## Protocol Section
### Identification Module
**NCT ID:** NCT06423885

**Brief Title:** A Study of BL-M07D1+PD-1 Monoclonal Antibody and BL-M07D1+PD-1 Monoclonal Antibody+Capecitabine in Patients With Locally Advanced or Metastatic HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma

**Official Title:** A Phase II Clinical Trial to Evaluate the Efficacy and Safety of BL-M07D1+PD-1 Monoclonal Antibody and BL-M07D1+PD-1 Monoclonal Antibody+Capecitabine as First-line Treatment in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma

#### Organization Study ID Info
**ID:** BL-M07D1-206
#### 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:** 2024-05-29

**Type:** ACTUAL

**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:** 2024-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-16
### 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 multicenter, open-label, phase II clinical trial to evaluate the safety and efficacy of BL-M07D1+PD-1 monoclonal antibody and BL-M07D1+PD-1 monoclonal antibody+ capecitabine in patients with unresectable locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma.

### Conditions Module

**Conditions:**

- HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 86

**Type:** ESTIMATED

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants received BL-M07D1+PD-1 monoclonal antibody and BL-M07D1+PD-1 monoclonal antibody+ capecitabine in the first cycle (3 weeks). Participants who had a clinical benefit could receive additional cycles of additional treatment. Administration will be discontinued because of disease progression or intolerable toxicity or for other reasons.

**Intervention Names:**

- Drug: BL-M07D1

- Drug: PD-1 monoclonal antibody

- Drug: Capecitabine

**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-M07D1

**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

#### Intervention 3

**Arm Group Labels:**

- Study treatment

**Description:** Oral administration for a cycle of 3 weeks.

**Name:** Capecitabine

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** ORR is defined as the percentage of participants, who has a CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experiences a confirmed CR or PR is according to RECIST 1.1.

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

**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-M07D1. The type, frequency and severity of TEAE will be evaluated during the treatment of BL-M07D1.

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

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

#### Secondary Outcomes

**Description:** The PFS is defined as the time from the participant's first dose of BL-M07D1 to the first date of either disease progression or death, whichever occurs first.

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

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

**Description:** Overall survival (OS) is defined as the time between the subject's randomization date and subject's death.

**Measure:** Overall survival (OS)

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

**Description:** The DCR is defined as the percentage of participants who has a CR, PR, or Stable Disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease \[PD: at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD\]).

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

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

**Description:** he DOR for a responder is defined as the time from the participant's initial objective response to the first date of either disease progression or death, whichever occurs first.

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

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

**Description:** Maximum serum concentration (Cmax) of BL-M07D1 will be investigated.

**Measure:** Cmax

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

**Description:** Time to maximum serum concentration (Tmax) of BL-M07D1 will be investigated.

**Measure:** Tmax

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

**Description:** Ctrough is defined as the lowest serum concentration of BL-M07D1 prior to the next dose will be administered.

**Measure:** Ctrough

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

**Description:** Frequency of anti-BL-M07D1 antibody (ADA) will be investigated.

**Measure:** ADA (anti-drug antibody)

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

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Voluntarily sign the informed consent and follow the requirements of the protocol;
2. No gender limit;
3. Age ≥18 years old and ≤75 years old at the time of signing the informed consent;
4. Expected survival time ≥3 months;
5. Patients with HER2-positive gastric or gastroesophageal junction adenocarcinoma confirmed by histopathology and/or cytology;
6. Provide tumor tissue samples within 2 years for detection of biomarkers such as HER2;
7. Must have at least one measurable lesion according to RECIST v1.1 definition;
8. ECOG 0 or 1;
9. Toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined by NCI-CTCAE v5.0;
10. No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
11. Blood transfusion is not allowed within 14 days before the first use of study drugs, and the use of colony-stimulating factors is not allowed, and the organ function level must meet the requirements;
12. Coagulation function: international normalized ratio (INR) ≤1.5 and activated partial thromboplastin time (APTT) ≤1.5×ULN;
13. Urine protein ≤2+ or ≤1000mg/24h;
14. Fertile female subjects or male subjects with fertile partners must use highly effective contraception from 7 days before the first dose until 24 weeks after the dose. Female subjects of childbearing potential had to have a negative serum pregnancy test within 7 days before the first dose.

