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NCT05417321 · ClinicalTrials.gov registry record · Phase 1
A Study Evaluating the Safety and Efficacy of HB0036 in Subjects With Advanced Solid Tumors
A Phase 1 study of Advanced Solid Tumor and NSCLC, sponsored by Shanghai Huaota Biopharmaceutical Co..
- Recruiting
- Registry status
- Phase 1
- Development phase
- 80
- Enrollment target
- 4
- Study locations
NCT05417321: Recruiting Phase 1 study of Advanced Solid Tumor and NSCLC, sponsored by Shanghai Huaota Biopharmaceutical Co..
NCT05417321 is a Phase 1 study of Advanced Solid Tumor and NSCLC that is actively recruiting participants, run by Shanghai Huaota Biopharmaceutical Co.. The registered enrollment target is 80 participants, below the 193-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (59% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05417321, a Phase 1 study of Advanced Solid Tumor and NSCLC, is actively recruiting participants, sponsored by Shanghai Huaota Biopharmaceutical Co..
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 80 participants
- Enrollment target
- 4
- Study locations
Study Summary
It is a Phase I/II, Open-label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of HB0036 in Subjects with Advanced Solid Tumors
Primary Outcome
Number of participants with a Dose Limiting Toxicity (DLT) \[ Time Frame: During the first 21 days \]DLTs will be assessed during the first 21 days of treatment for dose-escalation phase and are defined as toxicities that meet pre-defined severity criteria, and assessed as having a suspected or definite relationship to study drug.
Conditions Studied
Interventions
- DRUG HB0036
Study Locations (4)
Indiana
- Horizon Oncology - Lafayette
Texas
- Next Oncology - San Antonio
Washington
- Summit Cancer Centers - Spokane
Shandong
- Shandong Hospital - Jinan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2022-08-25 |
| Est. Completion | 2025-08-01 |
| Phase | Phase 1 |
What NCT05417321 shows while recruiting
NCT05417321 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 193-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (59% lower).
The record links to 2 conditions, with Advanced Solid Tumor appearing as the primary indexed condition, and to 1 intervention - of which HB0036 is the first listed.
NCT05417321 reports a single indexed study location in Indiana, Texas, Washington.
Frequently Asked Questions
What is clinical trial NCT05417321 about?
NCT05417321 is a clinical study titled "A Study Evaluating the Safety and Efficacy of HB0036 in Subjects With Advanced Solid Tumors". It is a Phase I/II, Open-label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of HB0036 in Subjects with Advanced Solid Tumors
What is the current status of trial NCT05417321?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 80 participants. The study started on 2022-08-25. Estimated completion is 2025-08-01.
What conditions does trial NCT05417321 study?
This clinical trial studies the following conditions: Advanced Solid Tumor, NSCLC.
What interventions are being tested in trial NCT05417321?
The interventions under investigation include: HB0036 (DRUG).
Who is sponsoring clinical trial NCT05417321?
This trial is sponsored by Shanghai Huaota Biopharmaceutical Co., which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05417321 being conducted?
This trial has 4 study locations across Indiana, Texas, Washington, Shandong. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Advanced Solid Tumor
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05417321's enrollment target sits among peer trials
80 134th of 189 higher than 54 of 189 other Advanced Solid Tumor trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Solid Tumor 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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