Small Cell Lung CancerPhase 1/2NCT05978284
Study of ZG006 in Participants With Small Cell Lung Cancer or Neuroendocrine Carcinoma
A Phase 1/2 study testing ZG006 in people with Small Cell Lung Cancer and Neuroendocrine Carcinoma, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd at 1 site in China.
Trial summary
This is a multi-center, open-label, Phase Ⅰ/Ⅱ clinical study of ZG006 for the treatment of participants with small cell lung cancer or neuroendocrine carcinoma who had no standard treatment available, or were intolerant to standard treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Small Cell Lung Cancer, Neuroendocrine Carcinoma
- What is being tested?
- ZG006
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteChina
- Study dates
- 27 Oct 2023to Oct 2026
- Phase
- Phase 1/2
- 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 and voluntarily sign the informed consent form;
- Male or female 18~75 years of age;
- Histologically or cytologically confirmed diagnosis of small cell lung cancer (SCLC), neuroendocrine carcinoma (NEC), who had no standard treatment available, or were intolerant to standard treatments;
- Archival tissue sample or fresh biopsy tissue sample must be available for DLL3 detection;
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
- Life expectancy ≥ 3 months;
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- Must have evaluable or measurable lesion. For lesions that have received radiation therapy, only after the progression of the lesions, they can be considered evaluable or measurable lesions;
- All adverse events from prior treatment have either returned to baseline or CTCAE 5.0 ≤ Grade 1, except for AEs not constituting a safety risk in the opinions of the investigators, e.g. alopecia, hypothyroidism which can be treated with a hormone replacement, etc.;
- Female and Male patients must agree to use a reliable form of contraception during the study treatment period and for at least 6 months after the last dose of the study drug.
Who cannot join
- Patients having received any of the following treatments:
- Anti-DLL3 and anti-CD3 drugs (including investigational drugs); Chemotherapy, biotherapy, endocrine therapy (except for hormone replacement), and biological targeted medicines ≤ 4 weeks before the study entry. Local palliative radiotherapy and a small molecule targeted therapy ≤ 2 weeks (or 5 half-lives, whichever is longer) before the study entry; Systemic immunosuppressive medications, such as corticosteroid (doses > 10 mg/day prednisone or equivalent dose) within 14 days prior to the study entry; Use of any vaccines against viral infections (COVID-19, influenza, varicella, etc.) within 4 weeks of study entry;
- Received any blood transfusion, EPO, G-CSF, albumin infusion and renal replacement therapy within 14 days prior to study entry.
- The main organ function meets any of the following criteria within 7 days prior to study entry; Hematological function: ANC < 1.5×10^9/L, PLT < 75×10^9/L, Hemoglobin (Hb) < 100 g/L; Hepatic function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≥ 3×ULN, ALT and AST ≥ 5×ULN for liver metastases patients; Total bilirubin (TBIL) ≥ 1.5×ULN; albumin < 30g/L; Creatinine clearance (Cockcroft-Gault formula) < 50 mL/min; INR > 1.5 or APTT > 1.5×ULN;
- Medical history, computed tomography (CT) or magnetic resonance imaging (MRI) results indicate the existence of central nervous system (CNS) metastases; Note: Not applicable to the following conditions: subjects with stable CNS metastases;
- Uncontrollable third cavity effusion (e.g. a large amount of pleural effusion, ascites, or pericardial effusion, etc.) requiring repeated drainage, which was judged by the investigator to be unsuitable for study;
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- Any other malignancy within 5 years (other than radically removed and has not recurred tumors including basal cell skin carcinoma, squamous cell skin carcinoma, superficial bladder cancer, localized prostate cancer, cervical cancer and other cancer in situ, etc.);
- Severe cardiac-cerebral vascular disease, including but not limited to:
- Acute myocardial infarction, unstable angina, stroke, or received coronary angioplasty or stent implantation within 6 months before study entry; New York Heart Association functional class II to IV congestive heart failure or left ventricular ejection fraction (LVEF) < 50% or the lower limit of normal; Uncontrollable hypertension (even though the best treatment is used but systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg).
