What is the mechanism of action of this treatment?

The most common treatments for Pleomorphic Sarcoma include chemotherapy, targeted therapy, and antibody-drug conjugates (ADCs) like Mecbotamab Vedotin. ADCs are designed to specifically target cancer cells by binding to antigens on their surface and delivering cytotoxic agents directly into the cancer cells. This targeted delivery helps to minimize damage to healthy cells, which is particularly important for Pleomorphic Sarcoma patients as it can reduce side effects and improve the overall efficacy of the treatment. By focusing on the unique markers of cancer cells, ADCs offer a promising approach to treating this aggressive form of sarcoma.

What side effects are associated with this type of intervention?

Common treatments for Pleomorphic Sarcoma, such as antibody-drug conjugates like Mecbotamab Vedotin, often result in side effects including fatigue, nausea, peripheral neuropathy, and hematologic toxicities. Other treatments like pazopanib and eribulin, frequently used for sarcomas, can cause hypertension, diarrhea, liver enzyme elevation, neutropenia, and fatigue. Patients should discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

There is limited specific information on FDA-approved Antibody-Drug Conjugates (ADCs) for the treatment of Pleomorphic Sarcoma. However, ADCs like Mecbotamab Vedotin are being studied for their efficacy in targeting cancer cells in various solid tumors, including sarcomas. For soft tissue sarcomas, treatments such as Pazopanib, a multikinase angiogenesis inhibitor, and Eribulin, a microtubule dynamics inhibitor, have been approved. These treatments focus on inhibiting tumor growth and proliferation, similar to the targeted approach of ADCs.

What other types of research exist?

Promising alternatives to Mecbotamab Vedotin for Pleomorphic Sarcoma patients include Pazopanib, which has shown activity in various soft tissue sarcomas in phase II and III trials, and Pembrolizumab plus Cetuximab, which is being investigated for treatment-refractory metastatic cancers. Additionally, metronomic chemotherapy is an investigational approach that targets tumor angiogenesis with lower toxicity.

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Antibody-drug conjugate

CAB-AXL-ADC + PD-1 Inhibitor for Sarcoma

Phase 1 & 2

Recruiting

Research Sponsored by BioAtla, Inc.

Eligibility Criteria Checklist

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

Must have

Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Age ≥ 12 years (Phase 2)

Must not have

Patients must not have known non-controlled CNS metastasis

Patients must not have a history of ≥ Grade 3 allergic reactions to mAb therapy as well as known or suspected allergy or intolerance to any agent given during this study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing mecbotamab vedotin, a medicine that targets and kills cancer cells, in patients with advanced solid tumors, including specific types of sarcomas. It works by using an antibody to find the cancer cells and a drug to destroy them.

Who is the study for?

This trial is for adolescents and adults with various types of sarcoma, including Ewing Sarcoma and Osteosarcoma. Participants need to have a life expectancy of at least three months, be aged 12 or older (for Phase 2), and have good kidney, liver, and blood function. They should also be relatively active (ECOG status of 0 or 1). People who've had certain prior therapies, significant heart disease, uncontrolled brain metastasis, severe allergies to monoclonal antibodies or components used in the study are excluded.

What is being tested?

The trial is testing CAB-AXL-ADC's safety and effectiveness against solid tumors in patients with sarcoma. It will also involve a PD-1 inhibitor as part of the treatment regimen. The goal is to see how well these interventions work together in treating different kinds of sarcomas.

What are the potential side effects?

Potential side effects may include reactions related to the immune system due to the PD-1 inhibitor such as fatigue, skin issues or inflammation inside the body; allergic reactions from monoclonal antibody therapy; plus any risks associated with CAB-AXL-ADC which could affect organ functions.

Eligibility Criteria

Inclusion Criteria

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

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I am fully active or restricted in physically strenuous activity but can do light work.

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I am 12 years old or older.

Exclusion Criteria

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

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I do not have uncontrolled brain metastases.

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I have never had a severe allergic reaction to monoclonal antibody therapy.

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I have not had major surgery in the last 4 weeks.

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I have never been treated with auristatin or vinca-binding site targeting drugs.

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I do not have HIV, active hepatitis B, or hepatitis C.

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I do not have any serious heart conditions.

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I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Phase 1 and 2: Safety Profile

Phase 1: Safety Profile

Phase 2: Confirmed overall response rate (ORR) per RECIST v1.1

Secondary study objectives

Phase 1 and 2: Best overall response (BOR)

Phase 1 and 2: Disease control rate (DCR)

Phase 1 and 2: Duration of response (DOR)

+7 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Combination TherapyExperimental Treatment2 Interventions

Phase 2: BA3011 in combination with PD-1 inhibitor.

Group II: BA3011Experimental Treatment1 Intervention

Phase 1: All patients will receive BA3011, CAB-AXL-ADC. Phase 2: All patients will receive either BA3011 alone or in combination with PD-1 inhibitor.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PD-1 inhibitor

2022

Completed Phase 2

~40

0 / 9Eligibility 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

The most common treatments for Pleomorphic Sarcoma include chemotherapy, targeted therapy, and antibody-drug conjugates (ADCs) like Mecbotamab Vedotin. ADCs are designed to specifically target cancer cells by binding to antigens on their surface and delivering cytotoxic agents directly into the cancer cells. This targeted delivery helps to minimize damage to healthy cells, which is particularly important for Pleomorphic Sarcoma patients as it can reduce side effects and improve the overall efficacy of the treatment. By focusing on the unique markers of cancer cells, ADCs offer a promising approach to treating this aggressive form of sarcoma.

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