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Monoclonal Antibodies

ADG116 for Solid Tumors

Q: What is the desired outcome of this medical experiment?

<p>Merck Sharp &#x26; Dohme LLC have provided the primary outcome that will be assessed over a 9-month period: dose-limiting toxicity (DLT) and RP2D of ADG116 in combination with pembrolizumab. As for secondary outcomes, there are measurements related to maximum plasma concentration (Cmax), pharmacokinetic profile/parameters such as area under the time concentration curve (AUC0-inf), and time to reach maximum peak concentration (Tmax).</p>

Phase 1

Waitlist Available

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 month

Awards & highlights

Study Summary

This trial is testing a new cancer treatment that combines two existing drugs. The goal is to see if the combination is more effective than either drug alone.

Eligible Conditions

Solid Tumors

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 9 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~9 month

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Dose-limiting toxicity (DLT) and RP2D of ADG116 in combination with pembrolizumab.

The safety and tolerability of ADG116 in combination with pembrolizumab

Secondary outcome measures

Maximum (peak) plasma concentration (Cmax)

Pharmacokinetic (PK) profile/parameters

Time to maximum (peak) concentration (Tmax)

+1 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183

21%

Fatigue

13%

Nausea

11%

Back pain

Shortness of Breath

Anemia

Abdominal pain

Diarrhea

Pneumonia

Kidney Injury and/or Infection

Dyspnea

Weight Loss

Malnutrition, Hypercalcemia and Weakness

Pneumothorax

Intractable pain, back pain, hip pain

Activated partial thromboplastin time prolonged

Pleural effusion

Atrial fibrillation with rapid ventricular response

Thrombocytopenia

Respiratory failure

Skin rash

colitis

100%

80%

60%

40%

20%

Study treatment Arm

Single Arm

Trial Design

1Treatment groups

Experimental Treatment

Group I: Dose escalationExperimental Treatment1 Intervention

ADG116 combination treatment with pembrolizumab (KEYTRUDA®), both drugs will be administered in each cohort.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Adagene IncLead Sponsor

10 Previous Clinical Trials

935 Total Patients Enrolled

Merck Sharp & Dohme LLCIndustry Sponsor

3,886 Previous Clinical Trials

5,054,547 Total Patients Enrolled

Jiping Zha, MDStudy ChairAdagene Inc

Frequently Asked Questions

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

What potential hazards are posed by ADG116 for human health?

"Due to the limited data available, our team has assigned ADG116 a score of 1 concerning safety. This is due to it being in its first phase of clinical trials and not having much evidence supporting efficacy or safety."

Answered by AI

What is the current patient population of this clinical research endeavor?

"Affirmative. Per the clinicaltrials.gov page, this medical research is currently searching for participants after being initially posted on February 9th 2022 and updated as recently as March 23rd 2022. This endeavour needs 12 patients to be recruited from two distinct centres of care."

Answered by AI

What is the desired outcome of this medical experiment?

"Merck Sharp & Dohme LLC have provided the primary outcome that will be assessed over a 9-month period: dose-limiting toxicity (DLT) and RP2D of ADG116 in combination with pembrolizumab. As for secondary outcomes, there are measurements related to maximum plasma concentration (Cmax), pharmacokinetic profile/parameters such as area under the time concentration curve (AUC0-inf), and time to reach maximum peak concentration (Tmax)."

Answered by AI

Does this research project accept new participants?

"Yes, this research trial is still looking for participants. As evidenced on clinicaltrials.gov, the study was first announced in February of 2022 and last modified in March of that same year."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

ADG116 in Combination With Pembrolizumab in Patients With Advanced/Metastatic Solid Tumors

2022. "ADG116 in Combination With Pembrolizumab in Patients With Advanced/Metastatic Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05277402.