A Phase II Clinical Study to Evaluate HLX43 in Subjects With Advanced Pancreatic Cancer

NCT07301229 | Not Yet Recruiting Phase 2

• 1 other identifier: HLX43-PDAC201
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study is being conducted to to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in Patients with Pancreatic ductal adenocarcinoma (PDAC)

Conditions

Pancreatic Ductal Adenocarcinoma (PDAC)

Outcome Measures

Primary Outcomes (2)

• ORR

  Objective response rate (ORR) is the proportion of subjects with the best overall response being CR or PR (assessed by investigator per RECIST v1.1)

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 weeks

• PFS

  Defined as the time (in months) from randomization to the first confirmed and documented progressive disease or death (whichever occurs first) as assessed by INV per RECIST v1.1.

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months

Secondary Outcomes (6)

• ORR

  up to 24 week

• PFS

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months

• OS

  From randomization to death from any cause (up to approximately 18 months)

• DOR

  up to 18 months

• DCR

  up to 12 months

Study Arms (2)

HLX43 DOSE 1 (2.5 mg/kg)

EXPERIMENTAL

Patients with good tolerability and well controlled disease will receive the treatment once every 3 weeks (Q3W), Until disease progression, initiation of a new anti-tumor therapy, death, emergence of intolerable toxicity, or withdrawal of informed consent (whichever occurs first)

Drug: HLX43 DOSE 1 (2.5 mg/kg)

HLX43 DOSE 2 (3.0 mg/kg)

EXPERIMENTAL

Patients with good tolerability and well controlled disease will receive the treatment once every 3 weeks (Q3W), Until disease progression, initiation of a new anti-tumor therapy, death, emergence of intolerable toxicity, or withdrawal of informed consent (whichever occurs first)

Drug: HLX43 DOSE 2 (3.0 mg/kg)

Interventions

HLX43 DOSE 1 (2.5 mg/kg) DRUG

HLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8.

HLX43 DOSE 1 (2.5 mg/kg)

HLX43 DOSE 2 (3.0 mg/kg) DRUG

HLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8.

HLX43 DOSE 2 (3.0 mg/kg)

Eligibility Criteria

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

You may qualify if:

• Fully understand the study content, procedures, and potential adverse reactions before the trial, sign the informed consent form (ICF), voluntarily participate in the trial, and be able to complete the study per the protocol requirements;
• Age ≥ 18 years, ≤75 years, at the time of signing the ICF, regardless of gender;
• Histologically or cytologically confirmed, unresectable locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC),who has failed at least one prior line of standard systemic therapy. The prior therapy must have included a fluoropyrimidine-based or gemcitabine-based regimen;
• At least one measurable lesion per RECIST v1.1 within 4 weeks before randomization;
• Willing to provide archived (preferably within 2 years) or fresh tumor tissue specimens for the detection of PD-L1 expression.
• At least 3 weeks (or 5 half-lives, whichever is shorter) since last major surgery, medical device treatment, radiotherapy (except palliative bone radiotherapy), cytotoxic chemotherapy, immunotherapy, or biological therapy; ≥2 weeks since last hormonal therapy or small molecule targeted therapy; ≥1 week since last traditional Chinese medicine treatment with anti-tumor indications or minor surgery; with treatment-related adverse events recovered to CTCAE v5.0 ≤ grade 1 (except grade 2 peripheral neuropathy and alopecia);
• ECOG performance status 0-2 within 1 week before randomization;
• Expected survival ≥ 3 months；
• Adequate organ function within 1 week before randomization (no blood transfusion or colony-stimulating factors within 14 days prior to first dose)
• Fertile participants must use ≥1 highly effective contraceptive method during the trial and for ≥6 months after last dose; females of childbearing potential must have negative pregnancy test within 7 days before enrollment.

You may not qualify if:

• Histologically or cytologically confirmed as other pathological types of pancreatic cancer or containing components of other pathological differentiation;
• Prior treatment with an antibody-drug conjugate (ADC) of topoisomerase I;
• Received radical radiotherapy within 3 months prior to the first dose;
• History of other malignancies within 2 years prior to randomization (except radically treated early-stage malignancies);
• History of an adverse event that led to permanent discontinuation of prior immunotherapy, or a history of ≥ Grade 2 immune-mediated pneumonitis or immune-mediated myocarditis;
• Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage;
• Presence of spinal cord compression or clinically active central nervous system metastases (defined as untreated or symptomatic metastases, or those requiring corticosteroids or anticonvulsants), carcinomatous meningitis, or leptomeningeal disease;
• History or presence of clinically significant pulmonary impairment due to concurrent lung disease, Subjects with a history of radiation pneumonitis within the past 6 months are also excluded;
• Poorly controlled cardiovascular/cerebrovascular conditions;
• Active systemic infections requiring IV antibiotics within 2 weeks pre-randomization;
• Use of strong CYP2D6/CYP3A inhibitors/inducers within 2 weeks pre-randomization;
• Systemic corticosteroid use (\>10mg prednisone/day equivalent) or immunosuppressants within 2 weeks pre-randomization. Exceptions: Topical/ocular/intra-articular/nasal/inhaled steroids; short-term prophylactic use for contrast agents;
• Active/suspected autoimmune diseases. Exceptions: Hypothyroid patients on thyroid replacement; controlled type 1 diabetes with insulin;
• Live/attenuated vaccines within 4 weeks pre-randomization;
• History of severe hypersensitivity to biologics/monoclonal antibodies or trial drug components;

Sponsors & Collaborators

• Shanghai Henlius Biotech: lead

Central Study Contacts

Xianjun Yu, Dr

CONTACT

+86 13801669875; yuxianjun@fudanpci.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 24, 2025
• Study Start: December 29, 2025
• Primary Completion (Estimated): February 21, 2028
• Study Completion (Estimated): March 23, 2028
• Last Updated: December 24, 2025

Record last verified: 2025-12