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

NCT05148195 | Terminated Phase 2

• 1 other identifier: B02B00302-KN035-201
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 24

Brief 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

Outcome Measures

Primary Outcomes (2)

• Part I: MTD（Maximum tolerable dose）or RD（Recommended dose）

  MTD: A maximum dose of acceptable safety, at least 6 patients treated with this dose, and less than 1/3 of patients experienced DLT(Dose limited toxicity). RD:The following will be taken into account to make decision about RD: MTD, if is reached; PK characteristics, efficacy and safety results.

  6 months

• Part II: ORR(Objective Response Rate ) by investigator

  Proportion of subjects who have a complete or partial response relative to baseline as assessed by investigator according to RECIST 1.1 criteria

  1.5 years

Secondary Outcomes (6)

• DOR(Duration Of Response) by investigator

  1.5 years

• PFS(Progression Free Survival) by investigator

  1.5 years

• DCR(Disease Control Rate) by investigator

  1.5 years

• OS（Overall Survival)

  2.5 years

• The incidence of AEs（adverse events) and SAEs（serious adverse events)

  2 years

Other Outcomes (3)

• PK(pharmacokinetics) of envofolimab and BD0801

  1.5 years

• Positive rate of ADA(anti-drug antibody)

  1.5 years

• Duration of immunogenicity positive reaction

  1.5 years

Study Arms (4)

A: Solid tumor

EXPERIMENTAL

Envofolimab（300mg，Q3W）+BD0801（2mg/kg，Q3W）

Drug: Envofolimab; Drug: BD0801

B: HCC

EXPERIMENTAL

Envofolimab（300mg，Q3W）+BD0801（2mg/kg，Q3W）

Drug: Envofolimab; Drug: BD0801

D：NSCLC

EXPERIMENTAL

Envofolimab（300mg，Q3W）+BD0801（2mg/kg，Q3W）+Docetaxel(75mg/m2，Q3W)

Drug: Envofolimab; Drug: BD0801; Drug: Docetaxel

D：CRC

EXPERIMENTAL

Envofolimab（200mg，Q2W）+BD0801（2mg/kg，Q2W）+FOLFIRI（Irinotecan 180 mg/m2，Leucovorin 400mg/m2，5-Fluorouridine 2400 mg/m2，Q2W）

Drug: Envofolimab; Drug: Irinotecan; Drug: Leucovorin calcium; Drug: 5-Fluorouridine

Interventions

Envofolimab DRUG

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

A: Solid tumor; B: HCC; D：CRC; D：NSCLC

BD0801 DRUG

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

A: Solid tumor; B: HCC; D：NSCLC

Docetaxel DRUG

75mg/m2，Q3W

D：NSCLC

Irinotecan DRUG

180 mg/m2，Q2W

D：CRC

Leucovorin calcium DRUG

400mg/m2，Q2W

D：CRC

5-Fluorouridine DRUG

2400 mg/m2，Q2W

D：CRC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients voluntarily signed informed consent;
• Age≥18 age years old, male or female;
• Patients diagnosed with unresectable or advanced solid tumors confirmed by histopathology or cytology; Cohort A: Patients must have progressed on standard of therapy, patients with NSCLC, CRC and HCC (include intrahepatic cholangiocarcinoma or mixed hepatocellular carcinoma-cholangiocarcinoma in safety run-in phase) are enrolled preferentially; Cohort B: Patients with histopathologically or cytologically or clinically diagnosed advanced HCC (Barcelona Clinic Liver Cancer (BCLC) Stage C; or BCLC Stage B patients who are not suitable for locoregional therapy (such as TACE) may also be enrolled), Child-Pugh liver function grade A and patients received at least one standard first-line systemic treatment and no more than 3 systemic regimens for HCC; Cohort C: Histologically confirmed NSCLC (except for patients with central and cavernous lung squamous cell carcinoma). Patients received at least one standard first line systemic treatment are required, if patients with EGFR、ALK or ROS1 gene positive, first line of target therapy will be required ( if patients with known EGFR mutation, they should be T790M negative or with osimertinib treatment failure); C1: Required prior anti-PD-1/PD-L1 therapy. C2: Never used prior anti-PD-1/PD-L1 therapy. Cohort D: Patients with advanced CRC confirmed with histology, the results of tissue samples must meet any of the following (1. the test result of immunohistochemistry is mismatch repair protein integrity (pMMR) 2. the test result of NGS is MSI-L or MSS 3 the test of result of PCR is MSI-L or MSS). Has received the oxaliplatin and 5-Fu containing regimen for the treatment of metastatic tumors.
• ECOG score 0 or 1;
• At least one measurable lesion as per RECIST V1.1;
• Normal major organ and marrow functions as defined and no blood transfusion and blood product within 2 weeks before screening, no use of hematopoietic stimulating factors;
• Life expectancy≥12 weeks;
• Women of childbearing potential must have a negative blood pregnancy test within 7 days prior to the first dose. Male or female patients of childbearing potential voluntarily use effective contraceptive methods from signing the informed consent form to 6 months after initiation of the study drug, such as double-barrier contraceptive methods, condoms, oral or injectable contraceptives, intrauterine devices, etc. All female patients are considered to be of childbearing potential unless they are postmenopausal (continuous menopause for 12 month), had undergone artificial menopause, or had undergone surgical sterilization (e.g., hysterectomy, surgical adnexectomy);

