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New antibody drug targets Hard-to-Treat cancers in early trial

NCT ID NCT05482893

Disease control Sponsor: Phanes Therapeutics 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 10, 2026 · Updated 3 times

Summary

This study tests a new drug called Spevatamig (PT886) in people with advanced stomach, pancreatic, or bile duct cancers that have spread or cannot be removed by surgery. The drug is a type of antibody that targets two proteins on cancer cells to help the immune system attack them. The trial will first find the safest dose, then test it alone or combined with chemotherapy or an immunotherapy drug. About 258 participants will take part to see if the drug is safe and shows signs of shrinking tumors.

What this could mean

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

Active substance
Spevatamig (PT886), a bispecific antibody targeting Claudin 18.2 and CD47, given alone or with chemotherapy (paclitaxel, gemcitabine, Abraxane) or an immune checkpoint inhibitor (pembrolizumab)
What this could lead to
If successful, this could lead to a new treatment option for people with advanced stomach, pancreatic, or bile duct cancers that have not responded to standard therapies.
What could go wrong
This is an early-phase trial (Phase 1/2) with a small number of participants, so safety and effectiveness are not yet proven. The drug may cause side effects or fail to shrink tumors.

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 258 people

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

Started

Mar 2023

Expected to finish

Apr 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. 18 years or older and able to sign informed consent and comply with the protocol. 2. Measurable disease as defined by RECIST V1.1 criteria for solid tumors. 3. 3\. Part A and Part B: Histologically or cytologically confirmed unresectable advanced or metastatic solid gastric, gastroesophageal junction (GEJ), biliary tract or pancreatic carcinomas previously treated for advanced (metastatic or unresectable) disease or for which treatment is not available or not tolerated. Part C, substudy C1: 2L m/a GC/GEJ-C patients will receive Spevatamig (PT886) in combination with Paclitaxel. Patients who are HER2 positive are eligible. Part C, substudy C2: 1L m/a PDAC patients will receive Spevatamig (PT886) in combination with Gemcitabine plus nab-Paclitaxel (Abraxane). Part C, substudy C3: 1L m/a PDAC patients will receive Spevatamig (PT886) in combination with Gemcitabine plus FOLFIRINOX/mFFX. Part C, substudy C4: Patients with m/a BTC who have progressed on 1L SOC chemotherapy (GemCis) ± ICI and are eligible for 2L SOC FOLFOX treatment. Part D, substudy D3: 2L or 3L m/a GC/GEJ-C patients will receive Spevatamig (PT886) in combination with KEYTRUDA® (pembrolizumab). Part D, substudy D4: 1L HER2 negative m/a GC/GEJ-C patients will receive Spevatamig (PT886) in combination with SOC chemotherapy and KEYTRUDA® (pembrolizumab). 4. Able to provide a formalin fixed, paraffin embedded (FFPE) tumor tissue sample (preferably fresh biopsy or if not possible, archival tissue) to be assessed for CLDN18.2 expression and other biomarkers. 5. ECOG performance status of 0 or 1. 6. Adequate organ function confirmed at screening and within 72 hours of initiating treatment. Key Exclusion Criteria Patients are excluded from the study if any of the following criteria apply: 1. Women who are pregnant or lactating. 2. Women of child-bearing potential (WOCBP) who do not use adequate birth control. 3. Has an active autoimmune disease that has required systemic treatment in the past 2 years. 4. Prior CLDN18.2 or CD47 targeting therapies, or SIRPα (signal regulatory protein alpha) targeting agents. Additional inclusion and exclusion criteria will apply.

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Conditions

The condition(s) this trial relates to.

biliary tract cancer Biliary Tract Neoplasms gastric adenocarcinoma gastroesophageal adenocarcinoma gastroesophageal junction adenocarcinoma pancreatic ductal adenocarcinoma

As listed by the trial registrant

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

Biliary tract cancer (BTC) Gastric or gastroesophageal junction adenocarcinoma Pancreatic ductal adenocarcinoma

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    10 sites. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • City of Hope (City of Hope National Medical Center, City of Hope Medical Center)

    RECRUITING

    Duarte, California, 91010, United States

  • Dana-Farber Cancer Institute (DFCI)

    ACTIVE_NOT_RECRUITING

    Boston, Massachusetts, 02215, United States

  • Duke Cancer Center

    RECRUITING

    Durham, North Carolina, 27710, United States

  • MD Anderson Cancer Center, GI Medical Oncology Dept

    RECRUITING

    Houston, Texas, 77030, United States

  • NEXT Oncology

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Norton Cancer Institute

    RECRUITING

    Louisville, Kentucky, 40202, United States

  • Sarah Cannon Research Institute (SCRI)

    RECRUITING

    Denver, Colorado, 80218, United States

  • USC Norris Comprehensive Cancer Center

    RECRUITING

    Los Angeles, California, 90033, United States

  • University of Iowa

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • University of Pittsburgh Medical Center (UPMC)

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

  • University of Wisconsin Carbone Cancer Center - University Hospital

    RECRUITING

    Madison, Wisconsin, 53792, United States

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