Advanced Solid TumorsPhase 1NCT06224855
A Study of DXC006 in Patients With Advanced Solid Tumors and Hematologic Malignancies
A Phase 1 study testing DXC006 in people with Advanced Solid Tumors and Hematological Malignancies, 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 DXC006 in patients with a variety of solid tumors, including small cell lung cancer, multiple myeloma, and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors, Hematological Malignancies
- What is being tested?
- DXC006
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 5 sitesChina
- Study dates
- 24 Jan 2024to 31 Dec 2027
- 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
- The patient voluntarily signed the informed consent form and followed the protocol requirements.
- Gender is not limited.
- Age ≥ 18 years old.
- Expected survival time ≥ 3 months.
- The Eastern Cooperative Oncology Group (ECOG) score 0-2.
- Subjects may provide biopsy or archival tumor tissue samples for the central laboratory to confirm expression levels of Target protein.
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- Patients with solid tumors or hematologic tumors who have failed standard therapy, including small cell lung cancer, multiple myeloma, neuroblastoma, etc..
- Patients who have received ASCT treatment must meet the following conditions:
- ASCT > 100 days from start of study treatment.
- no active infection.
- Toxicity from prior antineoplastic therapy has recovered to Grade ≤ 1 (except alopecia) as defined by NCI-CTCAE v5.0, including peripheral neuropathy ≤ Grade 2.
- Organ function must meet the following requirements: blood routine:
- Patients with multiple myeloma: absolute neutrophil count (ANC) ≥ 1.0×109/L (previous use of granulocyte colony-stimulating factor [G-CSF] is allowed, and G-CSF is not allowed within 7 days before laboratory examination during the screening period);Platelet count ≥ 50×109/L (platelet transfusion is not allowed within 7 days before laboratory tests during the screening period).
- Hemoglobin (HGB) ≥ 75 g/L (prior red blood cell [RBC] transfusions or recombinant human erythropoietin are allowed; Within 7 days before the laboratory examination during the screening period, red blood cell transfusion is not allowed).
- Other patients: Absolute neutrophil count (ANC) ≥ 1.5×109/L, Platelet count ≥ 100×109/L, Hemoglobin (HGB) ≥ 90 g/L Liver: total bilirubin (TBIL) ≤ 1.5×ULN, except for subjects with congenital bilirubinemia, such as Gilbert's syndrome (direct bilirubin ≤ 1.5×ULN); Glutamate aminotransferase (AST) and alanine aminotransferase (ALT) both ≤ 3.0×ULN.
- In the presence of liver metastases, both AST and ALT ≤ 5× ULN Kidney: creatinine clearance (Ccr) ≥ 30mL/min in patients with multiple myeloma, Creatinine ≤ 1.5×ULN in other patients.
- Coagulation:
- International Normalized Ratio (INR) ≤ 1.5, Activated partial thromboplastin time (APTT) or prothrombin time (PT) ≤ 1.5× ULN.
- corrected serum calcium ≤ 14 mg/dL (≤ 3.5 mmol/L). left ventricular ejection fraction (LVEF) ≥ 50%. 11. The patient and his/her spouse agree to take effective contraceptive measures (excluding contraception during the safe period) from the time of signing the informed consent form to 6 months after the last dose.
Who cannot join
- Within 14 days before the first dose: received plasmapheresis; Treatment with > 10 mg of prednisone or equivalent doses of systemic corticosteroids per day for more than 3 consecutive days (short-term use for the prevention of contrast allergy can be enrolled).
- Patients have received systemic anti-myeloma therapy or investigational drug therapy within 28 days or 5 half-lives (whichever is shorter) prior to the first dose; Radiotherapy within 14 days prior to the first dose.
- Patients have received monoclonal antibody therapy within 30 days before the first dose.
- Patients have received autologous hematopoietic stem cell transplantation within 100 days before the first dose.
- Patients who have undergone allogeneic hematopoietic stem cell transplantation (HSCT) or have a history of solid organ transplantation.
- Patients have received the same targeted therapy in the past (limited to phase Ia clinical trials).
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- Patient has symptomatic brain metastases or meningeal metastases.
- The patient had symptomatic amyloidosis, active plasma cell leukemia, and active POEMS syndrome at the time of screening.
- There is evidence of cardiovascular risk, including any of the following: a. QTcF interval ≥ 470 ms (QT interval must be corrected by Fridericia formula [QTcF]). b. Evidence of currently clinically significant, untreated arrhythmias, including clinically significant electrocardiogram abnormalities such as degree 2 (Mobitz type II) or degree 3 atrioventricular conduction (AV) block. c. History of myocardial infarction, acute coronary syndrome (including unstable angina pectoris), coronary angioplasty, or stenting or bypass grafting within 6 months prior to screening. d. Grade III or IV heart failure(New York Heart Association Functional Grading System). e. Uncontrolled severe hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥ 100 mmHg).
- The patient has difficulty breathing or currently requires continuous oxygen therapy, or currently has active pneumonia or interstitial lung disease (except for mild cases as determined by the investigator).
- The patient has a history of other primary malignancies, except the following: cured malignancies with a very low risk of recurrence within 5 years, such as skin basal cell carcinoma and skin squamous cell carcinoma, carcinoma in situ of the cervix or breast.
- Patients have severe unhealed wound ulcers or fractures, or have undergone major surgery within 28 days prior to dosing or are expected to undergo surgery during the clinical study.
- Previous history of allergy to any component or excipient of DXC006.
- Active hepatitis B (HBV-DNA greater than the central upper limit of normal or HBV-DNA testing greater than 1000 copies /mL); Hepatitis C infection (positive for hepatitis C antigen or positive for hepatitis C RNA PCR).
- Seropositive for human immunodeficiency virus (HIV); Active syphilis (patients with positive syphilis antibodies can be included); Possible active tuberculosis (chest imaging within 3 months prior to first dosing indicating active tuberculosis infection).
- Patients had active bleeding within 30 days prior to screening, or were at risk of massive gastrointestinal bleeding or hemoptysis as determined by researchers; Or have inherited bleeding tendencies or coagulation disorders, or bleeding symptoms that require other medical intervention.
- Severe arteriovenous thrombotic events, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, and pulmonary embolism, occurred within 6 months before the first dose.
- Female patients with a positive serological pregnancy test or who are breastfeeding.
- Active infections requiring medical treatment (CTCAE≥2); Uncontrollable pleural fluid, ascites, pericardial effusion requiring repeated drainage;
- Received live attenuated vaccine within 28 days before the first dose.
- The patient has other conditions that the investigator or sponsor has determined may affect the 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
Hunan Cancer Hospital
Changsha, Hunan, 410013
Yongchang Zhang, Doctor, +86-073188651900, zhangyongchang@hnca.org.cn
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Zhang Li Zhang Li, Doctor, +86-020-87343565, zhangli@sysucc.org.cn
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Zhengbo Song, Doctor, +86-057188122222, zjccgcp_phase1@126.com
- Recruiting
Anhui Cancer Hospital
Hefei, Anhui, 230031
Yueying Pan, Doctor, +86-055165327666, yueyinpan1965@126.com
- Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Jianjun Tang, Doctor, +86-079188692748, tangjianjun204@163.com
About this study
Official title: An Open-label Dose Escalation and Cohort Expansion Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and and Efficacy of DXC006 in Patients With Advanced Solid Tumors and Hematologic Malignancies
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 DXC006 in patients with a variety of solid tumors, including small cell lung cancer, multiple myeloma, and neuroblastoma, and hematological malignancies.
Read the detailed description
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 DXC006 in patients with a variety of solid tumors, including small cell lung cancer, multiple myeloma, and neuroblastoma, and hematological. malignancies.
- Conditions
- Advanced Solid Tumors, Hematological Malignancies
- Being tested
- DXC006
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DXC006Drug
Also called Recombinant Humanized Antibody-drug conjugate
Dose escalation period: DXC006 is administered intravenously every two weeks (Q2W) at the dose corresponding to the enrolled dose cohort.
Dose expansion period: DXC006 is administered intravenously Q2W at the corresponding dose.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Dose Escalation DXC006, Cohort Expansion DXC006 Receives: Drug: DXC006 |
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 (13)
Maximum observed serum or plasma concentration (Cmax)
One of the pharmacokinetics parameters for DXC006investigator 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 DXC006.
Measured: Through study completion an average of 1 year
Apparent volume of distribution(Vd)
One of the pharmacokinetics parameters for DXC006.
Measured: Through study completion an average of 1 year
Volume of distribution at steady state (Vss)
One of the pharmacokinetics parameters for DXC006.
Measured: Through study completion an average of 1 year
Terminal phase elimination half life (t½)
One of the pharmacokinetics parameters for DXC006.
