Small Cell Lung CancerPhase 1NCT07177937
A Study of DXC014 in Patients With Advanced Solid Tumors.
A Phase 1 study testing DXC014 in people with Small Cell Lung Cancer and Melanoma, run by Hangzhou DAC Biotechnology Co., Ltd. at 5 sites in China.
Trial summary
This is a phase I, open-label, first-in-human clinical study designed to evaluate the safety, tolerability, MTD, DLT, RP2D, the PK characteristics, preliminary anti-tumor activity, the immunogenicity of DXC014 in patients with Advanced Solid Tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Cancer, Melanoma, Prostate Cancer
- What is being tested?
- DXC014
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 5 sitesChina
- Study dates
- 3 Mar 2026to 20 Oct 2030
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily sign the informed consent form and comply with the protocol requirements.
- Male or female.
- For other solid tumor patients: Age ≥18 years and ≤75 years；For prostate cancer patients: Age ≥18 years.
- 4 .Life expectancy ≥ 3 months. 5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- 6. Prostate cancer,other solid tumors. 7. Prostate Cancer (Two Parallel Cohorts): Cohort 1: At least one measurable lesion as defined by RECIST v1.1. Cohort 2: Presence of ≥1 metastatic lesion(s) confirmed by baseline CT, MRI, or bone scan.Participants and their partners agree to use effective methods of contraception (excluding the rhythm method) from the time of signing the informed consent form until 6 months after the last dose of study drug.
- Other Solid Tumors: At least one measurable lesion as defined by RECIST v1.1. 8. Toxicities from prior anti-tumor therapy have recovered to Grade ≤1 as defined by NCI-CTCAE v5.0 (except alopecia). Grade 2 toxicities per NCI-CTCAE v5.0 may be permitted if judged by the investigator to pose no safety risk.
- 9. Adequate organ function as defined by the following laboratory values: Hematological:(1) Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹/L (No use of G-CSF or granulocyte-/white blood cell-boosting drugs within 7 days prior to the screening lab test). (2) Platelet count ≥ 100 × 10⁹/L (No platelet or whole blood transfusion or platelet-boosting drugs within 7 days prior to the screening lab test). (3) Hemoglobin (HGB) ≥ 90 g/L (No red blood cell (RBC) or whole blood transfusion or hemoglobin-boosting drugs within 7 days prior to the screening lab test).Hepatic: (1) Total Bilirubin (TBIL) ≤ 1.5 × ULN (Upper Limit of Normal); except for participants with congenital bilirubinemia, e.g., Gilbert's syndrome (Direct bilirubin ≤ 1.5 × ULN). (2) AST and ALT ≤ 3.0 × ULN. (3) AST and ALT ≤ 5.0 × ULN in the presence of liver metastases. Renal: Creatinine Clearance (Ccr) ≥ 60 mL/min OR Serum Creatinine (Cr) ≤ 1.5 × ULN. For participants with urinalysis showing urine protein ≥ 2+ at screening, a 24-hour urine protein quantification should be performed; participants with a 24-hour urine protein ≤ 1 g may be enrolled. Coagulation: (1) International Normalized Ratio (INR) ≤ 1.5. (2) Activated Partial Thromboplastin Time (APTT) or Prothrombin Time (PT) ≤ 1.5 × ULN. Cardiac: Left Ventricular Ejection Fraction (LVEF) ≥ 50%.
- 10. Participants and their partners agree to use effective methods of contraception (excluding the rhythm method) from the time of signing the informed consent form until 6 months after the last dose of study drug.
Who cannot join
- Within 14 days prior to the first dose: Underwent plasmapheresis; received systemic corticosteroid therapy at a dose >10 mg/day prednisone or equivalent for more than 3 consecutive days, or other anti-inflammatory drugs with equivalent activity (short-term use for preventing contrast agent allergy is allowed for enrollment).
- Received systemic anti-tumor therapy or investigational drug treatment within 28 days or 5 half-lives (whichever is shorter) prior to the first dose; received palliative radiotherapy within 14 days prior to the first dose; received treatment with Chinese patent medicines or herbal medicines explicitly indicated for anti-tumor purposes in the NMPA-approved drug label within 1 week prior to the first dose.
- History of solid organ transplantation.
- Prostate Cancer: Leptomeningeal metastasis or brain metastasis. Other Solid Tumors: Participants with active central nervous system (CNS) metastases and/or leptomeningeal metastases or spinal cord compression, with the following exceptions: asymptomatic and stable brain metastases, or participants who have received treatment for brain metastases with no evidence of new or enlarging brain metastases on imaging for at least 4 weeks and no related symptoms, and who have discontinued steroid or anticonvulsant therapy for at least 14 days prior to initiation of study treatment.
