## Protocol Section
### Identification Module
**NCT ID:** NCT06437509

**Brief Title:** A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Extensive-stage Small Cell Lung Cancer

**Official Title:** A Phase II Clinical Trial to Evaluate the Efficacy and Safety of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Extensive-stage Small Cell Lung Cancer

#### Organization Study ID Info
**ID:** BL-B01D1-204-01
#### Organization
**Class:** INDUSTRY
**Full Name:** Sichuan Baili Pharmaceutical Co., Ltd.
### Status Module
#### Completion Date
**Date:** 2026-06

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-27

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-06

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-27
**Study First Submit QC Date:** 2024-05-27
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Sichuan Baili Pharmaceutical Co., Ltd.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This study is a phase II clinical study to explore the efficacy and safety of BL-B01D1 + PD-1 monoclonal antibody combination therapy in patients with extensive-stage small cell lung cancer.

### Conditions Module

**Conditions:**

- Extensive-stage Small-cell Lung Cancer

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 60

**Type:** ESTIMATED

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants receive BL-B01D1 + PD-1 monoclonal antibody as intravenous infusion for the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.

**Intervention Names:**

- Drug: BL-B01D1

- Drug: PD-1 monoclonal antibody

**Label:** Study treatment

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Study treatment

**Description:** Administration by intravenous infusion for a cycle of 3 weeks.

**Name:** BL-B01D1

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Study treatment

**Description:** Administration by intravenous infusion for a cycle of 3 weeks.

**Name:** PD-1 monoclonal antibody

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Objective response rate (ORR) is defined as the number of CR and PR in the treatment and control groups divided by the number of that group in the full analysis set (FAS).

**Measure:** Objective Response Rate (ORR)

**Time Frame:** Up to approximately 24 months

**Description:** The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for phase II study, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation study of BL-B01D1.

**Measure:** Recommended Phase II Dose (RP2D)

**Time Frame:** Up to approximately 24 months

#### Secondary Outcomes

**Description:** Progression-free survival (PFS) as assessed by BIRC is defined as the time between the date subjects are randomized and the first observation of disease progression (based on BICR's image-based assessment) or death.

**Measure:** Progression-free survival (PFS)

**Time Frame:** Up to approximately 24 months

**Description:** Disease Control Rate (DCR) : Percentage of all randomized subjects who rated the best overall response (BOR) as complete response (CR), partial response (PR), and disease stabilization (SD) according to RECIST 1.1 criteria.

**Measure:** Disease Control Rate (DCR)

**Time Frame:** Up to approximately 24 months

**Description:** Duration of Response (DOR) : defined as the period from the date when tumor response is first recorded to the date when objective tumor progression is first recorded or the date of death.

**Measure:** Duration of Response (DOR)

**Time Frame:** Up to approximately 24 months

**Description:** TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition during the treatment of BL-B01D1. The type, frequency and severity of TEAE will be evaluated during the treatment of BL-B01D1.

**Measure:** Treatment Emergent Adverse Event (TEAE)

**Time Frame:** Up to approximately 24 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Subject volunteered to participate in the study and signed an informed consent;
2. Male or female aged ≥18 years and ≤75 years;
3. Expected survival time ≥3 months;
4. ECOG score 0-1;
5. Newly diagnosed patients with extensive-stage small cell lung cancer confirmed by histopathology and / or cytology;
6. A archived tumor tissue sample or fresh tissue sample of the primary or metastatic lesion must be provided within 3 years;
7. At least one measurable lesion meeting the RECIST v1.1 definition was required;
8. No blood transfusion and no use of cell growth factors and/or platelet-raising drugs within 14 days before screening, and the organ function level must meet the requirements;
9. The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0;
10. For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before the initiation of treatment, a serum or urine pregnancy test must be negative, and the patient must not be lactating; All enrolled patients should take adequate barrier contraception during the entire treatment cycle and for 6 months after the end of treatment.

