What side effects are associated with this type of intervention?

Common treatments for solid tumors, such as chemotherapy and immunotherapy, have well-documented side effects. Chemotherapy can cause nausea, vomiting, fatigue, hair loss, and increased infection risk due to bone marrow suppression. Immunotherapy, including checkpoint inhibitors, may lead to immune-related adverse events like colitis, pneumonitis, hepatitis, and endocrinopathies. Investigational therapies, like ADA-011, may present a range of side effects, often including fatigue, gastrointestinal disturbances, and immune-related effects, depending on their specific mechanisms of action.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of solid tumors, particularly those involving immunotherapy and targeted therapy. For instance, pembrolizumab and nivolumab are checkpoint inhibitors approved for various solid tumors, including melanoma and non-small cell lung cancer. Targeted therapies like dabrafenib and trametinib have been approved for BRAF-mutant melanoma. Additionally, drugs like gemtuzumab ozogamicin, an immunoconjugate targeting CD33, have been approved for specific cancer types such as acute myeloid leukemia. These approvals highlight the FDA's focus on innovative treatments that target specific pathways or enhance the immune response against cancer cells.

What other types of research exist?

Promising novel alternatives for solid tumor patients in 2024 include: 1) Pembrolizumab, an immune checkpoint inhibitor, which has shown efficacy in various cancers including non-small-cell lung cancer. 2) Alectinib and Ceritinib, which are ALK inhibitors effective in ALK-positive non-small-cell lung cancer. 3) Ivosidenib, a mutant-IDH1 inhibitor, showing promise in IDH1-mutant gliomas. 4) Vorasidenib, a dual mutant-IDH1/2 inhibitor, currently in phase III trials for IDH1/2-mutant gliomas. These therapies represent advancements in targeted and immunotherapy approaches for solid tumors.

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Monoclonal Antibodies

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

Phase 1

Waitlist Available

Research Sponsored by Adanate, Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 36 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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).

What are the potential side effects?

Potential side effects include typical reactions to immune therapies like inflammation in various organs which might cause symptoms depending on the area affected (e.g., lung inflammation causing breathlessness), fatigue, possible infusion-related reactions such as fever or chills during administration of the drug(s), as well as risks associated with PD(L)-1 inhibitors.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Dose-Limiting Toxicities (DLTs)

Number of Participants Who Experienced an Adverse Event (AE)

Secondary study objectives

Pharmacokinetic (PK) Profile of Participants Treated with ADA-011 (AUC)

Pharmacokinetic (PK) Profile of Participants Treated with ADA-011 (Cmax)

Other study objectives

Number of Participants Positive for Anti-Drug Antibodies (ADA) After Treatment with ADA-011

Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for solid tumors include chemotherapy, immunotherapy, and targeted therapy. Chemotherapy works by killing rapidly dividing cancer cells, but it can also affect normal cells, leading to side effects. Immunotherapy, such as checkpoint inhibitors, enhances the body's immune response against cancer cells by blocking proteins that prevent immune cells from attacking tumors. Targeted therapy involves drugs designed to target specific molecules involved in cancer cell growth and survival, minimizing damage to normal cells. These mechanisms are crucial for solid tumor patients as they offer different approaches to control tumor growth, improve survival rates, and potentially reduce side effects compared to traditional treatments. The study of ADA-011, particularly in combination with checkpoint inhibitors, highlights the ongoing efforts to enhance the efficacy and safety of immunotherapy in treating solid tumors.