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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 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.

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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

Conditions Studied

Advanced Solid Tumor

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

FieldValue
Enrollment Target 100 participants
Start Date 2021-04-01
Est. Completion 2026-06-15
Phase Phase 1

Sponsor

ABL Bio

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04762641

The ClinicalTrials.gov registry entry for NCT04762641 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 192-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (48% lower). The listed sponsor is ABL Bio, which has 3 total studies on file at ClinicalTrials.gov.

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 reports 8 study locations spanning 4 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.