SCLCPhase 1NCT07416695
A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HLX3901 in Patients With Advanced SCLC or NEC
A Phase 1 study testing HLX3901 in people with SCLC and NEC, run by Shanghai Henlius Biotech at 2 sites in China.
Trial summary
This study is an open-label first-in-human phase I clinical study to evaluate the safety, tolerability, and pharmacokinetic characteristics of HLX3901 in patients with Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- What is being tested?
- HLX3901
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 2 sitesChina
- Study dates
- 17 Apr 2026to 30 Jun 2029
- Phase
- Phase 1
- 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
- Have a full understanding of the study content, process, and possible adverse reactions before the study, and sign the informed consent form (ICF); voluntarily participate in the study; be able to complete the study as per protocol requirements;
- Aged ≥ 18 years and ≤ 75 years at the time of signing the ICF, male or female;
- Histologically or cytologically confirmed advanced small cell lung cancer or neuroendocrine carcinoma; patients with advanced small cell lung cancer must have experienced intolerance, recurrence, or disease progression following prior treatment with a platinum-based therapy combined with immune checkpoint inhibitors, while patients with neuroendocrine carcinoma must have experienced intolerance, recurrence, or disease progression following prior platinum-based therapy; allowed histological subtypes include combined small cell lung cancer and mixed neuroendocrine-non-neuroendocrine neoplasms.
- At least one measurable lesion as per RECIST 1.1 within 4 weeks prior to the first administration;
- An ECOG performance status score of 0-1 within 7 days prior to the first administration;
- Expected survival > 3 months;
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- The following conditions must be met in terms of the time of the first administration of the investigational product: at least 28 days from the previous major surgery, medical device treatment, locoregional radiotherapy (except for palliative radiotherapy for bone lesions), cytotoxic chemotherapy, immunotherapy, or biological product therapy; at least 14 days from the previous small molecule targeted drug therapy and previous hormone therapy; at least 7 days from the previous administration of the traditional Chinese medicine for anti-tumor indications or minor surgery; recovery of treatment-induced AEs to Grade ≤ 1 (CTCAE v6.0, except for alopecia);
- Participants who agree to provide archived tumor tissue specimens that meet the testing requirements (either from the most recent surgery or biopsy, preferably within 2 years) or agree to undergo a biopsy to collect tumor tissue for DLL3 expression testing; Note: Formalin-fixed paraffin-embedded (FFPE) tumor samples (paraffin blocks or unstained sections, which must meet the quality control criteria for testing) collected from non-radiotherapy sites during the most recent surgery or biopsy at or after the diagnosis of malignant tumor and pathological reports of such specimens shall also be provided.
- Adequate organ function as confirmed by laboratory tests within 7 days prior to the first administration of the investigational product, with no therapies such as blood transfusion, albumin infusion, renal replacement therapy, granulocyte colony-stimulating factor (G-CSF), thrombopoietin, or erythropoietin administered within 14 days prior to the first administration:
- Male and female participants with child-bearing potential must agree to use at least one highly effective contraception method during the study and within at least 6 months after the last dose of the investigational product; female participants of childbearing age must be negative for pregnancy test within 7 days prior to enrollment.
Who cannot join
- History of other malignant tumors within 2 years prior to the first administration, except cured cervical carcinoma in situ or cutaneous basal cell carcinoma;
- Presence of Grade ≥ 2 immune-related pneumonitis or immune-related myocarditis, or severe, life-threatening immune-mediated AEs or infusion-related reactions, including those leading to permanent discontinuation, when receiving previous anti-tumor immunotherapy;
- History or presence of clinically significant pulmonary impairment due to concurrent lung disease, including but not limited to any underlying lung disease (e.g., pulmonary embolism within 3 months prior to the first administration, severe asthma, severe chronic obstructive pulmonary disease, restrictive pulmonary disease, interstitial pneumonia, pneumoconiosis, drug-related pneumonitis, and pleural effusion), any autoimmune, connective tissue, or inflammatory disease that may involve the lungs (i.e., rheumatoid arthritis, Sicca syndrome, and sarcoidosis), prior pneumonectomy that may interfere with the detection and management of suspected drug-related pulmonary toxicity, or history of radiation pneumonitis within the past 6 months;
- With central nervous system diseases within 12 months prior to enrollment, such as seizures, cerebral hemorrhage, paralysis, aphasia, cerebral infarction (except for old cerebral infarction), severe brain injury, dementia, Parkinson's disease, cerebellar disease, mental illness, or any autoimmune disease involving the central nervous system;
