Small Cell Lung CancerPhase 1/2NCT07038096
ZG006 and ZG005 in Participants With Small Cell Lung Cancer or Neuroendocrine Carcinoma
A Phase 1/2 study testing ZG006 and ZG005 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 study is a randomized, multicenter, Phase Ib/II clinical trial, aimed at evaluating the efficacy and safety of the combination of ZG006 and ZG005 in patients with advanced small cell lung cancer and neuroendocrine carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Small Cell Lung Cancer, Neuroendocrine Carcinoma
- What is being tested?
- ZG006 and ZG005
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteChina
- Study dates
- 23 Sep 2025to Sep 2027
- 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 70 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 18-70 years of age.
- Participants with advanced small cell lung cancer or neuroendocrine carcinoma confirmed by histopathology or cytology.
- Eastern Cooperative Oncology Group (ECOG) 0 to 1.
- Life expectancy > 3 months.
Who cannot join
- The investigator believes that the subject has other reasons that make them unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guanzhou, Guangdong
Li Zhang
About this study
Official title: A Phase Ib/II Study of the Tolerability, Safety, Efficacy, and Pharmacokinetics of ZG006 in Combination With ZG005 in Participants With Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma(NEC)
This study is a randomized, multicenter, Phase Ib/II clinical trial, aimed at evaluating the efficacy and safety of the combination of ZG006 and ZG005 in patients with advanced small cell lung cancer and neuroendocrine carcinoma.
- Conditions
- Small Cell Lung Cancer, Neuroendocrine Carcinoma
- Being tested
- ZG006, ZG005
- 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.
ZG006Drug
ZG006 will be administered as an intravenous (IV) infusion.
ZG005Drug
ZG005 will be administered as an intravenous (IV) infusion.
| Study group | Role | What they receive |
|---|---|---|
| Phase Ib: Part1-Dose Escalation | Experimental | This study will employ the traditional "3+3" dose escalation design. Ultimately, two combination dosing cohorts will be selected to enter Part 2, the dose expansion phase, based on a comprehensive evaluation of the safety and pharmacokinetic (PK) data obtained by the investigators and the sponsor. Receives: Drug: ZG006; Drug: ZG005 |
| Phase Ib: Part2-Dose Expansion | Experimental | The safety and pharmacokinetic (PK) data obtained in Part 1 will be used to determine two expansion phase doses of the ZG006 and ZG005 combination. The dose expansion study will further evaluate the efficacy of the two selected combination dosing cohorts in patients with advanced small cell lung cancer and neuroendocrine carcinoma. Receives: Drug: ZG006; Drug: ZG005 |
| Phase II | Experimental | Participants will receive the RP2D of ZG006 in combination with ZG005 identified in Phase Ib of the study. Receives: Drug: ZG006; Drug: ZG005 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experienced Dose-limiting Toxicity (DLT)
Measured: up to 28 days
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Measured: Up to 2 years
Objective Response Rate (ORR)
The objective response rate was defined as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR) based on the modified RECIST v1.1.
Measured: Up to 2 years
Secondary outcomes (4)
Duration of Response (DOR)
Measured: Up to 2 years
Disease Control Rate (DCR)
Measured: Up to 2 years
Progression-free Survival (PFS)
Measured: Up to 2 years
Overall Survival (OS)
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start23 Sep 2025
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (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
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jason Wu, Study chair, Suzhou Zelgen Biopharmaceuticals Co.,Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07038096
- Sponsor's protocol ID
- ZG006-ZG005-001
- Status last verified
- Dec 2025
- First submitted
- 18 Jun 2025
- 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 Ib/II Study of the Tolerability, Safety, Efficacy, and Pharmacokinetics of ZG006 in Combination With ZG005 in Participants With Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma(NEC)
- ClinicalTrials.gov ID
- NCT07038096
- Acronym / sponsor ID
- ZG006-ZG005-001
- Conditions
- Small Cell Lung Cancer, Neuroendocrine Carcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 23 Sep 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 26 Jun 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.
This study is a randomized, multicenter, Phase Ib/II clinical trial, aimed at evaluating the efficacy and safety of the combination of ZG006 and ZG005 in patients with advanced small cell lung cancer and neuroendocrine carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase Ib: Part1-Dose Escalation | Experimental | Drug: ZG006, Drug: ZG005This study will employ the traditional "3+3" dose escalation design. Ultimately, two combination dosing cohorts will be selected to enter Part 2, the dose expansion phase, based on a comprehensive evaluation of the safety and pharmacokinetic (PK) data obtained by the investigators and the sponsor. |
| Phase Ib: Part2-Dose Expansion | Experimental | Drug: ZG006, Drug: ZG005The safety and pharmacokinetic (PK) data obtained in Part 1 will be used to determine two expansion phase doses of the ZG006 and ZG005 combination. The dose expansion study will further evaluate the efficacy of the two selected combination dosing cohorts in patients with advanced small cell lung cancer and neuroendocrine carcinoma. |
| Phase II | Experimental | Drug: ZG006, Drug: ZG005Participants will receive the RP2D of ZG006 in combination with ZG005 identified in Phase Ib of the study. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Fully understand the study and voluntarily sign the informed consent form.
- Male or female 18-70 years of age.
- Participants with advanced small cell lung cancer or neuroendocrine carcinoma confirmed by histopathology or cytology.
- Eastern Cooperative Oncology Group (ECOG) 0 to 1.
- Life expectancy > 3 months.
Key exclusion criteria (1 listed)
- The investigator believes that the subject has other reasons that make them unsuitable for participation in this study.
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. | Drug | Phase II, Phase Ib: Part1-Dose Escalation, Phase Ib: Part2-Dose Expansion |
| ZG005ZG005 will be administered as an intravenous (IV) infusion. | Drug | Phase II, Phase Ib: Part1-Dose Escalation, Phase Ib: Part2-Dose Expansion |
Primary outcome
Number of Participants Who Experienced Dose-limiting Toxicity (DLT)
Time frame: up to 28 days
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to 2 years
Objective Response Rate (ORR)
Time frame: Up to 2 years
The objective response rate was defined as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR) based on the modified RECIST v1.1.
4 secondary outcomes
Duration of Response (DOR)
Time frame: Up to 2 years
Disease Control Rate (DCR)
Time frame: Up to 2 years
Progression-free Survival (PFS)
Time frame: Up to 2 years
Overall Survival (OS)
Time frame: Up to 2 years
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.
Jason Wu study chair
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
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 and ZG005 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 5 inclusion and 1 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 (+86-0512-57309965, yinhw@zelgen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Experienced Dose-limiting Toxicity (DLT) (time frame: up to 28 days). The study lists 3 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.