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 sites200 target enrollmentMay 8, 2019

ConditionsMetastatic or Locally Advanced Solid Tumors and Cervical Cancer MedDRA version: 21.1Level: LLTClassification code 10008231Term: Cervical cancer recurrentSystem Organ Class: 100000004864 Therapeutic area: Diseases [C] - Cancer [C04]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Metastatic or Locally Advanced Solid Tumors and Cervical Cancer
Sponsor: Agenus Inc.
Enrollment: 200
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

May 8, 2019

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Investigators

Sponsor

Agenus Inc.

Eligibility Criteria

Inclusion Criteria

•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.
•Note: The following cervical tumors are not eligible: minimal deviation/adenoma malignum, gastric type adenocarcinoma, clear cell carcinoma, and mesonephric carcinoma.
•II. Has cervical cancer and has relapsed after a platinum\-based treatment (first line) regimen for advanced (recurrent, unresectable, or metastatic) disease; Note: Subject receiving chemotherapy concurrently with primary radiation (e.g.,
•weekly cisplatin) or subject receiving adjuvant chemotherapy following completion of radiation therapy (e.g., paclitaxel and carboplatin for \= 4 cycles) and progressed within 6 months after treatment completion will be eligible as this systemic therapy will be considered as first line treatment.
•4\. Measurable disease – based on investigator assessment

Exclusion Criteria

•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.