Search Cancer Clinical Trials
Recruiting
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.
- 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
- AVB-001 (Dose Escalation Phase)
- AVB-001 (Dose Expansion Phase)
Phase 1/Phase 2
Interventional
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)
44
December 9, 2022
- Gender: All
- Minimum age: 18 Years
- Maximum age: N/A
- Healthy volunteers: No
Avenge Bio, Inc
Avenge Bio, Inc
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
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.