A Multi-national, Open-label, Randomized Phase II/III Clinical Study of Utidelone Capsule (UTD2) Combined With Fluoropyrimidine- and Platinum-containing Therapy in First-line Treatment of Patients With Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Beijing Biostar Pharmaceuticals Co., Ltd.

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.

Eligibility

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: * Participants must meet the following criteria to be eligible for the study: 1. 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. 2. Male and female aged ≥ 18 years as of the date of baseline visit. 3. 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. 4. Phase II Study: No restriction o…

Interventions

Drug

Utidelone Capsule

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

Drug

Utidelone Capsule

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

Drug

Utidelone Capsule

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

Drug

Fluoropyrimidine- and Platinum-containing Therapy

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.

Drug

Oxaliplatin

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

Drug

Utidelone Capsule

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

Drug

PD-1 inhibitor

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.

Drug

Capecitabine

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

Drug

Capecitabine

Capecitabine, 2000 mg/m2/d, po, bid, d1-14, q3w

Summary

Eligibility

Interventions

Locations (10)