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New hope for pancreatic cancer: targeted drug combo enters human trials

NCT ID NCT07444541

Disease control Sponsor: Anova Innovation Limited 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jul 28, 2026 · Updated 3 times

Summary

This study tests a new biologic drug called ANO31905 combined with standard chemotherapy as a first treatment for people with advanced pancreatic cancer that has a specific marker (CLDN18.2). The trial has two phases: first to find a safe dose, then to see if the combination shrinks tumors. About 84 participants will be enrolled, and treatment may last up to 2 years.

What this could mean

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

Active substance
ANO31905 (a biologic drug) combined with chemotherapy (gemcitabine and nanoparticle albumin-bound paclitaxel)
What this could lead to
If it works, this could offer a new first-line treatment option for people with a specific type of advanced pancreatic cancer, potentially shrinking tumors and extending life.
What could go wrong
This is an early-phase trial (Phase 1/2) with only 84 participants, so results are preliminary. The drug may cause serious side effects like cytokine release syndrome, and it may not work better than standard chemotherapy alone.

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 84 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Dec 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. Males or females aged ≥ 18 at the time of signing the ICF; 2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1; 3. Expected survival ≥ 3 months; 4. Histologically or cytologically confirmed diagnosis of pancreatic ductal adenocarcinoma; 5. At least one measurable lesion according to RECIST v1.1; 6. Tumor tissue samples are determined to be CLDN18.2-positive by immunohistochemistry (IHC) in the central laboratory; 7. Patients with sufficient organ function within 7 days before the first study dose; 8. Non-pregnant or -lactating women. Exclusion Criteria: 1. Patients with other malignant tumors except pancreatic adenocarcinoma within 5 years before the first dose of the study treatment; Any previous systematic anti-cancer therapy 2. Any previous systematic anti-cancer therapy; 3. Previous treatment targeting CLDN18.2; 4. Patients with a history of active autoimmune disorders or autoimmune disorders requiring systemic treatment; 5. Patients with known hypersensitivity to any component or excipient of ANO31905, gemcitabine, and nanoparticle albumin-bound paclitaxel; 6. Patients with known metastases to the central nervous system; 7. Patients with severe cardiovascular and cardiovascular diseases; 8. Presence risks of thrombosis or bleeding; 9. Patients who have received attenuated live vaccines within 28 days before the first study dose or are expected to receive attenuated live vaccines during study treatment; 10. Patients with gastrointestinal diseases that are not suitable for enrollment as judged by the investigator; 11. Patients with other conditions that may place the patients at increased undue study-related risks.

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Conditions

The condition(s) this trial relates to.

malignant pancreatic neoplasm pancreatic ductal adenocarcinoma pancreatic neoplasm

As listed by the trial registrant

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

Pancreatic cancer

How to take part

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

  1. The places running it

    1 site. 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

  • California Research Institute

    RECRUITING

    Los Angeles, California, 90027, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.