Utidelone Capsule Combined With Fluoropyrimidine- and Platinum-containing Therapy in First-line Treatment of Patients With Gastric or Gastroesophageal Junction Adenocarcinoma

NCT06841679 | Recruiting Phase 2 FDA Drug

• 1 other identifier: BG02-2404
• Study Type: interventional
• Target: 778
• Locations: 2 countries
• Sites: 10

Brief Summary

This is a multi-national, open-label, randomized, seamless phase II/III clinical study of UTD2 combined with fluoropyrimidine- and platinum-containing therapy to evaluate the efficacy and safety in patients with locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma untreated with systemic treatment in advanced setting.

Conditions

Gastric or Gastroesophageal Junction Adenocarcinoma

Keywords

UTD2; GC; GEJ

Outcome Measures

Primary Outcomes (2)

• Safety and tolerability of UTD2 and capecitabine in combination with oxaliplatin in Phase II

  dose limiting toxicity (DLT), defined as any toxicity meeting the criteria outlined in the protocol during Cycle 1 in a 21-days cycle

  From Day 1 to Day 21

• Overall Survival (OS)

  From the first dosing until death (from any cause), follow-up began after the end of treatment

  12 months

Secondary Outcomes (8)

• Objective Response Rate (ORR)

  12 months

• Progression Free Survival (PFS)

  12 months

• Maximum (or peak) serum concentration (Cmax)

  12 months

• Time to peak drug concentration (Tmax)

  12 months

• the area under the concentration-time curve from dosing (time 0) to time t (AUC0-t)

  12 months

Other Outcomes (1)

• Patient reported outcomes (PRO)

  12 months

Study Arms (5)

Cohort 1

EXPERIMENTAL

UTD2 40 mg/m2/d, po, qd, d1-5, q3w combined with CAPOX/FOLFOX with or without a PD-1 inhibitor ( tislelizumab, or pembrolizumab, or nivolumab )

Drug: Utidelone Capsule; Drug: Fluoropyrimidine- and Platinum-containing Therapy; Drug: PD-1 inhibitor

Cohort 2

EXPERIMENTAL

UTD2 50 mg/m2/d, po, qd, d1-5, q3w combined with CAPOX/FOLFOX with or without a PD-1 inhibitor ( tislelizumab, or pembrolizumab, or nivolumab )

Drug: Utidelone Capsule; Drug: Fluoropyrimidine- and Platinum-containing Therapy; Drug: PD-1 inhibitor

Cohort 3

EXPERIMENTAL

UTD2 60 mg/m2/d, po, qd, d1-5, q3w combined with CAPOX/FOLFOX with or without a PD-1 inhibitor ( tislelizumab, or pembrolizumab, or nivolumab )

Drug: Utidelone Capsule; Drug: Fluoropyrimidine- and Platinum-containing Therapy; Drug: PD-1 inhibitor

Arm A

EXPERIMENTAL

UTD2 po, on d1-5, q3w (dose decided after the phase II) in combination with CAPOX

Drug: Oxaliplatin; Drug: Utidelone Capsule; Drug: Capecitabine

Arm B

ACTIVE COMPARATOR

CAPOX

Drug: Oxaliplatin; Drug: Capecitabine

Interventions

Utidelone Capsule DRUG

UTD2 40 mg/m2/d, po, qd, day 1-5, q3w

Cohort 1

Fluoropyrimidine- and Platinum-containing Therapy DRUG

CAPOX: Capecitabine 1700 mg/m2/d, po, bid, d1-14，q3w, Oxaliplatin 130 mg/m2, iv, d1, q3w. After completing 6 times (18 weeks) of oxaliplatin treatment, the investigator may decide whether to continue oxaliplatin treatment for up to 8 times (24 weeks) based on the participant's benefits and safety. FOLFOX: Oxaliplatin 85 mg/m2, iv, d1, q2w. Folinic Acid 400 mg/m2, iv, d1, q2w, 5-FU 400 mg/m2 IV bolus d1 then 5-FU 2400 mg/m2 IV infusion over 46 to 48 hours, q2w. After completing 9 times (18 weeks) of treatment with oxaliplatin combined with folinic acid and 5-FU, the investigator may decide whether to continue FOLFOX treatment for up to 12 times (24 weeks) based on the participant's benefits and safety.

Cohort 1; Cohort 2; Cohort 3

Oxaliplatin DRUG

130 mg/m2/d, iv, day1, q3w, oxaliplatin will be given up to 6 cycles

Arm A; Arm B

PD-1 inhibitor DRUG

Whether to combine a PD-1 inhibitor will depend on the locally approved indications for the PD-1 inhibitor. If the participant's condition meets the locally approved indications for PD-1 inhibitors, the investigator may determine, in accordance with clinical guidelines, that the participant is eligible to receive treatment with UTD2 combined with fluoropyrimidine- and platinum-containing therapy, with or without a PD-1 inhibitor. If a PD-1 inhibitor is administered in combination, tislelizumab (200 mg), or pembrolizumab (200 mg), or nivolumab (360 mg), iv, day1, q3w. Alternatively, the investigator may select the dosage and administration cycle of other locally approved PD-1 inhibitors in accordance with the locally approved package inserts. The PD-1 inhibitor will be given up to 2 years.

