ADA-011 + PD(L)-1 Inhibitor for Solid Tumors
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing ADA-011 alone and with another drug to see if it is safe and can be tolerated by patients. It focuses on people who might not respond to usual treatments. ADA-011 aims to boost the immune system to fight cancer more effectively.
Will I have to stop taking my current medications?
The trial requires that you stop taking any local or systemic cancer treatments, including chemotherapy, hormonal therapy, or radiation, at least 2 weeks before starting the trial. If you are using corticosteroids, you must not exceed 10 mg daily of prednisone or equivalent within 4 weeks before the trial.
What safety information is available for ADA-011 and PD(L)-1 inhibitors in humans?
PD-L1 inhibitors, like durvalumab, are generally safe for most patients with solid tumors, but some people may experience side effects like lung inflammation, liver inflammation, colon inflammation, nerve problems, and heart inflammation. These treatments can also cause skin and mouth issues, and when used with certain other drugs, they might lead to severe immune-related side effects.12345
How is the ADA-011 + PD(L)-1 inhibitor drug different from other treatments for solid tumors?
The ADA-011 + PD(L)-1 inhibitor drug is unique because it combines a novel agent, ADA-011, with a PD(L)-1 inhibitor, which is part of a class of drugs that help the immune system recognize and attack cancer cells. This combination may offer a new approach to treating solid tumors by enhancing the body's immune response against cancer.678910
What data supports the effectiveness of the drug ADA-011 + PD(L)-1 inhibitor for solid tumors?
Are You a Good Fit for This Trial?
This trial is for adults with advanced solid tumors that can't be removed or have come back after treatment, and there's no standard therapy left to try. They should be fairly active (ECOG ≤2), have measurable tumor growth, and their organs must work well. People with severe autoimmune diseases, unresolved side effects from past cancer treatments (except hair loss), infections including COVID-19, recent antineoplastic therapies or surgeries, high-dose steroid use, organ transplants, brain disease involvement or serious drug-related brain toxicity are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
ADA-011 monotherapy and combination therapy with a PD(L)-1 inhibitor are administered intravenously every 3 weeks at escalating doses to determine safety and tolerability
Dose Expansion
ADA-011 monotherapy is administered at the recommended phase 2 dose to further evaluate safety, tolerability, and preliminary efficacy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ADA-011
- PD(L)-1 inhibitor
Find a Clinic Near You
Who Is Running the Clinical Trial?
Adanate, Inc
Lead Sponsor