Exclusion Criteria:

1. Major surgery within 4 weeks before the first dose, palliative radiotherapy within 2 weeks before the first dose, etc;
2. Prior ADC drug therapy with camptothecin derivative as toxin;
3. The history of severe cardiovascular and cerebrovascular diseases in the past six months;
4. Serious impairment of lung function due to pulmonary diseases;
5. QT prolongation, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia;
6. Other primary malignancies diagnosed within 5 years before the first dose;
7. Poorly controlled hypertension;
8. A history of ILD requiring steroid therapy, current ILD/interstitial pneumonia or suspected to have such a condition during screening;
9. Patients with active central nervous system metastases;
10. Patients who are allergic to any excipients of the trial drug;
11. Systemic corticosteroids or immunosuppressive agents are required within 2 weeks before study dosing;
12. Patients with massive or symptomatic effusions or poorly controlled effusions;
13. Severe systemic infection within 4 weeks before screening;
14. Active autoimmune and inflammatory diseases;
15. Human immunodeficiency virus antibody positive, active hepatitis B virus infection or hepatitis C virus infection;
16. Previous history of allogeneic stem cell, bone marrow or organ transplantation;
17. A history of severe neurological or psychiatric illness;
18. Pregnant or lactating women;
19. The presence of other serious physical or laboratory abnormalities or poor compliance may increase the risk of participating in the study risk, or interference with the results of the study, and patients who were deemed by the investigators to be unsuitable for participation in the study.

**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:** Weijian Guo

- **Role:** CONTACT

**Country:** China

**Facility:** Fudan University Shanghai Cancer Center

**State:** Shanghai

#### Overall Officials

**Official 1:**

**Affiliation:** Fudan University

**Name:** Weijian Guo

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000002277

- Term: Carcinoma

- ID: D000009375

- Term: Neoplasms, Glandular and Epithelial

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

- ID: D000005770

- Term: Gastrointestinal Neoplasms

- ID: D000004067

- Term: Digestive System Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000006258

- Term: Head and Neck Neoplasms

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000004935

- Term: Esophageal Diseases

- ID: D000005767

- Term: Gastrointestinal Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: All

- Name: All Conditions

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M3585

- Name: Adenocarcinoma

- Relevance: HIGH

- As Found: Adenocarcinoma

- ID: M8088

- Name: Esophageal Neoplasms

- Relevance: HIGH

- As Found: Gastroesophageal Junction Adenocarcinoma

- ID: M5534

- Name: Carcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M12320

- Name: Neoplasms, Glandular and Epithelial

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M8886

- Name: Gastrointestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7256

- Name: Digestive System Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M9348

- Name: Head and Neck Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8085

- Name: Esophageal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T2141

- Name: Esophageal Cancer

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000000230

- Term: Adenocarcinoma

- ID: D000004938

- Term: Esophageal Neoplasms

### Intervention Browse Module - Ancestors

- ID: D000007155

- Term: Immunologic Factors

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000000964

- Term: Antimetabolites, Antineoplastic

- ID: D000000963

- Term: Antimetabolites

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000000970

- Term: Antineoplastic Agents

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: ANeo

- Name: Antineoplastic Agents

### 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: M377

- Name: Capecitabine

- Relevance: HIGH

- As Found: Function

- ID: M10184

- Name: Immunoglobulins

- Relevance: LOW

- As Found: Unknown

- ID: M10201

- Name: Immunologic Factors

- Relevance: LOW

- As Found: Unknown

- ID: M4281

- Name: Antimetabolites

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000069287

- Term: Capecitabine

- ID: D000000906

- Term: Antibodies

- ID: D000000911

- Term: Antibodies, Monoclonal

### Misc Info Module

- Version Holder: 2024-05-31
