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Advanced/Metastatic Solid TumorsPhase 1NCT05277402

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

A Phase 1 study testing ADG116 in people with Advanced/Metastatic Solid Tumors, run by Adagene Inc at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a Phase 1b, open-label, dose escalation study to evaluate the safety, tolerability, PK, and immunogenicity of an ADG116-pembrolizumab combination regimen in patients with advanced/metastatic solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced/Metastatic Solid Tumors
What is being tested?
ADG116
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
2 sitesUnited States
Study dates
9 Feb 2022to 1 Dec 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must meet all of the following inclusion criteria to be eligible for participation in this study:
  • ≥ 18 years of age at the time of informed consent.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 with no deterioration over the previous 2 weeks.
  • Patients with advanced or metastatic solid tumors, histologically or pathologically confirmed, who have progressed after all standard therapies, or for whom no further standard therapy exists. Patients who have declined standard therapy or have no access to standard therapy may be enrolled and the reasons for lack of access need to be documented.
  • Patients should have at least 1 measurable lesion at baseline according to the definition of RECIST v1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
  • Patients previously treated with anti-CTLA 4 checkpoint inhibitors or anti programmed cell death 1 (PD-1)/L1 will also be recruited if they meet all eligibility criteria. For anti-PD-1/L1 patients, patients must have progressed on treatment with an anti PD 1/L1 monoclonal antibody (mAb) administered either as monotherapy, or in combination with other checkpoint inhibitors or other therapies. Anti PD-1/L1 treatment progression is defined by meeting all of the following criteria:
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  • Has received at least 2 doses of an approved anti-PD-1/L1 mAb.
  • Has demonstrated disease progression (PD) after PD-1/L1 as defined by RECIST v1.1. The initial evidence of PD is to be confirmed by a second assessment no less than 4 weeks from the date of the first documented PD, in the absence of rapid clinical progression.
  • Progressive disease has been documented within 12 weeks from the last dose of anti-PD-1/L1 mAb.
  • Progressive disease is determined according to iRECIST. ii. This determination is made by the Investigator. Once PD is confirmed, the initial date of PD documentation will be considered the date of disease progression.
  • Adequate hematologic function, defined by the following:
  • Absolute neutrophil count (ANC) ≥ 1.5 × 109/L, without the use of granulocyte colony stimulating factor such as filgrastim within 2 weeks prior to study treatment.
  • Platelet count ≥ 100 × 109/L without transfusion within 2 weeks (≤ 14 days) prior to study treatment.
  • Hemoglobin ≥ 9 g/dL without transfusion or erythropoietin within 2 weeks (≤ 14 days) prior to study treatment.
  • Aspartate transaminase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN), and total bilirubin ≤ 1.5 × ULN. Exceptions: Patients who have serum bilirubin increases due to documented underlying Gilbert's Syndrome or familial benign unconjugated hyperbilirubinemia may be enrolled. Patients with known liver metastases or patients with hepatocellular carcinoma may be enrolled with AST, ALT, and/or total bilirubin ≤ 5 × the ULN.
  • Adequate renal function defined by either a creatinine clearance ≥ 45 mL/min (by Cockcroft-Gault formula) or serum creatinine (SCr) ≤ 1.5 × ULN
  • Coagulation tests, defined by the following:
  • Activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN.
  • International normalized ratio (INR) ≤ 1.5 × ULN. Exception: INR 2 to ≤ 3 × ULN is acceptable for patients on Warfarin anticoagulation.
  • Left ventricular ejection fraction (LVEF) ≥ 50% measured by multiple-gated acquisition (MUGA) or echocardiogram (ECHO.).
  • Previous antitumor therapy (including endocrine, chemoradiotherapy/ radiotherapy, targeted therapy, or immunotherapy) that has ended at least 4 weeks prior to administration of ADG116. Focal radiation therapy for symptom relief must have been completed at least 2 weeks prior to the first dose of ADG116. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤ 2 weeks of radiotherapy) to non-CNS disease. Exception: hormonal therapy for prostate cancer is allowed (Section 6.7).
  • Previous AEs have been improved to baseline or Grade ≤ 1 NCI CTCAE v5.0 (except for patients with alopecia). Participants with Grade ≤ 2 neuropathy may be eligible. Participants with endocrine-related AEs Grade ≤ 2 requiring treatment or hormone replacement may be eligible.