- Evidence of cardiovascular risk, including any of the following: a. QTcF interval ≥ 470 milliseconds (QT interval must be corrected using Fridericia's formula [QTcF]). b. Evidence of current clinically significant untreated arrhythmias, including clinically significant ECG abnormalities such as 2nd-degree (Mobitz Type II) or 3rd-degree atrioventricular block. c. History of myocardial infarction, acute coronary syndrome (including unstable angina), coronary angioplasty, stenting, or bypass grafting within 6 months prior to screening. d. Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system. e. Uncontrolled severe hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg).
- Uncontrolled diabetes mellitus.
Show all 18Show fewer
- Current interstitial lung disease or pulmonary fibrosis, pneumoconiosis, radiation pneumonitis, severely impaired pulmonary function, or other conditions that may interfere with the detection or management of suspected drug-related pulmonary toxicity.
- History of or current other malignancies within the past 5 years. Participants may be enrolled in the following two scenarios: other malignancies treated with single surgery alone, achieving continuous 5-year disease-free survival (DFS); adequately treated carcinoma in situ with no evidence of recurrence, such as cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor infiltrating basement membrane)].
- Presence of severe unhealed wounds, ulcers, or fractures; major surgery within 28 days prior to the first dose or anticipated major surgery during the clinical study period.
- History of allergy to any component or excipient of DXC014 .
- Active hepatitis B (HBsAg positive and HBV DNA ≥ 500 IU/mL or above the upper limit of normal [ULN] of the testing unit); active hepatitis C (HCV antibody positive and HCV RNA above the lower limit of detection).
- Known positive HIV serology; active syphilis (participants with only a positive syphilis antibody test may be enrolled); suspected active tuberculosis (chest imaging within 3 months prior to the first dose suggests active tuberculosis infection).
- Active bleeding within 30 days prior to screening, or judged by the investigator to be at risk of major gastrointestinal bleeding, hemoptysis, etc.; or hereditary bleeding tendency or coagulation dysfunction; or hemorrhagic symptoms requiring other medical intervention.
- History of severe arterial/venous thrombotic events within 6 months prior to the first dose, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis, pulmonary embolism.
- Female participants who are pregnant (positive serum pregnancy test) or breastfeeding.
- Active infection requiring systemic medication (CTCAE ≥ Grade 2) within 2 weeks prior to the first dose of study treatment; uncontrolled pleural effusion, ascites, or pericardial effusion requiring repeated drainage.
- Administration of a live attenuated vaccine within 28 days prior to the first dose or planned vaccination during the study period.
- Any other condition that, in the judgment of the investigator or sponsor, may affect the participant's participation in this study.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Yu Fan, 86-010-83572211, dantefanbmu@126.com
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410000
Weiqing, Han, 86-0731-88651900, md70210@sina.com
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Zhengbo Song, 86-0571-88122222, songzb@zjcc.org.cn
- Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Bin Fu, 86-0791-86319333, uroroc@126.com
- Recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266555
Tao Jiang, 86-0532-82911767, jiangtao111@sina.com
About this study
Official title: An Open-Label, Multicenter, First-in-Human, Dose-Escalation and Expansion Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of DXC014 for Injection in Patients With Advanced Solid Tumors.
This is a phase I, open-label, first-in-human clinical study designed to evaluate the safety, tolerability, MTD, DLT, RP2D, the PK characteristics, preliminary anti-tumor activity, the immunogenicity of DXC014 in patients with Advanced Solid Tumors.
- Being tested
- DXC014
- Medical subject headings
- Small Cell Lung Carcinoma, Melanoma, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DXC014Drug
Dose Escalation DXC014, Cohort Expansion DXC014
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Dose Escalation DXC014, Cohort Expansion DXC014 Receives: Drug: DXC014 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants that experienced dose limiting toxicities(DLTs) at given dose level.
Dose Limiting Toxicities (DLTs) In Order to Determine the Maximum Tolerated.
Measured: 28 days
Number of participants with adverse events (AEs)
The adverse events will be evaluated in accordance with CTCAE v5.0. The investigator shall assess the relationship between the events and investigational product.
Measured: After first infusion of study drug, Through study completion an average of 1 year
Secondary outcomes (2)
Maximum observed serum or plasma concentration (Cmax)
One of the pharmacokinetics parameters for DXC014 investigator shall assess the relationship between the events and investigational product.
