A Phase II Study of Envofolimab and BD0801 With/Without Chemotherapy in Patients With Advanced Solid Tumors

Sponsor
Jiangsu Simcere Pharmaceutical Co., Ltd.
Study ID
NCT05148195
Phase
PHASE2
Status
Terminated

Conditions

  • Advanced Solid Tumor

Eligibility Criteria

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

Interventions

  • Envofolimab — DRUG
    300mg，Q3W (arm A,B and C)or 200mg, Q2W(arm D)
  • BD0801 — DRUG
    2mg/kg，Q3W(armA, B and C) or 2mg/kg，Q2W
  • Docetaxel — DRUG
    75mg/m2，Q3W
  • Irinotecan — DRUG
    180 mg/m2，Q2W
  • Leucovorin calcium — DRUG
    400mg/m2，Q2W
  • 5-Fluorouridine — DRUG
    2400 mg/m2，Q2W

Study Details

This is an open label, multi-cohort, multicenter Phase II study, the purpose of this study is to assess the efficacy and safety of envofolimab in combination with BD0801 injection with/without chemotherapy for the treatment of advanced solid tumors

Key Dates

Start date
Dec 22, 2021
Status verified
Apr 2022
Primary completion
Jul 26, 2023
Completion
Jul 26, 2023

Study Design

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

Arms

  • Experimental: A: Solid tumor
    Envofolimab（300mg，Q3W）+BD0801（2mg/kg，Q3W）
  • Experimental: B: HCC
    Envofolimab（300mg，Q3W）+BD0801（2mg/kg，Q3W）
  • Experimental: D：NSCLC
    Envofolimab（300mg，Q3W）+BD0801（2mg/kg，Q3W）+Docetaxel(75mg/m2，Q3W)
  • Experimental: D：CRC
    Envofolimab（200mg，Q2W）+BD0801（2mg/kg，Q2W）+FOLFIRI（Irinotecan 180 mg/m2，Leucovorin 400mg/m2，5-Fluorouridine 2400 mg/m2，Q2W）

Primary Outcome Measure

Part I: MTD（Maximum tolerable dose）or RD（Recommended dose） [ Time Frame: 6 months ]

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