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Advanced/Metastatic Solid TumorsPhase 1/2NCT05405595

ADG126 in Combination With Pembrolizumab in Patients With Advanced/Metastatic Solid Tumors

A Phase 1/2 study testing ADG126 and Pembrolizumab (KEYTRUDA®) in people with Advanced/Metastatic Solid Tumors, run by Adagene Inc at 21 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a Phase 1b/2, open-label, dose escalation, dose expansion and dose optimization study to evaluate the safety, tolerability, PK, and immunogenicity of ADG126-pembrolizumab combination regimens 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?
ADG126 and Pembrolizumab (KEYTRUDA®)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
186 participants
Where
21 sitesin 3 countries
Study dates
15 Jun 2022to 31 Dec 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

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

  • ≥18 years of age at the time of informed consent.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  • Wash out period from previous antitumor therapies
  • At least 1 measurable lesion at baseline according to the definition of RECIST v1.1.
  • Adequate organ function.
  • An archival tumor biopsy is required and should be taken within 2 years of enrollment. If not available, a fresh tumor biopsy is acceptable.
  • For Dose Escalation Phase Only: Patients with histologically or cytologically confirmed, locally advanced or metastatic solid tumors, who have progressed after all standard therapies, or for whom no further standard therapy exists.
  • Dose Expansion Phase Only: Tumor tissues (archived tissue) before treatment are required for all patients.

Who cannot join

  • Pregnant or breastfeeding females.
  • Childbearing potential who does not agree to the use of contraception during the treatment period.
  • Treatment with any investigational drug within washout period.
  • Prior treatment with a PD-1, PD-L1 targeting agent or a next-generation anti-CTLA-4 therapy with enhanced ADCC function.
  • History of significant irAEs or irAE.
  • Central nervous system (CNS) disease involvement.
Show all 15Show fewer
  • History or risk of autoimmune disease.
  • Patients requiring systemic treatment with corticosteroids or other immunosuppressive medications (>10 mg/day prednisone or equivalent).
  • Any uncontrolled active infections requiring systemic antimicrobial treatment (viral, bacterial, or other), or uncontrolled or poorly controlled, asthma, chronic obstructive pulmonary disease (COPD).
  • Major surgery within 4 weeks prior to the first dose of the study drug.
  • Has had an allogeneic tissue/solid organ transplant.
  • Has received a COVID-19 vaccine within 7 days prior to the first dose of study treatment. Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study treatment. Note: Administration of killed vaccines are allowed.
  • A positive COVID-19 test within 14 days of Cycle 1 Day 1.
  • History of Hypersensitivity or known to be allergic to protein drugs or recombinant protein.
  • Active hemoptysis or central airway invasion by metastatic tumor.

