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A: Solid tumor for Solid Tumors

Phase 2
Waitlist Available
Research Sponsored by Jiangsu Simcere Pharmaceutical Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2.5 years
Awards & highlights

Summary

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

Eligible Conditions
  • Solid Tumors

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2.5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Part I: MTD（Maximum tolerable dose）or RD（Recommended dose）
Part II: ORR(Objective Response Rate ) by investigator
Secondary study objectives
DCR(Disease Control Rate) by investigator
DOR(Duration Of Response) by investigator
ORR in subgroup of different TMB、PDL-1 and MSI status
+3 more
Other study objectives
PK(pharmacokinetics) of envofolimab and BD0801

Trial Design

4Treatment groups
Experimental Treatment
Group I: D：NSCLCExperimental Treatment3 Interventions
Envofolimab（300mg，Q3W）+BD0801（2mg/kg，Q3W）+Docetaxel(75mg/m2，Q3W)
Group II: D：CRCExperimental Treatment4 Interventions
Envofolimab（200mg，Q2W）+BD0801（2mg/kg，Q2W）+FOLFIRI（Irinotecan 180 mg/m2，Leucovorin 400mg/m2，5-Fluorouridine 2400 mg/m2，Q2W）
Group III: B: HCCExperimental Treatment2 Interventions
Envofolimab（300mg，Q3W）+BD0801（2mg/kg，Q3W）
Group IV: A: Solid tumorExperimental Treatment2 Interventions
Envofolimab（300mg，Q3W）+BD0801（2mg/kg，Q3W）
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Docetaxel
1995
Completed Phase 4
~5620
Irinotecan
2017
Completed Phase 3
~2580
Leucovorin calcium
2014
Completed Phase 3
~3620

Find a Location

Who is running the clinical trial?

Jiangsu Simcere Pharmaceutical Co., Ltd.Lead Sponsor
69 Previous Clinical Trials
14,804 Total Patients Enrolled
Zhengguang LvStudy DirectorJiangsu Simcere Pharmaceutical Co., Ltd.
~23 spots leftby Sep 2025
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