- Active paraneoplastic syndrome;
- History of hypophysitis or pituitary dysfunction;
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- Presence of uncontrolled third-space effusions (e.g., massive pleural effusion, ascites, or pericardial effusion) requiring repeated drainage and considered by the investigator to be unsuitable for enrollment;
- Prior allogeneic stem cell or solid organ transplantation;
- Prior exposure to any of the following: (1) combination or sequential therapy targeting DLL3, CD3, or CD28; (2) treatment with antibody-drug conjugates (ADCs); (3) major surgery, chemotherapy, biologic therapy, endocrine therapy, or macromolecular targeted therapy within 4 weeks prior to the first administration. Traditional Chinese medicine and small molecule targeted therapy with anti-tumor indications ≤ 2 weeks from the first administration of the investigational product;
- Known history of severe allergic reactions, anaphylactoid reactions, or other hypersensitivity reactions to humanized antibodies or fusion proteins, severe allergic reactions to macromolecular protein preparations/monoclonal antibodies, or allergy to components of the investigational product preparations;
- Active systemic infectious diseases requiring intravenous antibiotics within 2 weeks prior to the first administration of the investigational product;
- Any poorly-controlled cardiovascular and cerebrovascular clinical symptoms or diseases, including but not limited to: (1) NYHA Class II or greater heart failure or left ventricular ejection fraction (LVEF) < 50%; (2) unstable angina pectoris; (3) myocardial infarction or cerebrovascular accident within 6 months (except lacunar infarction, slight cerebral ischemia, or transient ischemic attack); (4) poorly controlled arrhythmia (including QTc intervals ≥ 450 ms for males and ≥ 470 ms for females) (QTc intervals are calculated by Fridericia's formula); (5) poorly-controlled hypertension (systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg after active treatment);
- Active central nervous system (CNS) metastases and/or carcinomatous meningitis known or diagnosed at screening. However, the following participants are allowed to be enrolled: 1) Patients with asymptomatic brain metastases (i.e., no progressive central nervous system symptoms caused by brain metastases, no requirement for corticosteroids, and lesion size ≤ 1.5 cm) may be included, but are required to receive regular brain imaging as a site of disease. 2) Participants with treated brain metastases that have been stable for at least 2 months (confirmed by 2 imaging assessments at least 4 weeks apart following brain metastasis treatment), with no evidence of new or enlarging brain metastases and discontinued steroids at least 3 days prior to administration (stable brain metastases here should be confirmed before the first administration of the investigational product).
- Patients with known active or suspected autoimmune diseases. Patients with autoimmune-related hypothyroidism who are receiving thyroid hormone replacement therapy and those with type 1 diabetes mellitus controlled with insulin therapy are eligible to be enrolled;
- Patients who have received systemic corticosteroids (prednisone > 10 mg/day or equivalent dose of a similar drug) or other immunosuppressive agents within 14 days prior to the first administration; Except: patients treated with topical, ocular, intra-articular, intranasal, and inhaled corticosteroids; those with short-term use of corticosteroids for prophylaxis if a contrast agent is used;
- Patients with active tuberculosis;
- Patients with a history of immunodeficiency, including human immunodeficiency virus (HIV)-positive or other acquired or congenital immunodeficiencies, or a history of organ transplantation;
- Patients with active HBV or HCV infection or HBV/HCV co-infection; Note: Patients who are HBsAg (+) and/or HBcAb (+) must undergo an HBV-DNA test and have a result < 500 IU/mL, < 2500 copies/mL, or < ULN to be enrolled. Enrolled participants with detectable HBV-DNA must consent to receive antiviral nucleoside/nucleotide therapy.
- If HCV antibody (+), HCV-RNA must be tested, and the result must be < ULN for the participant to be eligible.
- Participants with HBV/HCV co-infection shall be excluded (positive for HBsAg or HBcAb and positive for HCV antibody).
- Have received live vaccines within 28 days prior to the first administration;
- Pregnant or lactating women;
- Participants who are not suitable for participating in this clinical study due to any clinical or laboratory abnormalities or other reasons as assessed by the investigator.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing
Mengzhao Wang, Dr, 010-69151188, Mengzhaowang@sina.com
- Not yet recruiting
Shanghai Chest Hospital
Shanghai
Shun Lu, Dr, 15216769608, shunlu_shchest@sina.com
About this study
Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HLX3901 (DLL3 × DLL3 × CD3 × CD28 Tetra-specific Antibody) in Patients With Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma
This study is an open-label first-in-human phase I clinical study to evaluate the safety, tolerability, and pharmacokinetic characteristics of HLX3901 in patients with Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma.
