## Protocol Section
### Identification Module
**NCT ID:** NCT06413615

**Brief Title:** A Study of FDA022-BB05 in Advanced/Metastatic Solid Tumors

**Official Title:** A Phase 2, Multicenter, Open-Label Study to Assess the Efficacy, Safety, Tolerability and Pharmacokinetics of FDA022-BB05 in Patients With Advanced/Metastatic Solid Tumors

#### Organization Study ID Info
**ID:** F0034-201
#### Organization
**Class:** INDUSTRY
**Full Name:** Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
### Status Module
#### Completion Date
**Date:** 2026-06-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-14

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-12

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-07-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-13

**Type:** ESTIMATED

**Status Verified Date:** 2024-04

#### Study First Post Date
**Date:** 2024-05-14
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-08
**Study First Submit QC Date:** 2024-05-12
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Shanghai Fudan-Zhangjiang Bio-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 is an open-label, multicenter, Phase II study to evaluate the efficacy and safety of FDA022-BB05 for the treatment in locally advanced, unresectable, or metastatic patients with selected HER2 overexpressing/expressing solid tumors which are not eligible for curative therapy.

### Conditions Module

**Conditions:**

- Advanced Solid Tumor

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 150

**Type:** ESTIMATED

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Enrolled Subjects will receive a 5.4 mg/kg IV dose of FDA022-BB05 on Day 1 of each cycle Q3W

**Intervention Names:**

- Drug: FDA022-BB05

**Label:** HER2 Low Metastatic/Recurrent Breast Cancer

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Enrolled Subjects will receive a 5.4 mg/kg IV dose of FDA022-BB05 on Day 1 of each cycle Q3W

**Intervention Names:**

- Drug: FDA022-BB05

**Label:** HER2 Expressing Metastatic/Recurrent Endometrial Cancer

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Enrolled Subjects will receive a 5.4 mg/kg IV dose of FDA022-BB05 on Day 1 of each cycle Q3W

**Intervention Names:**

- Drug: FDA022-BB05

**Label:** HER2 Overxpressing/Mutant Metastatic/Recurrent Solid tumor

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- HER2 Expressing Metastatic/Recurrent Endometrial Cancer

- HER2 Low Metastatic/Recurrent Breast Cancer

- HER2 Overxpressing/Mutant Metastatic/Recurrent Solid tumor

**Description:** Monoclonal antibody-drug conjugate for injection

**Name:** FDA022-BB05

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** The percentage of patients with CR and PR assessed by investigators according to RECIST v 1.1

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

**Time Frame:** up to 24 month

**Description:** Occurrence of AEs and SAEs graded according to NCI CTCAE v5.0.

**Measure:** Occurrence of adverse events (AEs) and serious adverse events (SAEs)

**Time Frame:** up to 24 month

#### Secondary Outcomes

**Description:** DOR is defined as the time from the date of first documented response until the date of documented progression or death.

**Measure:** Duration of response (DoR)

**Time Frame:** up to 24 month

**Description:** DCR is the percentage of subjects who have a best overall response of complete response (CR) or partial response (PR) or stable disease (SD).

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

**Time Frame:** up to 24 month

**Description:** PFS is the time from date of first dose of study treatment until the date of objective disease progression or death.

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

**Time Frame:** up to 24 month

**Description:** OS is the time from date of first dose of study treatment until death due to any cause.

**Measure:** Overall survival (OS)

**Time Frame:** up to 24 month

**Description:** The serum PK parameters of FDA022-BB05 and its analytes for area under the concentration-versus-time curve from time 0 to the last quantifiable concentration as calculated by the linear-up log-down trapezoidal method (AUClast) and AUC from time 0 to infinity (AUCinf) elimination rate constant associated with the terminal phase were estimated using standard non-compartmental methods.

**Measure:** Pharmacokinetic (PK) Analysis: Area Under the Concentration Versus Time Curve (AUC) of Serum FDA022-BB05 Following First Dose

**Time Frame:** From cycle1 to Cycle10 (each cycle is 21 days. )

**Description:** The serum PK parameters Maximum (peak) Observed serum concentration of FDA022-BB05 and its analytes were estimated using standard non-compartmental method.

**Measure:** Pharmacokinetic Analysis: Maximum (Peak) Observed Serum Concentration (Cmax) of Serum FDA022-BB05 Following First Dose

**Time Frame:** From cycle1 to Cycle10 (each cycle is 21 days. )

**Description:** The serum PK parameters of Time of maximum plasma concentration (Tmax) for FDA022-BB05 and its analytes were estimated using standard non-compartmental methods.

**Measure:** Pharmacokinetic Analysis: Time of Maximum Plasma Concentration (Tmax) of Serum FDA022-BB05 Following First Dose

**Time Frame:** From cycle1 to Cycle10 (each cycle is 21 days. )

**Description:** The serum PK parameters of Terminal elimination half-life for FDA022-BB05 and its analytes was estimated using standard non-compartmental methods.

