Anti-CD137 + Anti-CTLA-4 Monoclonal Antibodies for Advanced Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests new treatments for advanced solid tumors, a type of cancer that has spread or cannot be removed. The trial aims to assess the safety and tolerability of these treatments when used alone or in combination. Participants will receive either a single treatment or a combination to determine which doses are most effective with minimal side effects. The treatments being tested include AGEN1181 (Botensilimab) and AGEN2373, both monoclonal antibodies. The trial seeks individuals with certain advanced cancers for which standard treatments have failed. Those with a solid tumor that has spread and for whom treatments have not succeeded may find this trial suitable. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive these new therapies.
Do I have to stop taking my current medications to join the trial?
The trial protocol does not clearly specify if you must stop taking your current medications. However, there are specific 'washout' periods (time without taking certain medications) for some treatments, like a 3-week period for cytotoxic agents and a 4-week period for monoclonal antibodies, before starting the study treatment.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that AGEN2373, when tested alone, was generally well-tolerated by patients with solid tumors. Importantly, it did not cause liver damage, a common concern with similar treatments. Early reports also suggest positive patient responses to this treatment.
Regarding botensilimab, studies have found it effective for patients who did not respond well to other cancer treatments. It was also well-tolerated, even by those with extensive prior treatments.
While these results are promising, it is important to remember that this study is in an early phase. Researchers are still determining the best and safest dose levels. However, both treatments have demonstrated good safety in initial research.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments because they represent a novel approach for targeting advanced cancer. AGEN1181, AGEN2373, and Botensilimab are monoclonal antibodies that work by engaging the immune system in a unique way. Unlike standard treatments like chemotherapy, these drugs specifically target proteins like CD137 and CTLA-4, which play a crucial role in regulating immune responses against tumors. This dual targeting can potentially enhance the body's ability to fight cancer more effectively while possibly reducing side effects associated with standard therapies. Additionally, the combination therapies being tested may offer a synergistic effect, boosting the overall treatment efficacy.
What evidence suggests that this trial's treatments could be effective for advanced cancer?
Studies have shown that AGEN2373, one of the treatments in this trial, holds promise for treating advanced solid tumors, whether used alone or with another drug called botensilimab. AGEN2373 strengthens the body's immune response against tumors without causing liver damage, a common side effect of similar treatments. Research indicates that patients who received AGEN2373 alone experienced positive outcomes, even when other treatments failed. In this trial, some participants will receive AGEN2373 alone, while others will receive it with botensilimab to potentially enhance the immune response further. These findings suggest it could effectively fight certain advanced cancers, though more research is needed to confirm these results.15678
Who Is on the Research Team?
Medical Monitor
Principal Investigator
Agenus Inc.
Are You a Good Fit for This Trial?
Adults with advanced solid tumors that have spread or are inoperable, and who've had no success with standard treatments. They must be healthy enough overall, not pregnant, willing to use contraception, and able to provide a recent tumor tissue sample. People can't join if they've recently received certain vaccines or treatments, have severe allergies to human antibodies, uncontrolled health issues like heart disease or infections, mental incapacity, or are pregnant.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive AGEN2373 as monotherapy or in combination with botensilimab, with dose escalation to determine the maximum tolerated dose
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension (optional)
Participants may opt into continuation of treatment long-term
What Are the Treatments Tested in This Trial?
Interventions
- AGEN1181
- AGEN2373
- Botensilimab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Agenus Inc.
Lead Sponsor