AzTrials
AzTrials

Gastric Cancer/Gastroesophageal Junction AdenocarcinomaPhase 2NCT07874425

Retlirafusp Alfa Combined With Zeprumetostat, Apatinib, and Chemotherapy as First-Line Treatment for Metastatic GC/GEJC

A Phase 2 study testing Retlirafusp alfa, zeprumetostat and apatinib in people with Gastric Cancer/Gastroesophageal Junction Adenocarcinoma, run by Fudan University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record

Search all trials

Trial summary

The goal of this exploratory study is to evaluate the efficacy and safety of zeprumetostat in combination with retlirafusp alfa, apatinib, and chemotherapy as first-line treatment in patients with HER2-negative unresectable locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma who have not… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Retlirafusp alfa, zeprumetostat and apatinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
No sites listed yet
Study dates
Oct 2026to Dec 2028
Phase
Phase 2

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have a thorough understanding of this study and have voluntarily signed the informed consent form;
  • Age between 18 and 65 years old, male or female;
  • Patients with unresectable locally advanced or metastatic gastric/esophageal gastroesophageal junction adenocarcinoma confirmed by pathological or histological examination;
  • ECOG physical condition score of 0-1;
  • Expected survival of ≥ 3 months;
  • Have not received any anti-tumor treatment (including chemotherapy, targeted therapy, immunotherapy, etc.) for unresectable locally advanced or metastatic gastric cancer before (including any adjuvant treatment after gastric cancer radical surgery, provided that the time from the end of the last adjuvant chemotherapy to the discovery of metastatic disease is greater than 6 months);
Show all 15Show fewer
  • Have at least one measurable lesion (meets RECIST v1.1 criteria);
  • The functions of important organs meet the following requirements (do not use any blood components, and cell growth factors within 14 days before enrollment):
  • Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L; platelets ≥ 100 × 10^9/L; hemoglobin ≥ 90 g/L;
  • Total bilirubin ≤ 1.5 × upper limit of normal (ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 5.0 × ULN; albumin ≥ 30 g/L
  • Serum creatinine ≤ 1.5 × ULN and creatinine clearance rate (calculated using the Cockcroft-Gault formula) ≥ 60 ml/min;
  • Good coagulation function, and need to meet the following conditions: international normalized ratio (INR) ≤ 1.5 (for those not receiving anticoagulation treatment); prothrombin time (PT) ≤ 1.5 × ULN; activated partial thromboplastin time (APTT) ≤ 1.5 × ULN;
  • Normal thyroid function, defined as thyroid stimulating hormone (TSH) within the normal range. (If the baseline TSH is outside the normal range, and total T3 (or FT3) and FT4 are within the normal range, and there are no clinical symptoms, they can also be enrolled);
  • No active bleeding, such as hematemesis, hematochezia, gingival bleeding, epistaxis, and hemorrhage from hemorrhoids, and fecal occult blood ≤ +; gastroscopy shows no high bleeding risk of the primary lesion (such as exposed blood vessels at the ulcer base);
  • Patients with potential fertility need to use a medically approved contraceptive method (such as intrauterine device, contraceptive pills, or condoms) during the study treatment and within 1 month after the end of the study treatment; and the serum or urine HCG test must be negative within 72 hours before enrollment, and must be non-lactating.

Who cannot join

  • Patients with a known HER-2 status as positive (immunohistochemistry 3+, or, immunohistochemistry 2+ and FISH positive);
  • Those who had other malignant tumors within 5 years before enrollment, including skin basal cell or squamous cell carcinoma after radical surgery, or cervical carcinoma in situ, excluding;
  • Those who had received allogeneic bone marrow transplantation or organ transplantation in the past;
  • Those who had severe cardiovascular diseases within 6 months before enrollment, including unstable angina pectoris or myocardial infarction;
  • Subjects who were allergic to the study drug or any of its auxiliary preparations;
  • Those who had uncontrolled hypertension before enrollment, defined as: systolic blood pressure ≥ 150 mmHg and/or diastolic blood pressure ≥ 90 mmHg;
Show all 20Show fewer
  • Those who had any disease or condition that affected drug absorption before enrollment, or who could not take the drug orally;
  • Those who had active peptic ulcers in the stomach and duodenum, ulcerative colitis, or active bleeding from any unresected tumor, or conditions that the investigator judged might cause gastrointestinal bleeding or perforation;
  • Those who had clear evidence or history of significant bleeding within 3 months before enrollment (3-month bleeding > 30 mL, accompanied by hematemesis, melena, or bloody stool), hemoptysis (fresh blood > 5 mL within 4 weeks), or a thromboembolic event within 12 months (including stroke events and/or transient ischemic attacks);
  • Those with significant clinical cardiovascular diseases, including but not limited to acute myocardial infarction within 6 months before enrollment, severe/ unstable angina pectoris or coronary artery bypass surgery; congestive heart failure with NYHA classification > 2; drug-induced ventricular arrhythmias; LVEF (left ventricular ejection fraction) < 50%;
  • Active or uncontrolled severe infections (≥ CTCAE v5.0 grade 2 infection);
  • Known human immunodeficiency virus (HIV) infection. Those with a clinically significant history of liver disease, including viral hepatitis [for those known to be HBV carriers, active HBV infection must be excluded, i.e., HBV DNA positive (> 1×104 copies/mL or > 2000 IU/ml); known hepatitis C infection (HCV) and HCV RNA positive (> 1×103 copies/mL)];
  • Patients with any active autoimmune disease or a history of autoimmune disease (as listed below, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitaryitis, vasculitis, nephritis, hyperthyroidism; patients with vitiligo; those who had complete remission of childhood asthma and no intervention required after adulthood can be included; patients with bronchial asthma requiring medical intervention cannot be included); alternative treatments are not considered systemic treatments; the following patients can be included: those with autoimmune-related hypothyroidism who received thyroid hormone replacement therapy; those with type 1 diabetes that can be controlled with insulin therapy;
  • Those who used immunosuppressants or systemic hormone therapy to achieve immunosuppression purposes within 7 days before enrollment (dose > 10mg/day prednisone or other equivalent efficacy hormones);
  • Those who currently have interstitial lung disease or pneumonia, pulmonary fibrosis, acute pulmonary diseases, radiation pneumonia;
  • Pregnant (positive pregnancy test before medication) or lactating women;
  • Any other diseases, clinically significant metabolic abnormalities, physical examination abnormalities or laboratory test abnormalities, as judged by the investigator, suggesting that the patient has a certain disease or condition that is not suitable for using the study drug (such as having epilepsy and requiring treatment), or will affect the interpretation of the study results, or place the patient at a high risk;
  • Urinalysis indicates that urine protein is ≥ 2+, and the 24-hour urine protein volume is > 1.0g;
  • Other acute or chronic diseases, mental disorders, or abnormal laboratory test results that may lead to the following outcomes: increase the risk of participating in the study or receiving the study drug, or interfere with the interpretation of the study results, and according to the researcher's judgment, patients classified as not eligible to participate in this study are considered unsuitable for inclusion by the researcher;
  • Participating in another interventional clinical study at the same time, unless participating in an observational (non-interventional) clinical study or in the follow-up stage of an interventional study; patients considered not suitable for inclusion in this study by the researcher.

