MedTrace Logo

ALG.APV-527 First-in-human Study

NCT05934539 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2023-07-07

No results posted yet for this study

Summary

A first-in-human, multicenter, open-label, dose escalation and dose expansion phase 1 study in patients with advanced solid tumors to evaluate the safety of intravenously administered ALG.APV-527 (Short title: ALG.APV-527 first-in-human study). Adult patients with advanced/metastatic solid tumors likely to express 5T4 antigen who have failed standard of care regimens for their cancer, have become refractory to standard treatment, or for whom no effective therapy exists based on investigator judgment may be enrolled in this study.

Part 1 (Dose Escalation): Approximately 36 evaluable patients planned to be enrolled.

Part 2 (Dose Expansion): Approximately 20 evaluable patients planned to be enrolled.

Conditions

Interventions

DRUG

ALG.APV-527

ALG.APV-527 is a human bispecific antibody in the ADAPTIR™ format with a silenced immunoglobulin 1 (IgG1) Fc domain targeting the co-stimulatory receptor 4-1BB, expressed on immune cells such as CD8+ T cells and natural killer (NK) cells, and the tumor associated antigen 5T4. ALG.APV-527 is being co-developed by Alligator Bioscience AB (Lund, Sweden) and Aptevo Therapeutics Inc. (Seattle, WA, USA) as a cancer immunotherapy.

Sponsors & Collaborators

  • Alligator Bioscience AB

    collaborator INDUSTRY

  • Aptevo Therapeutics

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-23
Primary Completion
2024-01-01
Completion
2025-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05934539 on ClinicalTrials.gov