Cohort 1; Cohort 2; Cohort 3

Capecitabine DRUG

Capecitabine 1700 mg/m2/d po, bid, d1-14，q3w

Arm A

Eligibility Criteria

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

You may qualify if:

• Participants must meet the following criteria to be eligible for the study:
• Sign the informed consent form (ICF) to participate with accordance with GCP, ICH and local regulations and are willing to adhere to the study protocol.
• Male and female aged ≥ 18 years as of the date of baseline visit.
• Participant must have unresectable locally advanced or metastatic GC or GEJ and have histologically/pathologic confirmed predominant adenocarcinoma. The documentation of GEJ involvement can include biopsy, endoscopy, or imaging.
• Phase II Study: No restriction on PD-L1 expression. Phase III study: Participant must have tumor with PD-L1 Combined Positive Score (CPS) \< 1 by immunohistochemical (IHC). IHC results from site are acceptable.
• Participant must have at least one measurable lesion per RECIST 1.1 criteria.
• Participant must not receive previously systemic treatment in the advanced setting. Previously neoadjuvant/adjuvant therapy for GC or GEJ with no progression after 6 months from completion is allowed. Palliative radiotherapy is allowed.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
• Participant with adequate hematological function (CTCAE v5.0 Grade ≤ 1) within 1 week before enrollment (based on routine laboratory values at each site) and who have not received recombinant human granulocyte colony-stimulating factor (rhG-CSF) or blood products/erythropoietin (EPO) within 14 days before enrollment.
• White blood cell count (WBC) ≥ 3.0 × 109/L;
• Absolute neutrophil count (ANC) ≥ 1.5 × 109/L;
• Platelet count (PLT) ≥ 100 × 109/L;
• Hemoglobin (Hb) ≥ 9.0 g/dL.
• Participant with adequate liver and renal function (CTCAE v5.0 Grade ≤ 1) within 1 week before enrollment (based on routine laboratory values at each site).
• Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN);

You may not qualify if:

• Participants will be excluded from the study for any of the following reasons:
• Known HER2-positive tumor (HER2-positive is defined as having an IHC score of 3 +, or IHC2 + and positive HER2 expression by in situ hybridization (ISH) (refer to ASCO/CAP guidelines 2020).
• Participants with other malignancies over the past 5 years, except for cured skin basal cell carcinoma, in-situ carcinoma of the cervix, or papillary thyroid cancer.
• Participants who have received radiotherapy or other investigational drug or investigational therapy within 4 weeks prior to the first dose of investigational product.
• Participants who have undergone major surgery (except biopsy) had significant trauma within 4 weeks prior to the first dose of investigational product or required elective surgery during the study.
• Participants with pre-existing \> Grade 1 peripheral sensory neuropathy (NCI CTCAE 5.0).
• Participants with known hypersensitivity to any components of the investigational product.
• Participants who are pregnant (positive pregnancy test) or lactating.
• Adverse events due to previous anti-tumor therapy have not recovered to CTCAE v5.0 Grade ≤ 1 (except for alopecia and other toxicities judged by the investigator to have no safety risk).
• Participants with esophageal obstruction, pyloric obstruction, intestinal obstruction, or inability to eat on their own after gastrointestinal resection, or other factors that cause difficulty swallowing and inability to take oral drugs.
• Participants with symptomatic/uncontrollable central nervous system metastases or meningeal metastases, including but not limited to those with confirmed metastatic disease progression by examination within 2 months after radiotherapy or other local treatment, or who are ineligible for enrollment as judged by the investigator.
• Participants with uncontrollable bone metastases, i.e., existing or recent fracture risk, recent need for surgery or local radiotherapy, or other crisis conditions as judged by the investigator.
• Participants with uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage (once monthly or more frequently).
• Participants with an active infection and who currently require systematic anti-infective therapy.
• Participants with known history of human immunodeficiency virus (HIV) infection with an exception that if they have not had an opportunistic infection within the past 12 months, they are eligible.

Sponsors & Collaborators

• Beijing Biostar Pharmaceuticals Co., Ltd.: lead

Study Sites (10)

Bioresearch Partner

Hialeah, Florida, 33013, United States

NOT YET RECRUITING

AnYang Tumor Hospital

Anyang, China

RECRUITING

Sun Yat-sen University Cancer Center

Guangzhou, China

RECRUITING

Jinan Municipal Central Hospital

Jinan, China

RECRUITING

Shandong First Medical University Affiliated Tumor Hospital

Jinan, China

RECRUITING

Liaoning Cancer Hospital

Shenyang, China

RECRUITING

Shanxi Cancer Hospital

Taiyuan, China

NOT YET RECRUITING

Tianjin Medical University Cancer Institute & Hospital

Tianjin, China

NOT YET RECRUITING

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, China

NOT YET RECRUITING

Henan Cancer Hospital

Zhengzhou, China

RECRUITING

MeSH Terms

Interventions

Oxaliplatin; Immune Checkpoint Inhibitors; Capecitabine

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Central Study Contacts

Rongguo Qiu

CONTACT

010-56315388; Rqiu2001@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: February 24, 2025
• Study Start: August 28, 2025
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): September 1, 2030
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); CN (9)