Read the detailed description
phase Ia is the dose escalation and backfill stage, accelerated titration and 3 + 3 dose escalation method will be adopted in the dose escalation stag, and the patients will be administered with HLX3901 at different doses via intravenous infusion. The DLT observation period lasts for 4 weeks after the first administration of HLX3901. The backfill cohort will enrolls 2 to 3 dose groups.
Part Ib is a dose-expansion study of HLX3901, designed to explore and confirm the efficacy and safety of HLX3901 monotherapy in advanced small-cell lung cancer or neuroendocrine carcinoma.The Safety Review Committee will recommend dose groups for expansion based on the safety, efficacy and PK data of the dose escalation phase.
- Being tested
- HLX3901
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HLX3901Drug
- HLX3901 will be administered as an intravenous (IV) infusion.
| Study group | Role | What they receive |
|---|---|---|
| Phase Ia：Dose Escalation and Backfill | Experimental | A total of seven dose escalations were preset: Dose1, Dose2, Dose3, Dose4, Dose5, Dose6, and Dose7. The backfill cohort will enrolls 2 to 3 dose groups. Receives: Drug: HLX3901 |
| Experimental: Phase Ib：Dose Expansion | Experimental | Participants will receive the RP2D identified in Dose Escalation Study . Receives: Drug: HLX3901 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Dose-Limiting Toxicity (DLT) of HLX3901 within 28 days after the first Administration
DLT refers to the AEs that are determined to be related to the investigational product by the investigator, whose severity will affect the escalation of dose level. In this study, the DLT observation period lasts for 28 days after the first administration of HLX3901.
Measured: From first dose to the end of Cycle 1 (each cycle is 4 weeks)
The maximum tolerated dose (MTD) of HLX3901
The highest dose level, at which DLT is observed in no more than one of 6 evaluable patients, is defined as MTD of HLX3901
Measured: From first dose to the end of Cycle 1 (each cycle is 4 weeks)
RP2D
The recommended phase 2 dose of HLX3901
Measured: approximately up to 24 months
Objective response rate (ORR)
Percentage of participants with complete response (CR) and partial response (PR) based on investigator assessment.
Measured: approximately up to 24 months
Secondary outcomes (5)
Number of participants with adverse events (AEs)
The types and frequencies of adverse events (AEs) evaluated according to the National Cancer Institute Common Terminology Criteria for adverse events (NCI-CTCAE) version 6.0
Measured: Up to approximately 2 years
Number of participants with serious adverse events (SAEs)
Measured: Up to approximately 2 years
Duration of response (DOR)
DOR is defined as the time from first evidence of response (CR or PR per RECIST 1.1) to earlier date of disease progression or death due to any cause
Measured: Up to approximately 2 years
Progression-free survival (PFS)
The PFS is defined as the time from the date of enrollment to the date of the first objective documentation of disease progression (as per RECIST v1.1) or death due to any cause,whichever occurred first.
Measured: approximately up to 24 months
Overall survival (OS)
Time from the date of enrollment to the date of death for any cause.
Measured: approximately up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start17 Apr 2026
- Primary completion30 May 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SCLCStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 138 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
- NCT07416695
- Sponsor's protocol ID
- HLX3901-FIH101
- Status last verified
- Jul 2026
- First submitted
- 11 Feb 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HLX3901 (DLL3 × DLL3 × CD3 × CD28 Tetra-specific Antibody) in Patients With Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma
- ClinicalTrials.gov ID
- NCT07416695
- Acronym / sponsor ID
- HLX3901-FIH101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Shanghai Henlius BiotechIndustry (pharma, biotech, devices)
- Study start
- 17 Apr 2026 (actual)
- Primary completion
- 30 May 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 18 Feb 2026 (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.
This study is an open-label first-in-human phase I clinical study to evaluate the safety, tolerability, and pharmacokinetic characteristics of HLX3901 in patients with Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma.
Detailed description
phase Ia is the dose escalation and backfill stage, accelerated titration and 3 + 3 dose escalation method will be adopted in the dose escalation stag, and the patients will be administered with HLX3901 at different doses via intravenous infusion. The DLT observation period lasts for 4 weeks after the first administration of HLX3901. The backfill cohort will enrolls 2 to 3 dose groups.