Who cannot join

  • Patients who meet any of the following criteria cannot be enrolled:
  • Pregnant or breastfeeding females.
  • Females of childbearing potential and males whose partners are of childbearing potential who do not agree to the use of 2 forms of highly effective contraception during the treatment period and for 6 months after the last dose of study drug.
  • Treatment with any investigational drug within 4 weeks prior to the first dose of study drug.
  • Grade ≥ 3 immune-related AEs (irAEs) or irAE that lead to discontinuation of prior immunotherapy.
  • Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.
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  • History of severe hypersensitivity (Grade ≥ 3) or known to be allergic to protein drugs or recombinant proteins or any ingredients contained in the ADG116 or pembrolizumab drug formulation.
  • Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
  • Patients requiring systemic treatment with corticosteroids (>10 mg/day prednisone or equivalent) or other immunosuppressive medications within 21 days before the planned first dose of study drug. Ophthalmologic, nasal, inhaled and intra-articular injections of steroids are allowed.
  • Patients receiving granulocyte colony stimulating factor (G-CSF), granulocyte macrophage colony stimulating factor (GM-CSF), erythropoietin, or blood (red blood cell [RBC] or platelet) transfusion within 14 days prior to the first dose of the study drug.
  • Any evidence of underlying liver dysfunction due to other causes; Any history of significant alcohol abuse, alcoholic or drug-induced hepatitis, or documented nonalcoholic steatohepatitis.
  • Active viral (any etiology) hepatitis patients are excluded. Hepatitis B virus (HBV) carriers are ineligible. Cured Hepatitis C (HCV) (negative HCV ribonucleic acid [RNA] test) patients may be enrolled after consulting with the Medical Monitor.
  • Any uncontrolled active infections requiring systemic antimicrobial treatment (viral, bacterial, or other), or uncontrolled or poorly controlled diabetes as evidenced by Screening (baseline) HbA1c≥ 7.5, asthma, chronic obstructive pulmonary disease (COPD), or other conditions that pose a risk to the patient participating on study.
  • Has a known history of HIV infection.
  • Patients with any type of primary immunodeficiency or autoimmune disorder requiring treatment.
  • Major surgery within 4 weeks prior to the first dose of the study drug.
  • Has had an allogeneic tissue/solid organ transplant.
  • Clinically significant cardiac conditions, including myocardial infarction within the last 6 months, uncontrolled angina, viral myocarditis, pericarditis, cerebrovascular accident, or other acute uncontrolled heart disease <3 months prior to the first dose of the study drug; LVEF <50%, New York Heart Association (NYHA) Class III or IV congestive heart failure, or uncontrolled hypertension.
  • Patients with underlying hemoglobinopathies (e.g., thalassemia) will be excluded.
  • Pulmonary embolism or deep vein thrombosis within 3 months prior to the first dose of study drug.
  • Has received a COVID-19 vaccine within 7 days prior to the first dose of study treatment. Has received any other live or live-attenuated vaccine within 30 days prior to the first dose of study treatment. Note: Administration of killed vaccines are allowed.
  • Has received a positive COVID-19 test within 14 days of Cycle 1 Day 1.
  • Has a history of (non-infectious) pneumonitis / interstitial lung disease that required steroids or has current pneumonitis / interstitial lung disease.
  • Any known, documented, or suspected history of illicit substance abuse.
  • Any other disease or clinically significant abnormality in laboratory parameters, including serious medical or psychiatric illness/condition, which in the judgment of the Investigator might compromise the safety of the patient or integrity of the study, interfere with the patient participation in the trial or compromise the trial objectives.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Carolina BioOncology Institute

    Huntersville, North Carolina, 28078

  • Next Oncology

    San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: A Phase 1b, Open-Label, Dose Escalation Study of ADG116 in Combination With Pembrolizumab (Anti-PD-1 Antibody) in Patients With Advanced/Metastatic Solid Tumors

This is a Phase 1b, open-label, dose escalation study to evaluate the safety, tolerability, PK, and immunogenicity of an ADG116-pembrolizumab combination regimen in patients with advanced/metastatic solid tumors. Study drug ADG116, is an anti -CTLA-4 fully human monoclonal antibody that specifically binds to human CTLA-4. Pembrolizumab is a PD-1 receptor-blocking antibody (a humanized IgG4 monoclonal antibody) which is indicated for the treatment of patients across a number of indications. The treatment strategy of using anti-PD 1 therapy combined with anti-CTLA-4 therapy is to explore the potential of combination checkpoint inhibition regimens for the enhanced antitumor efficacy results.

Being tested
ADG116

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ADG116Drug

    Also called Pembrolizumab (KEYTRUDA®)

    IV infusion

Study groups in NCT05277402
Study groupRoleWhat they receive
Dose escalationExperimentalADG116 combination treatment with pembrolizumab (KEYTRUDA®), both drugs will be administered in each cohort.
Receives: Drug: ADG116

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Number of participants experiencing dose-limiting toxicities escalating dose levels in adults with advanced / metastatic solid tumor

    Measured: 9 months

  2. The safety and tolerability of ADG116 in combination with pembrolizumab

    Number of participants with adverse events as assessed by CTCAE v5.0

    Measured: 9 month

Secondary outcomes (4)

  1. Pharmacokinetic (PK) profile/parameters

    Area under the time concentration curve (AUC) from time zero to infinity (AUC0-inf)

    Measured: 9 Months

  2. Maximum (peak) plasma concentration (Cmax)

    Maximum (peak) plasma concentration (Cmax)

    Measured: 9 months

  3. Time to maximum (peak) concentration (Tmax)

    Time to maximum (peak) concentration (Tmax) Time to maximum (peak) concentration (Tmax)

    Measured: 9 month

  4. Trough concentration (Ctrough)

    Trough concentration (Ctrough)

    Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2022
  2. Study start9 Feb 2022
  3. Primary completion1 Aug 2022
  4. Study completion1 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05277402
Sponsor's protocol ID
ADG116-P001
Other IDs
KEYNOTE-C97/MK-3475-C97
Status last verified
Feb 2024
First submitted
9 Feb 2022
Last updated
26 Feb 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ADG116 in people with Advanced/Metastatic Solid Tumors, run by Adagene Inc at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting toxicity (DLT) and RP2D of ADG116 in combination with pembrolizumab. (time frame: 9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05277402.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2024.

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