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 sites85 target enrollmentMarch 1, 2018

ConditionsMetastatic or Locally Advanced Solid Tumors and Cervical Cancer MedDRA version: 20.0Level: 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: 85
Status: Active, not recruiting
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

March 1, 2018

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Agenus Inc.

Eligibility Criteria

Inclusion Criteria

•Inclusion Criteria: Dose Escalation (Safety Cohort)
•1\. Signed written informed consent.
•2\. Age \= 18 years.
•3\. Histologically or cytologically proven metastatic or locally advanced solid tumors for which no standard therapy exists or standard therapy has failed. Availability of tumor archival material or fresh biopsies is optional for subjects in dose escalation.
•4\. ECOG performance status of 0 to 1 at trial entry and estimated life expectancy of \= 3 months.
•5\. Evidence of objective disease. A measurable lesion is not necessary.
•6\. Adequate hematological function, defined as white blood cell (WBC) count \=3 × 10e9/L; absolute neutrophil count (ANC) \= 1\.5 × 10e9/L; lymphocyte count \= 0\.5 × 10e9/L; platelet count \=100 × 10e9/L; and hemoglobin \= 9 g/dL (may have been transfused).
•7\. Adequate hepatic function, defined as total bilirubin \= 1\.5 × upper limit of normal (ULN); AST\= 2\.5 × ULN; and ALT \=2\.5 × ULN. For subjects with documented metastatic disease to the liver, AST and ALT: \=5 × ULN.
•8\. Adequate renal function, defined as estimated creatinine clearance \>50 mL/min according to Cockcroft\-Gault formula or measured 24\-hour creatinine clearance (or local institutional standard method).
•9\. Effective contraception for both male and female subjects if risk of conception exists (Section 0\).

Exclusion Criteria

•Exclusion Criteria (Dose Escalation and Expansion Cohorts)
•1\. Concurrent treatment with a non\-permitted drug (Section 6\.5\.2\).
•2\. Prior therapy with 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. For subjects with metastatic melanoma, prior treatment with CTLA\-4–blocking antibody is permissible.
•3\. Concurrent anticancer treatment (e.g., cytoreductive therapy, radiotherapy except for palliative bone\-directed radiotherapy, immune therapy, or cytokine therapy except for erythropoietin) within 28 days before start of trial treatment; major surgery within 28 days before start of trial treatment (excluding prior diagnostic biopsy); use of hormonal agents within 7 days before start of trial treatment, except for subjects with castration\-resistant prostate cancer, who may remain on treatment with luteinizing hormone–releasing hormone agonists or antagonists; or use of any investigational drug within 28 days before start of trial treatment.
•Note: Small molecule or antibody targeted therapy is permissible \<14 days from start of trial treatment.
•4\. Subjects receiving immunosuppressive agents (such as steroids) for any reason should be tapered off these drugs 14 days before initiation of study treatment. Steroids with no or minimal systemic effect (topical, inhalation) are allowed.
•Note: Subjects receiving bisphosphonate or denosumab are eligible provided that treatment was initiated \=14 days before first dose of AGEN2034\.
•Note: Use of inhaled or topical corticosteroid use is permitted.
•Note: Steroid pre\-medication for radiographic imaging for dye allergies is permitted.
•5\. Previous malignant disease (other than target malignancy to be investigated in this trial) within last 5 years, with the exception of basal or squamous cell carcinoma of the skin.