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Rovalpituzumab Tesirine in Delta-Like Protein 3-Expressing Advanced Solid Tumors | Clinical Trials | Clareo Health

TERMINATEDPHASE1/PHASE2

Rovalpituzumab Tesirine in Delta-Like Protein 3-Expressing Advanced Solid Tumors

An Open-Label Study of Rovalpituzumab Tesirine in Subjects With Delta-Like Protein 3-Expressing Advanced Solid Tumors

NCT02709889•AbbVie

Summary

The primary objective of this study is to assess the safety and tolerability of rovalpituzumab tesirine in subjects with specific delta-like protein 3-expressing advanced solid tumors.

Detailed Description

This is a multicenter, open-label study involving multiple specific advanced solid tumor types, consisting of a dose escalation part A followed by an expansion part B. Cancer subtypes will be studied in separate disease-specific cohorts in both Parts. Eight separate cohorts will enroll malignant melanoma, medullary thyroid cancer (MTC), glioblastoma, large cell neuroendocrine carcinoma (LCNEC), neuroendocrine prostate cancer (NEPC), high-grade gastroenteropancreatic neuroendocrine carcinoma (GEP NEC), other NEC, and solid tumors other than the above.

Eligibility

Age

18 - 99 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologically confirmed, unresectable advanced solid malignancy with documented disease progression after at least 1 prior systemic therapy
•Disease is relapsed/refractory to prior standard systemic therapy or for which standard or curative therapy does not exist or is not considered appropriate by the Investigator.
•Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
•Delta-like protein 3 (DLL3)-expressing malignancy based on central immunohistochemical (IHC) testing of representative baseline tumor tissue (archived tissue or on-study biopsy). Positive is defined as staining in ≥ 1% of tumor cells.
•Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
•Minimum life expectancy of at least 12 weeks
•Subjects with a history of central nervous system (CNS) metastases must have documentation of stable or improved brain imaging for at least 2 weeks after completion of definitive treatment and within 2 weeks prior to first dose of Study Drug, off or on a stable dose of corticosteroids. Definitive treatment may include surgical resection, whole brain irradiation, and/or stereotactic radiation therapy. (Applicable to tumor types of non-CNS primary origin only)
•Recovery to Grade 1 of any clinically significant toxicity (excluding alopecia) prior to initiation of study drug administration
•Adequate hematologic and organ function as confirmed by laboratory values
•Last dose of any prior therapy administered by the following time intervals before the first dose of study drug:
+3 more criteria

Exclusion Criteria

•Any significant medical condition, including any suggested by screening laboratory findings that, in the opinion of the investigator or sponsor, may place the subject at undue risk from the study, including but not necessarily limited to uncontrolled hypertension and/or diabetes, clinically significant pulmonary disease (e.g., chronic obstructive pulmonary disease requiring hospitalization within 3 months) or neurological disorder (e.g., seizure disorder active within 3 months).
•Documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms consistent with New York Heart Association (NYHA) Class III-IV within 6 months prior to their first dose of study drug.
•Recent or ongoing serious infection, including:
•1. Any active grade 3 or higher (per National Cancer Institute Common Terminology Criteria for Adverse Events version \[NCI CTCAE\] 4.03) viral, bacterial, or fungal infection within 2 weeks of the first dose of the study drug. Routine antimicrobial prophylaxis is permitted.
•2. Known seropositivity for or active infection by human immunodeficiency virus (HIV).
•3. Active Hepatitis B (by surface antigen expression or polymerase chain reaction) or C (by polymerase chain reaction) infection or on hepatitis-related antiviral therapy within 6 months of first dose of study drug.
•Women who are pregnant or breastfeeding
•Systemic therapy with corticosteroids at \>20 mg/day prednisone or equivalent within 1 week prior to the first dose of study drug
•History of another invasive malignancy that has not been in remission for at least 3 years. Exceptions to the 3year limit include non-melanoma skin cancer, curatively treated localized prostate cancer, ductal carcinoma in situ, and cervical cancer in situ on biopsy or squamous intraepithelial lesion on pap smear.
•Prior exposure to a pyrrolobenzodiazepine (PBD)-based drug, prior participation in a rovalpituzumab tesirine clinical trial, or known hypersensitivity to rovalpituzumab tesirine or excipient contained in the drug formulation, unless undergoing retreatment with rovalpituzumab tesirine in the context of this protocol

Locations (30)

Banner MD Anderson Cancer Ctr /ID# 155424

Gilbert, Arizona, United States

Mayo Clinic - Scottsdale /ID# 155419

Scottsdale, Arizona, United States

University of California, Los Angeles /ID# 155429

Los Angeles, California, United States

Univ California, San Francisco /ID# 155409

San Francisco, California, United States

Cedars-Sinai Medical Center - West Hollywood /ID# 155428

West Hollywood, California, United States

Univ of Colorado Cancer Center /ID# 155415

Aurora, Colorado, United States

Sarah Cannon Research Institute at HealthONE - Denver /ID# 155420

Denver, Colorado, United States

University of Florida - Archer /ID# 155414

Gainesville, Florida, United States

Moffitt Cancer Center /ID# 170220

Tampa, Florida, United States

Emory University Hospital /ID# 155417

Atlanta, Georgia, United States

Key Dates

Start Date

September 23, 2016

Primary Completion Date

August 27, 2019

Completion Date

August 27, 2019

Last Updated

October 19, 2020

Enrollment

200

ACTUAL participants

Conditions

Malignant MelanomaMedullary Thyroid CancerGlioblastomaLarge-Cell Neuroendocrine CarcinomaNeuroendocrine Prostate CancerHigh Grade Gastroenteropancreatic Neuroendocrine CarcinomaOther Neuroendocrine CarcinomaOther Solid Tumors

Interventions

Rovalpituzumab tesirine

DRUG

Dexamethasone

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 19, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Rovalpituzumab Tesirine in Delta-Like Protein 3-Expressing Advanced Solid Tumors

Inclusion Criteria

Exclusion Criteria

Collection of Blood and Urine Samples in Patients Receiving Radiation Therapy for Glioblastoma Multiforme

Testing the Addition of an Anti-Cancer Drug, Triapine, to the Usual Radiation Therapy for Recurrent Glioblastoma or Astrocytoma

Targeted Pediatric High-Grade Glioma Therapy

Hypofractionation Trial of Re-irradiation in Good Prognosis Recurrent Glioblastoma

EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma

Study of TLX101-Tx Plus Standard of Care (SoC) Versus SoC Alone for the Treatment of Patients With Recurrent Glioblastoma