Pancreatic Ductal Adenocarcinoma (PDAC)Phase 2NCT07301229
A Phase II Clinical Study to Evaluate HLX43 in Subjects With Advanced Pancreatic Cancer
A Phase 2 study testing HLX43 DOSE 1 (2.5 mg/kg) and HLX43 DOSE 2 (3.0 mg/kg) in people with Pancreatic Ductal Adenocarcinoma (PDAC), run by Shanghai Henlius Biotech.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma (PDAC)
- What is being tested?
- HLX43 DOSE 1 (2.5 mg/kg) and HLX43 DOSE 2 (3.0 mg/kg)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 29 Dec 2025to 23 Mar 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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);
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- 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.
Who cannot join
- 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;
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- 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;
- Active tuberculosis;
- Immunodeficiency disorders (HIV-positive or congenital/acquired immune deficiencies);
- Active HBV/HCV infection or co-infection;
- Pregnant/lactating women;
- Undergone biliary stent placement within 7 days prior to randomization, or has unrelieved biliary or duodenal obstruction despite active treatment;
- Suspected acute pancreatitis or a history of pancreatitis requiring clinical intervention recently;
- Investigators' judgment of clinical/lab abnormalities or other factors making participation inappropriate.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Subjects With Advanced Pancreatic Cancer
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)
Read the detailed description
This study is an open-label phase II clinical study 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). In this study, eligible subjects will be randomized at 1:1 ratio, and the patients will be administered with HLX43 at different doses via intravenous infusion.
- Conditions
- Pancreatic Ductal Adenocarcinoma (PDAC)
- Being tested
- HLX43 DOSE 1 (2.5 mg/kg), HLX43 DOSE 2 (3.0 mg/kg)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Drug: HLX43 DOSE 2 (3.0 mg/kg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 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
Objective response rate (ORR) (assessed by the IRRC per RECIST v1.1)
Measured: up to 24 week
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 the IRRC per RECIST v1.1.
Measured: 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
Overall Survival
Measured: From randomization to death from any cause (up to approximately 18 months)
DOR
Duration of response (DOR) is defined as the time from first response (CR or PR) until PD (RECIST v1.1) or death due to any cause, whichever occurs first.
Measured: up to 18 months
DCR
Disease control rate (DCR) is defined as the proportion of subjects with a best overall response of CR, PR, or SD. Tumor response will be assessed by the investigator or IRRC as per RECIST v1.1.
Measured: up to 12 months
Incidence and severity of adverse events (AEs)
Adverse events (AEs), serious adverse events (SAEs), laboratory tests, vital signs, 12-lead ECG, and physical examination
Measured: time from the date of the first dose of study drug until 90 days after last dose, assessed up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start29 Dec 2025 (estimated)
- Primary completion21 Feb 2028 (estimated)
- Study completion23 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Ductal Adenocarcinoma (PDAC)Studies of the same condition, open and under way.
- More trials run by Shanghai Henlius BiotechThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Henlius Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07301229
- Sponsor's protocol ID
- HLX43-PDAC201
- Status last verified
- Dec 2025
- First submitted
- 25 Nov 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Subjects With Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT07301229
- Acronym / sponsor ID
- HLX43-PDAC201
- Conditions
- Pancreatic Ductal Adenocarcinoma (PDAC)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shanghai Henlius BiotechIndustry (pharma, biotech, devices)
- Study start
- 29 Dec 2025 (estimated)
- Primary completion
- 21 Feb 2028 (estimated)
- Study completion
- 23 Mar 2028 (estimated)
- First posted
- 24 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
This study is an open-label phase II clinical study 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). In this study, eligible subjects will be randomized at 1:1 ratio, and the patients will be administered with HLX43 at different doses via intravenous infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HLX43 DOSE 1 (2.5 mg/kg) | Experimental | Drug: HLX43 DOSE 1 (2.5 mg/kg)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) |
| HLX43 DOSE 2 (3.0 mg/kg) | Experimental | Drug: HLX43 DOSE 2 (3.0 mg/kg)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) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (22 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HLX43 DOSE 1 (2.5 mg/kg)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. | Drug | HLX43 DOSE 1 (2.5 mg/kg) |
| HLX43 DOSE 2 (3.0 mg/kg)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. | Drug | HLX43 DOSE 2 (3.0 mg/kg) |
Primary outcome
ORR
Time frame: 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
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)
PFS
Time frame: 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
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.
6 secondary outcomes
ORR
Time frame: up to 24 week
PFS
Time frame: 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
Time frame: From randomization to death from any cause (up to approximately 18 months)
DOR
Time frame: up to 18 months
DCR
Time frame: up to 12 months
Incidence and severity of adverse events (AEs)
Time frame: time from the date of the first dose of study drug until 90 days after last dose, assessed up to 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HLX43 DOSE 1 (2.5 mg/kg) and HLX43 DOSE 2 (3.0 mg/kg) in people with Pancreatic Ductal Adenocarcinoma (PDAC), run by Shanghai Henlius Biotech.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xianjun Yu, Dr (+86 13801669875, yuxianjun@fudanpci.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.