Trials / Terminated
TerminatedNCT04032704
A Study of Ladiratuzumab Vedotin in Advanced Solid Tumors
Open-Label Phase 2 Study of Ladiratuzumab Vedotin (LV) for Unresectable Locally Advanced or Metastatic Solid Tumors
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 205 (actual)
- Sponsor
- Seagen Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This trial will study ladiratuzumab vedotin (LV) alone and with pembrolizumab to find out if it works to treat different types of solid tumors. It will also find out what side effects may occur. A side effect is anything the drug does besides treating cancer.
Detailed description
This trial is designed to assess the antitumor activity, safety, and tolerability of LV alone and with pembrolizumab, for the treatment of solid tumors. Participants with the following advanced solid tumors will be enrolled: Cohort 1: small cell lung cancer (SCLC) Cohort 2: non-small cell lung cancer-squamous (NSCLC-squamous) Cohort 3: non-small cell lung cancer-nonsquamous (NSCLC-nonsquamous) Cohort 4: head and neck squamous cell carcinoma (HNSCC) Cohort 5: esophageal squamous cell carcinoma (esophageal-squamous) Cohort 6: gastric and gastroesophageal junction (GEJ) adenocarcinoma Cohort 7: castration-resistant prostate cancer (CRPC) Cohort 8: melanoma Participants will continue to receive study treatment until disease progression, unacceptable toxicity, investigator decision, consent withdrawal, study termination by the sponsor, pregnancy, or death, whichever comes first.
Conditions
- Small Cell Lung Cancer
- Non-small Cell Lung Cancer, Squamous
- Non-small Cell Lung Cancer, Non-squamous
- Head and Neck Squamous Cell Carcinoma
- Esophageal Squamous Cell Carcinoma
- Gastric Adenocarcinoma
- Gastroesophageal Junction Adenocarcinoma
- Prostate Cancer
- Melanoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ladiratuzumab vedotin | Intravenous (into the vein; IV) infusion |
| DRUG | pembrolizumab | 200mg given by IV on Day 1 of each 21-day cycle |
Timeline
- Start date
- 2019-10-09
- Primary completion
- 2023-11-28
- Completion
- 2023-11-28
- First posted
- 2019-07-25
- Last updated
- 2025-03-10
- Results posted
- 2025-03-10
Locations
66 sites across 6 countries: United States, Australia, Italy, South Korea, Taiwan, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04032704. Inclusion in this directory is not an endorsement.