You may not qualify if:

• Patients who have participated in clinical trials of other investigational drugs or investigational devices within 28 days prior to the first dose or received any systemic treatments within 2 weeks, include but not limited chemotherapy, radiotherapy (palliative radiotherapy is allowed at least 1 week before the study drug treatment), targeted therapy, Chinese herbal medicine or proprietary Chinese medicine for cancer control;
• Patients with a history of Envofolimab or BD0801 treatment;
• Patients who have ascites requiring drainage or diuretic treatment or pleural effusion or pericardial effusion requiring drainage and/or accompanied by shortness of breath within 2 weeks before the first dose of study drug treatment;
• Cholangiocarcinoma, mixed cell carcinoma, or fibroblastic layer cell carcinoma are known for Cohort B;
• Patients with other active malignancies within 2 years prior to the first administration of the study drug randomization, curable localized tumors, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, cervical carcinoma in situ, and carcinoma in situ of the breast can be included in the group;
• Patients whose toxicity and side effects (due to previous anticancer treatments) have not recovered to≤grade 1, unless such AE is not considered to pose safety risks (such as hair loss and neuropathy≤grade 2 caused by oxaliplatin)
• Patients with previous and current central nervous system (CNS)metastasis;
• Patients with a history of hepatic encephalopathy;
• Patients with active tuberculosis (TB), who are receiving anti-TB treatment or received anti-TB treatment within 3 months prior the first study drug administration;
• Abdominal fistula, gastrointestinal perforation, abdominal abscess and intestinal obstruction with clinical symptoms (including occlusive disease);
• Receipt of live or attenuated live vaccines 4 weeks prior to the first study drug treatment;
• Suffer from any disease that requires corticosteroids within 2 weeks prior to the first study drug administration, except for local corticosteroids or dose of prednisone or equivalent drugs≤ 10mg/ day;
• Patients with previous or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radioactive pneumonia, drug-associated pneumonia, and severe impairment of lung function that may interfere with the detection and management of suspected drug-related lung toxicity;
• Patients with known activity or autoimmune diseases or history. Except subjects with vitiligoare not requiring systemic treatment within 2 years prior the first study drug, type 1 diabetes mellitus, hypothyroidism requiring only hormone replacement therapy, pituitaritis and adrenal cortical insufficiency requiring only physiological hormone replacement therapy or psoriasis who do not require systemic treatment may be allowed;
• Major surgery before enrollment or expected major surgery during the study period;

Sponsors & Collaborators

• Jiangsu Simcere Pharmaceutical Co., Ltd.: lead

Study Sites (24)

Beijing Cancer Hospital

Beijing, China

Location

The First Affiliated Hospital of Bengbu Medical College

Bengbu, China

Location

Jilin Cancer Hospital

Changchun, China

Location

Hunan Cancer Hospital

Changsha, China

Location

Sichuan Cancer Hospital

Chengdu, China

Location

Dezhou People'S Hospital

Dezhou, China

Location

First Affiliated Hospital of Gannan Medical Universit

Ganzhou, China

Location

Nanfang Hospital of Southern Medical University

Guangzhou, China

Location

Sun Yat-sen University affiliated with the Sixth Hospital

Guangzhou, China

Location

Sun Yat-sen University Cancer Center

Guangzhou, China

Location

Shaw Hospital Affiliated to Medical College of Zhejiang Universit

Hangzhou, China

Location

Zhejiang Provincial People'S Hospital

Hangzhou, China

Location

Harbin Medical University Cancer Hospital

Harbin, China

Location

Anhui Chest Hospital

Hefei, China

Location

Anhui Provincial Cancer Hospital

Hefei, China

Location

The First Affliated Hospital Of Anhui Medical University

Hefei, China

Location

Shandong Cancer Hospital

Jinan, China

Location

Mianyang Central Hospital

Mianyang, China

Location

Liaoning Cancer Hospital

Shenyang, China

Location

The Fourth Hospital of Hebei Medical University

Shijia Zhuang, China

Location

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, China

Location

Yantai Yuhuagnding Hospital

Yantai, China

Location

Henan Cancer Hospital

Zhengzhou, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, China

Location

MeSH Terms

Interventions

Docetaxel; Irinotecan; Leucovorin; 5-fluorouridine

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Camptothecin; Alkaloids; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes

Study Officials

• Zhengguang Lv

  Jiangsu Simcere Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2021
• First Posted: December 8, 2021
• Study Start: December 22, 2021
• Primary Completion: July 26, 2023
• Study Completion: July 26, 2023
• Last Updated: March 13, 2024

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (24)