A Study of ATG-031 in Advanced Solid Tumors or B-cell Non-Hodgkin Lymphomas

Part of paid clinical trials in San Francisco, California.

Sponsor
Antengene Biologics Limited
Study ID
NCT06028373
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Solid Tumors
  • B-cell Non-Hodgkin Lymphomas

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Dec 8, 2023
Status verified
Jun 2025
Primary completion
Dec 31, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Active Comparator: ATG-031 dose level 1
    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
  • Active Comparator: ATG-031 dose level 2
    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
  • Active Comparator: ATG-031 dose level 3
    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
  • Active Comparator: ATG-031 dose level 4
    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
  • Active Comparator: ATG-031 dose level 5
    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
  • Active Comparator: ATG-031 dose level 6
    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
  • Active Comparator: ATG-031 dose level 7
    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
  • Active Comparator: ATG-031 dose level 8
    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

Primary Outcome Measure

AE [ Time Frame: 90 days after last dose of treatment ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
University of California San Francisco (UCSF)San FranciscoCalifornia94102
Bridget Keenan, PhD
Bridget Keenan, PhD (PRINCIPAL_INVESTIGATOR)
Regents of the University of ColoradoAuroraColorado80045
Alexis Leal, MD
Alexis Leal (PRINCIPAL_INVESTIGATOR)
Yale UniversityNew HavenConnecticut06520- 8087
Joseph Kim, MD
Joseph Kim, MD (PRINCIPAL_INVESTIGATOR)
University of Texas M.D. Anderson Cancer CenterHoustonTexas77030
Siqing Fu, MD
Siqing Fu (PRINCIPAL_INVESTIGATOR)

Find similar trials in San Francisco, CA

By research site
University of California San Francisco (UCSF)· San Francisco, CARegents of the University of Colorado· Aurora, COYale University· New Haven, CTUniversity of Texas M.D. Anderson Cancer Center· Houston, TX

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