- QTc (F) interval prolonged in electrocardiography during the screening baseline period (> 480 ms)
- History of autoimmune disease, including but not limited to systemic lupus erythematosus, nephritis, psoriasis, rheumatoid arthritis, inflammatory bowel disease, autoimmune hepatitis (except for the following: type I diabetes mellitus, skin diseases that do not require systemic treatment (such as vitiligo), controllable celiac disease, and childhood asthma that completely resolved in adulthood without intervention);
- Active infection (such as acute bacterial infection, tuberculosis, active hepatitis B/C, active syphilis, or active human immunodeficiency virus infection). Active hepatitis B is defined as: hepatitis B virus DNA titer > 10000 copies/mL or 2000 IU/mL; active hepatitis C is defined as: a positive hepatitis C antibody and HCV viral load above the limit of quantification; active human immunodeficiency virus infection is defined as: antibody positive;
- Active neurologic paraneoplastic syndrome;
- Interstitial lung disease or non-infectious pneumonitis (other than radiation-induced pneumonia);
- Having received prior allogeneic stem cell transplantation or solid organ transplantation;
- Known allergy to other mAbs or any antibody excipients; the history of a severe allergic reaction, anaphylactoid or other hypersensitivity reactions to humanized antibodies or fusion proteins;
- Known history of diagnosed neurological or mental disorders, for example, epilepsy, dementia, etc.;
- A female who is pregnant or nursing;
- Patients were deemed unsuitable for participating in the study by the investigator for any reason.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 1/2 Dose Escalation Study of the Tolerability, Safety, Efficacy and Pharmacokinetics of ZG006 in Participants With Small Cell Lung Cancer or Neuroendocrine Carcinoma
This is a multi-center, open-label, Phase Ⅰ/Ⅱ clinical study of ZG006 for the treatment of participants with small cell lung cancer or neuroendocrine carcinoma who had no standard treatment available, or were intolerant to standard treatment.
- Conditions
- Small Cell Lung Cancer, Neuroendocrine Carcinoma
- Being tested
- ZG006
- Medical subject headings
- Small Cell Lung Carcinoma, Carcinoma, Neuroendocrine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZG006Biological
ZG006 will be administered as an intravenous (IV) infusion.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Dose Escalation | Experimental | During the dose-escalation, an accelerated titration design (ATD) will be utilized for the first two dose groups (0.03mg and 0.1 mg), and the conventional "3+3" dose escalation method will be used for the subsequent dose groups. The entire duration of 28 days after the first dose of ZG006 is defined as the dose-limiting toxicity (DLT). Receives: Biological: ZG006 |
| Part 2: Dose Expansion | Experimental | Participants will receive the RP2D/MTD identified in Part 1 (dose exploration) of the study. Receives: Biological: ZG006 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of dose-limiting toxicity (DLT)
An event is considered to be a DLT if the event occurs within the first 28 days of treatment and meets the dose-limiting toxicity criteria
Measured: Up to 28 days
Maximum Tolerated Dose (MTD) of ZG006
Measured: Up to approximately 1 year
Determine the Recommended Phase 2 Dose (RP2D)
Measured: Up to approximately 1 year
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 5.0
Measured: Up to approximately 2 year
Number of participants with serious adverse events (SAEs)
Measured: Up to approximately 2 year
Incidence of abnormal laboratory results
Abnormal laboratory results of safety concerns such as ALT, AST, Cr and BUN, et al according to NCI-CTCAE 5.0 classification.
Measured: Up to approximately 2 year
Changes of ECGs from baselines
Changes of ECGs from baselines, such as QT interval
Measured: Up to approximately 2 year
Secondary outcomes (7)
Objective response rate (ORR)
ORR is defined as the percentage of participants achieving a confirmed complete response (CR) or partial response (PR) based on RECIST 1.1 criteria.
Measured: Up to approximately 2 year
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 year
disease control rate (DCR)
Measured: Up to approximately 2 year
Maximum plasma concentration (Cmax) of ZG006
Measured: Baseline and up to approximately 1 year
Time to peak concentration (Tmax)
Measured: Up to approximately 1 year
AUC from time zero to the last quantifiable concentration after dosing (AUC[0-t]) of ZG006
Measured: Up to approximately 1 year
Terminal phase half-life (t1/2) of ZG006
Measured: Up to approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start27 Oct 2023
- Primary completionSep 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Suzhou Zelgen Biopharmaceuticals Co.,LtdThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Qiming Wang, Principal investigator, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05978284
- Sponsor's protocol ID
- ZG006-001
- Status last verified
- Dec 2025
- First submitted
- 28 Jul 2023
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Dose Escalation Study of the Tolerability, Safety, Efficacy and Pharmacokinetics of ZG006 in Participants With Small Cell Lung Cancer or Neuroendocrine Carcinoma
- ClinicalTrials.gov ID
- NCT05978284
- Acronym / sponsor ID
- ZG006-001
- Conditions
