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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
≥18 years of age at the time of informed consent
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 months
Awards & highlights

Study Summary

This trial is testing a new combination drug regimen for safety, tolerability, how it is processed by the body, and its ability to provoke an immune response in patients with advanced solid tumors.

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.Check my eligibility
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.See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I have never received immunotherapy.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Incidence of ADAs
Maximum (peak) plasma concentration (Cmax)
Pharmacokinetic (PK) profile/parameters
+5 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Activated partial thromboplastin time prolonged
5%
Intractable pain, back pain, hip pain
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Skin rash
2%
Thrombocytopenia
2%
Respiratory failure
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

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.

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
3,868 Previous Clinical Trials
5,051,857 Total Patients Enrolled
Adagene IncLead Sponsor
10 Previous Clinical Trials
810 Total Patients Enrolled
Jiping zha, MDStudy ChairAdagene Inc

Media Library

ADG126 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05405595 — Phase 1 & 2
Solid Tumors Research Study Groups: ADG126 in combination with Pembrolizumab (Trade name KEYTRUDA®)
Solid Tumors Clinical Trial 2023: ADG126 Highlights & Side Effects. Trial Name: NCT05405595 — Phase 1 & 2
ADG126 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05405595 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has ADG126 been endorsed by the Federal Drug Administration?

"ADG126's safety profile has been deemed as a 1 due to its Phase 1 status, which implies that there is limited evidence of its efficacy and minimal data regarding safety."

Answered by AI

What main goals is this trial attempting to achieve?

"Merck Sharp & Dohme LLC, the primary sponsor of this study, has outlined a few objectives to be measured over 9 months. These include dose-limiting toxicity (DLT) and recommended phase 2 dosing (RP2D) in combination with pembrolizumab. Additionally, secondary outcomes like time to maximum concentration (Tmax), area under the time concentration curve from zero to infinity (AUC0-inf), as well as median survival times will also be assessed."

Answered by AI

How many individuals have been recruited for this trial thus far?

"Affirmative. Clinicaltrials.gov documents indicate that this medical trial, which first appeared on June 15th 2022, is actively recruiting participants. The study requires 102 people to be recruited from 2 distinct clinical sites."

Answered by AI

Is this clinical experiment open for enrollment?

"Affirmative, the listing on clinicaltrials.gov alludes to this experiment being open for recruitment at present. The trial was initially posted on June 15th 2022 and has been updated recently on July 22nd 2022. There is need for 102 participants distributed across two research sites."

Answered by AI
~48 spots leftby Mar 2025