Part Ib is a dose-expansion study of HLX3901, designed to explore and confirm the efficacy and safety of HLX3901 monotherapy in advanced small-cell lung cancer or neuroendocrine carcinoma.The Safety Review Committee will recommend dose groups for expansion based on the safety, efficacy and PK data of the dose escalation phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase Ia：Dose Escalation and Backfill | Experimental | Drug: HLX3901A total of seven dose escalations were preset: Dose1, Dose2, Dose3, Dose4, Dose5, Dose6, and Dose7. The backfill cohort will enrolls 2 to 3 dose groups. |
| Experimental: Phase Ib：Dose Expansion | Experimental | Drug: HLX3901Participants will receive the RP2D identified in Dose Escalation Study . |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Have a full understanding of the study content, process, and possible adverse reactions before the study, and sign the informed consent form (ICF); voluntarily participate in the study; be able to complete the study as per protocol requirements;
- Aged ≥ 18 years and ≤ 75 years at the time of signing the ICF, male or female;
- Histologically or cytologically confirmed advanced small cell lung cancer or neuroendocrine carcinoma; patients with advanced small cell lung cancer must have experienced intolerance, recurrence, or disease progression following prior treatment with a platinum-based therapy combined with immune checkpoint inhibitors, while patients with neuroendocrine carcinoma must have experienced intolerance, recurrence, or disease progression following prior platinum-based therapy; allowed histological subtypes include combined small cell lung cancer and mixed neuroendocrine-non-neuroendocrine neoplasms.
- At least one measurable lesion as per RECIST 1.1 within 4 weeks prior to the first administration;
- An ECOG performance status score of 0-1 within 7 days prior to the first administration;
Key exclusion criteria (23 listed)
- History of other malignant tumors within 2 years prior to the first administration, except cured cervical carcinoma in situ or cutaneous basal cell carcinoma;
- Presence of Grade ≥ 2 immune-related pneumonitis or immune-related myocarditis, or severe, life-threatening immune-mediated AEs or infusion-related reactions, including those leading to permanent discontinuation, when receiving previous anti-tumor immunotherapy;
- History or presence of clinically significant pulmonary impairment due to concurrent lung disease, including but not limited to any underlying lung disease (e.g., pulmonary embolism within 3 months prior to the first administration, severe asthma, severe chronic obstructive pulmonary disease, restrictive pulmonary disease, interstitial pneumonia, pneumoconiosis, drug-related pneumonitis, and pleural effusion), any autoimmune, connective tissue, or inflammatory disease that may involve the lungs (i.e., rheumatoid arthritis, Sicca syndrome, and sarcoidosis), prior pneumonectomy that may interfere with the detection and management of suspected drug-related pulmonary toxicity, or history of radiation pneumonitis within the past 6 months;
- With central nervous system diseases within 12 months prior to enrollment, such as seizures, cerebral hemorrhage, paralysis, aphasia, cerebral infarction (except for old cerebral infarction), severe brain injury, dementia, Parkinson's disease, cerebellar disease, mental illness, or any autoimmune disease involving the central nervous system;
- Active paraneoplastic syndrome;
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 |
|---|---|---|
| HLX3901• HLX3901 will be administered as an intravenous (IV) infusion. | Drug | Experimental: Phase Ib：Dose Expansion, Phase Ia：Dose Escalation and Backfill |
Primary outcome
The Dose-Limiting Toxicity (DLT) of HLX3901 within 28 days after the first Administration
Time frame: From first dose to the end of Cycle 1 (each cycle is 4 weeks)
DLT refers to the AEs that are determined to be related to the investigational product by the investigator, whose severity will affect the escalation of dose level. In this study, the DLT observation period lasts for 28 days after the first administration of HLX3901.
The maximum tolerated dose (MTD) of HLX3901
Time frame: From first dose to the end of Cycle 1 (each cycle is 4 weeks)
The highest dose level, at which DLT is observed in no more than one of 6 evaluable patients, is defined as MTD of HLX3901
RP2D
Time frame: approximately up to 24 months
The recommended phase 2 dose of HLX3901
Objective response rate (ORR)
Time frame: approximately up to 24 months
Percentage of participants with complete response (CR) and partial response (PR) based on investigator assessment.
5 secondary outcomes
Number of participants with adverse events (AEs)
Time frame: Up to approximately 2 years
Number of participants with serious adverse events (SAEs)
Time frame: Up to approximately 2 years
Duration of response (DOR)
Time frame: Up to approximately 2 years
Progression-free survival (PFS)
Time frame: approximately up to 24 months
Overall survival (OS)
Time frame: approximately up to 24 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 8 Jul 2026.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HLX3901 in people with SCLC and NEC, run by Shanghai Henlius Biotech at 2 sites in China.
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 23 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: looking for participants now, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Dose-Limiting Toxicity (DLT) of HLX3901 within 28 days after the first Administration (time frame: From first dose to the end of Cycle 1 (each cycle is 4 weeks)). The study lists 4 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 8 Jul 2026.