Pancreatic CancerPhase 3NCT07383922
A Study of FG-M108+Chemotherapy vs Placebo+Chemotherapy in Claudin18.2-positive Pancreatic Cancer
A Phase 3 study testing FG-M108, nab paclitaxel and Gemcitabine (GEM) in people with Pancreatic Cancer, run by FutureGen Biopharmaceutical (Beijing) Co., Ltd at 1 site in China.
Trial summary
Pancreatic cancer, which stands as one of the most lethal malignancies and a leading cause of cancer-related deaths globally, poses a significant challenge to human health worldwide. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- FG-M108, nab paclitaxel and Gemcitabine (GEM)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 524 participants
- Where
- 1 siteChina
- Study dates
- 28 Feb 2026to 31 Dec 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily sign the informed consent form, understand the study, are willing to comply with and have the ability to complete all trial procedures;
- Age 18-80 years (inclusive), any gender;
- Histologically or cytologically confirmed unresectable locally advanced or metastatic pancreatic ductal adenocarcinoma, without prior systemic therapy; or for subjects who have received prior neoadjuvant/adjuvant chemotherapy, the time from the last treatment to disease recurrence is >6 months;
- Able to provide archived or fresh pathological tissue for CLDN18.2 testing, with central laboratory testing confirming tumor tissue CLDN18.2 positive (defined as ≥40% of tumor cells with CLDN18.2 membrane staining ≥2+ by central laboratory IHC);
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
- Have at least one measurable tumor lesion according to RECIST 1.1 criteria;
- Expected survival ≥3 months;
- Adequate cardiac, bone marrow, liver, renal function;
Who cannot join
- Have received a live vaccine within 4 weeks prior to randomization;
- Have received radiotherapy within 2 weeks prior to randomization;
- Have received other anti-tumor drug therapy within 4 weeks or within 5 half-lives of the anti-tumor drug prior to randomization;
- Have undergone major surgery within 4 weeks prior to randomization;
- Have received any clinical study drug treatment within 4 weeks prior to randomization;
- Have previously received any treatment targeting CLDN18.2, such as CLDN18.2 monoclonal/bispecific antibodies, CLDN18.2 CAR-T, or CLDN18.2 ADC;
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- Have a history of other (non-study tumor) malignancies within 3 years prior to randomization;
- Have a history of central nervous system metastases and/or carcinomatous meningitis;
- Have adverse reactions from prior treatments that have not recovered to CTCAE v5.0 Grade ≤1 (excluding alopecia and anemia) prior to randomization;
- Have had clinically significant cardiovascular or cerebrovascular diseases within 6 months prior to randomization;
- Have uncontrolled systemic diseases assessed by the investigator, including diabetes, hypertension, pulmonary fibrosis, interstitial lung disease, etc.;
- The investigator judges the subject to have obvious active gastrointestinal bleeding;
- Known history of Hepatitis C or chronic active Hepatitis B;
- Require systemic treatment with corticosteroids (dose >10 mg/day prednisone or equivalent dose of similar drugs) or other immunosuppressants within ≤14 days prior to randomization;
- Any other condition of the subject (e.g., psychological, geographical, or medical condition) that does not permit compliance with the study and follow-up procedures;
- Are pregnant or breastfeeding;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Fudan University Shanghai Cancer Center
Shanghai
Xianjun Yu, +86-021-64175590, yuxianjun@fudanpci.org
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Phase 3 Study Comparing the Efficacy and Safety of FG-M108 Versus Placebo Combined With Standard Chemotherapy in First-line Treatment of Patients With Claudin18.2-Positive Advanced Pancreatic Cancer
Pancreatic cancer, which stands as one of the most lethal malignancies and a leading cause of cancer-related deaths globally, poses a significant challenge to human health worldwide. However, standard chemotherapeutic regimens show limited effectiveness in advanced pancreatic cancer, creating an urgent demand to investigate and develop novel therapeutic targets and combination treatment strategies. The primary objective of this study is to evaluate the efficacy of FG-M108 combined with gemcitabine and nab-paclitaxel (Nab-P+GEM) versus placebo combined with Nab-P+GEM as first-line treatment, as measured by overall survival (OS). This study will also assess safety, tolerability, pharmacokinetics, and the immunogenicity profile of FG-M108 monoclonal antibody, along with its impact on quality of life.
