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Safety, Tolerability, Immunogenicity and Pharmacokinetics of ONC-841

NCT06219499 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2024-04-03

No results posted yet for this study

Summary

The Phase 1 study is a randomized, double-blind, placebo-controlled, single ascending dose, multi-cohort study. The study will evaluate 5 dose levels of the investigational product, in 5 cohorts of 8 healthy volunteers per cohort. In each cohort, 6 volunteers will receive the investigational product and 2 volunteers will receive placebo.

Conditions

  • Advanced Solid Tumor

Interventions

DRUG

ONC-841

ONC-841 is a humanized monoclonal antibody.

OTHER

Placebo

Placebo

Sponsors & Collaborators

  • OncoC4, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-30
Primary Completion
2025-06-30
Completion
2026-06-30
FDA Drug
Yes

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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 NCT06219499 on ClinicalTrials.gov