A Phase 1 / 2, Open-Label, Multiple Ascending Dose Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological, and Clinical Activity of AGEN2034 in Subjects With Metastatic or Locally Advanced Solid Tumors, With Expansion to Second-Line Cervical Cancer

Agenus Inc.0 sites211 target enrollmentApril 29, 2019

Overview

No summary available.

Registry

who.int

Start Date

April 29, 2019

End Date

June 15, 2022

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Female subjects over the age of 18 years with recurrent and/or metastatic cervical cancer who have relapsed after a platinum\-based
•treatment regimen for advanced (recurrent, unresectable, or metastatic) disease.
•After the interim analyses, subsequent enrollment of subjects may be
•based on biomarker enrichment (including but not limited to PD\-L1
•expression). In such cases, tumor tissue must be positive for the
•selected entry biomarker prior to subject enrollment.
•1\. Voluntarily agree to participate by giving written informed consent. Participation in pharmacogenomics testing is optional.
•3\. Diagnosis and prior systemic treatment:
•b. Phase 2:
•I. Have (1\) a histologically or cytologically confirmed diagnosis of squamous\-cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix, and (2\) metastatic, locally advanced, and/or unresectable disease at the time of enrollment. Histologic confirmation of the original primary tumor is required via pathology report.

•1\. Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigation device within 4 weeks before the first dose of treatment.
•2\. Has an inadequate washout period prior to first dose of study drug defined as:
•a. Received systemic cytotoxic chemotherapy or biological therapy within 3 weeks before first dose,
•b. Received radiation therapy within 3 weeks before first dose, or
•c. Had major surgery within 4 weeks before first dose.
•3\. Has received prior therapy with:
•a. Any antibody/drug targeting T\-cell co\-regulatory proteins (immune checkpoints) such as anti–PD\-1, anti–PD\-L1, or anti–cytotoxic T\-lymphocyte antigen 4 (CTLA\-4\) antibodies
•b. For Phase 2: \> 1 systemic treatment regimen for the advanced (recurrent, unresectable, or metastatic) cervical cancer for which the subject is considered for the study
•Note: In Phase 1, prior treatment with a CTLA\-4 antibody is permissible for subjects with metastatic melanoma.
•4\. Has persisting toxicity related to prior therapy of NCI CTCAE Grade \> 1 severity.