Read the detailed description
This is a multicenter, randomized, double-blind, placebo-controlled phase 3 study designed to evaluate the efficacy and safety of FG-M108 injection combined with Nab-P+GEM versus placebo combined with Nab-P+GEM as first-line treatment in patients with Claudin18.2-positive, unresectable locally advanced or metastatic pancreatic ductal adenocarcinoma.
- Conditions
- Pancreatic Cancer
- Being tested
- FG-M108, nab paclitaxel, Gemcitabine (GEM), Placebo for FG-M108
- Keywords
- Pancreatic cancer, First-line treatment, Claudin18.2
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FG-M108Drug
Also called M108
FG-M108 monoclonal antibody will be administered as a minimum 2-hour Intravenous drip.
nab paclitaxelDrug
Also called Albumin-bound paclitaxel
Nab-paclitaxel will be administered as an Intravenous drip.
Gemcitabine (GEM)Drug
Also called Gemcitabine Hydrochloride
Gemcitabine will be administered as an Intravenous drip.
Placebo for FG-M108Drug
Placebo will be administered as an Intravenous drip.
| Study group | Role | What they receive |
|---|---|---|
| FG-M108 + Chemotherapy | Experimental | FG-M108 300mg/m2 Intravenous drip, day1, every 3 weeks Nab-paclitaxel 125mg/m2 Intravenous drip, day1, 8, every 3 weeks Nab-paclitaxel 125mg/m2 Intravenous drip, day1, 8, every 3 weeks Receives: Drug: FG-M108; Drug: nab paclitaxel; Drug: Gemcitabine (GEM) |
| Placebo + Chemotherapy | Active comparator | Placebo 300mg/m2 Intravenous drip, day1, every 3 weeks Nab-paclitaxel 125mg/m2 Intravenous drip, day1, 8, every 3 weeks Nab-paclitaxel 125mg/m2 Intravenous drip, day1, 8, every 3 weeks Receives: Drug: nab paclitaxel; Drug: Gemcitabine (GEM); Drug: Placebo for FG-M108 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
OS is defined as the time from randomization to deathdue to any cause.
Measured: Up to 24 months
Secondary outcomes (5)
Progression Free Survival (PFS)
PFS is defined as the duration from randomization to the first imaging confirmation of progressive disease per RECIST 1.1 by investigator evaluation or death due to any cause (whichever occurs first).
Measured: Up to 24 months
Objective Response Rate (ORR)
ORR is defined as the proportion of participants who have a best overall response of Complete Response (CR) or Partial Response (PR) as assessed by investigator evaluation per RECIST 1.1.
Measured: Up to 24 months
Disease control rate (DCR)
DCR is defined as the proportion of participants who have a best overall response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) as assessed by investigator evaluation per RECIST 1.1.
Measured: Up to 24 months
Duration Of Response (DOR)
DOR is defined as the time from the date of the first response (CR/PR) until the date of progressive disease as assessed by investigator evaluation per RECIST 1.1 or death due to any cause (whichever occurs first).
Measured: Up to 24 months
Safety assessed by Adverse Events (AEs)
An AE is any adverse medical event that occurs during a clinical study, whether or not related with medicinal product, including signs, symptoms, abnormal laboratory test results and diseases. The incidence and severity of AEs during the clinical study are recorded and analyzed.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start28 Feb 2026 (estimated)
- Primary completion30 Jun 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 524 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FutureGen Biopharmaceutical (Beijing) Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zhaoyu Jin, Ph.D, Study chair, FutureGen Biopharmaceutical (Beijing) Co., Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07383922
- Sponsor's protocol ID
- FG-M108-06
- Status last verified
- Feb 2026
- First submitted
- 26 Jan 2026
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Phase 3 Study Comparing the Efficacy and Safety of FG-M108 Versus Placebo Combined With Standard Chemotherapy in First-line Treatment of Patients With Claudin18.2-Positive Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT07383922
- Acronym / sponsor ID
- FG-M108-06
- Conditions
- Pancreatic Cancer
- Keywords
- Pancreatic cancer, First-line treatment, Claudin18.2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 524 participants (estimated)
- Lead sponsor
- FutureGen Biopharmaceutical (Beijing) Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2026 (estimated)
- Primary completion
- 30 Jun 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 3 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pancreatic cancer, which stands as one of the most lethal malignancies and a leading cause of cancer-related deaths globally, poses a significant challenge to human health worldwide. However, standard chemotherapeutic regimens show limited effectiveness in advanced pancreatic cancer, creating an urgent demand to investigate and develop novel therapeutic targets and combination treatment strategies. The primary objective of this study is to evaluate the efficacy of FG-M108 combined with gemcitabine and nab-paclitaxel (Nab-P+GEM) versus placebo combined with Nab-P+GEM as first-line treatment, as measured by overall survival (OS). This study will also assess safety, tolerability, pharmacokinetics, and the immunogenicity profile of FG-M108 monoclonal antibody, along with its impact on quality of life.
