## Protocol Section
### Identification Module
**NCT ID:** NCT06424665

**Brief Title:** A Study of FZ-AD005 in Patients With Advanced Solid Tumors

**Official Title:** A PhaseⅠStudy to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of FZ-AD005 in Patients With Advanced Solid Tumors

#### Organization Study ID Info
**ID:** F0041-101
#### Organization
**Class:** INDUSTRY
**Full Name:** Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
### Status Module
#### Completion Date
**Date:** 2026-06-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-16

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-12-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-30

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-12
**Study First Submit QC Date:** 2024-05-16
### 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:** A First-in-Human, Open Label, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of FZ-AD005 in Patients with Advanced Solid Tumors.

### Conditions Module

**Conditions:**

- Advanced Solid Tumor, SCLC(Small Cell Lung Cancer) or LCNEC (Large Cell Neuroendocrine Carcinoma)

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 162

**Type:** ESTIMATED

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: FZ-AD005

**Label:** FZ-AD005

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- FZ-AD005

**Description:** Every 21 days for 1 cycle. Subjects will receive an intravenous infusion of FZ-AD005 until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the study.

**Name:** FZ-AD005

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** To determine the dose limiting toxicities (DLTs) of FZ-AD005

**Measure:** The dose limiting toxicity ( DLT)

**Time Frame:** 21 Days (first cycle)

**Description:** To determine the maximum tolerated dose (MTD) and/or recommended doses for expansion (RDEs). RDEs will not exceed MTD.

**Measure:** Maximum Tolerable Dose (MTD)

**Time Frame:** 21 Days (first cycle)

**Description:** To check the numbers of AEs happened during the course of trial.

**Measure:** Adverse Events (AEs）

**Time Frame:** Screening up to study completion, assessed up to 60 months

**Description:** To evaluate the objective response rate (ORR) \[Complete Response (CR) + Partial Response (PR)\] of FZ-AD005 according to RECIST 1.1

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

**Time Frame:** Up to 60 months

#### Secondary Outcomes

**Description:** Progression-free survival (PFS) was defined as the interval from the first dose start date to the date of disease progression defined as documented progressive disease (PD) or death from any cause, whichever occurs first.

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

**Time Frame:** Up to 60 months

**Description:** Duration of Response was defined as the duration of overall response measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started).

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

**Time Frame:** Up to 60 months

**Description:** overall survival was defined as the time from the date of the first dose start date to the date of death due to any cause.

**Measure:** Overall Survival (OS)

**Time Frame:** Up to 60 months

**Description:** To check the" Anti Drug Antibody" develops in participants against the FZ-AD005 through blood sample

**Measure:** Anti Drug Antibody (ADA)

**Time Frame:** Up to 36 months

**Description:** To measure the time to reach the maximum contraction of Total Antibody, Free DXd and FZ-AD005 in study participants

**Measure:** Time to peak (Tmax)

**Time Frame:** Up to 18 weeks

**Description:** To measure the time of Total Antibody, Free DXd and FZ-AD005 will take to eliminate half of it's concentration from participants.

**Measure:** Terminal elimination half-life (t1/2)

**Time Frame:** Up to 18 weeks

**Description:** To measure the maximum concentration participants obtained of Total Antibody, Free DXd and FZ-AD004 in their blood plasma.

**Measure:** Maximum observed plasma concentration (Cmax)

**Time Frame:** Up to 18 weeks

**Description:** To measure the drug profile for absorption, distribution, metabolism and excretion for Total Antibody, Free DXd and FZ-AD005 in participants blood plasma

**Measure:** Area under the concentration-time curve (AUC 0-∞) from time 0 to infinity

**Time Frame:** Up to 18 weeks

**Description:** To measure the time to reach the maximum contraction of Total Antibody, Free DXd and FZ-AD005 in study participants

**Measure:** Time to Cmax (Tmax)

**Time Frame:** Up to 18 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Patients able to give written informed consent;
2. Age ≥ 18 and ≤ 75 years old, male or female;
3. Patients have histological or cytological diagnosis with advanced solid tumors ( especially SCLC or LCNEC);
4. Willingness to provide tumor tissue for testing ;
5. Have measurable lesions defined in RECIST v. 1.1;
6. Expected survival ≥ 3 months;
7. Eastern Cancer Cooperative Group (ECOG) performance status 0-1;
8. Patients of child bearing potential must agree to take contraception during the study and for 6 months after the last day of treatment.

