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ATG-031 study (alias: PERFORM) is a multicenter, open-label, Phase 1 study of ATG-031 in patients with advanced solid tumors or B-NHL. The study design includes a Dose Escalation Phase and a Dose Expansion Phase, and will enroll patients with advanced solid tumors (i.e., preferred tumor types) or relapsed/refractory (R/R) B-NHLs. The study's primary objective is to evaluate the safety and tolerability of ATG-031 and determine the RP2D(Refered Phase II dose) of ATG-031.
This is a multicenter, open-label, Phase 1 study of ATG-031 in patients with advanced solid tumors or B-NHL. The study design includes a Dose Escalation Phase and a Dose Expansion Phase. Dose Escalation Phase: approximately 30-48 patients . Dose Expansion Phase: the number of patients enrolled will depend on the number of disease cohorts to be expanded and data observed in the Dose Escalation Phase.The Dose Escalation Phase will enroll patients with advanced solid tumors. Based on data from dose escalation (e.g., adverse events [AEs], dose-limiting toxicity [DLT], efficacy data, pharmacodynamic [PDx] data, or pharmacokinetic [PK] data), the Dose Expansion Phase will enroll patients with selected advanced solid tumors or B-NHL.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ATG-031 dose level 1 | Active Comparator | Patients with advanced solid tumors or B-cell non-Hodgkin lymphomas will be enrolled in the Dose-Escalation Phase. Dose level is 0.03 mg/kg |
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| ATG-031 dose level 2 | Active Comparator | Patients with advanced solid tumors or B-cell non-Hodgkin lymphomas will be enrolled in the Dose-Escalation Phase. Dose level is 0.1 mg/kg |
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| ATG-031 dose level 3 | Active Comparator | Patients with advanced solid tumors or B-cell non-Hodgkin lymphomas will be enrolled in the Dose-Escalation Phase. Dose level is 0.3 mg/kg |
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| ATG-031 dose level 4 | Active Comparator | Patients with advanced solid tumors or B-cell non-Hodgkin lymphomas will be enrolled in the Dose-Escalation Phase. Dose level is 1.0 mg/kg |
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| ATG-031 dose level 5 | Active Comparator | Patients with advanced solid tumors or B-cell non-Hodgkin lymphomas will be enrolled in the Dose-Escalation Phase. Dose level is 2.0 mg/kg |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ATG-031 | Drug | ATG-031 will be infused Q3W on Day 1 of each cycle, at the starting dose of 0.03 mg/kg and a maximum dose of 9 mg/kg in the Dose Escalation Phase, and the defined MTD if available or OBD in the Dose Expansion Phase. Based on the emerging PK, PDx, safety, and other relevant data, SRC may decide to explore alternative dosing schedules. |
| Measure | Description | Time Frame |
|---|---|---|
| AE | Evaluate the safety and tolerability of ATG-031 | 90 days after last dose of treatment |
| DLT | Evaluate the safety and tolerability of ATG-031 | at the end of cycle 2 ( each cycle is 21 days) |
| RP2D | RP2D will be determined based on safety, tolerability, PK, and preliminary efficacy data | at the end of dose escalation, about 1 year |
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Key Inclusion Criteria:
Histological or cytologically confirmed advanced solid tumor or B-NHL which have relapsed from or been refractory to all locally available standard therapies.
Adequate hepatic function:
Adequate renal function: calculated creatinine clearance of ≥ 40 mL/min using the Cockroft- Gault formula.
Adequate bone marrow function without growth factors or blood transfusion within 7 days of the first dose of study treatment.
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ashley Liu | Contact | 0431292256 | ting.liu@antengene.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco (UCSF) | Recruiting | San Francisco | California | 94102 | United States |
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Dose levels are 0.03 mg/kg、 0.1 mg/kg、0.3 mg/kg 、0.5mg/kg ,or other dose level less than 1.0mg/kg determined by SRC
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| ATG-031 dose level 6 | Active Comparator | Patients with advanced solid tumors or B-cell non-Hodgkin lymphomas will be enrolled in the Dose-Escalation Phase. Dose level is 4.0 mg/kg |
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| ATG-031 dose level 7 | Active Comparator | Patients with advanced solid tumors or B-cell non-Hodgkin lymphomas will be enrolled in the Dose-Escalation Phase. Dose level is 6.0 mg/kg |
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| ATG-031 dose level 8 | Active Comparator | Patients with advanced solid tumors or B-cell non-Hodgkin lymphomas will be enrolled in the Dose-Escalation Phase. Dose level is 9.0 mg/kg |
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| Regents of the University of Colorado | Recruiting | Aurora | Colorado | 80045 | United States |
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| Yale University | Recruiting | New Haven | Connecticut | 06520- 8087 | United States |
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| University of Texas M.D. Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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