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)
One of the pharmacokinetics parameters for DXC006.
Measured: Through study completion an average of 1 year
Area under the serum or plasma concentration time curve from 0 to infinity (AUC0-inf)
One of the pharmacokinetics parameters for DXC006.
Measured: Through study completion an average of 1 year
Clearance (CL)
One of the pharmacokinetics parameters for DXC006.
Measured: Through study completion an average of 1 year
Anti-drug antibodies (ADA)
The titer,neutralizing activity and positive rate of anti-drug antibody (ADA).
Measured: Through study completion an average of 1 year
Objective Response Rate (ORR)
As determined by the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1, which will be complete response (CR) + 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
Duration of response (DOR)
DOR is defined as the time from the date of the first documentation of response (confirmed CR or confirmed PR) to the date of the first documentation of PD or death due to any cause, whichever occurs first.
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
Progression Free Survival (PFS)
PFS is defined as the time from the date of randomization to the earlier of the dates of the first documentation of progressive disease or death due to any cause.
Measured: om 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
Overall Survival (OS)
OS is defined as the time from the date of randomization to the date of death due to any cause.
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 posted25 Jan 2024
- Study start24 Jan 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (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
- Sequential
- Model description
- Dose 1:Drug(DXC006), Dose 2:Drug(DXC006), Dose 3:Drug(DXC006), Dose 4:Drug(DXC006), Dose 5:Drug(DXC006), Dose 6:Drug(DXC006).
- Masking
- None (open label)
- Enrolment
- 280 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
- NCT06224855
- Sponsor's protocol ID
- DXC006-001
- Status last verified
- Sep 2026
- First submitted
- 4 Jan 2024
- Last updated
- 25 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 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Dose Escalation and Cohort Expansion Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and and Efficacy of DXC006 in Patients With Advanced Solid Tumors and Hematologic Malignancies
- ClinicalTrials.gov ID
- NCT06224855
- Acronym / sponsor ID
- DXC006-001
- Conditions
- Advanced Solid Tumors, Hematological Malignancies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Hangzhou DAC Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Jan 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 25 Jan 2024 (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 DXC006 in patients with a variety of solid tumors, including small cell lung cancer, multiple myeloma, and neuroblastoma, and hematological malignancies.
Detailed description
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 DXC006 in patients with a variety of solid tumors, including small cell lung cancer, multiple myeloma, and neuroblastoma, and hematological. malignancies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Dose 1:Drug(DXC006), Dose 2:Drug(DXC006), Dose 3:Drug(DXC006), Dose 4:Drug(DXC006), Dose 5:Drug(DXC006), Dose 6:Drug(DXC006).
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: DXC006Dose Escalation DXC006, Cohort Expansion DXC006 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- The patient voluntarily signed the informed consent form and followed the protocol requirements.
- Gender is not limited.
- Age ≥ 18 years old.
- Expected survival time ≥ 3 months.
- The Eastern Cooperative Oncology Group (ECOG) score 0-2.
Key exclusion criteria (21 listed)
- Within 14 days before the first dose: received plasmapheresis; Treatment with > 10 mg of prednisone or equivalent doses of systemic corticosteroids per day for more than 3 consecutive days (short-term use for the prevention of contrast allergy can be enrolled).
- Patients have received systemic anti-myeloma therapy or investigational drug therapy within 28 days or 5 half-lives (whichever is shorter) prior to the first dose; Radiotherapy within 14 days prior to the first dose.
- Patients have received monoclonal antibody therapy within 30 days before the first dose.
- Patients have received autologous hematopoietic stem cell transplantation within 100 days before the first dose.
- Patients who have undergone allogeneic hematopoietic stem cell transplantation (HSCT) or have a history of solid organ transplantation.
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 |
|---|---|---|
| DXC006Also: Recombinant Humanized Antibody-drug conjugateDose escalation period: DXC006 is administered intravenously every two weeks (Q2W) at the dose corresponding to the enrolled dose cohort. Dose expansion period: DXC006 is administered intravenously Q2W at the corresponding dose. | 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.
13 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
Anti-drug antibodies (ADA)
Time frame: Through study completion an average of 1 year
Objective Response Rate (ORR)
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
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 1 year
Progression Free Survival (PFS)
Time frame: om 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
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 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 25 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 DXC006 in people with Advanced Solid Tumors and Hematological Malignancies, 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 19 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 25 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, 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 25 Sep 2026.