**Measure:** Pharmacokinetic Analysis: Terminal Elimination Half-life (t1/2) of Serum FDA022-BB05 Following First Dose

**Time Frame:** From cycle1 to Cycle10 (each cycle is 21 days. )

**Description:** Individual participant data and descriptive statistics will be provided for data at each time point.

**Measure:** Number of participants who developed measurable anti-drug antibodies

**Time Frame:** up to 24 month

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Subjects fully understand and voluntarily participate in this study and sign informed consent.

Left Ventricular Ejection Fraction (LVEF) ≥ 50% within 28 days prior to first dose.

Eastern Cooperative Oncology Group performance status( PS) of 0 or 1. Life expectancy ≥ 3 months.

Histopathologically or cytologically confirmed advanced/unresectable or metastatic solid malignant tumors that is refractory to or intolerable with standard treatment, or for which no standard treatment is available:

Cohort A: Pathologically documented breast cancer that:

* Is unresectable or metastatic.
* Has a history of low HER2 expression, defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested).
* For HR-positive participants, is documented refractory to endocrine therapy, defined as having progressed on at least 1 endocrine therapy and determined by the investigator that subject would no longer benefit from further treatment from endocrine therapy.
* Was never previously HER2-positive(IHC 3+ or IHC 2+/ISH+) on prior pathology testing or was historically HER2 IHC 0 only.

Cohort B: Pathologically documented endometrial cancer that:

* Is unresectable or metastatic.
* Has a history of HER2 expression, defined as HER2 1+, 2+, or 3+ score on immunohistochemistry (IHC).
* Have had at least one prior line of platinum-based therapy (in any setting).
* Was never previously received other ADC anti-tumor treatment.

Cohort C: Metastatic or advanced solid tumor that are HER2 overexpression or mutation(Including urothelial cancer, colorectal adenocarcinoma and non-small cell lung cancer).

Exclusion Criteria:

* A treatment history of antibody-drug conjugate containing topoisomerase I inhibitors.

Subjects with one of the following conditions prior to first dose, including, but not limiting to：A major operation or severe trauma history within 4 weeks; A history of chemotherapy, targeted therapy, anti-angiogenesis therapy, biotherapy, immunotherapy, radiotherapy or other anti-tumor therapy within 4 weeks; A history of endocrine therapy within 3 weeks; A history of autologous stem cell transplant within 3 months.

Subjects with other malignant tumors in the past three years (not including cured non-melanoma skin basal cell carcinoma, cervical carcinoma in situ and other malignancies of low malignant potential that have been effectively controlled without treatment).

Subjects with symptomatic CNS metastasis (for example, cerebral edema requiring glucocorticoids therapy, or progressive CNS metastasis), not including prior cerebral and meningeal metastasis that is confirmed stable with MRI and without systematic glucocorticoids therapy.

Adverse reactions from the previous anti-tumor treatment have not yet recovered (\>Grade 2 in NCI-CTCAE 5.0, with exception of alopecia and pigmentation or other adverse reactions judged no safety risk by the investigator).

Subjects with clinically significant cardiovascular or cerebrovascular disease, including, but not limiting to:

a medical history of symptomatic Congestive Heart Failure (CHF) (NYHA classes II-IV) or serious cardiac arrhythmia.

a medical history of myocardial infarction or unstable angina within 6 months prior to screening; a QTc prolongation to \> 450 millisecond (ms) in males and \> 470 ms in females.

Subjects with a medical history of interstitial lung disease (ILD)/pneumonia in need of glucocorticoids intervention，or with interstitial lung disease, or suspicious ILD by imaging detection at screening.

Subjects with any uncontrolled active infection within 1 week prior to first dose.

Subjects with concomitant disease potentially increasing toxicological risk. Known allergy to protein preparation or any protein drug with similar structure to FDA022-BB05.

Subjects with a History of alcohol abuse or psychotropic/narcotic drug abuse; Pregnant or lactating women. Subjects with poor compliance, or not suitable for this study as determined by the investigator due to other reasons.

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** syner2000@163.com

**Name:** Jian Zhang, MD

**Phone:** 021-64175590

**Phone Ext:** 85000

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Shanghai

**Contacts:**

***Contact 1:***

- **Email:** syner2000@163.com

- **Name:** Jian Zhang, MD

- **Phone:** 021-64175590

- **Phone Ext:** 85000

- **Role:** CONTACT

**Country:** China

**Facility:** Fudan University Shanghai Cancer Center

#### Overall Officials

**Official 1:**

**Affiliation:** Fudan University

**Name:** Jian Zhang, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Meshes

- ID: D000009369

- Term: Neoplasms

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4225

- Name: Antibodies

- Relevance: LOW

- As Found: Unknown

- ID: M4230

- Name: Antibodies, Monoclonal

- Relevance: LOW

- As Found: Unknown

- ID: M10184

- Name: Immunoglobulins

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
