Small Cell Lung CancerPhase 1/2NCT07559929
A Study of DXC006 With Immune Checkpoint Inhibitors or Platinum for Small Cell Lung Cancer.
A Phase 1/2 study testing DXC006, Toripalimab and Carboplatin in people with Small Cell Lung Cancer, run by Hangzhou DAC Biotechnology Co., Ltd. at 1 site in China.
Trial summary
This is a Phase Ib/II, open-label clinical study designed to evaluate the safety, tolerability, preliminary anti-tumor activity, recommended Phase 2 dose (RP2D), pharmacokinetic (PK) characteristics, and immunogenicity of DXC006 in combination with an immune checkpoint inhibitor (ICI) or platinum-based chemotherapy in… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Small Cell Lung Cancer
- What is being tested?
- DXC006, Toripalimab and Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 19 Aug 2026to 30 Dec 2030
- 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
- Voluntarily signed informed consent and willingness to comply with the protocol requirements.
- Male or female.
- Age ≥18 years and ≤75 years.
- Life expectancy ≥3 months.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
- Histologically or cytologically confirmed small cell lung cancer (SCLC).
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- Toxicity from prior anti-tumor therapy has resolved to ≤ Grade 1 as defined by NCI-CTCAE version 6.0 (except alopecia); peripheral neuropathy must have completely resolved.
- Adequate hepatic, renal, coagulation, and cardiac function.
- The participant and their spouse agree to use effective barrier or pharmacologic contraception (excluding rhythm method) from the time of signing the informed consent until 6 months after the last dose of study treatment.
Who cannot join
- Histologically or cytologically confirmed combined SCLC, NSCLC, sarcomatoid carcinoma, or large cell neuroendocrine carcinoma.
- Within 14 days prior to the first dose: underwent plasmapheresis; received systemic corticosteroid therapy at a daily dose >10 mg prednisone or equivalent (or equivalent anti-inflammatory activity) for more than 3 consecutive days (short-term use for prevention of contrast media allergy is permitted).
- Prior allogeneic hematopoietic stem cell transplantation (HSCT) or history of solid organ transplantation.
- Prior treatment with CD56-targeted therapy.
- Symptomatic brain metastases or leptomeningeal metastases.
- History of severe or life-threatening immune-related adverse events or infusion-related reactions (including permanent discontinuation of immuno-oncology therapy due to intolerance).
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- Active autoimmune disease or immunodeficiency, or a history of such conditions.
- Evidence of significant cardiovascular risk.
- Dyspnea or current requirement for continuous supplemental oxygen therapy, or current active pneumonitis or interstitial lung disease (except mild cases as determined by the investigator).
- History of other primary malignancies, with the exception of malignancies that have been cured and have a very low risk of recurrence within 5 years, such as basal cell carcinoma or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix or breast.
- Severe non-healing wound, ulcer, or bone fracture; or major surgery within 28 days prior to dosing, or anticipated major surgery during the study period.
- History of hypersensitivity to any component or excipient of DXC006, immune checkpoint inhibitors, or platinum-based chemotherapy.
- Active hepatitis B (HBV-DNA above the upper limit of normal at the central laboratory or >1000 copies/mL); hepatitis C infection (positive hepatitis C antibody or positive HCV RNA PCR result).
- Known positive serology for human immunodeficiency virus (HIV); active syphilis (patients with positive syphilis antibody only are eligible); potential active pulmonary tuberculosis (chest imaging within 3 months prior to the first dose suggestive of active tuberculosis infection).
- Active bleeding within 30 days prior to screening, or risk of major gastrointestinal bleeding or hemoptysis as determined by the investigator; or hereditary bleeding tendency, coagulopathy, or bleeding symptoms requiring other medical intervention.
- Severe arterial or venous thromboembolic events within 6 months prior to study drug administration, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis, or pulmonary embolism.
- Positive serum pregnancy test or currently breastfeeding female participants.
- Active infection requiring medical therapy (CTCAE Grade ≥2); uncontrollable pleural effusion, ascites, or pericardial effusion requiring repeated drainage.
- Administration of live attenuated vaccines within 28 days prior to the first dose.
- Other conditions that, in the judgment of the investigator, may affect the patient's participation in the study.
