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Agenus C-500-01: Study to evaluate the safety, pharmacokinetics, and pharmacodynamics of an anti-CTLA-4 human monoclonal antibody (AGEN1884), and to estimate the maximum tolerated dose in subjects with advanced or refractory cancer

Description

In phase 2, the selected combined dose level of AGEN2034 and AGEN1884, established in part A, will be administered for a maximum of two years or until confirmed progression, unacceptable toxicity, or any criterion for stopping the study drugs or withdrawal from the trial occurs. Cancer Treatment Centers of America® (CTCA) is participating in phase 2, part B: Cervical.

Status

Accepting new patients

Primary Study Objective(s)

The purpose of this trial is to assess the safety and tolerability of AGEN1884 in combination with AGEN2034 in subjects with metastatic and/or locally advanced solid tumors.

The objective of phase 2 of the trial is to assess the best overall response (BOR), as determined by the Independent Endpoint Review Committee (IERC), according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).

Core eligibility

Note: This is only a partial list of eligibility criteria.

Including patients who:

  • Sign informed consent
  • Are 18 years of age or older
  • Have a histological or cytological diagnosis of solid cancer or lymphoma that is considered incurable and without therapies with established benefit. (Biopsy is not necessary for subjects with known prior diagnosis and clinical or radiographic evidence of recurrence.)
  • Have an Eastern Cooperative Oncology Group score of 0 or 1
  • Have a life expectancy of more than 12 weeks
  • Have adequate cardiac function (≤New York Heart Association [NYHA] Class II)
  • Have adequate organ function defined as absolute neutrophil count ≥1,500×10^6/L, absolute lymphocyte count ≥500/mm^3, and platelet count ≥100,000×10^6/mm^3 (Adequate liver function defined as aspartate aminotransferase and alanine aminotransferase ≤2.5× the upper limit of institutional normal, bilirubin ≤1.5 mg/dL or 25 µmol/L. Adequate renal function defined as blood urea nitrogen and serum creatinine of ≤1.5 mg/dL or 130 µmol/L.)
  • Are female subjects of childbearing potential and fertile male subjects who agree to use adequate contraception or abstain from sexual activity from the time of consent through 90 days after the end of study drug (Adequate contraception includes: condoms with contraceptive foam,  oral, implantable, or injectable contraceptives, contraceptive patch, intrauterine device, diaphragm with spermicidal gel, or a sexual partner who is surgically sterilized or postmenopausal.)

Excluding patients who:

  • Are currently participating and receiving trial therapy or have participated in a trial of an investigational agent and received trial therapy or used an investigation device within three weeks of the first dose of treatment
  • Have received prior systemic cytotoxic chemotherapy, biological therapy, hormone therapy, or radiation therapy or major surgery, within three weeks of the first dose of trial treatment (In the case of the subject receiving long-acting or depot hormone therapy, a decision can be made by the medical monitor to shorten this exclusion period. This does not include hormonal contraceptive medications to prevent pregnancy and/or control uterine bleeding.)
  • Have received 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 (Note: In Phase 1, prior treatment with a CTLA-4 antibody is permissible for subjects with metastatic melanoma.)
  • Has persisting toxicity related to prior therapy of National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 (NCI-CTCAE) Grade >1 severity  (Note: Sensory neuropathy of Grade ≤2 is acceptable.)