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

Part of paid clinical trials in Duarte, California.

Sponsor
ABL Bio, Inc.
Study ID
NCT04762641
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ABL503 — DRUG
    ABL503 will be administered intravenously (IV) on Day 1 and Day 15 of every 28-day cycle in the dose-escalation part. The dosing interval to be used in the dose-expansion part will be re-evaluated based on the emerging safety and PK data from the dose-escalation part of the study.

Study Details

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

Key Dates

Start date
Apr 1, 2021
Status verified
Jan 2025
Primary completion
Nov 30, 2025
Completion
Jun 15, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: ABL503
    ABL503 will be administered biweekly of every 28-day cycle in the dose-escalation. The dosing interval to be used in the dose-expansion part will be re-evaluated based on the emerging safety and PK data from the dose-escalation part of the study.

Primary Outcome Measure

Number of Subjects with Dose-Limiting Toxicities (DLT) [ Time Frame: From Day 1 until disease progression or Day 28, whichever came first ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010
JuYeon Jeon
USCLos AngelesCalifornia90033
Juyeun Jeon
UCLASanta MonicaCalifornia90404
JuYeon Jeon
Sarah Cannon Research Institute at HealthONEDenverColorado80218
Juyeun Jeon
NEXT OncologySan AntonioTexas78229
Juyeun Jeon

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