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NCT04259450 · ClinicalTrials.gov registry record · Phase 1
Study to Assess AFM24 in Advanced Solid Cancers
A Phase 1 study, sponsored by Affimed.
- Terminated
- Registry status
- Phase 1
- Development phase
- 85
- Enrollment target
NCT04259450: Clinical Trial Phase 1 study, sponsored by Affimed.
NCT04259450 is a Phase 1 study that was terminated before completion, run by Affimed. The registered enrollment target is 85 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04259450, a Phase 1 study, was terminated before completion, sponsored by Affimed.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 85 participants
- Enrollment target
Study Summary
AFM24-101 is a first in human Phase 1/2a open-label, non-randomized, multi-center, multiple ascending dose escalation/expansion study evaluating AFM24 as monotherapy in patients with advanced solid malignancies whose disease has progressed after treatment with previous anticancer therapies. AFM24 is a tetravalent bispecific (anti-human EGFR x anti-human CD16A) innate immune cell engaging recombinant antibody being developed to target EGFR-expressing solid tumors and has been designed to specifically utilize the cytotoxic potential of the innate immune system, in particular natural killer cells and macrophages for the specific and efficient elimination of EGFR expressing cancer cells.
Primary Outcome
The number of patients with dose limiting toxicities (DLTs) in the first cycle, as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0. DLT is defined as an adverse event (AE) or abnormal laboratory value assessed as unrelated to underlying disease, disease progression, inter-current illness, or concomitant medications, that occurs ≤28 days following the first dose of AFM24 (Cycle 1).
Interventions
- DRUG 14 mg AFM24
- DRUG 40 mg AFM24
- DRUG 80 mg AFM24
- DRUG 160 mg AFM24
- DRUG 320 mg AFM24
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 85 participants |
| Start Date | 2020-04-07 |
| Est. Completion | 2024-06-24 |
| Phase | Phase 1 |
Why NCT04259450 stopped before completion
NCT04259450 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 85 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% higher).
The record links to 0 conditions, and to 5 interventions - of which 14 mg AFM24 is the first listed.
NCT04259450 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04259450 about?
NCT04259450 is a clinical study titled "Study to Assess AFM24 in Advanced Solid Cancers". AFM24-101 is a first in human Phase 1/2a open-label, non-randomized, multi-center, multiple ascending dose escalation/expansion study evaluating AFM24 as monotherapy in patients with advanced solid malignancies whose disease has progressed after treatment with previous anticancer therapies. AFM24 i...
What is the current status of trial NCT04259450?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 85 participants. The study started on 2020-04-07. Estimated completion is 2024-06-24.
What interventions are being tested in trial NCT04259450?
The interventions under investigation include: 14 mg AFM24 (DRUG), 40 mg AFM24 (DRUG), 80 mg AFM24 (DRUG), 160 mg AFM24 (DRUG), 320 mg AFM24 (DRUG).
Who is sponsoring clinical trial NCT04259450?
This trial is sponsored by Affimed, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04259450's enrollment target sits among peer trials
85 656th of 2000 higher than 1,342 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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