Prostate CancerPhase 1NCT06926283
A Study of DXC008 in Patients With Prostate Cancer and Other Solid Tumors
A Phase 1 study testing DXC008 in people with Prostate Cancer and Other 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 DXC008 in patients with prostate cancer and other solid tumors such as Ewing sarcoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Prostate Cancer, Other Solid Tumors, Ewing Sarcoma
- What is being tested?
- DXC008
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 4 sitesChina
- Study dates
- 15 May 2025to Apr 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Those who voluntarily sign the ICF and follow the protocol requirements.
- Male or female.
- Age: ≥ 18 years and ≤ 75 years.
- Expected life expectancy ≥ 6 months.
- ECOG performance status score: 0-2.
- Patients with various solid tumors who have failed standard treatment, including but not limited to progressive mCRPC.
Show all 23Show fewer
- Prostate Cancer： Serum testosterone level during screening and prior to the first dose of investigational product: ≤50 ng/dL (≤1.73 nmol/L).
- Prostate Cancer is divided into two cohorts： Cohort 1: At least one measurable lesion as defined by RECIST v1.1. Cohort 2: At least one metastatic lesion on CT/MRI, or bone scan imaging at baseline.Patients are assigned to the appropriate cohort as assessed by the investigator; the study procedures in Cohort 1 and Cohort 2 may be performed in parallel and simultaneously，it is not necessary to wait until all procedures in either cohort have been completed before initiating procedures in the other cohort.Other solid tumors：At least one measurable lesion as defined by RECIST v1.1.
- Toxicities from prior antitumor therapy must have recovered to Grade ≤ 1 as defined in the NCI-CTCAE v5.0 (except alopecia), or Grade 2 as defined by NCI-CTCAE v5.0, except for toxicity not constituting a safety risk by investigator judgment (eg, Grade 2 peripheral neurotoxicity).
- Organ function of the subjects must meet the following requirements:
- Hematology:
- ANC ≥ 1.5 × 10^9/L (prior use of G-CSF is allowed, but G-CSF use is not allowed within 7 days prior to the screening laboratory tests).
- Platelet count ≥100×10^9/L (platelet transfusion is not allowed within 7 days before the screening laboratory tests).
- HGB ≥ 90 g/L (RBC transfusion or recombinant human erythropoietin use is allowed; RBC transfusion is not allowed within 7 days prior to the screening laboratory tests).
- Liver function:
- Total bilirubin (TBIL) ≤1.5×ULN, except for subjects with congenital bilirubinemia, such as Gilbert syndrome (direct bilirubin ≤1.5×ULN).
- AST and ALT ≤ 3.0 × ULN.For patients with liver metastases, both AST and ALT ≤5×ULN.
- Renal function:
- Ccr ≥ 60 mL/min; or creatinine ≤ 1.5 × ULN; urinalysis results show protein urine ≤ 1 +. For subjects with urine protein ≥2+ in urinalysis during the screening period, a 24-hour urine protein quantification should be performed, and those with 24-hour urine protein quantification ≤1 g can be enrolled.
- Coagulation function:
- INR≤1.5.
- APTT or PT ≤ 1.5 × ULN. LVEF≥50%.
- Subjects and their spouses agree to use effective instrumental or pharmacologic contraception (excluding safe period contraception) from the time of ICF signing until 6 months after the last dose of investigational product.
Who cannot join
- Within 14 days prior to the first dose: Have undergone plasmapheresis, treated with prednisone at > 10 mg/day for > 3 consecutive days or equivalent dose of systemic corticosteroids or equivalent anti-inflammatory medication (Those who have received short-term treatment with such medications for the prevention of contrast media allergy may be enrolled).
- Have received systemic antineoplastic therapy or investigational product treatment within 28 days or 5 half-lives (whichever is shorter) prior to the first dose, have received radiotherapy within 14 days prior to the first dose.
- Have received monoclonal antibody therapy for anti-tumor purposes within 30 days prior to the first dose.
- History of solid organ transplantation.
- Ewing sarcoma：Prior treatment with XXX-targeted therapy (in Phase Ia clinical study only) Other olid tumors：Prior treatment with XXX-targeted therapy or topoisomerase inhibitors (in Phase Ia clinical study only).
- Presence of meningeal or brain metastases.
Show all 24Show fewer
- Evidence of cardiovascular risk, including any of the following:
- QTcF interval ≥ 470 msec (QT interval must be corrected for heart rate using the Fridericia formula [QTcF]).
- Evidence of current clinically significant untreated arrhythmias, including clinically significant ECG abnormalities including second-degree (Mobitz Type II) or third-degree atrioventricular (AV) block.
- Within 6 months before screening, history of myocardial infarct, acute coronary syndrome (including unstable angina pectoris), coronary angioplasty or stent implantation, or bypass grafting.
- Class III or IV heart failure - as defined by the New York Heart Association Functional Classification.
- Uncontrolled severe hypertension: systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥ 100 mmHg.
- Have dyspnea or any current condition that needs continuous oxygen therapy, or current active pneumonia or interstitial lung diseases (except mild cases as judged by the investigator).
- History of other primary malignancies, except for the following: malignancies that have been cured and have a very low risk of recurrence within 5 years, such as basal cell carcinoma and squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast.
- Have severe unhealed wound, ulceration or bone fracture, or have received major surgery within 28 days prior to administration or expected major surgery during the clinical study.
- Prior history of allergy to any component or excipient of DXC008.
- Active hepatitis B with HBV-DNA greater than central upper limit of normal or greater than 1000 copies/mL, active hepatitis C (Hepatitis C virus antibody positive with HCV RNA greater than lower limit of detection value).
