Advanced Solid TumorsPhase 1NCT07849218
A Study of DXC018 in Patients With Advanced Solid Tumors
A Phase 1 study testing DXC018 in people with Advanced Solid Tumors, run by Hangzhou DAC Biotechnology Co., Ltd. at 4 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 DXC018 in participants with Advanced Solid Tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- DXC018
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 4 sitesChina
- Study dates
- 18 Oct 2026to 31 Aug 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
- Voluntarily sign the informed consent form and comply with the protocol requirements.
- Male or female, age ≥18 years old and ≤75 years old.
- Participants with advanced malignancy confirmed by histology or cytology.
- Participants with locally advanced or metastatic solid tumors that cannot be surgically removed who have experienced disease progression after standard therapy, or are currently ineligible for standard therapy, or in lack of standard treatment. (Standard therapy is defined as per domestic consensus guidelines [where applicable] or treatment aligned with current domestic medical practice).
- At least one measurable lesion as defined by RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
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- Life expectancy ≥ 3 months.
- Toxicities from prior anti-tumor therapy have recovered to Grade ≤1 as defined by NCI-CTCAE v5.0 (except alopecia or vitiligo). Participants with grade 2 toxicities per NCI-CTCAE v5.0 may be enrolled with no safety risks judged by the investigators (e.g., Grade 2 peripheral neuropathy).
- Adequate organ function as defined by the following laboratory values:
- Hematological:
- 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).
- Platelet count ≥ 90 × 10⁹/L (No platelet or whole blood transfusion or platelet-boosting drugs within 7 days prior to the screening lab test).
- 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:
- Total Bilirubin (TBIL) ≤ 1.5 × ULN (Upper Limit of Normal); except for participants with congenital bilirubinemia, e.g., Gilbert's syndrome (TBIL ≤ 3.0 × ULN).
- AST and ALT ≤ 2.5 × ULN.
- 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:
- International Normalized Ratio (INR) ≤ 1.5.
- 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
- Participants with primary malignancies in other organs currently. Participants may be enrolled in the following scenarios: participants with healed basal cell or squamous cell skin cancer, cervical carcinoma in situ, papillary thyroid cancer, ductal carcinoma in situ of the breast.Or participants with other malignancies achieving over 5-year disease-free survival.
- Serum pregnancy test: Positive or breastfeeding woman.
- Received systemic anti-tumor therapy or investigational drug without washout. Received major surgeries treatment within 28 days prior to the first dose. Received local radiotherapy within 14 days prior to the first dose.
- History of solid organ transplantation.
- Participants with primary central nervous system (CNS) tumors or CNS metastases. With the following exceptions: asymptomatic and stable brain metastases, or participants who have not received steroid or other treatments for brain metastases ≥ 28 days.
- History of grade 3 or higher allergic reactions to trastuzumab injection, pertuzumab injection, or similar biological products. History of allergy to any component or excipient of DXC018.
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- Evidence of severe or uncontrollable heart diseases that require treatments, including any of the following: Class III or IV heart failure defined by the New York Heart Association (NYHA) functional classification system. Uncontrollable unstable angina. History of myocardial infarction within 6 months prior to screening. Evidence of clinically significant arrhythmias except atrial fibrillation and paroxysmal supraventricular tachycardia.
- QTcF interval ≥ 470 milliseconds (QT interval must be corrected using Fridericia's formula [QTcF]).
- Uncontrolled severe hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg).
- Received strong CYP3A4 inhibitors or inducers within 7 days prior to the first dose.
- Participants with interstitial lung disease or history of non-infectious pneumonia who have received steroid treatments currently (except mild illness judged by investigators, including mild interstitial lung disease, stable radiation pneumonitis, or chronic pneumonitis) Other conditions which result in severe pulmonary function impairement.
- Presence of severe unhealed wounds, ulcers, or fractures.
- Participants who have an active infection requiring medication within 2 weeks before the first dose of the study drug.
