46 Participants Needed

ADA-011 + PD(L)-1 Inhibitor for Solid Tumors

Recruiting at 5 trial locations
SD
Overseen ByStudy Director
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

Research shows that PD-1/PD-L1 inhibitors have been successful in treating lung cancer, suggesting potential benefits for other solid tumors. These inhibitors work by helping the immune system attack cancer cells more effectively.79111213

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

My cancer is advanced, cannot be surgically removed, and is getting worse despite treatment.
Measurable disease per RECIST v1.1 or per other criteria best suited for the specific tumor type being evaluated
My organs are working well.
See 1 more

Exclusion Criteria

I do not have any ongoing serious infections.
All my side effects from cancer treatment are mild, except for hair loss.
History or risk of severe, chronic, untreated, or currently active autoimmune disease
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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

21 days (cycle 1) for initial evaluation, up to 36 months for ongoing assessment
Every 3 weeks

Dose Expansion

ADA-011 monotherapy is administered at the recommended phase 2 dose to further evaluate safety, tolerability, and preliminary efficacy

Up to 36 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • ADA-011
  • PD(L)-1 inhibitor
Trial Overview The study tests ADA-011 alone and combined with a checkpoint inhibitor in people with advanced solid tumors. It starts by finding the safest dose of ADA-011 (dose escalation) and then checks its safety and early results on tumor control at this dose in more patients (dose expansion).
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Group I: Combination Therapy Dose EscalationExperimental Treatment2 Interventions
Combination therapy with ADA-011 and PD(L)-1 inhibitor (at escalating ADA-011 doses) will be administered IV Q3W, starting with Cycle 1, Day 1 in participants with histologically or cytologically confirmed solid tumors.
Group II: ADA-011 Monotherapy Dose ExpansionExperimental Treatment1 Intervention
ADA-011 monotherapy with the preliminary recommended phase 2 dose (RP2D) of ADA-011, in participants with histologically or cytologically confirmed solid tumors.
Group III: ADA-011 Monotherapy Dose EscalationExperimental Treatment1 Intervention
ADA-011 monotherapy will be administered intravenously (IV), every 3 weeks (Q3W) at escalating doses starting with Cycle 1, Day 1, until participant withdrawal. Participants enroll with histologically or cytologically confirmed solid tumors.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Adanate, Inc

Lead Sponsor

Trials
1
Recruited
50+

Published Research Related to This Trial

A total of 686 clinical trials are currently investigating anti-PD-(L)1 agents for intrathoracic tumors, with a significant focus on non-small cell lung cancer (NSCLC), indicating a robust interest in this area of immunotherapy.
The majority (81%) of these trials are exploring combination treatments, often pairing PD-(L)1 blockade with chemotherapy or other immunotherapies, highlighting a trend towards more comprehensive treatment strategies to enhance efficacy.
Current Landscape of Immunotherapy Trials Involving the Programmed Cell Death Protein 1/Programmed Death-Ligand 1 Axis in Intrathoracic Tumors.Kareff, SA., Samtani, S., Burotto, M., et al.[2022]
Soluble programmed death-1 ligand-1 (sPD-L1) levels were significantly higher in lung cancer patients compared to healthy controls, indicating its potential role as a biomarker for lung cancer.
Higher sPD-L1 levels were associated with more advanced stages of non-small cell lung cancer (NSCLC) and poorer overall health, suggesting that elevated sPD-L1 may indicate a negative prognosis for patients.
Analysis of soluble programmed death-1 ligand-1 of lung cancer patients with different characteristics.Zhu, HB., Song, X.[2023]
In a meta-analysis of 12 studies involving 1188 lung cancer patients, high levels of soluble PD-L1 (sPD-L1) were linked to significantly worse overall survival (OS) and progression-free survival (PFS) in patients receiving immune checkpoint inhibitors, indicating its potential as a negative prognostic factor.
Additionally, high sPD-L1 levels were associated with poorer OS and lower objective response rates in patients treated with non-immune checkpoint inhibitor therapies, suggesting that sPD-L1 could serve as a predictive biomarker for treatment outcomes in lung cancer.
Soluble PD-L1 as a predictive biomarker in lung cancer: a systematic review and meta-analysis.Cheng, Y., Wang, C., Wang, Y., et al.[2022]

Citations

Current Landscape of Immunotherapy Trials Involving the Programmed Cell Death Protein 1/Programmed Death-Ligand 1 Axis in Intrathoracic Tumors. [2022]
[Predictive Markers for Treating Efficacy of PD-1/PD-L1 Inhibitors in Patients with Lung Cancer: A Review of the 18th World Conference on Lung Cancer]. [2020]
An Immunohistochemical Analysis of PD-L1 Protein Expression in Surgically Resected Small Cell Lung Cancer Using Different Antibodies and Criteria. [2017]
Analysis of soluble programmed death-1 ligand-1 of lung cancer patients with different characteristics. [2023]
Soluble PD-L1 as a predictive biomarker in lung cancer: a systematic review and meta-analysis. [2022]
Anti-PD-1 and anti-PD-L1 drugs treatment-related adverse events for patients with cancer: Protocol for an overview of systematic reviews with meta-analyses. [2023]
Immune-Related Adverse Events and Their Association With the Effectiveness of PD-1/PD-L1 Inhibitors in Non-Small Cell Lung Cancer: A Real-World Study From China. [2022]
Severe immune-related adverse events are common with sequential PD-(L)1 blockade and osimertinib. [2023]
9.United Arab Emiratespubmed.ncbi.nlm.nih.gov
The Clinical Safety and Efficacy of Targeted PD-L1 Therapy with Durvalumab in Solid Tumors. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
Risk of dermatologic and mucosal adverse events associated with PD-1/PD-L1 inhibitors in cancer patients: A meta-analysis of randomized controlled trials. [2021]
The influence of plasma sPD-L1 concentration on the effectiveness of immunotherapy in advanced NSCLC patients. [2023]
Programmed death-ligand 1 expression and its associations with clinicopathological features, prognosis, and driver oncogene alterations in surgically resected lung adenocarcinoma. [2022]
Radiological Features of IDO1+/PDL1+ Lung Adenocarcinoma: A Retrospective Single-institution Study. [2021]
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