of this study is to evaluate the safety of a study drug known as LY3164530 in participants with cancer that is advanced and/or has spread to another part(s) of the body.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasm Metastasis | — | UNRESOLVED | — |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LY3164530 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- LY3164530
- description
- LY3164530 in escalating dose cohorts given intravenously (IV) once on Days 1 and 15 or on Days 1, 8, 15, and 22 of a 28-day cycle. Participants may continue to receive study drug until discontinuation criteria are met.
- interventionNames
- Drug: LY3164530
Primary outcomes (1)
- measure
- Recommended Phase 2 Dose of LY3164530: Maximum Tolerated Dose (MTD)
- timeFrame
- Cycle 1 (Cycle = 28 days)
- description
- Recommended Phase 2 Dose of LY3164530: MTD
Secondary outcomes (5)
- measure
- Maximum Serum Concentration (Cmax) of LY3164530 Epidermal Growth Factor Receptor (EGFR) Specific ELISA Assay
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria
* Have advanced or metastatic cancer and be an appropriate candidate for experimental therapy.
* Have adequate organ function.
* Prior Treatments:
* Systemic treatments: Must have discontinued previous systemic treatments for cancer and recovered from the acute effects of therapy. Participants must have discontinued:
* Cytotoxic therapies or targeted agents that are small molecule inhibitors for 5 half-lives or at least 28 days.
* Mitomycin-C or nitrosourea therapy for at least 42 days and biologic agents for at least 28 days.
* Radiation therapy and surgery must be completed 4 weeks prior to therapy, except for limited field radiation therapy, which must be completed 2 weeks before therapy.
* If participant is of reproductive potential, must agree to use medically approved contraceptive precautions during the study and for three months following the last dose of study drug.
* If the participant is a female of childbearing potential, must have had a negative serum or urine pregnancy test within 14 days of the first dose of study drug and must not be breast feeding.
Exclusion Criteria:
* Must not have taken an unapproved drug as treatment for any indication within the last 28 days prior to starting study treatment.
* Must not have an active symptomatic fungal, bacterial or viral infection, including human immunodeficiency virus (HIV) or Hepatitis A, B, or C.
* Must not have a serious preexisting medical conditions or concomitant disorders.
* Must not have leukemia.
* Must not have QT interval of \>470 millisecond.
* Must not have a serious cardiac condition, such as congestive heart failure, unstable angina pectoris, or heart attack within the last 3 months.References
Publications (0)
Data not yet available
No reference posted for this study.