## Protocol Section
### Identification Module
**NCT ID:** NCT06427239

**Brief Title:** Exploratory Clinical Study of HRS-4642 Combined With Adebelimab in the Treatment of Advanced Pancreatic Cancer

**Official Title:** A Single-center, Open-label, Exploratory Study of HRS-4642 Combined With Adebelimab in the Treatment of Advanced Pancreatic Cancer

#### Organization Study ID Info
**ID:** PANC-2nd-IIT-HRS4642-SHR1316
#### Organization
**Class:** OTHER
**Full Name:** Fudan University
### Status Module
#### Completion Date
**Date:** 2026-09

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-19

**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:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-19
**Study First Submit QC Date:** 2024-05-19
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Jiangsu HengRui Medicine Co., Ltd.

#### Lead Sponsor

**Class:** OTHER

**Name:** Fudan University

#### Responsible Party

**Investigator Affiliation:** Fudan University

**Investigator Full Name:** Xian-Jun Yu

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The study is being conducted to evaluate the safety, tolerability and efficacy of HRS-4642 combined with adebelimab in subjects with locally advanced or metastatic pancreatic ductal adenocarcinoma.

**Detailed Description:** This study is an open, single center, exploratory clinical trial aimed at evaluating the efficacy and safety of HRS-4642 combined with adebelimab in the treatment of patients with unresectable locally advanced or metastatic pancreatic ductal adenocarcinoma.

This study experiment is divided into two stages: dose exploration stage and efficacy exploration stage. During the dose exploration phase, RP2D was determined based on the safety, tolerability, and preliminary efficacy data of HRS-4642 combined with adelbizumab treatment, and then entered the efficacy exploration phase.

### Conditions Module

**Conditions:**

- Pancreatic Cancer

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SEQUENTIAL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 35

**Type:** ESTIMATED

**Phases:**

- PHASE1

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** For HRS-4642 in combination with Adebrelimab, for advanced or metastatic pancreatic ductal adenocarcinoma.

**Intervention Names:**

- Drug: HRS-4642

- Drug: Adebrelimab

**Label:** Part A: Dose Escalation; Part B: Dose Expansion

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Part A: Dose Escalation; Part B: Dose Expansion

**Description:** HRS-4642 will be administrated per dose level in which the patients are assigned.

**Name:** HRS-4642

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Part A: Dose Escalation; Part B: Dose Expansion

**Description:** Adebrelimab will be administrated per dose level in which the patients are assigned

**Name:** Adebrelimab

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** A DLT is defined as any event meeting the DLT criteria occurring within 21 days of first dose on Cycle 1 Day 1 (C1D1), excluding toxicities clearly related to disease progression or intercurrent illness

**Measure:** Dose Limited Toxicity (DLT)

**Time Frame:** Day 1 to Day 21 after the first combination therapy was administrated

**Description:** RP2D will be determined on the basis of evaluation on safety and efficacy data in dose escalation stages.

**Measure:** Recommended phase II dose (RP2D)

**Time Frame:** Approximately 12 months

**Description:** Evaluated by RECIST v1.1.

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

**Time Frame:** Up to approximately 12 months

#### Secondary Outcomes

**Description:** Evaluated by RECIST v1.1.

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

**Time Frame:** Up to approximately 12 months

**Description:** Evaluated by RECIST v1.1.

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

**Time Frame:** Up to approximately 12 months

**Description:** Time from the date of enrollment to of disease progression, or death of any cause, or date of lost follow-up, whichever comes first, otherwise subject data were censored at time last known disease free.

**Measure:** Progression Free Survival (PFS)

**Time Frame:** Up to approximately 12 months

**Description:** Time from the date of enrollment to data of death from any cause, or date of lost follow-up, whichever comes first, and otherwise censored at time last known alive.

**Measure:** Overall survival (OS)

**Time Frame:** Up to approximately 12 months

**Description:** AEs are assessed by NCI-CTCAE v5.0

**Measure:** Adverse events (AEs)

**Time Frame:** From the first drug administration to within 90 days for the last adebrelimab dose

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Patients volunteered to participate in this study and signed informed consent;
2. Age: ≥18 and ≤75 years old, male or female;
3. Advanced (metastatic or unresectable) Pancreatic ductal adenocarcinoma; and subjects must have at least one measurable lesion as defined by RECIST v1.1;
4. With failure or absence of standard treatment, and progress within 6 months of adjuvant therapy can also be included in the study;
5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
6. Life expectancy ≥ 12 weeks;
7. Adequate marrow and organ function;
8. AE caused by previous anti-tumor therapy must be restored to ≤ level 1 (CTCAE v5.0) or a stable state evaluated by the researcher, except for hair loss (any level) and peripheral neuropathy of level 2;
9. Female participants of childbearing age must undergo a pregnancy test within one week before the start of the study medication, and the result is negative. They are willing to use a medically recognized and efficient contraceptive method during the study period and within three months after the last administration of the study medication; For male participants whose partners are women of childbearing age, they should agree to use effective methods of contraception during the study period and within 3 months after the last study administration;

Exclusion Criteria:

1. Known to be allergic to the investigational drug or any of its components;
2. Have other active malignancies within 5 years;
3. Systemic antitumor therapy was received 4 weeks before the start of the study, and palliative radiotherapy was completed within 14 days before the first dose;
4. Previously received allogeneic hematopoietic stem cell transplantation or organ transplantation;
5. Accompanied by untreated or active central nervous system (CNS) metastases;
6. Within 6 months prior to entering the study, patients with severe cardiovascular and cerebrovascular thromboembolism;
7. Hypertension with poor drug control (continuous increase in systolic blood pressure ≥ 150mm Hg or diastolic blood pressure ≥ 100mmHg);
8. Late stage patients with symptoms that have spread to the internal organs and are at risk of life-threatening complications in the short term;
9. With interstitial lung disease, non-infectious pneumonia, severe and uncontrolled internal medicine diseases, acute infections, recent history of major surgery (within 28 days or not yet recovered from side effects);
10. Participated in clinical trials of any drug or medical device within 4 weeks prior to the first administration;
11. With congenital or acquired immune deficiency, such as people infected with HIV, active hepatitis B (HBV DNA ≥ 500 IU/ml), hepatitis C (hepatitis C antibody positive, and HCV-RNA higher than the detection limit of the analytical method) or combined with hepatitis B and hepatitis C infection;
12. With any active autoimmune diseases or a history of autoimmune diseases;
13. Received systemic treatment with corticosteroids or other immunosuppressants within 2 weeks prior to the first medication;
14. High risk of pancreatitis, serum amylase and/or lipase concentrations ≥ 3 times ULN; who have a simple increase in lipase, will be considered for inclusion by the researchers;
15. Other situations that researchers believe should not be included.

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Shanghai

**Country:** China

**Facility:** Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University

**State:** Shanghai

**Zip:** 200032

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000004067

- Term: Digestive System Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000004701

- Term: Endocrine Gland Neoplasms

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000010182

- Term: Pancreatic Diseases

- ID: D000004700

- Term: Endocrine System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M13110

- Name: Pancreatic Neoplasms

- Relevance: HIGH

- As Found: Pancreatic Cancer

- ID: M8886

- Name: Gastrointestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7256

- Name: Digestive System Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7863

- Name: Endocrine Gland 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: M13102

- Name: Pancreatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T4387

- Name: Pancreatic Cancer

- Relevance: HIGH

- As Found: Pancreatic Cancer

### Condition Browse Module - Meshes

- ID: D000010190

- Term: Pancreatic Neoplasms

### Misc Info Module

- Version Holder: 2024-05-31
