AzTrials
AzTrials

Small Cell Carcinoma of LungPhase 1NCT07550842

A Clinical Study for the Safety and Efficacy of BL0020 Injection in Combination With Toripalimab Injection in Patients With Recurrent Extensive-Stage Small Cell Lung Cancer

A Phase 1 study testing BL0020 and Toripalimab in people with Small Cell Carcinoma of Lung, run by Shanghai Best-Link Bioscience, LLC at 8 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

Lung cancer remains the leading cause of cancer deaths worldwide; in 2022, there were approximately 2.48 million new cases and 1.8 million deaths from lung cancer globally. Globally, lung cancer is the leading cause of cancer-related deaths in men and the second leading cause in women after breast cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Small Cell Carcinoma of Lung
What is being tested?
BL0020 and Toripalimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
8 sitesChina
Study dates
16 Jun 2026to 18 Aug 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

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

  • Volunteer to participate in the study, be able to understand the requirements of a clinical study, and willingness to sign a written informed consent form.
  • Aged ≥ 18 years, male or female.
  • Patients with histologically or cytologically confirmed ES-SCLC (per the American Veterans Administration Lung Study Group [VALG] staging system) who have relapsed or progressed following first-line platinum-based systemic treatment regimen.
  • Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1 at screening.
  • Life expectancy ≥ 12 weeks.

Who cannot join

  • Chemotherapy-free interval (CTFI: time from the last dose of first-line platinum-based chemotherapy to disease progression) < 30 days, regardless of maintenance treatment with immune checkpoint inhibitors.
  • Histologically or cytologically confirmed combined SCLC and transformed SCLC.
  • Patients with central nervous system (CNS) metastases or carcinoma meningitis. Note: Patients with asymptomatic CNS metastases may participate in this study if they meet all the following criteria:
  • 1)Patients with treated CNS metastases may participate in this study if the patient has completed radiotherapy or surgery for CNS metastases ≥ 4 weeks prior to study entry, and if the patient is neurologically stable ≥ 4 weeks after radiotherapy or surgery treatment (no new neurologic deficits from brain metastasis on screening clinical examination, no new findings on CNS imaging, and high doses of corticosteroids [> 10 mg prednisone daily or equivalent] were not required within 4 weeks prior to screening).
  • 2)Only supratentorial and cerebellar metastases allowed (i.e., no metastases to midbrain, pons, medulla or spinal cord).
  • 4.Previous or current autoimmune disease, including but not limited to Crohn's disease, ulcerative colitis, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis, with the following allowed exceptions:
Show all 14Show fewer
  • Patients with a history of autoimmune-related hypothyroidism on thyroid replacement hormone therapy.
  • Patients with controlled Type I diabetes mellitus on an insulin regimen.
  • Patients with vitiligo. 5.Patients with Gilbert's syndrome disease. 6.Patients who have a history of another primary malignancy (with the exception of patients with cured basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ of uterine cervix). A patient who has had no evidence of disease from another primary cancer for 3 or more years is allowed to participate in the study.
  • 7.Poorly controlled hypertension (defined as systolic blood pressure > 150 mmHg or diastolic blood pressure > 100 mmHg), or a history of hypertensive crisis or hypertensive encephalopathy.
  • 8.Patients who have a known diagnosis of Human Immunodeficiency Virus (HIV) infection or HIV antibody test positive during screening.
  • 9.Active hepatitis C or chronic hepatitis B at screening ("active hepatitis" defined as HCV RNA ≥ ULN at the local clinical site for hepatitis C, or HBV DNA ≥ ULN at the local clinical site for hepatitis B). Note: Antiviral therapy may be administered during the study to prevent viral reactivation if necessary.
  • 10.Patients who have not sufficient baseline organ function. 11.Those who have received live or attenuated vaccines (e.g., measles, mumps, rubella, varicella, yellow fever, rabies, BCG, typhoid vaccine) within 4 weeks before enrollment or scheduled to receive during the study.
  • 12.Known allergy to Toripalimab, BL0020, or any of their excipients. 13.Pregnant or lactating women. 14.Patients who are assessed disqualified to join clinical studies by investigator due to any causes.

Trial locations and contacts

8 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Zhuolun Fang contact

+8618357916536

fangzhuolun@bestlinkbio.com

8 sites in 1 country

China8 sites

  • The First People's Hospital of Changzhou

    Changzhou, Jiangsu, 213003

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150081

  • Shanghai Chest Hospital

    Shanghai, 200030

  • Shanghai Pulmonary Hospital

    Shanghai, 200433

  • The First Hospital of China Medical University

    Shenyang, Liaoning, 110001

  • Taizhou Hospital of Zhejiang Province

    Taizhou, Zhejiang, 317000

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

    Wuhan, Hubei, 430030

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450008

Other trials in China

About this study

Official title: An Open, Multi-center Phase I Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Efficacy of BL0020 Injection in Combination With Toripalimab Injection in Patients With Recurrent Extensive-Stage Small Cell Lung Cancer

Lung cancer remains the leading cause of cancer deaths worldwide; in 2022, there were approximately 2.48 million new cases and 1.8 million deaths from lung cancer globally. Globally, lung cancer is the leading cause of cancer-related deaths in men and the second leading cause in women after breast cancer. Among them, small cell lung cancer (SCLC) accounts for approximately 14% of all newly diagnosed lung cancers. Small cell lung cancer (SCLC) is a highly heterogeneous and aggressive disease with poor survival outcomes.

