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NCT06656390 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Antitumor Activity of ALK201 in Participants With Advanced Solid Tumors
A Phase 1 study, sponsored by Shanghai Allink Biotherapeutics Co..
- Recruiting
- Registry status
- Phase 1
- Development phase
- 202
- Enrollment target
NCT06656390: Recruiting Phase 1 study, sponsored by Shanghai Allink Biotherapeutics Co..
NCT06656390 is a Phase 1 study that is actively recruiting participants, run by Shanghai Allink Biotherapeutics Co.. The registered enrollment target is 202 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (237% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06656390, a Phase 1 study, is actively recruiting participants, sponsored by Shanghai Allink Biotherapeutics Co..
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 202 participants
- Enrollment target
Study Summary
This is a first-in-human (FIH), open-label, multicenter dose escalation and expansion study of ALK201. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and antitumor activity of ALK201 as a monotherapy in adult participants with Advanced Solid Tumors. The study will also identify recommended dose(s) for subsequent clinical studies of ALK201.
Primary Outcome
Dose-limiting toxicity (DLT); The incidence and severity of treatment-emergent adverse events (TEAEs) and treatment-related adverse events (TRAEs) according to CTCAE v5.0.
Interventions
- DRUG ALK201
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 202 participants |
| Start Date | 2024-10-24 |
| Est. Completion | 2028-04-22 |
| Phase | Phase 1 |
What NCT06656390 shows while recruiting
NCT06656390 is an interventional study that assigns participants to a tested intervention. The registered 202 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (237% higher).
The record links to 0 conditions, and to 1 intervention - of which ALK201 is the first listed.
NCT06656390 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06656390 about?
NCT06656390 is a clinical study titled "A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Antitumor Activity of ALK201 in Participants With Advanced Solid Tumors". This is a first-in-human (FIH), open-label, multicenter dose escalation and expansion study of ALK201. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and antitumor activity of ALK201 as a monotherapy in adult participants with Advanced Solid Tumors. The stu...
What is the current status of trial NCT06656390?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 202 participants. The study started on 2024-10-24. Estimated completion is 2028-04-22.
What interventions are being tested in trial NCT06656390?
The interventions under investigation include: ALK201 (DRUG).
Who is sponsoring clinical trial NCT06656390?
This trial is sponsored by Shanghai Allink Biotherapeutics Co., which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06656390's enrollment target sits among peer trials
202 258th of 2000 higher than 1,743 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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