SI-B001 as a Single Agent or in Combination With Chemotherapy in the Treatment of Digestive System Malignancies

Sponsor
Sichuan Baili Pharmaceutical Co., Ltd.
Study ID
NCT05039944
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SI-B001 — DRUG
    In Arm\_A, B and C, the intravenous infusion dose of SI-B001 was single drug RP2D selected in phase I (Q2W); In Cohort\_D, E, and F, SI-B001 was divided into two doses, the high dose was the single drug RP2D selected in phase I clinical trial, and the low dose was the second low dose of single drug RP2D, both of which were administered by intravenous infusion.
  • Irinotecan — DRUG
    Administration by intravenous infusion, 180 mg/m2 Q2W.
  • FOLFIRI Protocol — DRUG
    FOLFIRI is administered intravenously at the standard dose recommended by the guidelines(Q2W).
  • FOLFOX Protocol — DRUG
    FOLFOX is administered intravenously at the standard dose recommended by the guidelines(Q2W).

Study Details

This multi-center, open label Phase II clinical study is performed in patients with unresectable or metastatic malignant tumors of the digestive system (colorectal cancer, gastric cancer). This study is investigating the safety and efficacy of SI-B001 at monotherapy or optimal combination dose with chemotherapy in patients.

Key Dates

Start date
Nov 30, 2021
Status verified
Jul 2024
Primary completion
Jun 6, 2022
Completion
Jun 6, 2022

Study Design

Enrollment
7 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SI-B001_A
    Patients with unresectable or metastatic gastric cancer, HER2-negative and without standard treatment were treated with SI-B001 monotherapy.SI-B001 is administered by intravenous drip twice weekly (Q2W).
  • Experimental: SI-B001_B
    Patients with MSS KRASwt BRAFwt unresectable or metastatic colorectal cancer who had failed conventional chemotherapy combined with EGFR mab were treated with SI-B001 monotherapy.SI-B001 is administered by intravenous drip twice weekly (Q2W).
  • Experimental: SI-B001_C
    Patients with MSS KRASwt BRAFwt unresectable or metastatic colorectal cancer who had failed multiple lines of conventional chemotherapy (excluding EGFR monoclonal antibody) were treated with SI-B001 monotherapy.SI-B001 is administered by intravenous drip twice weekly (Q2W).
  • Experimental: SI-B001 combined with irinetecan_D
    Patients with MSI-H KRASwt BRAFwt unresectable or metastatic colorectal cancer who had previously failed to receive anti-PD-1 (L1) mab (excluding EGFR mab) in the first or second line were treated with SI-B001 in combination with irinetecan in the third line.SI-B001 is administered by intravenous drip twice weekly (Q2W).
  • Experimental: SI-B001 combined with FOLFIRI or FOLFOX_E
    Patients with MSI-H KRASwt BRAFwt unresectable or metastatic colorectal cancer who had previously failed first-line anti-PD-1 (L1) mab were treated with SI-B001 in combination with FOLFIRI or FOLFOX for second-line treatment.SI-B001 is administered by intravenous drip twice weekly (Q2W).
  • Experimental: SI-B001 combined with irinetecan_F
    Patients with MSS KRASwt BRAFwt unresectable or metastatic colorectal cancer who had failed standard first-line treatment containing oxaliplatin or irinotecan plus fluorouracil plus or minus bevacizumab were treated with SI-B001 plus irinotecan in the second-line.SI-B001 is administered by intravenous drip twice weekly (Q2W).

Primary Outcome Measure

ORR [ Time Frame: Up to approximately 24 months ]

Related Studies