Clinical trial · Interventional
A Study of E7130 in Participants With Solid Tumors
A Phase 1 Study of E7130 in Subjects With Solid Tumor
NCT03444701CI-TRIAL-00086850completedPhase 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)
The primary objective of this study is to evaluate the tolerability and safety profile of E7130 in participants with solid 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 |
|---|---|---|---|
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| E7130 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- E7130 (2-Week Regimen)
- description
- Part 1 (Cycle 1; 28 days): The first cohort of 3 participants will receive 25 micrograms per meters squared (μg/m\^2) of E7130, on Day 1 and Day 15 as an intravenous infusion. If a drug-related Grade 2 or higher toxicity excluding clinically insignificant events is not observed in the initial cohort, dose-limiting toxicities (DLTs) will be evaluated in successive dose levels with single participants until such a toxicity is observed. Once the maximum tolerated dose (MTD) will be determined. Part 2: Participants with squamous cell carcinoma of the head and neck and urothelial carcinoma will be evaluated at the dose level determined in Part 1 in a 2-week or in a 3-week regimen based on the evaluations in Part 1.
- interventionNames
- Drug: E7130
- type
- EXPERIMENTAL
- label
- E7130 (3-Week Regimen)
- description
- Part 1 (Cycle 1; 21 days): On Day 1, participants will receive E7130 at (-1) a lower dose than the dose at which the first DLT was observed in the 2-week regimen. Once the MTD will be determined. Part 2: Participants with squamous cell carcinoma of the head and neck and urothelial carcinoma will be evaluated at the dose level determined in Part 1 in a 3-week or in a 2-week regimen based on the evaluations in Part 1.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria:
* Participants who have provided voluntary written consent for participation in this clinical study
* Participants to whom the rules for complying with this clinical study have been adequately explained, and who intend to and can comply with these rules
* Participants aged greater than or equal to (\>=) 20 years at the time of informed consent
* Participants with adequate function of major organs
* Participants with Performance Status score of 0 to 1 established by the Eastern Cooperative Oncology Group (ECOG)
* Participants who are expected to survive for 3 months or longer after starting administration of the investigational drug
* Washout period required from the end of prior treatment to the first administration of study drug
* Participants who agree to submit blood samples prior and during study treatment for progressive disease (PD) markers.
Inclusion Criteria (Part 2 only):
* Measurable disease meeting the following criteria:
1. At least 1 lesion of \>=1.0 centimeter (cm) in the longest diameter for a non-lymph node or \>=1.5 cm in the short-axis diameter for a lymph node that is serially measurable according to response evaluation criteria in solid tumours (RECIST) 1.1 using computerized tomography/magnetic resonance imaging (CT/MRI).
2. Lesions that have had external beam radiotherapy (EBRT) or locoregional therapies such as radiofrequency (RF) ablation must show evidence of progressive disease to be deemed a target lesion.
Exclusion Criteria:
* Medical history of clinically significant cardiovascular impairment
* Serious concomitant systemic infection requiring medical treatment (including bacterial infection and fungal infection)
* Participants who test positive for human immunodeficiency virus (HIV antibody)
* Active viral hepatitis (B or C) as demonstrated by positive serology or requiring treatment hepatitis B surface antigen (HBsAg), anti-hepatitis B surface antibody (anti-HBs)/hepatitis B core antibody (HBcAb) and anti-hepatitis C virus (HCV) antibody test.
* Effusion requiring drainage
* Participants whose toxicity of previous treatment has not recovered to Grade 1 or lower (except for alopecia and hemoglobin)
* Other active malignancy
* Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin \[ß-hCG\] or human chorionic gonadotropin \[hCG\]).
* Women of childbearing potential or men of impregnate potential who don't agree that both the participant and his/her partner will use a medically effective method for contraception during the study and after study drug discontinuation (male; 90 days, female; 60 days)
* Known intolerance to the study drug or any of the excipients
* Any medical or other condition that in the opinion of the investigator(s) would preclude the participant's participation in the study
* Scheduled for surgery during the study
* Diagnosed with meningeal carcinomatosis
* Participants with brain or subdural metastases are not eligible.References
Publications (2)
- DERIVEDMatsubara N, Saijo K, Shimizu Y, Okano S, Nakano K, Nishio N, Otsuka T, Kuno H, Miura T, Kubota T, Ikezawa H, Umetsu Y, Ito K, Apfel A, Ye Y, Honma Y. First-In-Human Study: Dose Expansion of E7130 in Urothelial Carcinoma and Squamous Cell Carcinoma of the Head and Neck. Cancer Sci. 2026 Aug;117(8):2247-2258. doi: 10.1111/cas.70420. Epub 2026 May 27. PMID 42203677
- DERIVEDDoi T, Matsubara N, Naito Y, Kuboki Y, Harano K, Ono M, Urasaki T, Ohmoto A, Kawanai T, Hisai T, Ikezawa H, Shiba S, Ito K, Semba T, Asano O, Takahashi S. First-in-human study of E7130 (a tumor microenvironment-ameliorating microtubule inhibitor) in patients with advanced solid tumors: Primary results of the dose-escalation part. Cancer. 2023 Aug 1;129(15):2348-2359. doi: 10.1002/cncr.34788. Epub 2023 Apr 20. PMID 37080942