What side effects are associated with this type of intervention?

Common treatments for melanoma, particularly those involving monoclonal antibodies and small molecule inhibitors like those targeting the ROR2 receptor tyrosine kinase, often result in side effects such as partial alopecia, hair curling, and dyspigmentation. Additionally, immune checkpoint inhibitors used in melanoma can cause patchy hypopigmentation of the skin (vitiligo) and hair (poliosis), as well as alopecia. Other frequent adverse effects include rash, gastrointestinal distress, and fatigue. Severe toxicities, although less common, can include immune-related adverse events affecting various organs.

What prior FDA approvals exist?

The FDA has approved several treatments for melanoma, including targeted therapies and immunotherapies. Notably, pembrolizumab and nivolumab are immune checkpoint inhibitors that target PD-1, enhancing the immune system's ability to fight cancer. Additionally, combination therapies like nivolumab with ipilimumab, which targets CTLA-4, have shown efficacy. For targeted therapy, vemurafenib and dabrafenib, which inhibit the BRAF V600E mutation, are approved. While these treatments are not ADCs like CAB-ROR2-ADC, they represent significant advancements in targeted and immune-based therapies for melanoma.

What other types of research exist?

Promising novel alternatives to CAB-ROR2-ADC for melanoma patients include: 1) Niraparib, a PARP inhibitor, which has shown activity in patients with BRCA1 or BRCA2 mutations. 2) Pembrolizumab, an immune checkpoint inhibitor, which has demonstrated efficacy in various advanced solid tumors including melanoma. 3) Combination therapies such as axitinib plus pembrolizumab, which have shown promising results in advanced sarcomas and could be considered for melanoma. These alternatives offer different mechanisms of action and have shown potential in clinical trials.

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Antibody-drug conjugate

CAB-ROR2-ADC + PD-1 Inhibitor for Breast Cancer

Phase 1 & 2

Waitlist Available

Research Sponsored by BioAtla, Inc.

Eligibility Criteria Checklist

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

Must have

Patients must have histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumor and have failed all available standard of care (SoC) therapy and for whom no curative therapy is available or who are not eligible, intolerant to or refuse standard therapy.

Age ≥ 18 years.

Must not have

Patients must not have clinically significant cardiac disease.

Patients must not have had prior therapy with a conjugated or unconjugated auristatin derivative/vinca-binding site targeting payload.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new targeted cancer treatment called CAB-ROR2-ADC in patients with advanced solid tumors. The drug seeks out cancer cells with a specific marker and delivers a potent treatment directly to them.

Who is the study for?

This trial is for adults with advanced cancers like TNBC, head & neck cancer, NSCLC or melanoma that can't be removed by surgery or have spread and don't respond to standard treatments. Participants must have a life expectancy of at least three months, measurable disease, good performance status (able to carry out daily activities), and proper organ function.

What is being tested?

The study tests CAB-ROR2-ADC's safety and effectiveness in solid tumors. It includes patients who've exhausted all treatment options. The trial has two phases: the first checks dosage levels; the second expands testing to specific cancers like lung cancer and melanoma alongside a PD-1 inhibitor.

What are the potential side effects?

Potential side effects may include reactions related to immune system activation such as inflammation in various organs, infusion-related reactions similar to allergic responses during drug administration, fatigue, digestive issues including nausea or diarrhea, blood disorders affecting cell counts.

Eligibility Criteria

Inclusion Criteria

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

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My advanced cancer has not responded to standard treatments, and no curative options are available to me.

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I am 18 years old or older.

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

Exclusion Criteria

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

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I do not have any serious heart conditions.

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I have never been treated with auristatin or similar cancer drugs.

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

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I am not pregnant or breastfeeding.

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I do not have uncontrolled brain metastases.

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

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 Objective Response Rate (ORR)

Secondary study objectives

Phase 1 and 2: Best overall response (OR)

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: Monotherapy - CAB-ROR2-ADC (BA3021) aloneExperimental Treatment1 Intervention

BA3021 alone Q2W dosing regimen

Group II: Combination TherapyExperimental Treatment2 Interventions

CAB-ROR2-ADC (BA3021) 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 melanoma include immunotherapy, targeted therapy, and antibody-drug conjugates (ADCs). Immunotherapy, such as checkpoint inhibitors (e.g., pembrolizumab, nivolumab), works by enhancing the body's immune response against melanoma cells. Targeted therapy involves drugs that specifically target genetic mutations in melanoma cells, such as BRAF or MEK inhibitors. ADCs, like the CAB-ROR2-ADC being studied, combine an antibody specific to a cancer cell marker (e.g., ROR2 receptor) with a cytotoxic drug, allowing for targeted delivery of the toxin to melanoma cells. This targeted approach minimizes damage to healthy cells and enhances the efficacy of the treatment. These mechanisms are crucial for melanoma patients as they offer more personalized and effective treatment options, potentially leading to better outcomes and fewer side effects.