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NCT04762641 · ClinicalTrials.gov registry record · Phase 1
This is a Study to Evaluate the Safety and Tolerability of ABL503, and to Determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of ABL503 in Subjects with Any Progressive Locally Advanced or Metastatic Solid Tumors
A Phase 1 study of Advanced Solid Tumor, sponsored by ABL Bio.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 100
- Enrollment target
- 8
- Study locations
NCT04762641: Recruiting Phase 1 study of Advanced Solid Tumor, sponsored by ABL Bio.
NCT04762641 is a Phase 1 study of Advanced Solid Tumor that is actively recruiting participants, run by ABL Bio. The registered enrollment target is 100 participants, below the 192-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (48% lower). The trial reports 8 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04762641, a Phase 1 study of Advanced Solid Tumor, is actively recruiting participants, sponsored by ABL Bio.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 100 participants
- Enrollment target
- 8
- Study locations
Study Summary
This is a first-in-human Phase 1, single-arm, open-label, multicenter, multiple-dose, dose-escalation and dose-expansion study of ABL503 to evaluate the safety, tolerability, MTD and/or RP2D, PK, immunogenicity, preliminary antitumor activity, and the PD effect of ABL503 in subjects with any progressive locally advanced (unresectable) or metastatic solid tumors who are relapsed or refractory following the last line of treatment and have no available standard of care option. This study includes 3 parts: a dose-escalation part, a dose-expansion part and tumor-expansion part
Primary Outcome
Number of subjects with Dose-Limiting Toxicity (DLT)
Conditions Studied
Interventions
- DRUG ABL503
Study Locations (8)
California
- City of Hope - Duarte
- USC - Los Angeles
- UCLA - Santa Monica
Other
- Seoul National University Hospital - Seoul
- Severance Hospital - Seoul
- Asan Medical Center - Seoul
Colorado
- Sarah Cannon Research Institute at HealthONE - Denver
Texas
- NEXT Oncology - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2021-04-01 |
| Est. Completion | 2026-06-15 |
| Phase | Phase 1 |
What NCT04762641 shows while recruiting
NCT04762641 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 192-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (48% lower).
The record links to 1 condition, with Advanced Solid Tumor appearing as the primary indexed condition, and to 1 intervention - of which ABL503 is the first listed.
NCT04762641 lists 8 locations in 4 states (California, Other, Colorado).
Frequently Asked Questions
What is clinical trial NCT04762641 about?
NCT04762641 is a clinical study titled "This is a Study to Evaluate the Safety and Tolerability of ABL503, and to Determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of ABL503 in Subjects with Any Progressive Locally Advanced or Metastatic Solid Tumors". This is a first-in-human Phase 1, single-arm, open-label, multicenter, multiple-dose, dose-escalation and dose-expansion study of ABL503 to evaluate the safety, tolerability, MTD and/or RP2D, PK, immunogenicity, preliminary antitumor activity, and the PD effect of ABL503 in subjects with any progres...
What is the current status of trial NCT04762641?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 100 participants. The study started on 2021-04-01. Estimated completion is 2026-06-15.
What conditions does trial NCT04762641 study?
This clinical trial studies the following conditions: Advanced Solid Tumor.
What interventions are being tested in trial NCT04762641?
The interventions under investigation include: ABL503 (DRUG).
Who is sponsoring clinical trial NCT04762641?
This trial is sponsored by ABL Bio, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04762641 being conducted?
This trial has 8 study locations across California, Colorado, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04762641's enrollment target sits among peer trials
100 116th of 189 higher than 73 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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