## Protocol Section
### Identification Module
**NCT ID:** NCT06434597

**Brief Title:** A Clinical Study of SPH5030 Tablets in the Treatment of Her2-positive/Mutated Biliary Tract OR Colorectal Cancer Patients.

**Official Title:** A Multicenter, Open, Single-arm Phase II Clinical Study to Evaluate the Efficacy and Safety of SPH5030 Tablets in Subjects With Her2-positive/Mutated Biliary Tract OR Colorectal Cancer.

#### Organization Study ID Info
**ID:** SPH5030-201
#### Organization
**Class:** INDUSTRY
**Full Name:** Shanghai Pharmaceuticals Holding Co., Ltd
### Status Module
#### Completion Date
**Date:** 2026-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-23

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-30

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Shanghai Pharmaceuticals Holding Co., Ltd

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** To evaluate the efficacy and safety of SPH5030 tablets in subjects with Her2-positive/mutated biliary tract OR colorectal cancer.

### Conditions Module

**Conditions:**

- Biliary Tract or Colorectal Cancer With Her2-positive/Mutated

### 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

**Intervention Names:**

- Drug: SPH5030

**Label:** SPH5030

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- SPH5030

**Description:** SPH5030：Oral, QD, 600mg

**Name:** SPH5030

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1.

**Measure:** Objective response rate (ORR)

**Time Frame:** Approximately 2 years

#### Secondary Outcomes

**Description:** DOR was defined for participants who had an objective response as the time from the first occurrence of a documented unconfirmed response (CR or PR) to the date of disease progression per RECIST v1.1 or death from any cause.

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

**Time Frame:** Approximately 2 years

**Description:** DCR was defined as the percentage of patients who have achieved complete response, partial response and stable disease.

**Measure:** Disease control rate (DCR)

**Time Frame:** Approximately 2 years

**Description:** From the start date of study treatment to the date of progression disease or death , whichever occurred first.

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

**Time Frame:** Approximately 2 years

**Description:** Determination of the overall survival times of all patients

**Measure:** Overall Survival (OS)

**Time Frame:** Approximately 2 years

**Description:** Adverse event type, incidence, duration

**Measure:** Incidence of Treatment-Emergent Adverse Events

**Time Frame:** Approximately 2 years

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Metastatic and/or unresectable advanced colorectal adenocarcinoma, or locally advanced, recurrent, metastatic and/or unresectable advanced biliary tract carcinoma
2. HER2 positive or HER2 gene mutation;
3. Meet the requirements of previous treatment;
4. ECOG performance status of 0 or 1；
5. Expected survival ≥ 3 months;
6. No serious abnormalities in hematopoietic function, liver or kidney function;
7. Females who are not pregnant, non-lactating.. Subjects who complied with the contraceptive requirements of the protocol.;
8. Fully informed subjects who voluntarily sign the ICF.

Exclusion Criteria:

1. Subjects who have previously received anti-HER2 molecular targeted therapy;
2. Subjects who have been treated with any other clinical trial drug within 4 weeks prior to the first dose;
3. Subjects with uncontrolled or severe cardiovascular and cerebrovascular diseases; Subjects with severe lung disease; 4. Subjects who may have conditions that affect the absorption, distribution, metabolism, or excretion of the study drug determined by the investigator;

5 Subjects who are taking potent CYP3A4 or CYP2C8 inhibitors or inducers; 6 Subjects with other malignancies in the past 5 years; 7 Subjects with CNS system metastasis with clinical symptoms; 8 Subjects who do not meet the protocol requirements for hepatitis B and C at screening, have a history of immunodeficiency, or other acquired、congenital immunodeficiency diseases, or have a history of organ transplantation; 9. Other situations that do not meet the requirements of the protolol.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** jfjzyygw@163.com

**Name:** Jianming Xu

**Phone:** 0086-010-66937166

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Beijing

**Contacts:**

***Contact 1:***

- **Name:** Jianming Xu

- **Role:** CONTACT

**Country:** China

**Facility:** Chinese PLA General hospital

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007414

- Term: Intestinal Neoplasms

- ID: D000005770

- Term: Gastrointestinal Neoplasms

- ID: D000004067

- Term: Digestive System Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000005767

- Term: Gastrointestinal Diseases

- ID: D000003108

- Term: Colonic Diseases

- ID: D000007410

- Term: Intestinal Diseases

- ID: D000012002

- Term: Rectal Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M17890

- Name: Colorectal Neoplasms

- Relevance: HIGH

- As Found: Colorectal Cancer

- ID: M10448

- Name: Intestinal Neoplasms

- 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: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6336

- Name: Colonic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10444

- Name: Intestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14844

- Name: Rectal Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000015179

- Term: Colorectal Neoplasms

### Misc Info Module

- Version Holder: 2024-05-31
