A Study of ATG-031 in Advanced Solid Tumors or B-cell Non-Hodgkin Lymphomas
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAntengene Biologics Limited
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histological or cytologically confirmed advanced solid tumor or B-NHL which have relapsed from or been refractory to all locally available standard therapies.
AST and ALT ≤ 2.5×times ULN (≤ 5 × ULN if liver metastases).
Total bilirubin ≤ 1.5×ULN (except Gilbert syndrome).
Lipase and amylase ≤ 2×ULN.
Disqualifiers
Patients with CNS malignancies, except those who are clinically stable for ≥ 4 weeks and off corticosteroids following prior surgery, whole-brain radiation, or stereotactic radiosurgery.
Received any other investigational product or prior systemic anticancer therapy including chemotherapy, immunotherapy, radiotherapy, or other anticancer within 21 days prior to first dose of study
Grade ≥3 irAEs or irAEs that lead to discontinuation of prior immunotherapy.8. Other primary malignancies developed within 5 years prior to the first dose of the study treatment
Other primary malignancies developed within 5 years prior to the first dose of the study treatment
Trial design
Design model
Sequential
Treatments tested in this trial
ATG-031
DrugATG-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.
Treatment groups
80 Participants
are divided into 8 treatment groups8
Treatment groupsSee each treatment group below.
Group A: ATG-031 dose level 1Active comparator 1 intervention
Group B: ATG-031 dose level 2Active comparator 1 intervention
Group C: ATG-031 dose level 3Active comparator 1 intervention
Group D: ATG-031 dose level 4Active comparator 1 intervention
Group E: ATG-031 dose level 5Active comparator 1 intervention
Group F: ATG-031 dose level 6Active comparator 1 intervention
Group G: ATG-031 dose level 7Active comparator 1 intervention
Group H: ATG-031 dose level 8Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
AE
Evaluate the safety and tolerability of ATG-031
Time frame
90 days after last dose of treatment2
DLT
Evaluate the safety and tolerability of ATG-031
Time frame
at the end of cycle 2 ( each cycle is 21 days)3
RP2D
RP2D will be determined based on safety, tolerability, PK, and preliminary efficacy data
Time frame
at the end of dose escalation, about 1 yearSponsors and contacts
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Source ClinicalTrials.gov