What side effects are associated with this type of intervention?

Common treatments for esophageal cancer, such as antibody-drug conjugates (e.g., sigvotatug vedotin) and immune checkpoint inhibitors (e.g., pembrolizumab), often have side effects including fatigue, nausea, and decreased appetite. Specific to antibody-drug conjugates, side effects can include peripheral neuropathy, infusion reactions, and hematologic toxicities like neutropenia. Immune checkpoint inhibitors may cause immune-related adverse events such as colitis, pneumonitis, and dermatitis. When combined with chemotherapy agents like carboplatin or cisplatin, additional side effects can include myelosuppression, nephrotoxicity, and ototoxicity.

What prior FDA approvals exist?

Currently, there are no specific FDA-approved antibody-drug conjugates (ADCs) like sigvotatug vedotin for the treatment of esophageal cancer. However, other targeted therapies and immunotherapies have been approved. Pembrolizumab, an anti-PD-1 monoclonal antibody, has been approved for use in esophageal cancer, particularly for tumors expressing PD-L1. Additionally, other systemic therapies, including chemotherapy and targeted agents like ramucirumab, have been used in the treatment of advanced or metastatic esophageal cancer.

What other types of research exist?

Promising novel alternatives to Sigvotatug Vedotin for esophageal cancer patients include: 1) Ramucirumab in combination with paclitaxel, which has shown improved progression-free survival and overall survival in advanced gastric or gastroesophageal junction adenocarcinoma. 2) Pembrolizumab, an immune checkpoint inhibitor, either alone or in combination with chemotherapy, which has demonstrated efficacy in various solid tumors, including esophageal cancer. 3) Durvalumab in combination with FLOT chemotherapy, which is being evaluated for resectable gastric and gastroesophageal junction cancer and may offer benefits in esophageal cancer as well.

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Monoclonal Antibodies

SGN-B6A for Cancer

Q: What is the mechanism of action of this treatment?

Common treatments for esophageal cancer include antibody-drug conjugates (ADCs) like sigvotatug vedotin, which target cancer cells specifically and deliver cytotoxic drugs directly to them, minimizing harm to normal cells. Immune checkpoint inhibitors such as pembrolizumab enhance the immune system's ability to attack cancer cells by blocking proteins like PD-1/PD-L1. Chemotherapy agents like cisplatin and carboplatin work by damaging the DNA of rapidly dividing cells, leading to their death. Understanding these mechanisms helps in selecting effective treatments, improving patient outcomes, and reducing side effects.

Phase 1

Recruiting

Research Sponsored by Seagen Inc.

Eligibility Criteria Checklist

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

Must have

Participants must have histologically or cytologically confirmed metastatic or unresectable solid malignancy within specified tumor types

Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

Must not have

Known DLCO <50% predicted

Prior therapy with specified agents and discontinued due to a Grade 3 or higher immune-mediated adverse event

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called sigvotatug vedotin alone and with other treatments to see if it is safe and effective for people with solid tumors. It will also check for any side effects. The study includes different parts to determine the best dose and to see how well the drug works alone and in combination with other treatments.

Who is the study for?

This trial is for adults with certain advanced solid tumors, including esophageal, breast, lung cancers and more. Participants must have relapsed or be intolerant to standard treatments. They should not have received prior therapies that caused severe immune reactions and must not have active brain metastases or serious infections.

What is being tested?

SGN-B6A alone and in combination with pembrolizumab, with or without chemotherapy drugs cisplatin or carboplatin, is being tested across four parts of the study to determine safety and effectiveness in treating various solid tumors.

What are the potential side effects?

Potential side effects include those common to cancer treatments such as fatigue, nausea, allergic reactions but also specific ones related to SGN-B6A which will be closely monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

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

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My cancer is confirmed to be advanced and cannot be removed by surgery.

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

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My tumor can be biopsied, and I agree to undergo this procedure.

Exclusion Criteria

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

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My lung's ability to transfer gas is less than half of what's expected.

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I stopped a treatment because of a severe immune reaction.

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I haven't had a severe infection in the last 2 weeks.

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I have taken specific medications before.

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I have a severe lung condition not caused by my cancer.

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I have brain metastases that are currently active or have been treated.

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I have cancer cells in the fluid around my brain and spinal cord.

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I have or might have lung inflammation that imaging tests could not rule out.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 3 years 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 participants with adverse events (AEs)

Secondary study objectives

Apparent terminal elimination half-life (t1/2)

Area under the concentration-time curve (AUC)

Concentration at the end of infusion (Ceoi)

+7 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

5Treatment groups

Experimental Treatment

Group I: Part D: sigvotatug vedotin combination therapy in 1L NSCLCExperimental Treatment3 Interventions

sigvotatug vedotin + pembrolizumab +/- (carboplatin)

Group II: Part D: sigvotatug vedotin combination therapy in 1L HNSCCExperimental Treatment4 Interventions

sigvotatug vedotin + pembrolizumab +/- (carboplatin or cisplatin)

Group III: Part C: sigvotatug vedotin combination therapy in NSCLC, HNSCC, ESCCExperimental Treatment4 Interventions

sigvotatug vedotin + pembrolizumab +/- (carboplatin or cisplatin)

Group IV: Part B: Dose expansionExperimental Treatment1 Intervention

sigvotatug vedotin monotherapy

Group V: Part A: Dose escalationExperimental Treatment1 Intervention

sigvotatug vedotin monotherapy

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

pembrolizumab

2017

Completed Phase 3

~5890

cisplatin

1997

Completed Phase 3

~3290

carboplatin

2010

Completed Phase 3

~4790

0 / 11Eligibility 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 esophageal cancer include antibody-drug conjugates (ADCs) like sigvotatug vedotin, which target cancer cells specifically and deliver cytotoxic drugs directly to them, minimizing harm to normal cells. Immune checkpoint inhibitors such as pembrolizumab enhance the immune system's ability to attack cancer cells by blocking proteins like PD-1/PD-L1. Chemotherapy agents like cisplatin and carboplatin work by damaging the DNA of rapidly dividing cells, leading to their death. Understanding these mechanisms helps in selecting effective treatments, improving patient outcomes, and reducing side effects.