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Gastric (Cardia, Body) CancerPhase 2NCT06904300

Ivonescimab (AK112) Plus Paclitaxel as Second-line Therapy in Patients With Advanced G/GEJ Cancer

A Phase 2 study testing AK112 + paclitaxel and Paclitaxel ± ramucirumab in people with Gastric (Cardia, Body) Cancer, run by Sun Yat-sen University.

Not yet recruiting

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

Official record
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Trial summary

A Randomized, Controlled, Multi-center Phase II Study of Ivonescimab (AK112) plus Paclitaxel versus Paclitaxel with or without Ramucirumab as second-line therapy in subjects with advanced gastric or gastroesophageal junction（G/GEJ）cancer who failed immunochemotherapy Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Gastric (Cardia, Body) Cancer
What is being tested?
AK112 + paclitaxel and Paclitaxel ± ramucirumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
No sites listed yet
Study dates
15 Aug 2025to 31 Dec 2028
Phase
Phase 2
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntary written informed consent provided
  • Age ≥18 and ≤75 years, regardless of gender
  • Histologically or cytologically confirmed advanced or metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma
  • Prior treatment failure with PD-1/L1 inhibitor combined with platinum-based chemotherapy; no other systemic antitumor therapy allowed (only first-line therapy permitted, with initial immunotherapy duration ≥12 weeks).Note: Patients who previously received adjuvant/neoadjuvant PD-1 inhibitor plus platinum-based chemotherapy for non-metastatic disease or curative-intent platinum chemoradiotherapy + PD-1 inhibitor for locally advanced or recurrent/metastatic disease are eligible if disease progression occurred within <6 months after the last treatment and no subsequent systemic therapy was administered.
  • ECOG performance status of 0-1
  • Life expectancy ≥3 months
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  • At least one measurable lesion per RECIST v1.1. Previously irradiated lesions may qualify as target lesions if evidence of post-radiotherapy progression exists and no alternative target lesions are available.
  • Adequate organ function:
  • Hematology (without transfusions/growth factors for 7 days): ANC ≥1.5×10⁹/L; platelets ≥100×10⁹/L; hemoglobin ≥90 g/L.
  • Liver: Total bilirubin ≤1.5×ULN; AST/ALT ≤2.5×ULN (≤5×ULN for hepatic metastases); albumin ≥28 g/L.
  • Kidney: Serum creatinine ≤1.5×ULN and CrCl ≥50 mL/min; urine protein <2+ or 24-hour urinary protein <1.0 g.
  • Coagulation: INR/PT ≤1.5×ULN (unless on anticoagulants with therapeutic ranges maintained).
  • Cardiac: LVEF ≥50%.
  • For females of childbearing potential: Negative pregnancy test within 3 days prior to treatment; highly effective contraception required during screening and for 120 days post-treatment. Postmenopausal women (amenorrhea ≥1 year) or surgically sterilized females are exempt.
  • For non-sterilized males with childbearing partners: Effective contraception during screening and for 120 days post-treatment.
  • Willingness and ability to comply with protocol-specified visits, treatments, and laboratory tests.

Who cannot join

  • Histologically or cytologically confirmed as other pathological types (e.g., squamous cell carcinoma, undifferentiated carcinoma, neuroendocrine carcinoma). Mixed pathological types will be categorized based on the predominant component; only subjects with >70% adenocarcinoma component confirmed by a pathologist may enroll.
  • History of other malignancies within 3 years prior to enrollment. Exceptions include malignancies cured by local therapy (e.g., basal or squamous cell skin cancer, superficial bladder cancer, in situ cervical or breast cancer).
  • Systemic anti-cancer therapy (e.g., chemotherapy, radiotherapy, immunotherapy, targeted therapy [<2 weeks for small-molecule agents], biologics) within 3 weeks prior to first dose; palliative local therapy for non-target lesions within 2 weeks.
  • Prior immunotherapy other than PD-1/PD-L1 inhibitors, including checkpoint inhibitors (anti-CTLA-4, anti-CD47, anti-SIRPα, anti-LAG-3), checkpoint agonists (ICOS, CD40, CD137, GITR, OX40), cell therapies, or biologics targeting tumor immunity.
  • Prior treatment with ramucirumab, VEGFR2 antagonists, or other VEGFR2-targeting antibodies/proteins.
  • Prior use of taxane-based agents (e.g., paclitaxel, docetaxel) in first-line systemic therapy.
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  • Prior PD-1/PD-L1 inhibitor treatment with any of the following:
  • Grade ≥3 irAEs (excluding endocrine irAEs), irAEs leading to permanent discontinuation, Grade 2 immune-related cardiotoxicity, or any-grade neurological/ocular irAEs.
  • Unresolved toxicities from prior PD-1/PD-L1 therapy (not resolved to ≤Grade 1). Grade ≥2 endocrine toxicities are allowed if stable and asymptomatic under replacement therapy.
  • IrAEs requiring non-corticosteroid immunosuppressants or recurrent irAEs necessitating systemic corticosteroids.
  • Hypersensitivity to any study drug component or history of severe allergic reactions to monoclonal antibodies.
  • Bleeding diathesis or coagulation disorders.
  • Imaging showing tumor invasion of adjacent organs/vessels, necrosis, or cavitation posing risk of perforation/hemorrhage.
  • Major surgery/trauma within 30 days prior to first dose or planned surgery within 30 days post-dose; minor surgery within 3 days prior to first dose (excluding PICC/port placement).
  • Gastrointestinal risks:Esophagogastric varices, severe ulcers, unhealed wounds, perforation, fistula, abscess, or acute bleeding within 6 months; Arterial thromboembolism or Grade ≥3 venous thromboembolism (per NCI CTCAE v5.0), TIA, stroke, hypertensive crisis, or COPD exacerbation within 6 months; Uncontrolled hypertension (≥160/100 mmHg on oral therapy).
  • Cardiac history:Myocarditis, cardiomyopathy, malignant arrhythmia; Unstable angina, MI, NYHA Class ≥2 heart failure, or aortic aneurysm within 12 months; Poorly controlled arrhythmias or ischemia.
  • Active autoimmune disease requiring systemic treatment within 2 years (excluding hormone replacement).
  • Symptomatic effusions requiring diuretics or drainage (pleural, pericardial, or ascites).
  • Severe infection (hospitalization-required/sepsis) within 4 weeks; active infection requiring systemic antibiotics within 2 weeks (excluding antiviral therapy for HBV/HCV).
  • Active tuberculosis (must be ruled out if suspected) or active syphilis.
  • Organ or stem cell transplant history (excluding corneal transplants).
  • Immunodeficiency:HIV-positive; Chronic systemic corticosteroids/immunosuppressants.
  • Chronic viral hepatitis:Active HBV (HBsAg-positive with HBV DNA >500 IU/mL or >2500 copies/mL); Active HCV (allowed if cured or HCV RNA-negative).
  • Live/attenuated vaccines administered within 30 days prior to first dose or planned during the study (inactivated vaccines permitted).
  • Pregnancy, lactation.
  • History of psychiatric disorders, substance abuse, or alcoholism.
  • Other conditions deemed ineligible by the investigator.