Exclusion Criteria:

1. Patients who have had previous treatment with any anti-DLL3 antibody；
2. Have had other malignant tumors in the past 5 years;
3. Patients who are receiving other anti-tumor treatments within 4 weeks prior to the first dose;
4. Have active CNS (central nervous system) metastasis；
5. Had undergone major surgery or severe trauma within 4 weeks prior to the first dose;
6. Had undergone systemic high-dose steroids within 2 weeks of initiation of study treatment;
7. Patients have psychiatric history;
8. Female patients who are breastfeeding or pregnant;
9. Other reasons that researchers believe are inappropriate to participate in this study.

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** mlzhou@fd-zj.com

**Name:** Mengli Zhou

**Phone:** 00-86-021-58953355

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Changsha

**Contacts:**

***Contact 1:***

- **Name:** Lin Wu

- **Role:** CONTACT

**Country:** China

**Facility:** Hunan Cancer Hospital

**State:** Hunan

**Zip:** 410013

**Location 2:**

**City:** Shanghai

**Contacts:**

***Contact 1:***

- **Name:** Caicun Zhou

- **Role:** CONTACT

**Country:** China

**Facility:** Shanghai East Hospital

**State:** Shanghai

**Zip:** 200120

**Location 3:**

**City:** Shanghai

**Contacts:**

***Contact 1:***

- **Name:** Shengxiang Ren

- **Role:** CONTACT

**Country:** China

**Facility:** Shanghai Pulmonary Hospital

**State:** Shanghai

**Zip:** 200120

**Location 4:**

**City:** Hangzhou

**Contacts:**

***Contact 1:***

- **Name:** Zhengbo Song

- **Role:** CONTACT

**Country:** China

**Facility:** Zhejiang Cancer Hospital

**State:** Zhejiang

**Zip:** 310022

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009369

- Term: Neoplasms

- ID: D000002283

- Term: Carcinoma, Bronchogenic

- ID: D000001984

- Term: Bronchial Neoplasms

- ID: D000008175

- Term: Lung Neoplasms

- ID: D000012142

- Term: Respiratory Tract Neoplasms

- ID: D000013899

- Term: Thoracic Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000008171

- Term: Lung Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000018358

- Term: Neuroendocrine Tumors

- ID: D000017599

- Term: Neuroectodermal Tumors

- ID: D000009373

- Term: Neoplasms, Germ Cell and Embryonal

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000000230

- Term: Adenocarcinoma

- ID: D000002277

- Term: Carcinoma

- ID: D000009375

- Term: Neoplasms, Glandular and Epithelial

- ID: D000009380

- Term: Neoplasms, Nerve Tissue

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: All

- Name: All Conditions

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M5534

- Name: Carcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M11172

- Name: Lung Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M28323

- Name: Small Cell Lung Carcinoma

- Relevance: HIGH

- As Found: Small Cell Lung Cancer

- ID: M20423

- Name: Carcinoma, Neuroendocrine

- Relevance: HIGH

- As Found: Neuroendocrine Carcinoma

- ID: M5540

- Name: Carcinoma, Bronchogenic

- Relevance: LOW

- As Found: Unknown

- ID: M5260

- Name: Bronchial Neoplasms

- 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: M20495

- Name: Neuroendocrine Tumors

- Relevance: LOW

- As Found: Unknown

- ID: M19845

- Name: Neuroectodermal Tumors

- Relevance: LOW

- As Found: Unknown

- ID: M20388

- Name: Neuroectodermal Tumors, Primitive

- Relevance: LOW

- As Found: Unknown

- ID: M12318

- Name: Neoplasms, Germ Cell and Embryonal

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M3585

- Name: Adenocarcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M12320

- Name: Neoplasms, Glandular and Epithelial

- Relevance: LOW

- As Found: Unknown

- ID: M12325

- Name: Neoplasms, Nerve Tissue

- Relevance: LOW

- As Found: Unknown

- ID: T5271

- Name: Small Cell Lung Cancer

- Relevance: HIGH

- As Found: Small Cell Lung Cancer

- ID: T4091

- Name: Neuroendocrine Tumor

- Relevance: LOW

- As Found: Unknown

- ID: T4092

- Name: Neuroepithelioma

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000055752

- Term: Small Cell Lung Carcinoma

- ID: D000018278

- Term: Carcinoma, Neuroendocrine

### Misc Info Module

- Version Holder: 2024-05-31
