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New cancer drug DB-1317 enters first human tests

NCT ID NCT07141706

Disease control Sponsor: DualityBio 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 28, 2026 · Updated 2 times

Summary

This early-phase trial is testing a new drug called DB-1317 in people with advanced solid tumors that have not responded to standard treatments. The study has two parts: first, finding a safe dose, and then expanding to see if the drug shows any signs of shrinking tumors. About 233 participants will take part across multiple centers.

What this could mean

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

Active substance
DB-1317 (a drug given by IV)
What this could lead to
If it works, this could point toward a new treatment option for people with advanced solid tumors that have stopped responding to standard therapies.
What could go wrong
This is a very early (Phase 1) trial, so the main goal is safety, not effectiveness. It may not shrink tumors or improve survival, and side effects are unknown.

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 253 people

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

Started

Sep 2025

Expected to finish

Jun 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.

Key Inclusion Criteria: 1. Male or female adults 2. Unresectable advanced or metastatic selected solid tumors that have relapsed or progressed on or after standard systemic treatments. 3. Only applicable to backfilling participants in Phase 1a and participants in Phase 1b: At least one measurable lesion as assessed by the investigator according to RECIST version 1.1 criteria. Participants with non-measurable disease are allowed for CRPC participants. 4. Has a life expectancy of ≥ 3 months. 5. Has an ECOG PS of 0-1. 6. Has LVEF ≥ 50% within 28 days before enrollment. 7. Is willing to provide pre-existing resected tumor samples or undergo fresh tumor biopsy for the measurement of ADAM9 expression level and other biomarkers if no contra-indication. 8. Male and female participants of reproductive/childbearing potential must agree to use adequate contraceptive methods Key Exclusion Criteria: 1. Prior treatment with ADAM9 targeted therapy. 2. Prior treatment with antibody-drug conjugate with topoisomerase I inhibitor. 3. Has a medical history of symptomatic congestive heart failure or serious cardiac arrhythmia requiring treatment. 4. Has a medical history of myocardial infarction or unstable angina within 6 months before enrollment. 5. Has any clinically important abnormalities in rhythm, conduction or morphology of resting ECG 6. Has an average of Fredericia's formula-QT corrected interval (QTcF) prolongation to \> 470 ms in males and females 7. Has a history of (non-infectious) ILD/pneumonitis 8. Has a lung-specific intercurrent clinically significant illness 9. Has an uncontrolled infection requiring intravenous injection of antibiotics, antivirals, or antifungals. 10. Known human immunodeficiency virus (HIV) infection;Chronic, active, or uncontrolled hepatitis B; 11. Known chronic, active, or uncontrolled hepatitis C 12. Has clinically significant corneal disease. 13. Has clinically active brain metastases 14. Has unresolved toxicities from previous anticancer therapy Concurrent malignancy \< 3 years. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

metastatic malignant neoplasm 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

    14 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

  • AUS01-0

    RECRUITING

    Randwick, New South Wales, 2031, Australia

  • AUS02-0

    RECRUITING

    Nedlands, Western Australia, 6009, Australia

  • AUS03-0

    RECRUITING

    Liverpool, New South Wales, 2170, Australia

  • AUS04-0

    RECRUITING

    Westmead, New South Wales, 2145, Australia

  • CHN03-0

    RECRUITING

    Zhengzhou, Henan, China

  • CHN04-0

    RECRUITING

    Jinan, Shandong, China

  • CHN05-0

    RECRUITING

    Harbin, Heilongjiang, China

  • Chn01-1/Chn01-2

    RECRUITING

    Guangzhou, Guangdong, 510060, China

  • Site USA06-0

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

  • USA01-0

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • USA02-0

    RECRUITING

    Houston, Texas, 77030, United States

  • USA03-0

    RECRUITING

    San Antonio, Texas, 78229, United States

  • USA04-0

    RECRUITING

    Los Angeles, California, 90025, United States

  • USA05-0

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

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