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New bispecific antibody D3L-002 enters first human trial for Hard-to-Treat cancers

NCT ID NCT07667842

Disease control Sponsor: D3 Bio (Wuxi) Co., Ltd 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 18, 2026 · Updated 1 time

Summary

This Phase 1 trial tests D3L-002, a new drug that targets two immune checkpoints (TIGIT and PVRIG) to help the immune system fight cancer. It is for 24 adults with advanced solid tumors that have not responded to standard treatments. The main goals are to check safety, find the right dose, and see early signs of tumor shrinkage.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
D3L-002 (a bispecific antibody that targets two immune checkpoints, TIGIT and PVRIG)
What this could lead to
If this early trial shows safety and hints of tumor shrinkage, it could lead to a new treatment option for people with advanced solid tumors that have stopped responding to other therapies.
What could go wrong
This is a very early Phase 1 study with only 24 people, focused on safety and dosing. It is too soon to know if D3L-002 will work against cancer, and it may cause side effects or show no benefit.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 24 people

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

Started

Jul 2026

Expected to finish

Feb 2028

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. Ability to provide written informed consent and comply with study procedures 2. Age ≥18 years 3. Histologically confirmed metastatic or locally advanced incurable solid tumor that has progressed after ≥1 line of therapy or has no available standard treatment 4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 5. Adequate organ function (hematologic, hepatic, renal) 6. Life expectancy ≥12 weeks 7. Willingness to provide tumor tissue (if available) and blood samples 8. Agreement to use effective contraception 9. Negative pregnancy test for participants of childbearing potential Exclusion Criteria: 1. Prior anti-TIGIT or anti-PVRIG therapy 2. Recent anticancer therapy without adequate washout 3. Active or uncontrolled illness 4. Interstitial lung disease/pneumonitis 5. Active Central Nervous System (CNS) disease 6. Uncontrolled effusions 7. Unresolved ≥Grade 2 toxicities 8. Severe prior immunotherapy-related toxicity 9. Active autoimmune disease 10. Active infection 11. Active hepatitis B/C or HIV 12. Recent malignancy (exceptions apply) 13. Significant cardiovascular disease 14. Immunosuppressive therapy within 14 days 15. Live vaccine within 30 days 16. Pregnancy or breastfeeding 17. Hypersensitivity to study drug 18. Investigator-determined unsuitability

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Conditions

The condition(s) this trial relates to.

neoplasm

As listed by the trial registrant

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

Advanced solid tumor

How to take part

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

  1. The places running it

    6 sites in 2 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

  • D3 Bio Investigative Site 1101

    RECRUITING

    Macquarie Park, 2109, Australia

  • D3 Bio Investigative Site 1102

    RECRUITING

    Nedlands, 6009, Australia

  • D3 Bio Investigative Site 1201

    RECRUITING

    Seoul, 06591, South Korea

  • D3 Bio Investigative Site 1202

    RECRUITING

    Seoul, 03080, South Korea

  • D3 Bio Investigative Site 1203

    RECRUITING

    Seoul, 03722, South Korea

  • D3 Bio Investigative Site 1204

    RECRUITING

    Cheongju-si, 28644, South Korea

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