- Poor general condition, such as requirement for mechanical ventilation and/or intravenous catecholamine infusion, and/or severe neurological impairment, coma, and/or quadriplegia with complete loss of communication ability (deafness, blindness, aphasia); uncontrolled seizures; other psychiatric disorders that may affect study participation.
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
Guangzhou, Guangdong, 510060
Li Zhang, Doctoral degree, +86-020-87343565, zhangli@sysucc.org.cn
About this study
Official title: A Phase Ib/II Study to Evaluate the Safety and Efficacy of DXC006 for Injection Combined With Immune Checkpoint Inhibitors or Platinum-Based Agents in Patients With Small Cell Lung Cancer.
This is a Phase Ib/II, open-label clinical study designed to evaluate the safety, tolerability, preliminary anti-tumor activity, recommended Phase 2 dose (RP2D), pharmacokinetic (PK) characteristics, and immunogenicity of DXC006 in combination with an immune checkpoint inhibitor (ICI) or platinum-based chemotherapy in patients with small cell lung cancer (SCLC).
- Conditions
- Small Cell Lung Cancer
- Being tested
- DXC006, Toripalimab, Carboplatin, Cisplatin
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DXC006Drug
Participants receive DXC006 intravenously on Day 1 every 3 weeks.
ToripalimabDrug
Participants receive Toripalimab intravenously on Day 1 every 3 weeks.
CarboplatinDrug
Participants receive Carboplatin intravenously on Day 1 every 3 weeks (up to 6 cycles).
CisplatinDrug
Participants receive Cisplatin intravenously on Day 1 every 3 weeks (up to 6 cycles).
| Study group | Role | What they receive |
|---|---|---|
| DXC006 + ICI | Experimental | Not described Receives: Drug: DXC006; Drug: Toripalimab |
| DXC006 + Platinum(Carboplatin ) | Experimental | Not described Receives: Drug: DXC006; Drug: Carboplatin |
| DXC006 + Platinum(Cisplatin ) | Experimental | Not described Receives: Drug: DXC006; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
Measured: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 year.
6-month progression-free survival rate
Measured: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months.
Recommended Phase 2 Dose (RP2D)
Measured: Final RP2D confirmation upon completion of the Phase Ib (up to 12 months).
Measurement of objective response rate (ORR) per RECIST 1.1
Measured: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 year.
Measurement of disease control rate (DCR)
Measured: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 year.
Incidence of Adverse Events (AEs)
Measured: After first infusion of study drug, through study completion an average of 2 year.
Secondary outcomes (12)
Maximum observed serum or plasma concentration (Cmax)
Measured: Through study completion an average of 1 year.
Maximum serum drug time（Tmax）
Measured: Through study completion an average of 1 year.
Apparent volume of distribution(Vd)
Measured: Through study completion an average of 1 year.
Volume of distribution at steady state (Vss)
Measured: Through study completion an average of 1 year.
Terminal phase elimination half life (t½)
Measured: Through study completion an average of 1 year.
Area under the serum or plasma concentration time curve from 0 to the last measurable point (AUC0-t).
Measured: Through study completion an average of 1 year.
Area under the serum or plasma concentration time curve from 0 to infinity (AUC0-inf)
Measured: Through study completion an average of 1 year.
Clearance (CL)
Measured: Through study completion an average of 1 year.
Ctrough
Measured: Through study completion an average of 1 year.
Anti-drug antibodies (ADA)
Measured: Through study completion an average of 1 year.
Overall Survival (OS)
Measured: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 year.
Duration of response (DOR)
Measured: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start19 Aug 2026
- Primary completion1 Jun 2028 (estimated)
- Study completion30 Dec 2030 (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.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hangzhou DAC Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07559929
- Sponsor's protocol ID
- DXC006-002
- Status last verified
- Sep 2026
- First submitted
- 24 Apr 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- 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 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II Study to Evaluate the Safety and Efficacy of DXC006 for Injection Combined With Immune Checkpoint Inhibitors or Platinum-Based Agents in Patients With Small Cell Lung Cancer.