About this study

Official title: An Exploratory Clinical Study of Retlirafusp Alfa Combined With Zeprumetostat, Apatinib, and Chemotherapy as First-Line Treatment for Metastatic Gastric/Gastroesophageal Junction Adenocarcinoma

The goal of this exploratory study is to evaluate the efficacy and safety of zeprumetostat in combination with retlirafusp alfa, apatinib, and chemotherapy as first-line treatment in patients with HER2-negative unresectable locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma who have not received prior anticancer therapy.

Read the detailed description

Participants will receive zeprumetostat combined with retlirafusp alfa, apatinib, and the CAPOX regimen (Q3W) at the RP2D determined from the dose-escalation phase. Tumor response evaluation will be performed every 2 treatment cycles (data analysis includes the 6 patients from the dose-escalation phase).

Being tested
Retlirafusp alfa, zeprumetostat, apatinib, Capecitabine, Oxaliplatin
Keywords
Retlirafusp Alfa, Zeprumetostat, Apatinib
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Retlirafusp alfaDrug

    Also called Retlirafusp alfa Injection

    (1800mg, iv., d1, q3w)

  • zeprumetostatDrug

    Also called Zeprumetostat Tablets

    (250mg, po, bid, q3w)

  • apatinibDrug

    Also called Apatinib Mesylate Tablets

    (250mg, po., qd or qod, q3w)

  • CapecitabineDrug

    Also called Capecitabine Tablets

    (1000mg/m², po,d1-14, q3w)

  • OxaliplatinDrug

    Also called Oxaliplatin for Injection

    (130mg/m², iv, d1,q3w)

Study groups in NCT07874425
Study groupRoleWhat they receive
Zeprumetostat+retlirafusp alfa+apatinib+CAPOXExperimentalZeprumetostat+retlirafusp alfa+apatinib+CAPOX (Q3W)
Receives: Drug: Retlirafusp alfa; Drug: zeprumetostat; Drug: apatinib; Drug: Capecitabine; Drug: Oxaliplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR)

    Objective Response Rate (ORR) is defined as the proportion of participants achieving a confirmed complete response (CR) or partial response (PR) according to RECIST v1.1 criteria.

    Measured: From first dose to disease progression or death (assessed up to 2 years)

Secondary outcomes (5)

  1. Progression free survival (PFS)

    Progression-Free Survival (PFS) is defined as the time from the date of first dose to the first documented disease progression (according to RECIST v1.1) or death due to any cause, whichever occurs first.

    Measured: From first dose to disease progression or death (assessed up to 2 years)

  2. Overall survival (OS)

    Overall Survival (OS) is defined as the time from the date of first dose to the date of death due to any cause. Participants who are alive at the time of analysis will be censored at the last known alive date.

    Measured: From first dose to death due to any cause (up to 5 years)

  3. Disease Control Rate (DCR)

    Disease Control Rate (DCR) is defined as the proportion of participants who achieve a confirmed complete response (CR), partial response (PR), or stable disease (SD) according to RECIST v1.1 criteria.

    Measured: From first dose to disease progression or death (assessed up to 2 years)

  4. During of Response (DOR)

    Duration of Response (DOR) is defined as the time from the first documentation of objective response (CR or PR) to the first documentation of disease progression or death due to any cause, whichever occurs first. This will be evaluated only in participants who achieve an objective response.

    Measured: From first documentation of response to disease progression or death (assessed up to 2 years)

  5. Incidence of Treatment-Emergent Adverse Events (TEAEs)

    Incidence, severity, and relationship to study drug of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) according to NCI CTCAE v6.0.

    Measured: From first dose to 90 days after the last dose (up to 2 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2026
  2. Study startOct 2026 (estimated)
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
55 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07874425
Sponsor's protocol ID
FDZL-REZAPA
Status last verified
Oct 2026
First submitted
8 Oct 2026
Last updated
14 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in