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HLX22 and Trastuzumab for HER2-Positive Pancreatic Cancer

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What is being tested

HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) in Combination with Trastuzumab and Chemotherapy

Drug
Who is being recruted

From 18 to 75 Years
+29 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: September 2025
See protocol details

Summary

Principal SponsorShanghai Zhongshan Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 30, 2025

Actual date on which the first participant was enrolled.

This study focuses on treating HER2-positive pancreatic cancer, a type of cancer with high mortality rates, by testing a new combination of treatments. Pancreatic cancer is often treated with a standard chemotherapy regimen using gemcitabine and nab-paclitaxel. However, researchers are exploring a new approach by adding two specific antibodies, HLX22 and trastuzumab, to this chemotherapy. The goal is to see if this combination can provide better outcomes for patients. By targeting the HER2 protein, which is sometimes overactive in certain cancers, this study hopes to offer a more effective treatment option for those affected by this aggressive cancer. In this phase II study, participants will receive the combination of HLX22 and trastuzumab along with the standard chemotherapy drugs gemcitabine and nab-paclitaxel. The treatments are administered through injections, and the study will monitor how well this treatment works and its safety profile. Researchers will evaluate the effectiveness by observing changes in the cancer's progression and the overall health of the participants. The study aims to identify improvements in treatment outcomes and provide insights into potential side effects or risks associated with this novel therapy combination. The study does not specify particular outcomes yet, but it intends to gather vital data on treatment efficacy and safety.

Official TitleA Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) in Combination With Trastuzumab and Chemotherapy for the First-Line Treatment of HER2-Positive Pancreatic Ductal Adenocarcinoma
NCT07176702
Principal SponsorShanghai Zhongshan Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

45 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

13 inclusion criteria required to participate
Voluntary Participation Willingly participate in the clinical study; fully comprehend the study details and sign the Informed Consent Form (ICF); commit to and demonstrate capacity to complete all trial procedures.
Age and Gender Any gender; age ≥18 and ≤75 years at the time of ICF signing.
Diagnosis Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma (PDAC).
Prior Therapy \*No prior systemic antitumor therapy for metastatic PDAC. \*Exception: Patients who received one cycle of chemotherapy (nab-paclitaxel + gemcitabine) as initial treatment for newly diagnosed PDAC may enroll. \*Prior neoadjuvant/adjuvant therapy is permitted if completed \>6 months before enrollment, and treatment-related adverse events (AEs) have recovered to NCI-CTCAE ≤ Grade 1 (alopecia excluded).
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16 exclusion criteria prevent from participating
Substance Abuse History of illicit drug use or psychiatric medication abuse.
Pregnancy/Lactation Pregnant or breastfeeding women.
Hypersensitivity Known severe allergy to monoclonal antibodies or excipients of the study drugs.
Prior HER2-Targeted Therapy Any previous HER2-targeted treatment (e.g., trastuzumab, pertuzumab).
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Suspended

Nanjing Drum Tower Hospital

Nanjing, ChinaOpen Nanjing Drum Tower Hospital in Google Maps
Suspended

Zhongshan Hospital, Fudan University

Shanghai, China
Suspended2 Study Centers