- Small Cell Lung Cancer, Neuroendocrine Carcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 27 Oct 2023 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 7 Aug 2023 (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 is a multi-center, open-label, Phase Ⅰ/Ⅱ clinical study of ZG006 for the treatment of participants with small cell lung cancer or neuroendocrine carcinoma who had no standard treatment available, or were intolerant to standard treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1: Dose Escalation | Experimental | Biological: ZG006During the dose-escalation, an accelerated titration design (ATD) will be utilized for the first two dose groups (0.03mg and 0.1 mg), and the conventional "3+3" dose escalation method will be used for the subsequent dose groups. The entire duration of 28 days after the first dose of ZG006 is defined as the dose-limiting toxicity (DLT). |
| Part 2: Dose Expansion | Experimental | Biological: ZG006Participants will receive the RP2D/MTD identified in Part 1 (dose exploration) of the study. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Fully understand the study and voluntarily sign the informed consent form;
- Male or female 18~75 years of age;
- Histologically or cytologically confirmed diagnosis of small cell lung cancer (SCLC), neuroendocrine carcinoma (NEC), who had no standard treatment available, or were intolerant to standard treatments;
- Archival tissue sample or fresh biopsy tissue sample must be available for DLL3 detection;
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
Key exclusion criteria (19 listed)
- Patients having received any of the following treatments:
- Anti-DLL3 and anti-CD3 drugs (including investigational drugs); Chemotherapy, biotherapy, endocrine therapy (except for hormone replacement), and biological targeted medicines ≤ 4 weeks before the study entry. Local palliative radiotherapy and a small molecule targeted therapy ≤ 2 weeks (or 5 half-lives, whichever is longer) before the study entry; Systemic immunosuppressive medications, such as corticosteroid (doses > 10 mg/day prednisone or equivalent dose) within 14 days prior to the study entry; Use of any vaccines against viral infections (COVID-19, influenza, varicella, etc.) within 4 weeks of study entry;
- Received any blood transfusion, EPO, G-CSF, albumin infusion and renal replacement therapy within 14 days prior to study entry.
- The main organ function meets any of the following criteria within 7 days prior to study entry; Hematological function: ANC < 1.5×10^9/L, PLT < 75×10^9/L, Hemoglobin (Hb) < 100 g/L; Hepatic function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≥ 3×ULN, ALT and AST ≥ 5×ULN for liver metastases patients; Total bilirubin (TBIL) ≥ 1.5×ULN; albumin < 30g/L; Creatinine clearance (Cockcroft-Gault formula) < 50 mL/min; INR > 1.5 or APTT > 1.5×ULN;
- Medical history, computed tomography (CT) or magnetic resonance imaging (MRI) results indicate the existence of central nervous system (CNS) metastases; Note: Not applicable to the following conditions: subjects with stable CNS metastases;
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 |
|---|---|---|
| ZG006ZG006 will be administered as an intravenous (IV) infusion. | Biological | Part 1: Dose Escalation, Part 2: Dose Expansion |
Primary outcome
The incidence of dose-limiting toxicity (DLT)
Time frame: Up to 28 days
An event is considered to be a DLT if the event occurs within the first 28 days of treatment and meets the dose-limiting toxicity criteria
Maximum Tolerated Dose (MTD) of ZG006
Time frame: Up to approximately 1 year
Determine the Recommended Phase 2 Dose (RP2D)
Time frame: Up to approximately 1 year
Number of participants with adverse events (AEs)
Time frame: Up to approximately 2 year
The types and frequencies of adverse events (AEs) evaluated according to the National Cancer Institute Common Terminology Criteria for adverse events (NCI-CTCAE) version 5.0
Number of participants with serious adverse events (SAEs)
Time frame: Up to approximately 2 year
Incidence of abnormal laboratory results
Time frame: Up to approximately 2 year
Abnormal laboratory results of safety concerns such as ALT, AST, Cr and BUN, et al according to NCI-CTCAE 5.0 classification.
Changes of ECGs from baselines
Time frame: Up to approximately 2 year
Changes of ECGs from baselines, such as QT interval
7 secondary outcomes
Objective response rate (ORR)
Time frame: Up to approximately 2 year
Duration of response (DOR)
Time frame: Up to approximately 2 year
disease control rate (DCR)
Time frame: Up to approximately 2 year
Maximum plasma concentration (Cmax) of ZG006
Time frame: Baseline and up to approximately 1 year
Time to peak concentration (Tmax)
Time frame: Up to approximately 1 year
AUC from time zero to the last quantifiable concentration after dosing (AUC[0-t]) of ZG006
Time frame: Up to approximately 1 year
Terminal phase half-life (t1/2) of ZG006
Time frame: Up to approximately 1 year
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 5 Jan 2026.
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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.
Qiming Wang principal investigator
Henan Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ZG006 in people with Small Cell Lung Cancer and Neuroendocrine Carcinoma, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd at 1 site 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 9 inclusion and 19 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 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined 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.
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 Hewen Yin (+86-02158942758, yinhw@zelgen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of dose-limiting toxicity (DLT) (time frame: Up to 28 days). The study lists 7 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 5 Jan 2026.