Trial locations and contacts

21 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Xiaohong She, MS contact

408-838-9296

kristine_she@adagene.com

Jiping Zha, MD, PhD contact

650-785-9347

jiping_zha@adagene.com

21 sites in 3 countries

South Korea10 sites, 6 recruiting

  • Chungbuk National University Hospital

    Cheongju-si, North Chungcheong, 28644

    Ki Hyeong Lee, MD

    Hee Kyung Kim, MD

    Recruiting

  • Keimyung University Dongsan Hospital

    Daegu, 41931

    Terminated

  • Dong -A University Hospital

    Seogu, Busan Gwangyeogsi, 49201

    Terminated

  • CHA Bundang Medical Center, CHA university

    Seongnam, Gyeonggido, 13496

    Hing Jae Chon, MD

    Song I Kang

    Recruiting

  • Samsung Medical Center

    Seoul, Seoul Teugbyeolsi, 06351

    Byoung Yong Shim, MD

    Jee Yun Lee, MD

    Recruiting

  • Seoul National University Hospital

    Seoul, 03080

    Seock -Ah Im, MD

    Sae Won Han, MD

    Recruiting

  • KangBuk Samsung Hospital

    Seoul, 03081

    Terminated

  • Asan Medical Center

    Seoul, 05505

    Sun Young Kim, MD

    Ko Eun- Young

    Recruiting

  • Severance Hospital Yonsei University Health System

    Seoul, 3722

    Sang Joon Shin, MD

    Da Seul Lee

    Recruiting

  • The Catholic University of Korea Street. Vincent Hospital

    Suwon, Gyeonggido, 16247

    Terminated

Other trials in South Korea

United States7 sites, 6 recruiting

  • The Cleveland Clinic

    Cleveland, Ohio, 44195-0001

    Smitha Krishnamurthi, MD

    Recruiting

  • City of Hope National Medical Center

    Duarte, California, 91010

    Daneng Li, MD

    Marwan Fakih, MD

    Recruiting

  • MD Anderson Cancer Center

    Houston, Texas, 77030

    David Hong, MD

    Mary Trahan

    Recruiting

  • City of Hope Orange County

    Irvine, California, 92618

    Pashtoon Kasi, MD

    Recruiting

  • Florida cancer specialist/Sarah Cannon Research Institute

    Sarasota, Florida, 34232

    Active, not recruiting

  • Honor Health Research Institute

    Scottsdale, Arizona, 85251

    Sharma Sunil, MD

    Recruiting

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109

    Rachael Safyan, MD

    Recruiting

Other trials in United States

China4 sites, 4 recruiting

  • Fujian Cancer Hospital

    Fuzhou, Fujian

    Yu Chen, MD

    Recruiting

  • SunYat-Sen University Cancer Center

    Guangzhou, Guangdong

    Ruihua Xu, MD

    Recruiting

  • Hong Kong Humanity & Health Clinical Trial Center

    Hong Kong, Hong Kong

    George Lau, MD

    Recruiting

  • Prince of Wales Hospital

    Hong Kong, Hong Kong

    Brigette B.Y Ma, MD

    Recruiting

Other trials in China

About this study

Official title: A Phase 1b/2, Open-Label, Dose Escalation and Expansion Study of ADG126 in Combination With Pembrolizumab (Anti PD-1 Antibody) in Patients With Advanced/Metastatic Solid Tumors

This is a Phase 1b/2, open-label, dose escalation, dose expansion and dose optimization study to evaluate the safety, tolerability, PK, and immunogenicity of ADG126-pembrolizumab combination regimens in patients with advanced/metastatic solid tumors.

The study drug ADG126 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).

Read the detailed description

This is a Phase 1b/2, open-label, multicenter, dose escalation, dose expansion and dose optimization study to evaluate the safety, tolerability, PK, and preliminary efficacy of ADG126-Pembrolizumab or ADG126-Pembrolizumab in combination with trifluridine/tipiracil-bevacizumab or fruquintinib in patients with advanced/metastatic solid tumors, with a focus on MSS CRC.

In Phase 2, the study will use a randomized design to evaluate the dose optimization regimen in patients with MSS CRC for ADG126- Pembrolizumab doublet only.

Being tested
ADG126, Pembrolizumab (KEYTRUDA®), Standard of Care (Trifluridine/Tipiracil-Bevacizumab), Standard of care (Fruquintinib)
Keywords
ADG126-P001

What participants receive

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

  • ADG126Drug

    ADG126 is an anti-CTLA-4 fully human monoclonal antibody that specifically binds to human CTLA-4.

  • Pembrolizumab (KEYTRUDA®)Drug

    Also called KEYTRUDA®

    Pembrolizumab (KEYTRUDA®) is a PD-1 receptor-blocking antibody (a humanized IgG4 monoclonal antibody).

  • Standard of Care (Trifluridine/Tipiracil-Bevacizumab)Drug

    Also called Lonsurf and Avastin

    The standard of care therapies will include Trifluridine/Tipiracil-Bevacizumab, approved for treating metastatic colorectal cancer (CRC)and various solid tumors.

  • Standard of care (Fruquintinib)Drug

    Also called Fruzaqla

    The standard of care therapy, Fruquintinib, is approved for treating metastatic colorectal cancer (CRC) and various solid tumors.

Study groups in NCT05405595
Study groupRoleWhat they receive
ADG126 in combination with Pembrolizumab (Trade name KEYTRUDA®)ExperimentalAn 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. ADG126 and Pembrolizumab (KEYTRUDA®) combination treatment both will be dosed until progressive disease (PD), intolerable toxicities, withdrawals of consent, or up to 35 cycles.
Receives: Drug: ADG126; Drug: Pembrolizumab (KEYTRUDA®)
ADG126 and pembrolizumab (KEYTRUDA®) in combination with Trifluridine/Tipiracil-BevacizumabExperimentalTo evaluate the preliminary antitumor efficacy of ADG126 and Pembrolizumab (KEYTRUDA®) in combination with SOC (Trifluridine/Tipiracil-Bevacizumab) while assessing safety and tolerability. Standard of care treatment will be administered according to the specifications outlined in the Investigational Brochure. Will be dosed until progressive disease (PD), intolerable toxicities, withdrawals of consent, or up to 35 cycles.
Receives: Drug: ADG126; Drug: Pembrolizumab (KEYTRUDA®); Drug: Standard of Care (Trifluridine/Tipiracil-Bevacizumab)
ADG126 and pembrolizumab (KEYTRUDA®) in combination with fruquintinibExperimentalTo evaluate the preliminary antitumor efficacy of ADG126 and Pembrolizumab (KEYTRUDA®) in combination with SOC (Fruquintinib) while assessing safety and tolerability. The dose strength for treatment will be based on the IB and protocol. Fruquintinib (Fruzaqla) is orally given once daily for the first 21 days of each 28-day cycle. Each treatment cycle consists of 14 days. Will be dosed until progressive disease (PD), intolerable toxicities, withdrawals of consent, or up to 35 cycles.
Receives: Drug: ADG126; Drug: Pembrolizumab (KEYTRUDA®); Drug: Standard of care (Fruquintinib)
Dose OptimizationExperimentalThe randomized phase 2 Dose Optimization arm is intended to test two dosing regimens of ADG126 in combination with pembrolizumab (KEYTRUDA®), which allows the selection of an optimal regimen. The study treatments may continue for up to 35 treatments for pembrolizumab (KEYTRUDA®) if given every 21 days and 18 treatments for pembrolizumab (KEYTRUDA®) if given every 42 days until PD, intolerable toxicities or withdrawal of consent.
Receives: Drug: ADG126; Drug: Pembrolizumab (KEYTRUDA®)

