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

NCT ID: NCT06427239

Last Updated: 2024-08-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-29
• Study Completion Date: 2026-09-30

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

Pancreatic Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dose Escalation 300mg

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

Group Type: EXPERIMENTAL

HRS-4642

Intervention Type: DRUG

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

Adebrelimab

Intervention Type: DRUG

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

Dose Escalation 400mg

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

Group Type: EXPERIMENTAL

HRS-4642

Intervention Type: DRUG

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

Adebrelimab

Intervention Type: DRUG

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

Dose Escalation 500mg

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

Group Type: EXPERIMENTAL

HRS-4642

Intervention Type: DRUG

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

Adebrelimab

Intervention Type: DRUG

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

Interventions

HRS-4642

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

Intervention Type: DRUG

Adebrelimab

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Xian-Jun Yu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Si Shi

Role: CONTACT

Shisi@fudanpci.org

+86-021-64179375

Facility Contacts

XianJun Yu, M.D., Ph.D.

Role: primary

yuxianjun@fudanpci.org

+86-21-6417-5590

Other Identifiers

PANC-2nd-IIT-HRS4642-SHR1316

Identifier Type: -

Identifier Source: org_study_id