- Known to be seropositive for the HIV; have active syphilis (only patients with a positive syphilis antibody are eligible for enrollment in the study), possible presence of active tuberculosis (chest imaging within 3 months prior to the first dose indicates active tuberculosis infection).
- Patients with active bleeding within 30 days before screening, or, judged by the investigator, to be at risk of massive digestive tract hemorrhage, hemoptysis, etc.; or with hereditary bleeding tendency or coagulation disorder, or bleeding symptoms requiring other medical intervention.
- Have experienced serious arterial/venous thrombosis events within 6 months prior to the first dose, such as cerebrovascular accident (including transient cerebral ischemic attack), deep venous thrombosis, pulmonary embolism.
- Female subjects with positive serum pregnancy test or who are breastfeeding.
- Those with active infection requiring drug intervention (CTCAE ≥ Grade 2) within 2 weeks prior to the first dose of study treatment, uncontrollable pleural effusion, ascites, pericardial effusion requiring repeated drainage.
- Have received vaccination with live attenuated vaccine within 28 days prior to the first dose or planned to receive such vaccination during the study period.
- Patients with other conditions judged by the investigator that may have adverse effect on the patient's participation in the 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, 4 recruiting
- Recruiting
Peking University First Hospital
Beijing, 100034
Zhisong He, Doctor, +86-010-83572600, wyj7074@sohu.com
Yu Fan, Doctor, +86-010-83572600, dantefanbmu@126.com
- Recruiting
Peking University People's Hospital
Beijing, 100044
Lu Xie, Doctor, +86-010-86491443, xielu@pkuph.edu.cn
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410000
Yongchang Zhang, Doctor, +086-0731-88651900, zhangyongchang@hnca.org.cn
- Recruiting
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310014
Qi Zhang, Doctor, +86-0571-85894399, zjsgcp@126.com
About this study
Official title: A Phase I, Open-Label, Multicenter, First-in-Human, Dose Escalation and Expansion Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profiles and Preliminary Efficacy of DXC008 in Patients With Prostate Cancer and Other Solid Tumors (Such as Ewing Sarcoma)
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 DXC008 in patients with prostate cancer and other solid tumors such as Ewing sarcoma.
- Conditions
- Prostate Cancer, Other Solid Tumors, Ewing Sarcoma
- Being tested
- DXC008
- Medical subject headings
- Prostatic Neoplasms, Sarcoma, Ewing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DXC008Drug
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 |
|---|---|---|
| DXC008 | Experimental | Not described Receives: Drug: DXC008 |
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 (5)
Maximum observed serum or plasma concentration (Cmax).
One of the pharmacokinetics parameters for DXC008 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 DXC008.
Measured: Through study completion an average of 1 year.
Apparent volume of distribution(Vd).
One of the pharmacokinetics parameters for DXC008.
Measured: Through study completion an average of 1 year.
Measurement of objective response rate (ORR) per RECIST 1.1.
Percentage of subjects achieving complete response (CR) or partial response (PR).
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 1 year.
ORR per Prostate Cancer Working Group 3 (PCWG3).
Percentage of subjects achieving complete response (CR) or partial response (PR).
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 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2025
- Study start15 May 2025
- Primary completionApr 2030 (estimated)
- Study completionApr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate 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
- 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
- NCT06926283
- Sponsor's protocol ID
- DXC008-001
- Status last verified
- Sep 2026
- First submitted
- 7 Apr 2025
- Last updated
- 23 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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
- A Phase I, Open-Label, Multicenter, First-in-Human, Dose Escalation and Expansion Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profiles and Preliminary Efficacy of DXC008 in Patients With Prostate Cancer and Other Solid Tumors (Such as Ewing Sarcoma)
- ClinicalTrials.gov ID
- NCT06926283
- Acronym / sponsor ID
- DXC008-001
- Conditions
- Prostate Cancer, Other Solid Tumors, Ewing Sarcoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Hangzhou DAC Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 May 2025 (actual)
- Primary completion
- Apr 2030 (estimated)
- Study completion
- Apr 2030 (estimated)
- First posted
- 13 Apr 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 DXC008 in patients with prostate cancer and other solid tumors such as Ewing sarcoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DXC008 | Experimental | Drug: DXC008 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Those who voluntarily sign the ICF and follow the protocol requirements.
- Male or female.
- Age: ≥ 18 years and ≤ 75 years.
- Expected life expectancy ≥ 6 months.
- ECOG performance status score: 0-2.
Key exclusion criteria (24 listed)
- Within 14 days prior to the first dose: Have undergone plasmapheresis, treated with prednisone at > 10 mg/day for > 3 consecutive days or equivalent dose of systemic corticosteroids or equivalent anti-inflammatory medication (Those who have received short-term treatment with such medications for the prevention of contrast media allergy may be enrolled).
- Have received systemic antineoplastic therapy or investigational product treatment within 28 days or 5 half-lives (whichever is shorter) prior to the first dose, have received radiotherapy within 14 days prior to the first dose.
- Have received monoclonal antibody therapy for anti-tumor purposes within 30 days prior to the first dose.
- History of solid organ transplantation.
- Ewing sarcoma：Prior treatment with XXX-targeted therapy (in Phase Ia clinical study only) Other olid tumors：Prior treatment with XXX-targeted therapy or topoisomerase inhibitors (in Phase Ia clinical study only).
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 |
|---|---|---|
| DXC008Cohort 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 | DXC008 |
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.
5 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.
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 1 year.
ORR per Prostate Cancer Working Group 3 (PCWG3).
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 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.
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
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 DXC008 in people with Prostate Cancer and Other 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 23 inclusion and 24 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 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, Doctor (+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.