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The safety of ADG106 combined with triprilimab has been fully understood.The overall clinical benefit of enrolled subjects was limited and further development of ADG106 was reconsidered.
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This is a Multicenter, Open-Label, Phase Ib/II Study of ADG106 in Combination with PD-1 Antibody in Advanced Solid Tumors and Relapsed/Refractory Non-Hodgkin Lymphoma.
The primary objective of Phase Ib: To evaluate the maximum tolerated dosage (MTD) of ADG106 in combination with PD-1 antibody in advanced solid tumors and relapsed/refractory non-Hodgkin lymphoma, and to determine the recommended phase II clinical studies dosage (RP2D).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADG106 combined with PD-1 antibody Dose Escalation Level 1 | Experimental |
| |
| ADG106 combined with anti PD-1 antibody Dose Escalation Level 2 | Experimental |
| |
| ADG106 combined with anti PD-1 antibody Expansion Phase | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADG106 injection | Biological | ADG106 injection, intravenous infusion, is administered as body weight every 3 weeks for 21 days as a cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants experiencing dosage limiting toxicity (DLT) in the first treatment cycle of the combination of ADG106 and PD-1 antibody. | From first dose of ADG106 and PD-1 antibody (Week 1 Day 1) until 21 days | |
| Objective response rate (ORR) of the combination of ADG106 and PD-1 antibody in advanced solid tumors and relapsed/refractory non-hodgkin lymphoma | From baseline to measured progressive disease (up to 24 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Type of adverse event, incidence, grade (according to NCI CTCAE V 5.0 classification), onset time, and relationship to study treatment | From the first dose of ADG106 and PD-1 antibody (Week 1 Day 1) to 28 days post last dose | |
| Area under the time concentration curve(AUC) from time zero to infinity (AUC0-inf)) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-Sen University Cancer Center | Guangzhou | Guangdong | 510000 | China |
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| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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| PD-1 antibody injection | Biological | PD-1 antibody injection is administered as an intravenous infusion and at a dose of 240mg every 3 weeks for 21 days as a cycle |
|
| From the first dose of ADG106 and PD-1 antibody (Cycle 1 Day 1,each cycle is 21 days) until the last dose (up to 2 years) |
| Maximum (peak) plasma concentration (Cmax) | From the first dose of ADG106 and PD-1 antibody (Cycle 1 Day 1,each cycle is 21 days) until the last dose (up to 2 years) |
| Time to maximum(peak) plasma concentration Tmax | From the first dose of ADG106 and PD-1 antibody (Cycle 1 Day 1,each cycle is 21 days) until the last dose (up to 2 years) |
| Through plasma concentration(Cthrough) | From the first dose of ADG106 and PD-1 antibody (Cycle 1 Day 1,each cycle is 21 days) until the last dose (up to 2 years) |
| Anti-drug antibody levels of ADG106 and PD-1 antibody | From the first dose of ADG106 and PD-1 antibody (Cycle 1 Day 1,each cycle is 21 days) until the last dose (up to 2 years) |
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |