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

NCT05148195 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2024-03-13

No results posted yet for this study

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

Conditions

  • Advanced Solid Tumor

Interventions

DRUG

Envofolimab

300mg，Q3W (arm A,B and C)or 200mg, Q2W(arm D)

DRUG

BD0801

2mg/kg，Q3W(armA, B and C) or 2mg/kg，Q2W

DRUG

Docetaxel

75mg/m2，Q3W

DRUG

Irinotecan

180 mg/m2，Q2W

DRUG

Leucovorin calcium

400mg/m2，Q2W

DRUG

5-Fluorouridine

2400 mg/m2，Q2W

Sponsors & Collaborators

  • Jiangsu Simcere Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Zhengguang Lv · Jiangsu Simcere Pharmaceutical Co., Ltd.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-22
Primary Completion
2023-07-26
Completion
2023-07-26

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05148195 on ClinicalTrials.gov