About this study

Official title: A Randomized, Controlled, Multi-center Phase II Study of Ivonescimab (AK112) Plus Paclitaxel Versus Paclitaxel With or Without Ramucirumab as Second-line Therapy in Subjects With Advanced Gastric or Gastroesophageal Junction（G.GEJ）Cancer Who Failed Immunochemotherapy

A Randomized, Controlled, Multi-center Phase II Study of Ivonescimab (AK112) plus Paclitaxel versus Paclitaxel with or without Ramucirumab as second-line therapy in subjects with advanced gastric or gastroesophageal junction（G/GEJ）cancer who failed immunochemotherapy

Read the detailed description

This is a randomized, controlled, multi-center Phase II trial (N ≈ 110) conducted in China to assess the safety and antitumor activity of AK112 combined with paclitaxel versus paclitaxel with or without ramucirumab in subjects with advanced gastric/gastroesophageal junction adenocarcinoma who failed immunochemotherapy. The study objective was to assess the progression-free survival (PFS) of AK112 combined with paclitaxel versus paclitaxel with or without ramucirumab in subjects with advanced gastric/gastroesophageal junction adenocarcinoma who failed immunochemotherapy. The primary endpoint was PFS assessed by RECIST v1.1, and the secondary endpoints were ORR, OS, DoR, time to response (TTR), DCR, and incidence/severity of adverse events (AEs) graded by NCI CTCAE v5.0. Eligible patients with progression after PD-1/L1 inhibitor plus platinum chemotherapy will be stratified by peritoneal metastasis (present vs. absent) and randomized 1:1 to: Group A (n=55): AK112 (20 mg/kg IV, D1/D15) + paclitaxel (80 mg/m² IV, D1/D8/D15), Q4W; Group B (n=55): Paclitaxel (80 mg/m² IV, D1/D8/D15) ± ramucirumab (8 mg/kg IV, D1/D15), Q4W. Treatment continues until disease progression, intolerable toxicity, or investigator-determined clinical futility.Tumor assessments occur every 8 weeks (±7 days) via RECIST v1.1.

Being tested
AK112 + paclitaxel, Paclitaxel ± ramucirumab
Keywords
immunotherapy
Medical subject headings
Neoplasms

What participants receive

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

  • AK112 + paclitaxelDrug

    AK112 (20 mg/kg IV, D1/D15) + paclitaxel (80 mg/m² IV, D1/D8/D15), Q4W

  • Paclitaxel ± ramucirumabDrug

    Paclitaxel (80 mg/m² IV, D1/D8/D15) ± ramucirumab (8 mg/kg IV, D1/D15), Q4W

Study groups in NCT06904300
Study groupRoleWhat they receive
Group AExperimentalAK112 (20 mg/kg IV, D1/D15) + paclitaxel (80 mg/m² IV, D1/D8/D15), Q4W
Receives: Drug: AK112 + paclitaxel
Group BActive comparatorPaclitaxel (80 mg/m² IV, D1/D8/D15) ± ramucirumab (8 mg/kg IV, D1/D15), Q4W
Receives: Drug: Paclitaxel ± ramucirumab

What is being measured

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

  1. PFS

    Measured: 12-24 months

Secondary outcomes (4)

  1. ORR

    Measured: 12-24 months

  2. DCR

    Measured: 12-24 months

  3. DoR

    Measured: 12-24 months

  4. OS

    Measured: 12-24 months

Timeline

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

  1. First posted1 Apr 2025
  2. Study start15 Aug 2025 (estimated)
  3. Primary completion30 Apr 2028 (estimated)
  4. Study completion31 Dec 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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
110 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06904300
Sponsor's protocol ID
AK112-IIT-003
Status last verified
Jun 2025
First submitted
25 Mar 2025
Last updated
5 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AK112 + paclitaxel and Paclitaxel ± ramucirumab in people with Gastric (Cardia, Body) Cancer, run by Sun Yat-sen University.

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 16 inclusion and 27 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 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS (time frame: 12-24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06904300.

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 5 Jun 2025.

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