ClinicalTrials.gg
RecruitingNCT07392892Updated Oct 13, 2026

Symbiotic-GI-16: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Gastroesophageal Cancer

A Phase 2/3 interventional study of PF-08634404 and Chemotherapy in Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction , or Esophageal Adenocarcinoma, Metastatic Gastric Cancer and Gastroesophageal Junction Cancer, sponsored by Pfizer. Recruiting at 102 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.

Sponsored by Pfizer · Phase 2/3, Interventional, and Treatment

From the registry’s dates

  • Started May 2026; still recruiting 6 months later.
Updated Oct 13, 2026First sites in Canada and FrancePrimary completion moved+4 moreGo to Updates ↓

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Phase
Phase 2/3
Study type
Interventional
Enrollment
840
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 27 studies in Stomach Neoplasms by Pfizer — 5 open to participants now, 7 under way, 1 of them phase 3. Stomach Neoplasms · Pfizer.

Planned enrollment
3rd of 25
840 · median 79
Started
2026
with 1 other
Phase 2/3
Only one
of the 27
Registered
26th of 27
by date

Among the 27 studies in Stomach Neoplasms by Pfizer, this one is the 3rd largest by planned enrollment of the 25 interventional ones that give a count, is one of 2 that started in 2026, is the only one in phase 2/3, and was the 26th registered.

Stomach Neoplasms

3,401 studies on the registry are indexed under Stomach Neoplasms; 993 are open to participants now.

Browse Stomach Neoplasms studies →

Open to participants now

5 of the 27 studies in Stomach Neoplasms by Pfizer are open now, in 12 countries. Recruiting first, the newest first:

By country, each count listing its studies:

All 5 open studies →

Who these studies take

Of the 704 Stomach Neoplasms studies recruiting now, 376 (53%) set no upper age limit and 194 (28%) stop at 75 or younger; 28 take children under 18; 69 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 27 studies in Stomach Neoplasms by Pfizer, or all of them as a file.
02

Study summary

This study is being done to learn more about a new medicine called PF-08634404 and how well it works when given with chemotherapy to people with gastroesophageal cancer that is locally advanced (spread to nearby tissues) or has spread to other parts of the body.

To join the study, participants must meet the following conditions:

Be 18 years or older. Have locally advanced or metastatic gastric, gastroesophageal junction or esophageal adenocarcinoma Be treatment naïve for advanced or metastatic disease Be in good physical condition and have healthy organs based on medical tests.

The study has two parts:

  • In the first part, researchers will check how safe the study medicine in combination with chemotherapy is and how well people respond to it.
  • In the second part, they will compare study medicine plus chemotherapy to another approved treatment (nivolumab plus chemotherapy) to see which works better.

The treatment will be given in repeated time periods called cycles.

03

Conditions studied

  • Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction , or Esophageal Adenocarcinoma
  • Metastatic Gastric Cancer
  • Gastroesophageal Junction Cancer
  • Esophageal Adenocarcinoma

Keywords

  • gastric cancer
  • gastroesophageal junction cancer
  • esophageal adenocarcinoma
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Histological or cytological confirmed gastric, gastroesophageal junction or esophageal adenocarcinoma.
  • Evidence of locally advanced or disease.
  • performance status (ECOG) 0-1
  • No prior systemic therapy for advanced or metastatic disease.
  • Adequate hepatic, liver, and renal function
  • negative status based on local testing
  • positive status based on local testing

Exclusion criteria

Exclusion Criteria:

  • Participants with known active , including , brainstem, meningeal, or spinal cord or compression
  • risk of hemorrhage or fistula
  • Major surgery or severe trauma within 4 weeks prior to the first dose, or planned major surgery during the study
  • History of allogeneic organ transplantation and hematopoietic stem cell transplantation.
  • Any Grade ≥3 bleeding/hemorrhage events within 28 days of Cycle 1 Day 1, or prior history of clinically significant bleeding events
  • Clinically significant cardiovascular disease, or other comorbidities, within 6 months prior to first dose
  • Participants with active diseases requiring systemic treatment within the past 2 years
  • Evidence of non-infectious or drug-induced interstitial lung disease (ILD) pneumonitis
Terms in these criteria, in plain language(9)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

HER2

HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.

In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.

PD-1, PD-L1 and checkpoint inhibitors

PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.

PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.

Brain metastases

Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).

Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.

Leptomeningeal disease

Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.

Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
840 participants (estimated)

Study arms

  • Experimental
    Phase 2 Portion

    PF-08634404 + Chemotherapy

    Biological: PF-08634404 · Drug: Chemotherapy

  • Experimental
    Phase 3: Arm A

    PF-08634404 + Chemotherapy

    Biological: PF-08634404 · Drug: Chemotherapy

  • Active comparator
    Phase 3: Arm B

    Nivolumab + Chemotherapy

    Drug: Chemotherapy · Biological: Nivolumab

Interventions

  • BiologicalPF-08634404

    Participants will receive PF-08634404 intravenously.

    Also known as: SSGJ-707

  • DrugChemotherapy

    Participants will receive PF-08634404 intravenously in combination with Chemotherapy.

  • BiologicalNivolumab

    Participants will receive Nivolumab intravenously.

06

What researchers measure

Primary outcomes

  1. Phase 2: Confirmed Objective response rate (ORR) using RECIST 1.1 as assessed by investigator

    Confirmed ORR by investigator is defined as the proportion of participants with confirmed Complete Response (CR) or Partial Response (PR) per RECIST v1.1 as assessed by investigator.

    Time frame: Approximately 4 years

  2. Phase 2: Number of participants with treatment-emergent adverse events

    Adverse Events (AEs) as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study intervention.

    Time frame: Through 90 days after the last study intervention; Approximately 4 years

  3. Phase 3: Progression Free Survival (PFS) using RECIST 1.1 as assessed by BICR

    PFS by BICR is defined as the time from the date of randomization to the date of first documented disease progression per RECIST 1.1 as assessed by BICR, or death due to any cause, whichever occurs first.

    Time frame: Approximately 4 years

  4. Phase 3: Overall Survival (OS)

    OS is defined as the time from the date of randomization to the date of death due to any cause.

    Time frame: Approximately 4 years

Secondary outcomes

  1. Phase 2: Duration of Response (DOR) using RECIST 1.1 as assessed by investigator

    DOR by investigator is defined as the time from the first documentation of objective response (CR or PR that is subsequently confirmed) to the date of first documented disease progression per RECIST 1.1 as assessed by investigator, respectively, or death due to any cause, whichever occurs first.

    Time frame: Approximately 4 years

  2. Phase 2: Progression Free Survival (PFS) using RECIST 1.1 as assessed by investigator

    PFS by investigator is defined as the time from the date of first dose to the date of first documented disease progression per RECIST 1.1 as assessed by investigator, or death due to any cause, whichever occurs first.

    Time frame: Approximately 4 years

  3. Phase 2: Overall Survival (OS)

    OS is defined as the time from the date of first dose to the date of death due to any cause.

    Time frame: Approximately 4 years

  4. Phase 2: Number of participants with laboratory abnormalities

    Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing. For laboratory tests without CTCAE grade definitions, results will be categorized as normal, high, low, or not done and be listed.

    Time frame: Through 90 days after the last study intervention; Approximately 4 years

  5. Phase 2: Serum concentrations of PF-08634404

    Predose and postdose concentrations of PF-08634404

    Time frame: Approximately 21 months

  6. Phase 2: Incidence of Anti-Drug Antibody (ADA) against PF-08634404

    Time frame: Approximately 21 months

  7. Phase 3: ORR using RECIST 1.1 as assessed by BICR

    ORR by BICR is defined as the proportion of participants with a Best Overall Response (BOR) of confirmed CR or confirmed PR per RECIST 1.1 as assessed by BICR.

    Time frame: Approximately 4 years

  8. Phase 3: ORR using RECIST 1.1 as assessed by investigator

    ORR by investigator is defined as the proportion of participants with a BOR of confirmed CR or confirmed PR per RECIST 1.1 as assessed by investigator.

    Time frame: Approximately 4 years

  9. Phase 3: Progression free survival (PFS) using RECIST 1.1 as assessed by investigator

    PFS by investigator is defined as the time from the date of randomization to the date of first documented disease progression per RECIST 1.1 as assessed by investigator, or death due to any cause, whichever occurs first

    Time frame: Approximately 4 years

  10. Phase 3: DOR using RECIST 1.1 as assessed by BICR

    DOR is defined as the time from the first documentation of objective response (CR or PR that is subsequently confirmed) to the date of first documented disease progression per RECIST 1.1 as assessed by BICR, respectively, or death due to any cause, whichever occurs first.

    Time frame: Approximately 4 years

  11. Phase 3: DOR using RECIST 1.1 as assessed by investigator

    DOR is defined as the time from the first documentation of objective response (CR or PR that is subsequently confirmed) to the date of first documented disease progression per RECIST 1.1 as assessed by investigator, respectively, or death due to any cause, whichever occurs first.

