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 Ib/II, open-label clinical study designed to evaluate the safety, tolerability, preliminary anti-tumor activity, recommended Phase 2 dose (RP2D), pharmacokinetic (PK) characteristics, and immunogenicity of DXC006 in combination with an immune checkpoint inhibitor (ICI) or platinum-based chemotherapy in patients with small cell lung cancer (SCLC).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DXC006 + ICI | Experimental |
| |
| DXC006 + Platinum(Carboplatin ) | Experimental |
| |
| DXC006 + Platinum(Cisplatin ) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DXC006 | Drug | Participants receive DXC006 intravenously on Day 1 every 3 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | 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 year. | |
| 6-month progression-free survival rate | From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months. | |
| Recommended Phase 2 Dose (RP2D) | Final RP2D confirmation upon completion of the Phase Ib (up to 12 months). | |
| Measurement of objective response rate (ORR) per RECIST 1.1 | 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 year. | |
| Measurement of disease control rate (DCR) | 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 year. | |
| Incidence of Adverse Events (AEs) | After first infusion of study drug, through study completion an average of 2 year. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed serum or plasma concentration (Cmax) | Through study completion an average of 1 year. | |
| Maximum serum drug time(Tmax) | Through study completion an average of 1 year. | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li Zhang, Doctoral degree | Contact | +86-020-87343565 | zhangli@sysucc.org.cn |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | 510060 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000656314 | toripalimab |
| D016190 | Carboplatin |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Toripalimab | Drug | Participants receive Toripalimab intravenously on Day 1 every 3 weeks. |
|
| Carboplatin | Drug | Participants receive Carboplatin intravenously on Day 1 every 3 weeks (up to 6 cycles). |
|
| Cisplatin | Drug | Participants receive Cisplatin intravenously on Day 1 every 3 weeks (up to 6 cycles). |
|
| Apparent volume of distribution(Vd) |
| Through study completion an average of 1 year. |
| Volume of distribution at steady state (Vss) | Through study completion an average of 1 year. |
| Terminal phase elimination half life (t½) | 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). | Through study completion an average of 1 year. |
| Area under the serum or plasma concentration time curve from 0 to infinity (AUC0-inf) | Through study completion an average of 1 year. |
| Clearance (CL) | Through study completion an average of 1 year. |
| Ctrough | Through study completion an average of 1 year. |
| Anti-drug antibodies (ADA) | Through study completion an average of 1 year. |
| Overall Survival (OS) | 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 year. |
| Duration of response (DOR) | 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 year. |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D017672 |
| Nitrogen Compounds |
| D017671 | Platinum Compounds |