- Active hepatitis B (HBsAg positive and HBV DNA ≥ 500 IU/mL or ≥ 2000 copies/mL; active hepatitis C (HCV antibody positive and HCV RNA above the lower limit of detection).
- HIV serology: positive; active syphilis (participants with only a positive syphilis antibody test may be enrolled).
- Active bleeding within 30 days prior to screening, at risk of massive gastrointestinal bleeding judged by the investigators, hemoptysis, etc.. Or hereditary bleeding tendency or coagulation dysfunction. Or hemorrhagic symptoms requiring other medical intervention.
- History of severe arterial/venous thrombotic events within 1 year prior to the first dose (except controllable stable low extremity deep venous thrombosis).
- Participants who have the third gap fluids (like a large amount of pleural effusion, pericardial effusion, ascites, etc.) that cannot be controlled by drainage or other methods. and who need drainage to control the third gap fluids within 14 days before the first dose of the study drug.
- Participants with more than 10 mg of prednisone or an equivalent dose of systemic corticosteroids, or other anti-inflammatory drugs with equivalent effects, or any form of immunosuppressive treatment within 2 weeks before the first dose of the study drug.
- Administration of a live attenuated vaccine within 4 weeks 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
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites
Fujian Provincial Cancer Hospital
Fuzhou, Fujian, 350000
Yigui Chen, +86-0591-83660063, 13509339525@163.com
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang
Yulong Zheng, +086-0571-87236114, drzhengyu@126.com
Jinan Central Hospital
Jinan, Shandong, 250000
Meili Sun, +086-0531-85695114, smli1980@163.com
FUDAN University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 201321
Jian Zhang, +086-021-64175590, Syner2000@163.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 DXC018 for Injection in Participants 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 DXC018 in participants with Advanced Solid Tumors.
- Conditions
- Advanced Solid Tumors
- Being tested
- DXC018
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DXC018Drug
Cohort A: Once every 2 weeks (Q2W) with a cycle length of 14 days. Cohort B: Once every 3 weeks (Q3W) with a cycle length of 21 days.
| Study group | Role | What they receive |
|---|---|---|
| DXC018 | Experimental | Not described Receives: Drug: DXC018 |
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
Measured: 28 days
Maximum tolerated dose
Measured: After first infusion of study drug, through study with an average completion of 2 years
Recommended Phase II dose
Measured: After first infusion of study drug, through study with an average completion of 2 years
Number of participants with adverse events (AEs)
Measured: After first infusion of study drug, through study with an average completion of 2 years
Secondary outcomes (14)
Maximum observed serum or plasma concentration (Cmax)
Measured: After first infusion of study drug, through study with an average completion of 2 years
Anti-drug antibodies (ADA)
Measured: After first infusion of study drug, through study with an average completion of 2 years
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 years
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 years
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 years
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 years
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 years
Maximum serum drug time（Tmax）
Measured: After first infusion of study drug, through study with an average completion of 2 years
Apparent volume of distribution(Vd)
Measured: After first infusion of study drug, through study with an average completion of 2 years
Volume of distribution at steady state (Vss)
Measured: After first infusion of study drug, through study with an average completion of 2 years
Terminal phase elimination half life (t½)
Measured: After first infusion of study drug, through study with an average completion of 2 years
Area under the serum or plasma concentration time curve from 0 to the last measurable point (AUC0-t)
Measured: After first infusion of study drug, through study with an average completion of 2 years
Area under the serum or plasma concentration time curve from 0 to infinity (AUC0-inf)
Measured: After first infusion of study drug, through study with an average completion of 2 years
Clearance (CL)
Measured: After first infusion of study drug, through study with an average completion of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start18 Oct 2026 (estimated)
- Primary completion31 Aug 2029 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies 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
- 110 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
- NCT07849218
- Sponsor's protocol ID
- DXC018-001
- Status last verified
- Sep 2026
- First submitted
- 22 Sep 2026
- Last updated
- 30 Sep 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 30 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 DXC018 for Injection in Participants With Advanced Solid Tumors.
