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

NCT06427239 | Recruiting Phase 1

• 1 other identifier: PANC-2nd-IIT-HRS4642-SHR1316
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (3)

• Dose Limited Toxicity (DLT)

  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

  Day 1 to Day 21 after the first combination therapy was administrated

• Recommended phase II dose (RP2D)

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

  Approximately 12 months

• Objective Response Rate (ORR)

  Evaluated by RECIST v1.1.

  Up to approximately 12 months

Secondary Outcomes (5)

• Disease Control Rate (DCR)

  Up to approximately 12 months

• Duration of Response (DOR)

  Up to approximately 12 months

• Progression Free Survival (PFS)

  Up to approximately 12 months

• Overall survival (OS)

  Up to approximately 12 months

• Adverse events (AEs)

  From the first drug administration to within 90 days for the last adebrelimab dose

Study Arms (3)

Dose Escalation 300mg

EXPERIMENTAL

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

Drug: HRS-4642; Drug: Adebrelimab

Dose Escalation 400mg

EXPERIMENTAL

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

Drug: HRS-4642; Drug: Adebrelimab

Dose Escalation 500mg

EXPERIMENTAL

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

Drug: HRS-4642; Drug: Adebrelimab

Interventions

HRS-4642 DRUG

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

Dose Escalation 300mg; Dose Escalation 400mg; Dose Escalation 500mg

Adebrelimab DRUG

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

Dose Escalation 300mg; Dose Escalation 400mg; Dose Escalation 500mg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients volunteered to participate in this study and signed informed consent;
• Age: ≥18 and ≤75 years old, male or female;
• Advanced (metastatic or unresectable) Pancreatic ductal adenocarcinoma; and subjects must have at least one measurable lesion as defined by RECIST v1.1;
• With failure or absence of standard treatment, and progress within 6 months of adjuvant therapy can also be included in the study;
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
• Life expectancy ≥ 12 weeks;
• Adequate marrow and organ function;
• 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;
• 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;

You may not qualify if:

• Known to be allergic to the investigational drug or any of its components;
• Have other active malignancies within 5 years;
• 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;
• Previously received allogeneic hematopoietic stem cell transplantation or organ transplantation;
• Accompanied by untreated or active central nervous system (CNS) metastases;
• Within 6 months prior to entering the study, patients with severe cardiovascular and cerebrovascular thromboembolism;
• Hypertension with poor drug control (continuous increase in systolic blood pressure ≥ 150mm Hg or diastolic blood pressure ≥ 100mmHg);
• Late stage patients with symptoms that have spread to the internal organs and are at risk of life-threatening complications in the short term;
• 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);
• Participated in clinical trials of any drug or medical device within 4 weeks prior to the first administration;
• 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;
• With any active autoimmune diseases or a history of autoimmune diseases;
• Received systemic treatment with corticosteroids or other immunosuppressants within 2 weeks prior to the first medication;
• Other situations that researchers believe should not be included.

Sponsors & Collaborators

• Fudan University: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Central Study Contacts

Si Shi

CONTACT

+86-021-64179375; Shisi@fudanpci.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 19, 2024
• First Posted: May 23, 2024
• Study Start: May 29, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: August 9, 2024

Record last verified: 2024-08

Locations

CN (1)