Measured: Through study completion an average of 1 year
Maximum serum drug time（Tmax）
One of the pharmacokinetics parameters for DXC014
Measured: Through study completion an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start3 Mar 2026
- Primary completion20 Oct 2030 (estimated)
- Study completion20 Oct 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 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
- NCT07177937
- Sponsor's protocol ID
- DXC014-001
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2025
- Last updated
- 23 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 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicenter, First-in-Human, Dose-Escalation and Expansion Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of DXC014 for Injection in Patients With Advanced Solid Tumors.
- ClinicalTrials.gov ID
- NCT07177937
- Acronym / sponsor ID
- DXC014-001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Hangzhou DAC Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Mar 2026 (actual)
- Primary completion
- 20 Oct 2030 (estimated)
- Study completion
- 20 Oct 2030 (estimated)
- First posted
- 17 Sep 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 is a phase I, open-label, first-in-human clinical study designed to evaluate the safety, tolerability, MTD, DLT, RP2D, the PK characteristics, preliminary anti-tumor activity, the immunogenicity of DXC014 in patients with Advanced Solid Tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: DXC014Dose Escalation DXC014, Cohort Expansion DXC014 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Voluntarily sign the informed consent form and comply with the protocol requirements.
- Male or female.
- For other solid tumor patients: Age ≥18 years and ≤75 years；For prostate cancer patients: Age ≥18 years.
- 4 .Life expectancy ≥ 3 months. 5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- 6. Prostate cancer,other solid tumors. 7. Prostate Cancer (Two Parallel Cohorts): Cohort 1: At least one measurable lesion as defined by RECIST v1.1. Cohort 2: Presence of ≥1 metastatic lesion(s) confirmed by baseline CT, MRI, or bone scan.Participants and their partners agree to use effective methods of contraception (excluding the rhythm method) from the time of signing the informed consent form until 6 months after the last dose of study drug.
Key exclusion criteria (18 listed)
- Within 14 days prior to the first dose: Underwent plasmapheresis; received systemic corticosteroid therapy at a dose >10 mg/day prednisone or equivalent for more than 3 consecutive days, or other anti-inflammatory drugs with equivalent activity (short-term use for preventing contrast agent allergy is allowed for enrollment).
- Received systemic anti-tumor therapy or investigational drug treatment within 28 days or 5 half-lives (whichever is shorter) prior to the first dose; received palliative radiotherapy within 14 days prior to the first dose; received treatment with Chinese patent medicines or herbal medicines explicitly indicated for anti-tumor purposes in the NMPA-approved drug label within 1 week prior to the first dose.
- History of solid organ transplantation.
- Prostate Cancer: Leptomeningeal metastasis or brain metastasis. Other Solid Tumors: Participants with active central nervous system (CNS) metastases and/or leptomeningeal metastases or spinal cord compression, with the following exceptions: asymptomatic and stable brain metastases, or participants who have received treatment for brain metastases with no evidence of new or enlarging brain metastases on imaging for at least 4 weeks and no related symptoms, and who have discontinued steroid or anticonvulsant therapy for at least 14 days prior to initiation of study treatment.
- Evidence of cardiovascular risk, including any of the following: a. QTcF interval ≥ 470 milliseconds (QT interval must be corrected using Fridericia's formula [QTcF]). b. Evidence of current clinically significant untreated arrhythmias, including clinically significant ECG abnormalities such as 2nd-degree (Mobitz Type II) or 3rd-degree atrioventricular block. c. History of myocardial infarction, acute coronary syndrome (including unstable angina), coronary angioplasty, stenting, or bypass grafting within 6 months prior to screening. d. Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system. e. Uncontrolled severe hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg).
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 |
|---|---|---|
| DXC014Dose Escalation DXC014, Cohort Expansion DXC014 | Drug | Experimental |
Primary outcome
Number of participants that experienced dose limiting toxicities(DLTs) at given dose level.
Time frame: 28 days
Dose Limiting Toxicities (DLTs) In Order to Determine the Maximum Tolerated.
Number of participants with adverse events (AEs)
Time frame: After first infusion of study drug, Through study completion an average of 1 year
The adverse events will be evaluated in accordance with CTCAE v5.0. The investigator shall assess the relationship between the events and investigational product.
2 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
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 23 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.
5 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 DXC014 in people with Small Cell Lung Cancer and Melanoma, run by Hangzhou DAC Biotechnology Co., Ltd. at 5 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 8 inclusion and 18 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 23 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 5 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?
Contact Pengyu Shi (86-0571-56050590, Shipengyu@dacbiotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants that experienced dose limiting toxicities(DLTs) at given dose level. (time frame: 28 days). 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 23 Sep 2026.