Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Dose Escalation DXC006, Cohort Expansion DXC006 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DXC006 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants that experienced dose limiting toxicities(DLTs) at given dose level. | Dose Limiting Toxicities (DLTs) In Order to Determine the Maximum Tolerated. | 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. | After first infusion of study drug, Through study completion an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed serum or plasma concentration (Cmax) | One of the pharmacokinetics parameters for DXC006investigator shall assess the relationship between the events and investigational product. | Through study completion an average of 1 year |
| Maximum serum drug time(Tmax) |
Not provided
Inclusion Criteria:
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.
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:
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:
(1) Patients with multiple myeloma: absolute neutrophil count (ANC) ≥ 1.0Ă—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 ≥ 50Ă—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).
(2) Other patients: Absolute neutrophil count (ANC) ≥ 1.5Ă—109/L, Platelet count ≥ 100Ă—109/L, Hemoglobin (HGB) ≥ 90 g/L Liver: total bilirubin (TBIL) ≤ 1.5Ă—ULN, except for subjects with congenital bilirubinemia, such as Gilbert's syndrome (direct bilirubin ≤ 1.5Ă—ULN); Glutamate aminotransferase (AST) and alanine aminotransferase (ALT) both ≤ 3.0Ă—ULN.
In the presence of liver metastases, both AST and ALT ≤ 5Ă— ULN Kidney: creatinine clearance (Ccr) ≥ 30mL/min in patients with multiple myeloma, Creatinine ≤ 1.5Ă—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.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pengyu Shi, Doctor | Contact | +86-0571-56050590 | Shipengyu@dacbiotech.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Cancer Hospital | Recruiting | Hefei | Anhui | 230031 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Oct 30, 2023 | Jan 15, 2024 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
Dose 1:Drug(DXC006), Dose 2:Drug(DXC006), Dose 3:Drug(DXC006), Dose 4:Drug(DXC006), Dose 5:Drug(DXC006), Dose 6:Drug(DXC006).
Not provided
Not provided
Not provided
Not provided
|
One of the pharmacokinetics parameters for DXC006. |
| Through study completion an average of 1 year |
| Apparent volume of distribution(Vd) | One of the pharmacokinetics parameters for DXC006. | Through study completion an average of 1 year |
| Volume of distribution at steady state (Vss) | One of the pharmacokinetics parameters for DXC006. | Through study completion an average of 1 year |
| Terminal phase elimination half life (t½) | One of the pharmacokinetics parameters for DXC006. | 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. | 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. | Through study completion an average of 1 year |
| Clearance (CL) | One of the pharmacokinetics parameters for DXC006. | Through study completion an average of 1 year |
| Anti-drug antibodies (ADA) | The titer,neutralizing activity and positive rate of anti-drug antibody (ADA). | 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). | 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. | 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. | 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. | 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 |
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
|
| Hunan Cancer Hospital | Recruiting | Changsha | Hunan | 410013 | China |
|
| The First Affiliated Hospital of Nanchang University | Recruiting | Nanchang | Jiangxi | 330006 | China |
|
| Zhejiang Cancer Hospital | Recruiting | Hangzhou | Zhejiang | 310022 | China |
|