A 2-stage system dividing patients into limited and extensive disease was developed in 1973 by the United States (US) Veteran's Administration Lung Cancer Study Group (VALG), which has been used to this day. Patients with limited-stage SCLC can be treated with chemotherapy and radiation with the potential for long-term survival. However, the majority (approximately 70%) of patients with SCLC are diagnosed with extensive-stage SCLC (ES-SCLC), which has poor survival prospects. Chest pain, dyspnea, and cough are among the most frequent disease-related symptoms experienced by patients with SCLC. Immune checkpoint inhibitors in combination with platinum-based systemic therapy can palliate symptoms and prolong survival for patients with ES-SCLC. However, long-term survival is rare.

Read more

The current standard first-line treatment for patients with ES-SCLC is immune checkpoint inhibitors in combination with platinum-based systemic therapy. Despite the impressive high objective response rates (approximately 60%-80%) observed with first-line treatment regimens, the median overall survival (OS) of patients rarely exceeds 16 months, and the median progression-free survival (PFS) is also limited to around 5 months. Second-line and subsequent therapeutic options are limited. The main treatment drugs include Topotecan, Lurbinectedin, Tarlatamab, etc., with objective response rates rarely exceeding 40%. Therefore, there is a significant need for improved novel treatment options for patients with ES-SCLC.

This is a multi-center, open-label study. The study is designed to evaluate the safety, tolerability, and preliminary efficacy of Toripalimab in combination with BL0020 in patients with ES-SCLC who have relapsed or progressed following first-line platinum-based systemic treatment regimen.

Being tested
BL0020, Toripalimab
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

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

  • BL0020Drug

    BL0020 will be administered via intravenous infusion on Day 1 of each 21-day treatment cycle.

  • ToripalimabDrug

    Toripalimab will be administered via intravenous infusion on Day 1 of each 21-day treatment cycle.

Study groups in NCT07550842
Study groupRoleWhat they receive
BL0020 in combination with ToripalimabExperimentalBL0020 will be escalated, in combination with Toripalimab
Receives: Drug: BL0020; Drug: Toripalimab

What is being measured

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

  1. MTD

    Maximum Tolerated Dose (MTD) of BL0020 in combination with Toripalimab

    Measured: Throughout the study for approximately 2 years

  2. RP3D

    Recommended Phase 3 Dose (RP3D) of BL0020 in combination with Toripalimab

    Measured: Throughout the study for approximately 2 years

Secondary outcomes (6)

  1. Objective response rate (ORR)

    ORR is defined as the proportion of patients with the best responses of Complete Response (CR) and Partial Response (PR) observed after study treatment

    Measured: Throughout the study for approximately 2 years

  2. Duration of response (DOR)

    DOR is defined as the time from the initial response (complete response [CR] or partial response [PR]) until first objective radiographic tumor progression or death from any cause

    Measured: Throughout the study for approximately 2 years

  3. Disease control rate (DCR)

    DCR is the sum of complete response (CR), partial response (PR), and stable disease (SD) rates

    Measured: Throughout the study for approximately 2 years

  4. Progression-free survival (PFS)

    PFS is defined as the time from the start date of study treatment until first objective radiographic tumor progression or death from any cause

    Measured: Throughout the study for approximately 2 years

  5. Overall survival (OS)

    OS is defined as the time from the start date of study treatment until death from any cause

    Measured: Throughout the study for approximately 2 years

  6. 12-Month Overall Survival rate (OS12)

    OS12 is defined the proportion of patients who are alive 12 months from the start date of the study treatment

    Measured: From the first study treatment to the 12-month time point

Timeline

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

  1. First posted24 Apr 2026
  2. Study start16 Jun 2026 (estimated)
  3. Primary completion28 Apr 2028 (estimated)
  4. Study completion18 Aug 2028 (estimated)

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
33 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07550842
Sponsor's protocol ID
BL0020-102
Status last verified
Apr 2026
First submitted
20 Apr 2026
Last updated
24 Apr 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BL0020 and Toripalimab in people with Small Cell Carcinoma of Lung, run by Shanghai Best-Link Bioscience, LLC at 8 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 5 inclusion and 14 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: opening soon, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact Zhuolun Fang (+8618357916536, fangzhuolun@bestlinkbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MTD (time frame: Throughout the study for approximately 2 years). 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 NCT07550842.

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 24 Apr 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in