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Double-Action antibody takes on Hard-to-Treat neuroendocrine cancers

NCT ID NCT05879055

Disease control Sponsor: Biotheus 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 09, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This phase II trial tests a new drug called PM8002, a bispecific antibody that targets two proteins (PD-L1 and VEGF) involved in tumor growth and immune evasion. It is given together with standard chemotherapy (FOLFIRI) to people with advanced neuroendocrine tumors that have worsened after initial platinum-based chemotherapy. The study aims to see if the combination can shrink tumors and control the disease, while monitoring side effects.

What this could mean

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

Active substance
PM8002 (a bispecific antibody targeting PD-L1 and VEGF) combined with FOLFIRI chemotherapy
What this could lead to
If successful, this combination could offer a new second-line treatment option for people with aggressive neuroendocrine tumors that have stopped responding to initial chemotherapy.
What could go wrong
This is an early phase II study with only 31 participants, so results may not apply to all patients. The combination may cause side effects, and the treatment may not shrink tumors or improve 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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

31 people

The number who actually took part.

Started

May 2023

Expected to finish

Jan 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. Signed informed consent form before any trial-related processes; 2. Aged ≥ 18 years; 3. Ki-67≥55% G3 NET and NEC were confirmed histologically or cytologically by pathological diagnosis in this study; 4. Subjects failed first-line platinum-based chemotherapy; 5. Adequate organ function; 6. The Eastern Cancer Cooperative Group (ECOG) performance score of 0 or 1; 7. Expected survival ≥ 12 weeks; 8. Had at least one measurable tumor lesion according to RECIST v1.1; Exclusion Criteria: 1. History of severe allergic disease, severe drug allergy or have known allergy to any component of the study drugs; 2. Evidence and history of severe bleeding tendency; 3. History of severe cardiovascular diseases within 6 months; 4. Subjects should provide formalin-fixed-paraffin-embedded (FFPE) tumor samples during the screening period (up to 24 months); 5. Current presence of uncontrolled pleural, pericardial, and peritoneal effusions; 6. History of allogeneic hematopoietic stem cell transplantation or allogeneic organ transplantation; 7. History of alcohol abuse, psychotropic substance abuse or drug abuse; 8. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome; 9. Pregnant or lactating women; 10. Other conditions considered unsuitable for this study by the investigator.

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Conditions

The condition(s) this trial relates to.

neuroendocrine carcinoma neuroendocrine neoplasm

As listed by the trial registrant

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

Neuroendocrine neoplasm

Contacts and locations

Locations

  • Chinese PLA General Hospital

    Beijing, China

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing Municipality, China

  • Fujian Province Cancer Hospital

    Fuzhou, Fujian, China

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, China

  • Hunan Cancer Hospital

    Changsha, Hunan, China

  • Jingzhou First People's Hospital

    Jingzhou, Hubei, China

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu, China

  • Shandong Cancer Hospital

    Jinan, Shandong, China

  • The Central Hospital of Yongzhou

    Yongzhou, Hunan, China

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, China

  • Union Hospital Tongji Medical College of Hust

    Wuhan, Hubei, China

  • Yunnan Cancer Hospital (The Third Affiliated Hospital of Kunming Medical University)

    Kunming, Yunnan, China

  • ZhongShan Hospital Fudan University

    Shanghai, China

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