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NCT05571969 · ClinicalTrials.gov registry record · Phase 1
Study of PARPi 2X-121 as Monotherapy and in Combination With Dovitinib in Patients With Advanced Solid Tumors
A Phase 1 study, sponsored by Allarity Therapeutics.
- Terminated
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
NCT05571969: Clinical Trial Phase 1 study, sponsored by Allarity Therapeutics.
NCT05571969 is a Phase 1 study that was terminated before completion, run by Allarity Therapeutics. The registered enrollment target is 14 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05571969, a Phase 1 study, was terminated before completion, sponsored by Allarity Therapeutics.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
Study Summary
This is a Phase Ib, two-part, multi-center study. In Part 1, the study will evaluate the safety and tolerability, antitumor activity, pharmacokinetics, and determine the maximum tolerated dose (MTD) of 2X-121 monotherapy (at BID regimen) in patients with advanced solid tumors. In Part 2, the study will evaluate safety and tolerability, antitumor activity, pharmacokinetics and determine the MTD of dovitinib when given in combination with the MTD of 2X-121 determined in Part 1.
Primary Outcome
To determine the maximum tolerated dose (MTD) of 2X-121 monotherapy given twice daily (BID) in patients with advanced solid tumors. The MTD was defined as one dose level below the dose in which DLTs were observed in at least 33% of participants in a Cohort during the first 14 days of the treatment period, after addition of subjects following the first reported DLT in a Cohort (if applicable). Therefore, the table below presents number of subjects with DLTs in each Cohort during the first 14 days
Interventions
- DRUG 2X-121 600 mg
- DRUG 2X-121 800 mg
- DRUG 2X-121 1000 mg
- COMBINATION_PRODUCT 2X-121 + 300 mg dovitinib
- COMBINATION_PRODUCT 2X-121 + 400 mg dovitinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2023-03-08 |
| Est. Completion | 2024-10-07 |
| Phase | Phase 1 |
Why NCT05571969 stopped before completion
NCT05571969 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 5 interventions - of which 2X-121 600 mg is the first listed.
NCT05571969 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05571969 about?
NCT05571969 is a clinical study titled "Study of PARPi 2X-121 as Monotherapy and in Combination With Dovitinib in Patients With Advanced Solid Tumors". This is a Phase Ib, two-part, multi-center study. In Part 1, the study will evaluate the safety and tolerability, antitumor activity, pharmacokinetics, and determine the maximum tolerated dose (MTD) of 2X-121 monotherapy (at BID regimen) in patients with advanced solid tumors. In Part 2, the study w...
What is the current status of trial NCT05571969?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2023-03-08. Estimated completion is 2024-10-07.
What interventions are being tested in trial NCT05571969?
The interventions under investigation include: 2X-121 600 mg (DRUG), 2X-121 800 mg (DRUG), 2X-121 1000 mg (DRUG), 2X-121 + 300 mg dovitinib (COMBINATION_PRODUCT), 2X-121 + 400 mg dovitinib (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT05571969?
This trial is sponsored by Allarity Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05571969's enrollment target sits among peer trials
14 1844th of 2000 higher than 154 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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