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Advanced Solid TumorPhase 2NCT05148195

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

A Phase 2 study testing Envofolimab, BD0801 and Docetaxel in people with Advanced Solid Tumor, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 24 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumor
What is being tested?
Envofolimab, BD0801 and Docetaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
86 participants
Where
24 sitesChina
Study dates
22 Dec 2021to 26 Jul 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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);

Who cannot join

  • 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)
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  • 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;
  • Severe unhealed wound, ulcers or fractures;
  • The current or recent (within 10 days before the first dose of study medication) use of aspirin for 10 days (> 325 mg/day) or other known to inhibit platelet function of NSAIDs; a history bleeding disorders or thrombosis within 6 months before the first study drug administration;
  • Patients with clinically significant cardiovascular diseases；
  • Cardiac function: Left ventricular ejection fraction (LVEF)<50%;
  • Human immunodeficiency virus (HIV) antibodies or acquired immune deficiency syndrome (AIDS);
  • Active hepatitis B (HBsAg positive and HBV- DNA ≥ULN) or hepatitis C (HCV antibody positive and quantitative HCV-RNA≥ULN);
  • Pregnant or lactating women during the study;
  • Patients with a history of allergy to studied drugs or similar drugs or excipients;
  • Other conditions that researchers consider inappropriate for inclusion;

Trial locations and contacts

24 sites in 1 country.

24 sites in 1 country

China24 sites

  • Beijing Cancer Hospital

    Beijing

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu

  • Jilin Cancer Hospital

    Changchun

  • Hunan Cancer Hospital

    Changsha

  • Sichuan Cancer Hospital

    Chengdu

  • Dezhou People'S Hospital

    Dezhou

  • First Affiliated Hospital of Gannan Medical Universit

    Ganzhou

  • Nanfang Hospital of Southern Medical University

    Guangzhou

  • Sun Yat-sen University affiliated with the Sixth Hospital

    Guangzhou

  • Sun Yat-sen University Cancer Center

    Guangzhou

  • Shaw Hospital Affiliated to Medical College of Zhejiang Universit

    Hangzhou

  • Zhejiang Provincial People'S Hospital

    Hangzhou

  • Harbin Medical University Cancer Hospital

    Harbin

  • Anhui Chest Hospital

    Hefei

  • Anhui Provincial Cancer Hospital

    Hefei

  • The First Affliated Hospital Of Anhui Medical University

    Hefei

  • Shandong Cancer Hospital

    Jinan

  • Mianyang Central Hospital

    Mianyang

  • Liaoning Cancer Hospital

    Shenyang

  • The Fourth Hospital of Hebei Medical University

    Shijia Zhuang

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

    Wuhan

  • Yantai Yuhuagnding Hospital

    Yantai

  • Henan Cancer Hospital

    Zhengzhou

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou

Other trials in China

About this study

Official title: An Open Label, Multi-cohort, Multicenter Phase II Study to Evaluate the Efficacy and Safety of Envofolimab in Combination With BD0801 Injection With/Without Chemotherapy in Patients With Advanced Solid Tumors

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

Read the detailed description

The efficacy of immune checkpoint inhibitors combined with antivascular agents has been preliminarily demonstrated in a variety of solid tumors. Based on the huge clinical needs, the efficacy of envofolimab combined with BD0801 in patients with advanced hepatocellular carcinoma, non-small cell lung cancer and advanced colorectal cancer deserves further exploration.

Being tested
Envofolimab, BD0801, Docetaxel, Irinotecan, Leucovorin calcium

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EnvofolimabDrug

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

  • BD0801Drug

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

  • DocetaxelDrug

    75mg/m2，Q3W

  • IrinotecanDrug

    180 mg/m2，Q2W

  • Leucovorin calciumDrug

    400mg/m2，Q2W

  • 5-FluorouridineDrug

    2400 mg/m2，Q2W

Study groups in NCT05148195
Study groupRoleWhat they receive
A: Solid tumorExperimentalEnvofolimab（300mg，Q3W）+BD0801（2mg/kg，Q3W）
Receives: Drug: Envofolimab; Drug: BD0801
B: HCCExperimentalEnvofolimab（300mg，Q3W）+BD0801（2mg/kg，Q3W）
Receives: Drug: Envofolimab; Drug: BD0801
D：NSCLCExperimentalEnvofolimab（300mg，Q3W）+BD0801（2mg/kg，Q3W）+Docetaxel(75mg/m2，Q3W)
Receives: Drug: Envofolimab; Drug: BD0801; Drug: Docetaxel
D：CRCExperimentalEnvofolimab（200mg，Q2W）+BD0801（2mg/kg，Q2W）+FOLFIRI（Irinotecan 180 mg/m2，Leucovorin 400mg/m2，5-Fluorouridine 2400 mg/m2，Q2W）
Receives: Drug: Envofolimab; Drug: Irinotecan; Drug: Leucovorin calcium; Drug: 5-Fluorouridine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 months

  2. 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

    Measured: 1.5 years

Secondary outcomes (6)

  1. DOR(Duration Of Response) by investigator

    Measured from the date of partial or complete response to therapy until the disease progression based on RECIST v1.1criteria.

    Measured: 1.5 years

  2. PFS(Progression Free Survival) by investigator

    PFS was defined as the time from the date of randomization to the first documented disease progression or death, whichever occurred first. Progression was based on tumor assessment made by the investigator according to the RECIST1.1 criteria

    Measured: 1.5 years

  3. DCR(Disease Control Rate) by investigator

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

    Measured: 1.5 years

  4. OS（Overall Survival)

    OS is the time interval from the date of randomization to death from any cause.

    Measured: 2.5 years

  5. The incidence of AEs（adverse events) and SAEs（serious adverse events)

    Frequency and severity of Adverse Events or Serious Adverse Events as defined by CTCAE version 5.0

    Measured: 2 years

  6. ORR in subgroup of different TMB、PDL-1 and MSI status

    Proportion of subjects who have a complete or partial response relative to baseline as assessed by investigator according to RECIST 1.1 criteria in subgroup of different TMB、PDL-1 and MSI status

    Measured: 1.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2021
  2. Study start22 Dec 2021
  3. Primary completion26 Jul 2023
  4. Study completion26 Jul 2023

Why it stopped: The study was terminated due to the sponsor's research and development strategy adjustment.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
86 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05148195
Sponsor's protocol ID
B02B00302-KN035-201
Status last verified
Apr 2022
First submitted
15 Nov 2021
Last updated
13 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ma L, Zhang Y, Fang Y, Hao C, Fan Q, Jiang D, Lu L, Su F, Yang C, Liu Z, Tian J, Sun X, Sun S, Cheng Y. Anti-PD-L1 envafolimab combined with anti-VEGF suvemcitug in pretreated solid tumors and hepatocellular carcinoma: an open-label phase II study with safety run-in stage. Invest New Drugs. 2025 Apr;43(2):181-190. doi: 10.1007/s10637-025-01506-x. Epub 2025 Jan 30.

    PubMed 39883265

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Envofolimab, BD0801 and Docetaxel in people with Advanced Solid Tumor, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 24 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The study was terminated due to the sponsor's research and development strategy adjustment.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part I: MTD（Maximum tolerable dose）or RD（Recommended dose） (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05148195, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.

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