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NCT04475523 · ClinicalTrials.gov registry record · Phase 1

Phase 1 Study of CI-8993 Anti-VISTA Antibody in Patients With Advanced Solid Tumor Malignancies

A Phase 1 study, sponsored by Curis.

Completed
Registry status
Phase 1
Development phase
26
Enrollment target

NCT04475523: Completed Phase 1 study, sponsored by Curis.

NCT04475523 is a Phase 1 study that has completed, run by Curis. The registered enrollment target is 26 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04475523, a Phase 1 study, has completed, sponsored by Curis.

COMPLETED
Registry status
Phase 1
Development phase
26 participants
Enrollment target

Study Summary

This is a phase 1, open-label, multicenter dose-escalation study to determine the RP2D of CI 8993 for administration to patients with relapsed/refractory solid tumors by evaluating the safety and tolerability and characterizing the PK, PD, and anti cancer activity of CI-8993 in this population.

Primary Outcome

The highest dose at a schedule, at which the DLT rate during the first cycle of this study (28 days from the first full dose) is \< 33% in at least 6 patients.

Interventions

  • DRUG CI-8993

Trial Details

FieldValue
Enrollment Target 26 participants
Start Date 2020-09-22
Est. Completion 2023-05-19
Phase Phase 1
Curis

12 total trials

What the finished NCT04475523 record still lists

NCT04475523 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower).

The record links to 0 conditions, and to 1 intervention - of which CI-8993 is the first listed.

NCT04475523 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04475523 about?

NCT04475523 is a clinical study titled "Phase 1 Study of CI-8993 Anti-VISTA Antibody in Patients With Advanced Solid Tumor Malignancies". This is a phase 1, open-label, multicenter dose-escalation study to determine the RP2D of CI 8993 for administration to patients with relapsed/refractory solid tumors by evaluating the safety and tolerability and characterizing the PK, PD, and anti cancer activity of CI-8993 in this population.

What is the current status of trial NCT04475523?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2020-09-22. Estimated completion is 2023-05-19.

What interventions are being tested in trial NCT04475523?

The interventions under investigation include: CI-8993 (DRUG).

Who is sponsoring clinical trial NCT04475523?

This trial is sponsored by Curis, which has 12 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04475523's enrollment target sits among peer trials

26 1482nd of 2000 higher than 506 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04475523, the US trial registry maintained by the National Library of Medicine. NCT04475523 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.