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ABL503 for Solid Cancers

Phase 1

Recruiting

Research Sponsored by ABL Bio, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

With AE(s) excluding alopecia or Grade 2 toxicities that are deemed stable or irreversible (eg, peripheral neuropathy) from prior therapy that have improved to Grade 1 or the baseline grade more than 14 days prior to the first administration of the study drug

Adequate hematologic, hepatic, and renal functions confirmed based on the screening laboratory tests and reconfirmed with additional safety laboratory tests performed within 72 hours prior to the first administration of ABL503

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from day 1 until disease progression or day 28, whichever came first

Awards & highlights

Study Summary

This trial is testing a new cancer drug to see if it is safe and effective.

Who is the study for?

This trial is for adults with advanced solid tumors that have worsened after treatment or don't respond to standard therapies. Participants must have recovered from major side effects of previous treatments, except hair loss and certain stable conditions, and should have good blood, liver, and kidney function.Check my eligibility

What is being tested?

ABL503 is being tested in this Phase 1 trial to find the safest dose for future studies. The study has three parts: finding the maximum tolerated dose (MTD), expanding the dose range (RP2D), and testing on specific tumor types.See study design

What are the potential side effects?

Potential side effects of ABL503 may include typical reactions seen with cancer drugs such as fatigue, nausea, inflammation-related symptoms but specifics will be determined as this is a first-in-human study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My side effects from previous treatments, except for hair loss or stable nerve damage, have mostly gone away.

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My blood, liver, and kidney tests are all within normal ranges.

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My cancer has returned or didn't respond to treatment and cannot be surgically removed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from day 1 until disease progression or day 28, whichever came first

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from day 1 until disease progression or day 28, whichever came first

This trial's timeline: 3 weeks for screening, Varies for treatment, and from day 1 until disease progression or day 28, whichever came first for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Subjects with Dose-Limiting Toxicities (DLT)

Number of subjects with AE, IrAEs, IRRs, SAEs and abnormalities in Lab

Secondary outcome measures

Immunogenicity of ABL503

Objective Response Rate (ORR)

Pharmacokinetic (PK) of ABL503

Trial Design

1Treatment groups

Experimental Treatment

Group I: ABL503Experimental Treatment1 Intervention

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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

ABL Bio, Inc.Lead Sponsor

5 Previous Clinical Trials

355 Total Patients Enrolled

Media Library

ABL503 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04762641 — Phase 1

Solid Tumors Research Study Groups: ABL503

Solid Tumors Clinical Trial 2023: ABL503 Highlights & Side Effects. Trial Name: NCT04762641 — Phase 1

ABL503 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04762641 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have been accepted into this scientific experiment?

"To complete the research at hand, 36 suitable candidates must take part in this experiment. People can sign up through NEXT Oncology, located in San Antonio Texas or Sarah Cannon Research Institute at HealthONE which is found in Denver Colorado."

Answered by AI

Is this clinical research endeavor currently recruiting participants?

"Correct. According to clinicaltrials.gov, this medical study began recruiting participants on April 1st 2021 and is presently seeking volunteers for enrollment. The investigation requires 36 individuals from 5 distinct healthcare facilities."

Answered by AI

How hazardous is ABL503 for human consumption?

"Since ABL503 is only in its inaugural trial, the safety rating was evaluated as a 1 due to limited evidence of efficacy and security."

Answered by AI

Are there any hospitals in North America conducting this research initiative?

"Patients have the option of enrolling in this trial at 5 separate medical facilities: NEXT Oncology, Sarah Cannon Research Institute, City of Hope Duarte and 2 other sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04762641.