What is being measured

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

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

    To determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) for ADG126+ pembrolizumab in dose escalation levels

    Measured: 9 months

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

    Incidence rate of AEs as assessed by CTCAE v5.0

    Measured: 9 months

  3. Access the preliminary antitumor activity of ADG126-pembrolizumab combination regimens

    Number of Participants with preliminary antitumor activity

    Measured: 9 months

  4. Maximum tolerated dose (MTD) and/or RP2D for ADG126 with Trifluridine/Tipiracil-Bevacizumab

    To assess the safety and tolerability of ADG126 + pembrolizumab in combination with the following SOC therapies (Trifluridine/tipiracil-bevacizumab) in MSS CRC

    To determine the MTD and/or RP2D for ADG126 + pembrolizumab in combination with the following SOC therapies in MSS CRC:

    Measured: 6 months

  5. Access the preliminary antitumor activity of ADG126 with Pembrolizumab in combination standard of care

    To assess the preliminary antitumor activity of ADG126 + pembrolizumab in combination with the following SOC therapies in MSS CRC (Trifluridine/tipiracil-bevacizumab)

    SOC (Fruquintinib)

    Measured: 6 months

  6. Access and characterize the optimal dose based on safety and efficacy parameters

    To characterize the optimal dose based on safety and efficacy parameters

    Measured: 9 months

Secondary outcomes (9)

  1. Pharmacokinetic (PK) profile/parameters

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

    Measured: From first dose (Cycle 1 Day 1,) until the last dose (up to 2 years)

  2. Maximum (peak) plasma concentration (Cmax)

    Maximum (peak) plasma concentration (Cmax)

    Measured: From first dose (Cycle 1 Day 1,) until the last dose (up to 2 years)

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

    Time to maximum (peak) concentration (Tmax)

    Measured: From first dose (Cycle 1 Day 1,) until the last dose (up to 2 years)

  4. Trough concentration (Ctrough)

    Trough concentration (Ctrough)

    Measured: From first dose (Cycle 1 Day 1,) until the last dose (up to 2 years)

  5. Incidence of ADAs

    this will be summarized for all patients who received at least 1 administration of ADG126. efficacy and safety will be evaluated.

    Measured: From first dose (Cycle 1 Day 1,) until the last dose (up to 2 years)

  6. To assess the disease control rate (DCR)

    this will be calculated as the proportion/percentage of patients with best overall response of CR,PR,SD or progressive disease will be calculated.

    Measured: From first dose (Cycle 1 Day 1,) until the last dose (up to 2 years)

  7. To assess the progression free survival (PFS)

    PFS will be censored at the time of the last evaluable tumor assessment (RECISTv1.1 and iRECIST)

    Measured: From first dose (Cycle 1 Day 1,) until the last dose (up to 2 years)

  8. To assess the overall survival (OS)

    This will be used to estimate median survival times where applicable.

    Measured: From first dose (Cycle 1 Day 1,) until the last dose (up to 2 years)

  9. To assess the efficacy outcomes in the defined patient population

    The dose optimization arm will be used to access the efficacy outcome derived in the defined patient population

    Measured: From first dose (Cycle 1 Day 1,) until the last dose (up to 2 years)

Timeline

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

  1. First posted6 Jun 2022
  2. Study start15 Jun 2022
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
186 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05405595
Sponsor's protocol ID
ADG126-P001
Other IDs
KEYNOTE-C98, MK-3475-C98
Status last verified
Oct 2026
First submitted
16 May 2022
Last updated
2 Nov 2026
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 1/2 study testing ADG126 and Pembrolizumab (KEYTRUDA®) in people with Advanced/Metastatic Solid Tumors, run by Adagene Inc at 21 sites in 3 countries.

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 8 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in South Korea, United States, China. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact Xiaohong She, MS (408-838-9296, kristine_she@adagene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose (MTD) and RP2D for ADG126 in combination with pembrolizumab. (time frame: 9 months). The study lists 6 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 NCT05405595.

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 2 Nov 2026.

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