    Time frame: Approximately 4 years

  12. Phase 3: PFS2 (PFS after next-line therapy) by investigator

    PFS2 is defined as the time from the date of randomization to the date of second objective disease progression or death due to any cause, whichever occurs first

    Time frame: Approximately 4 years

  13. Phase 3: Number of participants with treatment-emergent adverse events

    AEs as characterized by type, frequency, intensity as graded by NCI CTCAE version 5.0, timing, seriousness, and relationship to study intervention(s)

    Time frame: Through 90 days after the last study intervention; Approximately 4 years

  14. Phase 3: Number of participants with laboratory abnormalities

    Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing. For laboratory tests without CTCAE grade definitions, results will be categorized as normal, high, low, or not done and be listed.

    Time frame: Through 90 days after the last study intervention; Approximately 4 years

  15. Phase 3: Serum concentrations of PF-08634404

    Predose and postdose concentrations of PF-08634404

    Time frame: Approximately 21 months

  16. Phase 3: Incidence of ADA against PF-08634404

    Time frame: Approximately 21 months

  17. Phase 3: Change from baseline in Functional Assessment of Cancer Therapy - Gastric (FACT-Ga) Total score

    Time frame: Approximately 4 years

  18. Phase 3: Time to definitive deterioration in FACT-Ga Total score

    Time frame: Approximately 4 years

  19. Phase 3: Time to definitive deterioration in Gastric Cancer Subscale (GaCS) score

    Time frame: Approximately 4 years

07

Study locations

90 of 102 sites recruiting

Showing the first 100 of 102 sites across 10 countries. Choose a country and city above to see the rest.

08

References and documents

Individual participant data

Plan to share: Yes — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Data sharing details ↗ · www.pfizer.com

09

Timeline

3 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2026 (actual). Primary completion is estimated for Jul 2031, 62 months after the start.