- ClinicalTrials.gov ID
- NCT07849218
- Acronym / sponsor ID
- DXC018-001
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Hangzhou DAC Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Oct 2026 (estimated)
- Primary completion
- 31 Aug 2029 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 30 Sep 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 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 DXC018 in participants 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 |
|---|---|---|
| DXC018 | Experimental | Drug: DXC018 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Voluntarily sign the informed consent form and comply with the protocol requirements.
- Male or female, age ≥18 years old and ≤75 years old.
- Participants with advanced malignancy confirmed by histology or cytology.
- Participants with locally advanced or metastatic solid tumors that cannot be surgically removed who have experienced disease progression after standard therapy, or are currently ineligible for standard therapy, or in lack of standard treatment. (Standard therapy is defined as per domestic consensus guidelines [where applicable] or treatment aligned with current domestic medical practice).
- At least one measurable lesion as defined by RECIST v1.1.
Key exclusion criteria (21 listed)
- Participants with primary malignancies in other organs currently. Participants may be enrolled in the following scenarios: participants with healed basal cell or squamous cell skin cancer, cervical carcinoma in situ, papillary thyroid cancer, ductal carcinoma in situ of the breast.Or participants with other malignancies achieving over 5-year disease-free survival.
- Serum pregnancy test: Positive or breastfeeding woman.
- Received systemic anti-tumor therapy or investigational drug without washout. Received major surgeries treatment within 28 days prior to the first dose. Received local radiotherapy within 14 days prior to the first dose.
- History of solid organ transplantation.
- Participants with primary central nervous system (CNS) tumors or CNS metastases. With the following exceptions: asymptomatic and stable brain metastases, or participants who have not received steroid or other treatments for brain metastases ≥ 28 days.
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 |
|---|---|---|
| DXC018Cohort A: Once every 2 weeks (Q2W) with a cycle length of 14 days. Cohort B: Once every 3 weeks (Q3W) with a cycle length of 21 days. | Drug | DXC018 |
Primary outcome
Number of participants that experienced dose limiting toxicities(DLTs) at given dose level
Time frame: 28 days
Maximum tolerated dose
Time frame: After first infusion of study drug, through study with an average completion of 2 years
Recommended Phase II dose
Time frame: After first infusion of study drug, through study with an average completion of 2 years
Number of participants with adverse events (AEs)
Time frame: After first infusion of study drug, through study with an average completion of 2 years
14 secondary outcomes
Maximum observed serum or plasma concentration (Cmax)
Time frame: After first infusion of study drug, through study with an average completion of 2 years
Anti-drug antibodies (ADA)
Time frame: After first infusion of study drug, through study with an average completion of 2 years
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 years
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 years
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 years
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 years
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 years
Maximum serum drug time（Tmax）
Time frame: After first infusion of study drug, through study with an average completion of 2 years
Apparent volume of distribution(Vd)
Time frame: After first infusion of study drug, through study with an average completion of 2 years
Volume of distribution at steady state (Vss)
Time frame: After first infusion of study drug, through study with an average completion of 2 years
Terminal phase elimination half life (t½)
Time frame: After first infusion of study drug, through study with an average completion of 2 years
Area under the serum or plasma concentration time curve from 0 to the last measurable point (AUC0-t)
Time frame: After first infusion of study drug, through study with an average completion of 2 years
Area under the serum or plasma concentration time curve from 0 to infinity (AUC0-inf)
Time frame: After first infusion of study drug, through study with an average completion of 2 years
Clearance (CL)
Time frame: After first infusion of study drug, through study with an average completion of 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 30 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.
4 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 DXC018 in people with Advanced Solid Tumors, run by Hangzhou DAC Biotechnology Co., Ltd. at 4 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 24 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: opening soon, as of the sponsor's last update on 30 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 4 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 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 30 Sep 2026.