Exclusion Criteria:

1. Prior use of ADC drug therapy with small molecule toxins as topoisomerase I inhibitors;
2. Prior treatment with any systemic anti-tumor regimen for extensive-stage small cell lung cancer;
3. Pathology suggested small cell carcinoma containing non-small cell carcinoma components;
4. Subjects had used immunomodulatory drugs within 14 days before the first use of the study drug ;
5. Screening the history of severe cardiovascular and cerebrovascular diseases in the first half of the year ;
6. QT interval prolongation, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia ;
7. Active autoimmune diseases and inflammatory diseases ;
8. Receiving long-term systemic corticosteroid therapy or equivalent anti-inflammatory active drugs or any form of immunosuppressive therapy prior to the first dose;
9. Other malignancies that have progressed or require treatment within 5 years prior to the first dose;
10. Have ILD requiring steroid therapy, or currently have ILD, or suspected ILD at screening;
11. Prior to initiation of study treatment, there were: a) poorly controlled diabetes mellitus; b) with severe complications of diabetes; c) glycosylated hemoglobin levels of 8% or more; d) hypertension that is poorly controlled by two antihypertensive drugs; e) history of hypertensive crisis or hypertensive encephalopathy;
12. Unstable thrombotic events requiring therapeutic intervention within 6 months prior to screening; Except for infusion set-related thrombosis;
13. Concurrent pulmonary disease leading to severe clinical impairment of respiratory function;
14. Patients with active central nervous system metastases;
15. Patients with large serosal effusions, or symptomatic serosal effusions, or poorly controlled serosal effusions;
16. History of allergy to recombinant humanized antibody or human-mouse chimeric antibody or to any excipient component of the experimental drug;
17. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation;
18. Positive human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;
19. Severe infection within 4 weeks prior to first dose of study drug; Lung infection or active lung inflammation within 4 weeks;
20. Have participated in another clinical trial within 4 weeks prior to the first dose;
21. Have a history of psychotropic substance abuse and cannot be abstained from or have a history of severe neurological or psychiatric disorders;
22. Imaging examination showed that the tumor had invaded or encapsulated the large blood vessels in the chest;
23. Severe and non-healing wounds, ulcers, or fractures within 4 weeks prior to signing the informed policy;
24. Clinically significant bleeding or obvious bleeding tendency within 4 weeks prior to signing the informed policy;
25. Subjects who are scheduled to receive or receive a live vaccine within 28 days prior to the first dose;
26. Other conditions that the investigator considers unsuitable to participate in this clinical trial.

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** xiaosa@baili-pharm.com

**Name:** Sa Xiao, PHD

**Phone:** 15013238943

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Shanghai

**Contacts:**

***Contact 1:***

- **Name:** Caicun Zhou

- **Role:** CONTACT

**Country:** China

**Facility:** Shanghai East Hospital

**State:** Shanghai

#### Overall Officials

**Official 1:**

**Affiliation:** Shanghai East Hospital

**Name:** Caicun Zhou, PHD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012142

- Term: Respiratory Tract Neoplasms

- ID: D000013899

- Term: Thoracic Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000008171

- Term: Lung Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000002283

- Term: Carcinoma, Bronchogenic

- ID: D000001984

- Term: Bronchial Neoplasms

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M11172

- Name: Lung Neoplasms

- Relevance: HIGH

- As Found: Lung Cancer

- ID: M28323

- Name: Small Cell Lung Carcinoma

- Relevance: HIGH

- As Found: Small Cell Lung Cancer

- ID: M5534

- Name: Carcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M14979

- Name: Respiratory Tract Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M16658

- Name: Thoracic Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5540

- Name: Carcinoma, Bronchogenic

- Relevance: LOW

- As Found: Unknown

- ID: M5260

- Name: Bronchial Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: T5271

- Name: Small Cell Lung Cancer

- Relevance: HIGH

- As Found: Small Cell Lung Cancer

### Condition Browse Module - Meshes

- ID: D000008175

- Term: Lung Neoplasms

- ID: D000055752

- Term: Small Cell Lung Carcinoma

### Intervention Browse Module - Ancestors

- ID: D000007155

- Term: Immunologic Factors

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4225

- Name: Antibodies

- Relevance: HIGH

- As Found: Given

- ID: M4230

- Name: Antibodies, Monoclonal

- Relevance: HIGH

- As Found: Chemotherapy

- ID: M10184

- Name: Immunoglobulins

- Relevance: LOW

- As Found: Unknown

- ID: M10201

- Name: Immunologic Factors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000000906

- Term: Antibodies

- ID: D000000911

- Term: Antibodies, Monoclonal

### Misc Info Module

- Version Holder: 2024-05-31
