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Experimental pancreatic cancer combo trial halted early

NCT ID NCT04643405

Disease control Sponsor: Ascentage Pharma Group Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tested an experimental drug called APG-1387 combined with standard chemotherapy (gemcitabine and nab-paclitaxel) in people with advanced pancreatic cancer. The goal was to find the safest dose and see if the combination could shrink tumors. However, the trial was terminated early after enrolling only 21 participants, so the full results are not available.

What this could mean

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

Active substance
APG-1387 (an experimental drug) plus gemcitabine and nab-paclitaxel (standard chemotherapy)
What this could lead to
If successful, this combination could offer a new treatment option for advanced pancreatic cancer patients who have failed standard therapy.
What could go wrong
The trial was terminated early with only 21 participants, so results are limited. The drug combination may cause significant side effects, and it is unclear if it improves survival.

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

21 people

The number who actually took part.

Started

Mar 2021

Finished

Dec 2024

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. Subjects must be ≥18 years of age at time of informed consent 2. Able to comply with the study protocol, in the investigator's judgment 3. Expected survival ≥ 3 months 4. Histology or cytology confirmed as advanced pancreatic adenocarcinoma, and: * Standard treatment failed or intolerant to standard treatment(Phase Ib); * First line standard treatment failed (Phase II). 5. ECOG 0-1; 6. Adequate organ function. 7. Subjects must have at least one measurable lesion evaluated by Computed Tomography (CT) scan on RECIST ver.1.1 at pre-treatment Exclusion Criteria: 1. Has had chemotherapy, radiation, target or other antitumor therapy within 14 days prior to the first dose of study drug. 2. Has received an investigational agent or used an investigational device within 28 days of the first dose of study drug. 3. Has received a therapy with TNFα within 28 days of the first dose of study drug. 4. Known active central nervous system involvement. 5. Has received IAP-inhibitor before. 6. Has had major surgery within 28 days of dosing of investigational agent, or minor surgery within 14 days. 7. Patients with clinically evident Hepatitis B surface antigen (HBs) positive, Hepatitis C virus (HCV) antibody positive, Human Immunodeficiency Virus (HIV) antibody positive. 8. Pregnant or breastfeeding (lactating) women. 9. Other situations that investigator think not suit for study.

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Conditions

The condition(s) this trial relates to.

exocrine pancreatic carcinoma malignant pancreatic neoplasm pancreatic adenocarcinoma pancreatic neoplasm

As listed by the trial registrant

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

Advanced pancreatic cancer

Contacts and locations

Locations

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032, China

More trials for these conditions

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