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NCT04616196 · ClinicalTrials.gov registry record · Phase 1

Study of NKTR 255 in Combination With Cetuximab in Solid Tumors

A Phase 1 study, sponsored by Nektar Therapeutics.

Completed
Registry status
Phase 1
Development phase
25
Enrollment target

NCT04616196: Completed Phase 1 study, sponsored by Nektar Therapeutics.

NCT04616196 is a Phase 1 study that has completed, run by Nektar Therapeutics. The registered enrollment target is 25 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04616196, a Phase 1 study, has completed, sponsored by Nektar Therapeutics.

COMPLETED
Registry status
Phase 1
Development phase
25 participants
Enrollment target

Study Summary

This is a Phase 1b/2, open-label multicenter study evaluating NKTR-255 as a monotherapy and together with cetuximab in patients with head and neck squamous cell carcinoma (HNSCC) and colorectal carcinoma (CRC).

Primary Outcome

Safety and tolerability of NKTR-255 in combination with cetuximab as evaluated by dose limiting toxicities, incidence of drug-related Adverse Events (AEs), SAEs, and AEs leading to discontinuation, deaths, and clinical laboratory abnormalities per CTCAE 5.0

Interventions

  • DRUG Cetuximab
  • DRUG NKTR-255

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2020-10-30
Est. Completion 2023-03-30
Phase Phase 1
Nektar Therapeutics

37 total trials

What the finished NCT04616196 record still lists

NCT04616196 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower).

The record links to 0 conditions, and to 2 interventions - of which Cetuximab is the first listed.

NCT04616196 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04616196 about?

NCT04616196 is a clinical study titled "Study of NKTR 255 in Combination With Cetuximab in Solid Tumors". This is a Phase 1b/2, open-label multicenter study evaluating NKTR-255 as a monotherapy and together with cetuximab in patients with head and neck squamous cell carcinoma (HNSCC) and colorectal carcinoma (CRC).

What is the current status of trial NCT04616196?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2020-10-30. Estimated completion is 2023-03-30.

What interventions are being tested in trial NCT04616196?

The interventions under investigation include: Cetuximab (DRUG), NKTR-255 (DRUG).

Who is sponsoring clinical trial NCT04616196?

This trial is sponsored by Nektar Therapeutics, which has 37 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04616196's enrollment target sits among peer trials

25 1495th of 2000 higher than 481 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 NCT04616196, the US trial registry maintained by the National Library of Medicine. NCT04616196 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.