Clinical trial NCT04986865: A Study ATG-101 in Patients With Metastatic/Advanced Solid Tumors and Mature B-cell Non-Hodgkin Lymphomas
Official title: A First-in-Human Phase I Trial of ATG-101 in Patients With Metastatic/Advanced Solid Tumors and Mature B-cell Non-Hodgkin Lymphomas
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Advanced Solid Tumor
Metastatic Solid Tumor
Mature B-cell Non-Hodgkin Lymphoma
Keywords: Solid tumor, lymphoma, bispecific, antibody
Lead sponsor: Antengene Corporation
Sponsor class: INDUSTRY
First posted: 2021-08-03
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a First-in-Human Phase I trial of ATG-101 in Patients with Metastatic/Advanced Solid Tumors and Mature B-cell Non-Hodgkin Lymphomas.

Detailed description: This is a First-in-Human Phase I trial of ATG-101 in Patients with Metastatic/Advanced Solid Tumors and Mature B-cell Non-Hodgkin Lymphomas. Dose Escalation Phase: Approximately 40-50 subjects with a maximum number of 62; Dose Expansion Phase: Estimated 100-400 subjects depending on the number of cohorts to be expanded.

Eligibility criteria: Inclusion Criteria:

1. Provision of signed and dated, written informed consent prior to any study-specific procedures, sampling, and analyses.
2. Aged at least 18 years as of the date of consent.
3. Histological or cytological confirmation of a solid tumor, and has progressed despite standard therapy, or is intolerant to standard therapy, or has a tumor for which no standard therapy exists or for which standard therapy is not considered adequate. Estimated life expectancy of a minimum of 12 weeks.
4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
5. Female and male subjects should be using adequate contraceptive measures as requested.

Exclusion Criteria:

1. Subjects with CNS tumors or known CNS metastases will be excluded.
2. Prior ATG-101 administration or a 4-1BB agonist.
3. Prior anti-tumor systemic therapy within 21 days(a period of 5 'half- lives') of the first dose of study treatment.
4. Radiotherapy with a wide field of radiation within 28 days.
5. With the exception of alopecia, any unresolved toxicities from prior therapy greater than Grade 1 (CTCAE v5.0) at the time of ICF signature.
6. Active infection, including hepatitis B and/or hepatitis C.
7. Have uncontrolled intercurrent illness, including but not limited to:
8. Inadequate bone marrow reserve or organ function.
9. History of hypersensitivity or history of allergic reactions attributed to drugs with a similar chemical or biologic structure or class to ATG-101.
10. Prior organ allograft transplantations.
11. Pregnant or nursing females.
12. Have a history of another primary malignancy within 3 years prior to starting study treatment. Exceptions are as follows: the disease under study; adequately treated basal or squamous cell carcinoma of the skin; cancer of the cervix in situ, etc.
13. In the opinion of the investigator, subject's complications or other conditions may affect protocol compliance or may be unsuitable for participation in the study.

Primary outcomes:
measure: AEs
timeFrame: One year after last patient first dose
measure: SAEs
timeFrame: One year after last patient first dose
measure: DLT (for Dose Escalation Phase only)
timeFrame: One year after last patient first dose
Secondary outcomes:
measure: ORR
timeFrame: One year after last patient first dose
measure: DOR
timeFrame: One year after last patient first dose
measure: DCR
timeFrame: One year after last patient first dose
measure: PFS
timeFrame: One year after last patient first dose
measure: OS
timeFrame: One year after last patient first dose
measure: The incidence of ADA and NAb
timeFrame: One year after last patient first dose
measure: Serum concentrations of ATG-101 and derived PK parameters (for Dose Escalation Phase only)
timeFrame: One year after last patient first dose
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Saint Louis
country: United States
facility: Washington University School of Medicine in St. Louis
state: Missouri
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Randwick
country: Australia
facility: Scientia Clinical Research Ltd
state: New South Wales
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: East Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre (PMCC) - Victorian Comprehensive Cancer Centre Location (Peter MacCallum Cancer Centre - East Melbourne)
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Health - Olivia Newton-John Cancer Centre
state: Victoria
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
Study officials:
References: