This study is an open-label, Phase 1, multicenter study to evaluate the safety, tolerability,
PK, and PD profiles of AGEN2373 as a monotherapy and in combination with botensilimab (also
known as AGEN1181), and to assess the maximum tolerated dose (MTD) in subjects with advanced
This Phase 1 study will enroll up to approximately 200 evaluable adult patients with a
histologically confirmed diagnosis of advanced cancer for which no standard therapy is
available or standard therapy has failed, regardless of diagnosis and prior therapies. This
also includes patients with PD-1/PD-L1 R/R melanoma. Patients may be enrolled into one of 5
2-Week AGEN2373 monotherapy
3-Week AGEN2373 monotherapy
4-Week AGEN2373 monotherapy
Combination of AGEN2373 and botensilimab in patients with programmed cell death protein 1
(PD-1)/programmed death-ligand 1 (PD-L1) relapsed/refractory (R/R) melanoma.
Group 1 (Monotherapy Lead-in Combination): Q3W AGEN2373 lead-in followed by Q3W AGEN2373 in
combination with Q6W botensilimab. (AGEN2373 will be administered on Day 1 every 3 weeks.
Starting with Cycle 4 Day 1, botensilimab will be added as combination therapy and
administered every other cycle (Cycles 4, 6, 8, 10, etc.). (Botensilimab is administered
every 6 weeks.)
Group 2 (Combination): AGEN2373 will be administered Q3W in combination with botensilimab
administered every other cycle. (Botensilimab is administered every 6 weeks.)
The trial will consist of a 3+3 dose escalation that will evaluate different combination dose
levels of AGEN2373 monotherapy and in combination with botensilimab. Each patient will stay
on the dose level and schedule assigned at trial entry. Patients will receive treatment for ≤
2 years (i.e., maximum of 34 cycles) (AGEN2373) as monotherapy and botensilimab ≤ 1 year
(i.e., maximum of 8 doses) as combination therapy with AGEN2373 ≤ 2 years (i.e., maximum of
34 cycles), or until progressive disease, unacceptable toxicity, or any criterion for
stopping the study drug or withdrawal of trial occurs.
Patients who do not complete the DLT observation period (28 days for the 2-Week and 4-Week
AGEN2373 Monotherapy arms and 21 days for the 3-Week AGEN2373 Monotherapy and Combination
arms) after the first dose for reasons other than DLT will be replaced.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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