Of 26 phase 2/3 interventional studies under Stomach Neoplasms, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 52. This study's planned 62 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 30, 2026
First posted
Feb 6, 2026
StartActual
May 14, 2026
Primary completionEst.
Jul 22, 2031
CompletionEst.
Jul 21, 2032
Last update
Oct 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
31 sites added, 3 sites removed — first sites in Canada and France. 3 sites changed recruiting status (3 now recruiting)
Show 3 sites
  • National Cheng Kung University Hospital · Tainan, TaiwanNot yet recruiting→Recruiting
  • Hospital Universitari Vall d'Hebron · Barcelona, SpainNot yet recruiting→Recruiting
  • Hospital Universitario 12 de Octubre · Madrid, SpainNot yet recruiting→Recruiting
Show 31 added (21 United States, 3 China, 2 France, 2 Italy, 2 Spain, 1 Canada)
  • UCLA Hematology/Oncology - Atascadero · Atascadero, United States
  • UCLA Hematology/Oncology - Burbank · Burbank, United States
  • UCLA Hematology/Oncology - Encino · Encino, United States
  • UCLA Hematology/Oncology - Marina del Rey · Marina del Rey, United States
  • UCLA Hematology/Oncology - Porter Ranch · Porter Ranch, United States
  • UCLA Hematology/Oncology - San Luis Obispo · San Luis Obispo, United States
  • UCLA Hematology/Oncology - Santa Barbara · Santa Barbara, United States
  • UCLA Hematology/Oncology - Santa Monica · Santa Monica, United States
  • Florida Cancer Specialists · Daytona Beach, United States
  • Florida Cancer Specialists · Fleming Island, United States
  • Florida Cancer Specialists · Palm Beach Gardens, United States
  • Florida Cancer Specialists · Sebring, United States
  • Florida Cancer Specialists · Wellington, United States
  • Florida Cancer Specialists · West Palm Beach, United States
  • Memorial Sloan Kettering Cancer Center Pharmacy (IMP ship to address) · Long Island City, United States
  • Memorial Sloan Kettering Cancer Center Pharmacy (IMP storage location) · Long Island City, United States
  • Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street). · New York, United States
  • Rockefeller Outpatient Pavilion (53rd Street) · New York, United States
  • Memorial Sloan Kettering Cancer Center - Main Campus · New York, United States
  • London Health Sciences Centre - Verspeeten Family Cancer Centre · London, Canada
  • The Sixth Affiliated hospital, Sun Yat-sen University · Guangzhou, China
  • Hubei Cancer Hospital · Wuhan, China
  • Sichuan Cancer hospital · Chengdu, China
  • Hôpital Européen Georges Pompidou · Paris, France
  • Istituto Europeo di Oncologia IRCCS · Milan, Italy
  • Hospital Universitario 12 de Octubre · Madrid, Spain
  • Complexo Hospitalario Universitario de Ourense · Ourense, Spain
  • UCSF Helen Diller Family Comprehensive Cancer Center · San Francisco, United States
  • UCSF Investigational Drugs Pharmacy · San Francisco, United States
  • Hôpital Européen Georges Pompidou · Paris, France
  • …and 1 more on the registry record
Show 3 removed
  • Istituto Europeo di Oncologia IRCCS · Milan, Italy
  • Hôpital Européen Georges Pompidou · Paris, France
  • Istituto Europeo di Oncologia IRCCS · Milan, Italy
across 2 updates, Sep 28, 2026 – Oct 8, 2026
Primary completion
Changed, then back to Jul 22, 2031
moved 2 times, Sep 28, 2026 – Oct 13, 2026
Study completion
Changed, then back to Jul 21, 2032
moved 2 times, Sep 28, 2026 – Oct 13, 2026
Show all 3 updates
  1. Oct 13, 2026
    Primary completion Jan 15, 2032→Jul 22, 2031
    Study completion Jan 14, 2033→Jul 21, 2032
  2. Oct 8, 2026
    4 sites added, 2 sites removed. 2 sites changed recruiting status (2 now recruiting)
    Show 2 sites
    • Hospital Universitari Vall d'Hebron · Barcelona, SpainNot yet recruiting→Recruiting
    • Hospital Universitario 12 de Octubre · Madrid, SpainNot yet recruiting→Recruiting
    Show 4 added (2 United States, 1 France, 1 Italy)
    • UCSF Helen Diller Family Comprehensive Cancer Center · San Francisco, United States
    • UCSF Investigational Drugs Pharmacy · San Francisco, United States
    • Hôpital Européen Georges Pompidou · Paris, France
    • Istituto Europeo di Oncologia IRCCS · Milan, Italy
    Show 2 removed
    • Hôpital Européen Georges Pompidou · Paris, France
    • Istituto Europeo di Oncologia IRCCS · Milan, Italy
    + 1 other change: verification date
  3. Sep 28, 2026
    27 sites added, 1 site removed — first sites in Canada and France. National Cheng Kung University Hospital is now Recruiting
    Show 27 added (19 United States, 3 China, 2 Spain, 1 Canada, 1 France, 1 Italy)
    • UCLA Hematology/Oncology - Atascadero · Atascadero, United States
    • UCLA Hematology/Oncology - Burbank · Burbank, United States
    • UCLA Hematology/Oncology - Encino · Encino, United States
    • UCLA Hematology/Oncology - Marina del Rey · Marina del Rey, United States
    • UCLA Hematology/Oncology - Porter Ranch · Porter Ranch, United States
    • UCLA Hematology/Oncology - San Luis Obispo · San Luis Obispo, United States
    • UCLA Hematology/Oncology - Santa Barbara · Santa Barbara, United States
    • UCLA Hematology/Oncology - Santa Monica · Santa Monica, United States
    • Florida Cancer Specialists · Daytona Beach, United States
    • Florida Cancer Specialists · Fleming Island, United States
    • Florida Cancer Specialists · Palm Beach Gardens, United States
    • Florida Cancer Specialists · Sebring, United States
    • Florida Cancer Specialists · Wellington, United States
    • Florida Cancer Specialists · West Palm Beach, United States
    • Memorial Sloan Kettering Cancer Center Pharmacy (IMP ship to address) · Long Island City, United States
    • Memorial Sloan Kettering Cancer Center Pharmacy (IMP storage location) · Long Island City, United States
    • Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street). · New York, United States
    • Rockefeller Outpatient Pavilion (53rd Street) · New York, United States
    • Memorial Sloan Kettering Cancer Center - Main Campus · New York, United States
    • London Health Sciences Centre - Verspeeten Family Cancer Centre · London, Canada
    • The Sixth Affiliated hospital, Sun Yat-sen University · Guangzhou, China
    • Hubei Cancer Hospital · Wuhan, China
    • Sichuan Cancer hospital · Chengdu, China
    • Hôpital Européen Georges Pompidou · Paris, France
    • Istituto Europeo di Oncologia IRCCS · Milan, Italy
    • Hospital Universitario 12 de Octubre · Madrid, Spain
    • Complexo Hospitalario Universitario de Ourense · Ourense, Spain
    Show 1 removed
    • Istituto Europeo di Oncologia IRCCS · Milan, Italy
    Primary completion Jul 22, 2031→Jan 15, 2032
    Study completion Jul 21, 2032→Jan 14, 2033
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07392892
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Feb 6, 2026
Start date
May 14, 2026
Primary completion
Jul 22, 2031 (estimated)
Completion
Jul 21, 2032 (estimated)
Last update
Oct 13, 2026

Study contacts

Pfizer CT.gov Call Center
Contact
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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