Detailed description
This is a multicenter, randomized, double-blind, placebo-controlled phase 3 study designed to evaluate the efficacy and safety of FG-M108 injection combined with Nab-P+GEM versus placebo combined with Nab-P+GEM as first-line treatment in patients with Claudin18.2-positive, unresectable locally advanced or metastatic pancreatic ductal adenocarcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FG-M108 + Chemotherapy | Experimental | Drug: FG-M108, Drug: nab paclitaxel, Drug: Gemcitabine (GEM)FG-M108 300mg/m2 Intravenous drip, day1, every 3 weeks Nab-paclitaxel 125mg/m2 Intravenous drip, day1, 8, every 3 weeks Nab-paclitaxel 125mg/m2 Intravenous drip, day1, 8, every 3 weeks |
| Placebo + Chemotherapy | Active comparator | Drug: nab paclitaxel, Drug: Gemcitabine (GEM), Drug: Placebo for FG-M108Placebo 300mg/m2 Intravenous drip, day1, every 3 weeks Nab-paclitaxel 125mg/m2 Intravenous drip, day1, 8, every 3 weeks Nab-paclitaxel 125mg/m2 Intravenous drip, day1, 8, every 3 weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Voluntarily sign the informed consent form, understand the study, are willing to comply with and have the ability to complete all trial procedures;
- Age 18-80 years (inclusive), any gender;
- Histologically or cytologically confirmed unresectable locally advanced or metastatic pancreatic ductal adenocarcinoma, without prior systemic therapy; or for subjects who have received prior neoadjuvant/adjuvant chemotherapy, the time from the last treatment to disease recurrence is >6 months;
- Able to provide archived or fresh pathological tissue for CLDN18.2 testing, with central laboratory testing confirming tumor tissue CLDN18.2 positive (defined as ≥40% of tumor cells with CLDN18.2 membrane staining ≥2+ by central laboratory IHC);
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
Key exclusion criteria (16 listed)
- Have received a live vaccine within 4 weeks prior to randomization;
- Have received radiotherapy within 2 weeks prior to randomization;
- Have received other anti-tumor drug therapy within 4 weeks or within 5 half-lives of the anti-tumor drug prior to randomization;
- Have undergone major surgery within 4 weeks prior to randomization;
- Have received any clinical study drug treatment within 4 weeks prior to randomization;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FG-M108Also: M108FG-M108 monoclonal antibody will be administered as a minimum 2-hour Intravenous drip. | Drug | FG-M108 + Chemotherapy |
| nab paclitaxelAlso: Albumin-bound paclitaxelNab-paclitaxel will be administered as an Intravenous drip. | Drug | FG-M108 + Chemotherapy, Placebo + Chemotherapy |
| Gemcitabine (GEM)Also: Gemcitabine HydrochlorideGemcitabine will be administered as an Intravenous drip. | Drug | FG-M108 + Chemotherapy, Placebo + Chemotherapy |
| Placebo for FG-M108Placebo will be administered as an Intravenous drip. | Drug | Placebo + Chemotherapy |
Primary outcome
Overall Survival (OS)
Time frame: Up to 24 months
OS is defined as the time from randomization to deathdue to any cause.
5 secondary outcomes
Progression Free Survival (PFS)
Time frame: Up to 24 months
Objective Response Rate (ORR)
Time frame: Up to 24 months
Disease control rate (DCR)
Time frame: Up to 24 months
Duration Of Response (DOR)
Time frame: Up to 24 months
Safety assessed by Adverse Events (AEs)
Time frame: Up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhaoyu Jin, Ph.D study chair
FutureGen Biopharmaceutical (Beijing) Co., Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing FG-M108, nab paclitaxel and Gemcitabine (GEM) in people with Pancreatic Cancer, run by FutureGen Biopharmaceutical (Beijing) Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhaoyu Jin, Ph.D (010-60709130, pr@futuregenbiopharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.