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Part 1 escalating ABV-001 between 0.6 and 3.6 ug hIL-2/kg/day; and Part 2 ABV-001 at the MTD/RP2D for High Grade Serous Carcinoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
High Grade Serous Carcinoma+7 MoreABV-001 (Dose Expansion Phase) - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

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.

Eligible Conditions
  • High Grade Serous Carcinoma
  • Primary Peritoneal Cancer
  • Primary Peritoneal Carcinoma
  • Ovarian Adenocarcinoma
  • Ovarian Cancer
  • Peritoneal Cancer
  • Ovarian Neoplasm

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

5 Primary · 12 Secondary · Reporting Duration: 1 year (Part 1); 1 year (Part 2)

1 year
Concentrations of hIL-2 in blood and ascites/IP fluid during the Dose Escalation Phase (Part 1)
Concentrations of hIL-2 in blood and ascites/IP fluid during the Dose Expansion Phase (Part 2)
DOR in the Dose Expansion Phase (Part 2)
Duration of response (DOR) in the Dose Escalation Phase (Part 1)
Therapeutic procedure
Therapeutic procedure
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 ORR per RECIST v1.1 of IP administered AVB-001 in the Dose Escalation Phase (Part 1)
Investigator-assessed ORR per iRECIST of IP administered AVB-001 in the Dose Expansion Phase (Part 2)
Investigator-assessed ORR per the modified RECIST guideline for immunotherapy (iRECIST) 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)
OS in the Dose Expansion Phase (Part 2)
Overall survival (OS) in the Dose Escalation Phase (Part 1)
PFS in the Dose Expansion Phase (Part 2)
Progression Free Survival (PFS) in the Dose Escalation Phase (Part 1)
Year 1
Analysis of anti-drug antibodies (ADA) to AVB-001 in human serum in the Dose Escalation and Dose Expansion Phases (Parts 1 and 2)
Immunologic changes in peripheral blood and IP environments in the Dose Escalation and Dose Expansion Phases (Parts 1 and 2)
4 weeks
Incidence of dose limiting toxicities (DLTs) of IP administered ABV-001 to determine the MTD and RP2D in the Dose Escalation Phase (Part 1)
Incidence of dose limiting toxicities (DLTs) of IP administered AVB-001 to determine the MTD and RP2D in the Dose Escalation Phase (Part 1)

Trial Safety

Safety Progress

1 of 3

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Adavosertib
1
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Trial Design

2 Treatment Groups

Part 1 escalating ABV-001 between 0.6 and 3.6 ug hIL-2/kg/day; and Part 2 ABV-00...
1 of 2
Part 1 escalating AVB-001 between 0.6 and 3.6 ug hIL-2/kg/day; and Part 2 AVB-00...
1 of 2

Experimental Treatment

44 Total Participants · 2 Treatment Groups

Primary Treatment: Part 1 escalating ABV-001 between 0.6 and 3.6 ug hIL-2/kg/day; and Part 2 ABV-001 at the MTD/RP2D · No Placebo Group · Phase 1 & 2

Part 1 escalating ABV-001 between 0.6 and 3.6 ug hIL-2/kg/day; and Part 2 ABV-001 at the MTD/RP2DExperimental Group · 2 Interventions: ABV-001 (Dose Expansion Phase), ABV-001 (Dose Escalation Phase) · Intervention Types: Drug, Drug
Part 1 escalating AVB-001 between 0.6 and 3.6 ug hIL-2/kg/day; and Part 2 AVB-001 at the MTD/RP2DExperimental Group · 2 Interventions: AVB-001 (Dose Escalation Phase), AVB-001 (Dose Expansion Phase) · Intervention Types: Drug, Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year (part 1); 1 year (part 2)

Who is running the clinical trial?

Avenge Bio, IncLead Sponsor
Claudio Dansky Ullmann, MDStudy DirectorAvenge Bio, Inc
1 Previous Clinical Trials
14 Total Patients Enrolled
Claudio Dansky Ullman, MDStudy DirectorAvenge Bio, Inc

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Have an Eastern Cooperative Oncology Group performance status 0 to 1 at Screening.
You have a hemoglobin level of at least 9.0 g/dL (transfusion allowed).
References

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