Retlirafusp Alfa Combined With Apatinib and Nab-Paclitaxel as Second-line Treatment for Gastric or Gastroesophageal Junction Cancer

NCT07610629 | Not Yet Recruiting Phase 2

• 1 other identifier: MA-GC-II-032
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, single-arm, investigator-initiated phase II clinical study. The study evaluates the efficacy and safety of retlirafusp alfa (a PD-L1/TGF-βRII bifunctional fusion protein) combined with apatinib (a VEGFR-2 tyrosine kinase inhibitor) and nab-paclitaxel in patients with locally advanced unresectable, locally recurrent, or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma who have progressed after first-line immunotherapy-containing treatment.

Conditions

Gastric Adenocarcinoma

Keywords

Immunotherapy-Pretreated Gastric Cancer; retlirafusp alfa

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  Proportion of patients achieving complete response (CR) or partial response (PR) per RECIST 1.1 criteria, assessed every 6 weeks

  From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months after the last subject enrolled

Secondary Outcomes (5)

• Disease Control Rate (DCR)

  From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months after the last subject enrolled

• Progression-Free Survival (PFS)

  From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months after the last subject enrolled

• Overall Survival (OS)

  From date of enrollment until the date of death from any cause, assessed up to 12 months after the last subject enrolled

• Duration of Response (DoR)

  From first response to progression or death, up to 10 months after the last subject enrolled

• Incidence and severity of adverse events (AEs)

  From informed consent until 30 days after last dose, assessed up to 7 months after the last subject enrolled

Study Arms (1)

Retlirafusp alfa + Apatinib + Nab-paclitaxel

EXPERIMENTAL

Drug: Retlirafusp alfa + Apatinib + Nab-paclitaxel

Interventions

Retlirafusp alfa + Apatinib + Nab-paclitaxel DRUG

Retlirafusp alfa: 1800 mg, intravenous infusion, day 1, every 3 weeks; until disease progression, unacceptable toxicity, or withdrawal; maximum 2 years Apatinib: 250 mg, oral, once daily; until disease progression, unacceptable toxicity, or withdrawal Nab-paclitaxel: 260 mg/m², intravenous infusion, day 1, every 3 weeks; for 4-6 cycles

Retlirafusp alfa + Apatinib + Nab-paclitaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to provide written informed consent prior to any study-specific procedures
• Age ≥ 18 years
• ECOG performance status 0 or 1
• Histologically or cytologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma, locally advanced unresectable, locally recurrent, or metastatic
• Human epidermal growth factor receptor 2 (HER2) negative
• Failed first-line immunotherapy-containing systemic treatment
• At least one measurable lesion per RECIST Version 1.1
• Adequate organ function:
• )Hemoglobin ≥ 90 g/L 2)Absolute neutrophil count ≥ 1.5 × 10⁹/L 3)Platelet count ≥ 80 × 10⁹/L 4)Total bilirubin \< 1.5 × upper limit of normal (ULN) 5)ALT/AST \< 2.5 × ULN; \< 5 × ULN in patients with liver metastasis 6)Serum creatinine ≤ 1.5 × ULN or creatinine clearance \> 60 mL/min 7)Urine protein \< 2+ or 24-hour urine protein \< 1 g 8)Left ventricular ejection fraction (LVEF) ≥ 50% 9)Coagulation function: INR ≤ 1.5 × ULN, APTT ≤ 1.5 × ULN 8.Fertile male and female subjects must agree to use highly effective contraception during the study and for 6 months after the last dose of study treatment; female subjects must have a negative pregnancy test within 7 days before enrollment

You may not qualify if:

• Known hypersensitivity to any component of the study drugs
• Prior treatment with any VEGFR inhibitor (including apatinib, sorafenib, sunitinib)
• Prior treatment with retlirafusp alf
• Received any investigational drug within 4 weeks before first dose
• Received systemic corticosteroid (\> 10 mg prednisone equivalent daily) or other immunosuppressive agents within 2 weeks before first dose, except for allowed topical/inhaled use or physiological replacement
• Active autoimmune disease or history of autoimmune disease (except controlled hypothyroidism, type 1 diabetes with stable insulin, vitiligo, resolved childhood asthma)
• Known immunodeficiency (including HIV infection), organ transplantation, or allogeneic hematopoietic stem cell transplantation
• Uncontrolled cardiac disease: NYHA Class ≥ II heart failure, unstable angina, myocardial infarction within 1 year, clinically significant arrhythmia requiring intervention
• Severe infection (CTCAE Grade \> 2) within 4 weeks before first dose; active pulmonary infection, interstitial lung disease, non-infectious pneumonitis, pulmonary fibrosis; active tuberculosis
• Active hepatitis B (HBV DNA ≥ 2000 IU/mL) or active hepatitis C (HCV RNA positive)
• History of other malignancy within 5 years before enrollment, except adequately treated basal cell carcinoma, squamous cell carcinoma of skin, or carcinoma in situ of cervix
• Pregnant or lactating women
• Unwilling or unable to comply with study procedures
• Any other condition deemed inappropriate by the investigator

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Sites (1)

Henan Cancer Hospital

Zhengzhou, Henan, China

Location

MeSH Terms

Interventions

apatinib; 130-nm albumin-bound paclitaxel

Central Study Contacts

Ying Liu

CONTACT

+86 13783604602; yaya7207@126.com

Ying Liu

CONTACT

+8613783604602; yaya7207@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: May 28, 2026
• Study Start: May 5, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): June 30, 2029
• Last Updated: May 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)