What is the mechanism of action of this treatment?

Common treatments for solid tumors, such as immune checkpoint inhibitors like pembrolizumab, work by enhancing the body's immune response against cancer cells. Pembrolizumab blocks the PD-1 pathway, which tumors use to hide from the immune system, thereby allowing immune cells to recognize and attack the cancer. Novel agents like ADG126 are designed to complement these effects, potentially by targeting additional pathways or further boosting the immune response. This approach is significant for solid tumor patients as it offers a more targeted treatment, potentially leading to better outcomes and fewer side effects compared to traditional therapies.

What side effects are associated with this type of intervention?

Pembrolizumab, a PD-1 inhibitor, is commonly associated with side effects such as fatigue, rash, pruritus, diarrhea, and nausea. More serious immune-mediated side effects can include pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis. Novel agents like ADG126, which are still under investigation, may have additional side effects that are being evaluated for safety and tolerability, but common concerns include infusion reactions, immune-related adverse events, and organ-specific toxicities.

What prior FDA approvals exist?

Pembrolizumab, a PD-1 inhibitor, has received FDA approval for treating various solid tumors, including non-small cell lung cancer (NSCLC), melanoma, and endometrial cancer. It is often used in combination with chemotherapy or other targeted therapies to enhance the immune response against tumors. For example, pembrolizumab combined with chemotherapy has improved overall survival in NSCLC and triple-negative breast cancer. Additionally, pembrolizumab has been combined with lenvatinib for advanced endometrial cancer. These combinations aim to boost the immune system's ability to fight cancer, similar to the ADG126-pembrolizumab combination being studied.

What other types of research exist?

Promising alternatives to the ADG126-pembrolizumab combination for solid tumors include: 1) Atezolizumab plus bevacizumab and chemotherapy, which has shown efficacy in non-small-cell lung cancer (NSCLC) and other solid tumors. 2) Nivolumab combined with relatlimab, which has demonstrated improved outcomes in melanoma. 3) Cemiplimab monotherapy, which has shown promise in NSCLC with high PD-L1 expression. These combinations and monotherapies are supported by clinical trial data and represent potential options for solid tumor treatment in 2024.

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ADG126 + Pembrolizumab for Advanced Cancer

Phase 1 & 2

Recruiting

Research Sponsored by Adagene 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 9 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a combination of two drugs, ADG126 and Pembrolizumab, in patients with advanced or metastatic solid tumors. ADG126 helps activate immune cells to attack cancer by targeting a specific protein. Pembrolizumab boosts the immune response by blocking another protein that usually stops immune cells from attacking cancer. The goal is to see if this combination is safe and effective for these patients.

Who is the study for?

Adults over 18 with advanced or metastatic solid tumors that have worsened after standard treatments, or when no other standard treatments are available. Participants must be in good physical condition (ECOG status 0 or 1), have at least one measurable tumor, and adequate organ function. A recent tumor biopsy is needed for enrollment.

What is being tested?

The trial tests a combination of ADG126 and Pembrolizumab to assess safety, tolerability, how the body processes the drugs (pharmacokinetics), and immune response in patients with advanced cancer. It's an early-phase study where doses will be increased to find the right balance between effectiveness and safety.

What are the potential side effects?

Potential side effects may include reactions related to the immune system since both drugs target it to fight cancer. This can lead to inflammation in various organs, infusion-related reactions, fatigue, possible changes in blood counts leading to higher infection risk among others.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 9 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~9 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 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

Access the preliminary antitumor activity of ADG126-pembrolizumab combination regimens

Maximum tolerated dose (MTD) and RP2D for ADG126 in combination with pembrolizumab.

the safety and tolerability of ADG126 at escalating dose level in combination with pembrolizumab in adults with advanced metastatic solid tumors

Secondary study objectives

Incidence of ADAs

Maximum (peak) plasma concentration (Cmax)

Pharmacokinetic (PK) profile/parameters

+5 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: ADG126 in combination with Pembrolizumab (Trade name KEYTRUDA®)Experimental Treatment1 Intervention

An IV infusion of ADG126 over 60-90 minutes will be administered 30-60 minutes after administration of pembrolizumab (KEYTRUDA®) infusion. A treatment cycle will consist of 21 days.

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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, such as immune checkpoint inhibitors like pembrolizumab, work by enhancing the body's immune response against cancer cells. Pembrolizumab blocks the PD-1 pathway, which tumors use to hide from the immune system, thereby allowing immune cells to recognize and attack the cancer. Novel agents like ADG126 are designed to complement these effects, potentially by targeting additional pathways or further boosting the immune response. This approach is significant for solid tumor patients as it offers a more targeted treatment, potentially leading to better outcomes and fewer side effects compared to traditional therapies.