- ClinicalTrials.gov ID
- NCT07559929
- Acronym / sponsor ID
- DXC006-002
- Conditions
- Small Cell Lung Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hangzhou DAC Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Aug 2026 (actual)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 30 Dec 2030 (estimated)
- First posted
- 30 Apr 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 is a Phase Ib/II, open-label clinical study designed to evaluate the safety, tolerability, preliminary anti-tumor activity, recommended Phase 2 dose (RP2D), pharmacokinetic (PK) characteristics, and immunogenicity of DXC006 in combination with an immune checkpoint inhibitor (ICI) or platinum-based chemotherapy in patients with small cell lung cancer (SCLC).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DXC006 + ICI | Experimental | Drug: DXC006, Drug: Toripalimab |
| DXC006 + Platinum(Carboplatin ) | Experimental | Drug: DXC006, Drug: Carboplatin |
| DXC006 + Platinum(Cisplatin ) | Experimental | Drug: DXC006, Drug: Cisplatin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Voluntarily signed informed consent and willingness to comply with the protocol requirements.
- Male or female.
- Age ≥18 years and ≤75 years.
- Life expectancy ≥3 months.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
Key exclusion criteria (21 listed)
- Histologically or cytologically confirmed combined SCLC, NSCLC, sarcomatoid carcinoma, or large cell neuroendocrine carcinoma.
- Within 14 days prior to the first dose: underwent plasmapheresis; received systemic corticosteroid therapy at a daily dose >10 mg prednisone or equivalent (or equivalent anti-inflammatory activity) for more than 3 consecutive days (short-term use for prevention of contrast media allergy is permitted).
- Prior allogeneic hematopoietic stem cell transplantation (HSCT) or history of solid organ transplantation.
- Prior treatment with CD56-targeted therapy.
- Symptomatic brain metastases or leptomeningeal 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 |
|---|---|---|
| DXC006Participants receive DXC006 intravenously on Day 1 every 3 weeks. | Drug | DXC006 + ICI, DXC006 + Platinum(Carboplatin ), DXC006 + Platinum(Cisplatin ) |
| ToripalimabParticipants receive Toripalimab intravenously on Day 1 every 3 weeks. | Drug | DXC006 + ICI |
| CarboplatinParticipants receive Carboplatin intravenously on Day 1 every 3 weeks (up to 6 cycles). | Drug | DXC006 + Platinum(Carboplatin ) |
| CisplatinParticipants receive Cisplatin intravenously on Day 1 every 3 weeks (up to 6 cycles). | Drug | DXC006 + Platinum(Cisplatin ) |
Primary outcome
Progression Free Survival (PFS)
Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 year.
6-month progression-free survival rate
Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months.
Recommended Phase 2 Dose (RP2D)
Time frame: Final RP2D confirmation upon completion of the Phase Ib (up to 12 months).
Measurement of objective response rate (ORR) per RECIST 1.1
Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 year.
Measurement of disease control rate (DCR)
Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 year.
Incidence of Adverse Events (AEs)
Time frame: After first infusion of study drug, through study completion an average of 2 year.
12 secondary outcomes
Maximum observed serum or plasma concentration (Cmax)
Time frame: Through study completion an average of 1 year.
Maximum serum drug time（Tmax）
Time frame: Through study completion an average of 1 year.
Apparent volume of distribution(Vd)
Time frame: Through study completion an average of 1 year.
Volume of distribution at steady state (Vss)
Time frame: Through study completion an average of 1 year.
Terminal phase elimination half life (t½)
Time frame: Through study completion an average of 1 year.
Area under the serum or plasma concentration time curve from 0 to the last measurable point (AUC0-t).
Time frame: Through study completion an average of 1 year.
Area under the serum or plasma concentration time curve from 0 to infinity (AUC0-inf)
Time frame: Through study completion an average of 1 year.
Clearance (CL)
Time frame: Through study completion an average of 1 year.
Ctrough
Time frame: Through study completion an average of 1 year.
Anti-drug antibodies (ADA)
Time frame: Through study completion an average of 1 year.
Overall Survival (OS)
Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 year.
Duration of response (DOR)
Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 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 24 Sep 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.
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 DXC006, Toripalimab and Carboplatin in people with Small Cell Lung Cancer, run by Hangzhou DAC Biotechnology 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 21 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 24 Sep 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 Li Zhang, Doctoral degree (+86-020-87343565, zhangli@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) (time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 year.). The study lists 6 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 Sep 2026.