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NCT03409458 · ClinicalTrials.gov registry record · Phase 1

A Dose Escalation and Confirmation Study of PT-112 in Advanced Solid Tumors in Combination With Avelumab

A Phase 1 study, sponsored by Promontory Therapeutics.

Completed
Registry status
Phase 1
Development phase
68
Enrollment target

NCT03409458: Completed Phase 1 study, sponsored by Promontory Therapeutics.

NCT03409458 is a Phase 1 study that has completed, run by Promontory Therapeutics. The registered enrollment target is 68 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03409458, a Phase 1 study, has completed, sponsored by Promontory Therapeutics.

COMPLETED
Registry status
Phase 1
Development phase
68 participants
Enrollment target

Study Summary

This is a Phase 1/2, open-label, multi-center, non-randomized, dose-escalation study of PT-112 in combination with the anti-PD-L1 antibody, avelumab, in selected advanced solid tumors. The study is to be conducted in two parts: the Dose Escalation Phase of PT-112 within the combination and the Dose Confirmation Phase in patients with non-small cell lung cancer who will be treated at the RP2D.

Interventions

  • DRUG PT-112
  • BIOLOGICAL avelumab

Trial Details

FieldValue
Enrollment Target 68 participants
Start Date 2018-04-24
Est. Completion 2022-08-31
Phase Phase 1
Promontory Therapeutics

3 total trials

What the finished NCT03409458 record still lists

NCT03409458 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% higher).

The record links to 0 conditions, and to 2 interventions - of which PT-112 is the first listed.

NCT03409458 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03409458 about?

NCT03409458 is a clinical study titled "A Dose Escalation and Confirmation Study of PT-112 in Advanced Solid Tumors in Combination With Avelumab". This is a Phase 1/2, open-label, multi-center, non-randomized, dose-escalation study of PT-112 in combination with the anti-PD-L1 antibody, avelumab, in selected advanced solid tumors. The study is to be conducted in two parts: the Dose Escalation Phase of PT-112 within the combination and the Dose...

What is the current status of trial NCT03409458?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 68 participants. The study started on 2018-04-24. Estimated completion is 2022-08-31.

What interventions are being tested in trial NCT03409458?

The interventions under investigation include: PT-112 (DRUG), avelumab (BIOLOGICAL).

Who is sponsoring clinical trial NCT03409458?

This trial is sponsored by Promontory Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03409458's enrollment target sits among peer trials

68 776th of 2000 higher than 1,219 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 NCT03409458, the US trial registry maintained by the National Library of Medicine. NCT03409458 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.