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Protocol # 22-540

Status

Recruiting

Description

This is an open-label, First-in-Human, Phase 1/2, multicenter study to evaluate the safety and efficacy of a single dose of AVB-001. AVB-001 is an encapsulated cell product engineered to produce native human interleukin-2 (hIL-2). It is delivered intraperitoneally (IP) to patients with high grade serous adenocarcinoma of the ovary, primary peritoneum, or fallopian tube.

Condition

  • Neoplasm, Ovarian
  • Fallopian Tube Cancer
  • Primary Peritoneal Cavity Cancer
  • Adenocarcinoma Ovary
  • Serous Adenocarcinoma of Ovary
  • Serous Adenocarcinoma of Primary Peritoneum
  • Primary Peritoneal Carcinoma
  • High Grade Serous Adenocarcinoma

Interventions

  • AVB-001 (Dose Escalation Phase)
  • AVB-001 (Dose Expansion Phase)

Phase

Phase 1/Phase 2

Study Type

Interventional

Further Study Details

Primary Outcome:

  • Incidence of dose limiting toxicities (DLTs) of IP administered AVB-001 to determine the MTD and RP2D in the Dose Escalation Phase (Part 1)
  • Incidence of treatment-emergent adverse events (AEs) and serious AEs (SAEs) of IP administered AVB-001 in the Dose Escalation Phase (Part 1)
  • Investigator-assessed objective response rate (ORR) per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 of IP administered AVB-001 in the Dose Expansion Phase (Part 2)

Secondary Outcome:

  • Investigator-assessed ORR per RECIST v1.1 of IP administered AVB-001 in the Dose Escalation Phase (Part 1)
  • Investigator-assessed ORR per the modified RECIST guideline for immunotherapy (iRECIST) of IP administered AVB-001 in the Dose Escalation Phase (Part 1)
  • Duration of response (DOR) in the Dose Escalation Phase (Part 1)
  • Progression Free Survival (PFS) in the Dose Escalation Phase (Part 1)
  • Overall survival (OS) in the Dose Escalation Phase (Part 1)
  • Concentrations of hIL-2 in blood and ascites/IP fluid during the Dose Escalation Phase (Part 1)
  • Incidence of treatment-emergent AEs and SAEs of IP administered AVB-001 in the Dose Expansion Phase (Part 2)
  • Investigator-assessed ORR per iRECIST of IP administered AVB-001 in the Dose Expansion Phase (Part 2)
  • DOR in the Dose Expansion Phase (Part 2)
  • PFS in the Dose Expansion Phase (Part 2)
  • OS in the Dose Expansion Phase (Part 2)
  • Concentrations of hIL-2 in blood and ascites/IP fluid during the Dose Expansion Phase (Part 2)

Enrollment

44

Study Start Date

December 9, 2022

Eligibility

  • Gender:     All
  • Minimum age:     18 Years
  • Maximum age:     N/A
  • Healthy volunteers:     No

Sponsors

Avenge Bio, Inc

Source

Avenge Bio, Inc

Official title

A Phase 1/2 Open-Label, Multicenter, Dose Escalation and Expansion Study of AVB-001, an Intraperitoneally Administered, Cell-Generated, Human IL-2 Immunotherapy in Patients With Platinum-Resistant, High-Grade, Serous Adenocarcinoma of the Ovary, Primary Peritoneum, or Fallopian Tube

Clinicaltrials.gov Identifier

NCT05538624

     

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.