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RecruitingLast updated: 14 August 2026

DB-1317-101: Testing different dose levels of a new medicine called DB-1317 in people with advanced or metastatic solid cancers that have progressed after previous treatment.A Phase 1a/1b, Multicenter, Open-Label, First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1317 in Participants With Selected Advanced/Metastatic Solid Tumors

Trial purpose

Medical clipboardCancer treatment

Tumor type

Multi-Cancer Multi-Cancer

Age

People18+

Trial acronym

DB-1317-101

Clinical summary

Summary

This study is testing a new experimental cancer medicine called DB-1317 in people with advanced or metastatic solid tumours.

Who  can take part?
You may be eligible for this study if:

  • you have an advanced solid cancer that has spread (metastatic) or is unable to be removed through surgery (unresectable)
  • your cancer has progressed during or after standard treatment, or standard treatment is no longer suitable for you

The study has two parts.

Phase 1a: Finding the safest dose
The first part of the study aims to find the safest and most appropriate dose of DB-1317. Participants will receive DB-1317 as an infusion every 3 weeks. Small groups of participants will receive increasing doses so researchers can monitor side effects and determine the highest dose that can be given safely.

During the first treatment cycle (21 days), participants will be closely monitored for significant side effects. Once a participant starts a particular dose level, they will usually remain at that dose throughout treatment.

Researchers may also explore different dosing schedules, such as giving the treatment every 2 weeks, if earlier results show this may be safe.

Phase 1b: Further testing in specific cancers
Once a suitable dose has been identified, the study will expand to include more participants with selected cancer types.

The aim is to learn more about:

  • The safety of DB-1317
  • How well people tolerate the treatment
  • Whether the treatment shows signs of shrinking or controlling cancer

The study plans to enrol people with selected solid tumours that may respond to DB-1317. These may include:

  • Stomach (gastric) cancer
  • Bowel (colorectal) cancer
  • Pancreatic cancer

Some participants will be randomly assigned to different dose levels, while others will receive a single selected dose. Researchers may also open additional groups for other cancer types if promising results are seen during the study.

What participation involves
Participants may:

  • Receive DB-1317 by infusion during regular treatment cycles
  • Attend study visits for physical examinations, blood tests and scans
  • Be monitored closely for side effects
  • Continue receiving treatment while it remains safe and their cancer does not get worse

Conditions

This trial is treating people with advanced, metastatic or unresectable solid cancers

Eligibility

Inclusion

  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

Exclusion

  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.

Inclusion

  • You have had treatment, but your cancer has come back (relapsed or recurrent).
  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • Your cancer has not spread to other parts of the body, but it is not possible to perform surgery to remove it (unresectable).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

DualityBio Inc.

Scientific Title

A Phase 1a/1b, Multicenter, Open-Label, First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1317 in Participants With Selected Advanced/Metastatic Solid Tumors

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