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New drug duo aims to shrink Hard-to-Treat tumors

NCT ID NCT05405595

Disease control Sponsor: Adagene Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new drug called ADG126 combined with pembrolizumab (a standard immunotherapy) in people with advanced or metastatic solid tumors that have not responded to other treatments. The goal is to find the safest dose and see if the combination can shrink tumors. About 186 adults will take part in this early-phase trial.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 186 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2022

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. ≥18 years of age at the time of informed consent. 2. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. 3. Wash out period from previous antitumor therapies 4. At least 1 measurable lesion at baseline according to the definition of RECIST v1.1. 5. Adequate organ function. 6. An archival tumor biopsy is required and should be taken within 2 years of enrollment. If not available, a fresh tumor biopsy is acceptable. 7. 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. 8. Dose Expansion Phase Only: Tumor tissues (archived tissue) before treatment are required for all patients. Exclusion Criteria: 1. Pregnant or breastfeeding females. 2. Childbearing potential who does not agree to the use of contraception during the treatment period. 3. Treatment with any investigational drug within washout period. 4. Prior treatment with a PD-1, PD-L1 targeting agent or a next-generation anti-CTLA-4 therapy with enhanced ADCC function. 5. History of significant irAEs or irAE. 6. Central nervous system (CNS) disease involvement. 7. History or risk of autoimmune disease. 8. Patients requiring systemic treatment with corticosteroids or other immunosuppressive medications (\>10 mg/day prednisone or equivalent). 9. Any uncontrolled active infections requiring systemic antimicrobial treatment (viral, bacterial, or other), or uncontrolled or poorly controlled, asthma, chronic obstructive pulmonary disease (COPD). 10. Major surgery within 4 weeks prior to the first dose of the study drug. 11. Has had an allogeneic tissue/solid organ transplant. 12. 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. 13. A positive COVID-19 test within 14 days of Cycle 1 Day 1. 14. History of Hypersensitivity or known to be allergic to protein drugs or recombinant protein. 15. Active hemoptysis or central airway invasion by metastatic tumor.

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Conditions

The condition(s) this trial relates to.

colorectal cancer metastatic malignant neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced/metastatic solid tumors

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    16 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Asan Medical Center

    RECRUITING

    Seoul, 05505, South Korea

  • CHA Bundang Medical Center, CHA university

    RECRUITING

    Seongnam, Gyeonggido, 13496, South Korea

  • Chungbuk National University Hospital

    RECRUITING

    Cheongju-si, North Chungcheong, 28644, South Korea

  • City of Hope National Medical Center

    RECRUITING

    Duarte, California, 91010, United States

  • City of Hope Orange County

    RECRUITING

    Irvine, California, 92618, United States

  • Dong -A University Hospital

    TERMINATED

    Seogu, Busan Gwangyeogsi, 49201, South Korea

  • Florida cancer specialist/Sarah Cannon Research Institute

    ACTIVE_NOT_RECRUITING

    Sarasota, Florida, 34232, United States

  • Fred Hutchinson Cancer Center

    RECRUITING

    Seattle, Washington, 98109, United States

  • Fujian Cancer Hospital

    RECRUITING

    Fuzhou, Fujian, China

  • Hong Kong Humanity & Health Clinical Trial Center

    RECRUITING

    Hong Kong, Hong Kong, China

  • Honor Health Research Institute

    RECRUITING

    Scottsdale, Arizona, 85251, United States

  • KangBuk Samsung Hospital

    TERMINATED

    Seoul, 03081, South Korea

  • Keimyung University Dongsan Hospital

    TERMINATED

    Daegu, 41931, South Korea

  • MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Prince of Wales Hospital

    RECRUITING

    Hong Kong, Hong Kong, China

  • Samsung Medical Center

    RECRUITING

    Seoul, Seoul Teugbyeolsi, 06351, South Korea

  • Seoul National University Hospital

    RECRUITING

    Seoul, 03080, South Korea

  • Severance Hospital Yonsei University Health System

    RECRUITING

    Seoul, 3722, South Korea

  • SunYat-Sen University Cancer Center

    RECRUITING

    Guangzhou, Guangdong, China

  • The Catholic University of Korea Street. Vincent Hospital

    TERMINATED

    Suwon, Gyeonggido, 16247, South Korea

  • The Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195-0001, United States

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