What side effects are associated with this type of intervention?

Common treatments for solid tumors, such as chemotherapy, immunotherapy, and targeted therapies, often have a range of side effects. Chemotherapy can cause nausea, vomiting, hair loss, fatigue, and increased risk of infections due to bone marrow suppression. Immunotherapy, including checkpoint inhibitors, may lead to immune-related adverse events like colitis, pneumonitis, hepatitis, and endocrinopathies. Targeted therapies can cause side effects specific to the drug's mechanism, such as skin rashes, hypertension, and diarrhea. Patients should discuss potential side effects with their healthcare provider to manage and mitigate these risks effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for solid tumors, including immunotherapies and targeted therapies. Pembrolizumab, an anti-PD-1 antibody, is approved for various solid tumors, including melanoma and non-small cell lung cancer. Nivolumab, another anti-PD-1 antibody, is approved for melanoma, renal cell carcinoma, and other cancers. Targeted therapies like enasidenib, approved for relapsed or refractory AML with an IDH2 mutation, and gemtuzumab ozogamicin, an anti-CD33 monoclonal antibody for AML, represent other approaches. These treatments, focusing on specific genetic mutations or immune checkpoints, are similar to the investigational approaches being studied in the ABL503 trial.

What other types of research exist?

Promising novel alternatives for solid tumor patients in 2024 include: 1) Pembrolizumab (Keytruda) - an immune checkpoint inhibitor showing efficacy in various solid tumors. 2) Nivolumab (Opdivo) combined with Ipilimumab (Yervoy) - another immune checkpoint inhibitor combination with promising results in multiple solid tumors. 3) Cabozantinib (Cabometyx) - a tyrosine kinase inhibitor effective in medullary thyroid cancer and other solid tumors. 4) Capmatinib - a MET inhibitor for MET exon 14-mutated non-small cell lung cancer. 5) Futibatinib - an FGFR inhibitor for cholangiocarcinoma with FGFR2 fusions/rearrangements.

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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

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

Be older than 18 years old

Must not have

Discontinued from prior immunomodulatory therapy due to any intolerable immune-related adverse events (IrAEs) requiring systemic steroid treatment

History of drug-induced pneumonitis (interstitial lung disease) or currently has pneumonitis

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug called ABL503 in patients with advanced cancers that have no other treatment options. It aims to find out if the drug is safe, how well patients can tolerate it, and if it shows any early signs of fighting cancer.

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.

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.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I stopped previous immune therapy due to severe side effects needing steroids.

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I have or had lung inflammation caused by a drug.

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I have been treated with an anti-4-1BB antibody before.

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I haven't had chemotherapy, radiation, or targeted therapy recently and have recovered from their side effects.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Subjects with Dose-Limiting Toxicities (DLT)

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

Secondary study objectives

Immunogenicity of ABL503

Objective Response Rate (ORR)

Pharmacokinetic (PK) of ABL503

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for solid tumors include chemotherapy, which works by killing rapidly dividing cells; targeted therapy, which blocks specific molecules involved in tumor growth and progression; immunotherapy, which enhances the body's immune system to recognize and destroy cancer cells; and radiation therapy, which uses high-energy particles to damage the DNA of cancer cells, leading to cell death. Understanding these mechanisms is vital for patients as it helps in selecting the most appropriate treatment based on the tumor's characteristics and potential response, thereby improving outcomes and minimizing side effects. Investigational treatments like ABL503, which are being studied for their safety and efficacy, may offer new avenues by combining or enhancing these mechanisms, providing hope for more effective and personalized cancer care.

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