What side effects are associated with this type of intervention?

Common side effects of cancer treatments similar to XmAb20717, which target PD-1 and CTLA-4 to enhance immune response, include immune-related adverse events such as pneumonitis, colitis, hepatitis, endocrinopathies (e.g., thyroiditis, adrenal insufficiency), and skin reactions (e.g., rash, pruritus). These treatments can also cause fatigue, diarrhea, and infusion-related reactions. Severe adverse events, though less common, may include grade 3 or 4 toxicities such as severe pneumonitis, colitis, and hepatitis, which often require management with corticosteroids or other immunosuppressive agents.

What prior FDA approvals exist?

The FDA has approved several drugs targeting PD-1 and CTLA-4 pathways for cancer treatment. Notably, nivolumab (Opdivo) and pembrolizumab (Keytruda) are PD-1 inhibitors approved for various cancers, including non-small cell lung cancer and melanoma. Ipilimumab (Yervoy) is a CTLA-4 inhibitor approved for melanoma. Combination therapies, such as nivolumab plus ipilimumab, have also been approved for enhanced efficacy in treating advanced melanoma and other cancers. These treatments aim to enhance the immune response against cancer cells, similar to the investigational bispecific antibody XmAb20717.

What other types of research exist?

Promising alternatives to XmAb20717 for cancer patients include: 1) Pembrolizumab (anti-PD-1) combined with chemotherapy, which has shown improved overall survival and progression-free survival in various cancers. 2) Nivolumab (anti-PD-1) combined with ipilimumab (anti-CTLA-4), which has demonstrated long-term survival benefits in melanoma and other cancers. 3) PRS-344/S095012, a PD-L1/4-1BB bispecific antibody, which elicits strong T-cell stimulation in a tumor-localized manner and is advancing toward clinical development.

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Monoclonal Antibodies

XmAb20717 for Rare Cancers

Phase 2

Waitlist Available

Led By Arvind adasari@mdanderson.org, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Cervical Cancer: Has recurrent, metastatic, or persistent cervical cancer and has received at least one prior line of systemic therapy and not amenable to curative treatment

Is of age ≥ 18

Must not have

Has untreated or unstable brain metastases

Received treatment with targeted therapies or investigational therapies within 21 days or for the duration of 5 half-lives prior to initiation of study treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing XmAb20717, a new drug, on patients with advanced rare cancers. The drug aims to boost the immune system to help it fight cancer more effectively.

Who is the study for?

Adults with advanced rare cancers like mesothelioma, lung cancer, neuroendocrine carcinoma, cervical cancer, and Hodgkin's lymphoma. Participants must have measurable disease by specific criteria, be in good physical condition (ECOG 0-1), use effective birth control if applicable, and meet certain lab test requirements. Exclusions include recent treatment for the studied cancer or other therapies, severe allergies to study drug components, untreated brain metastases among others.

What is being tested?

The trial is testing XmAb20717's safety and effectiveness on patients with various advanced rare cancers. It aims to see how well this intervention works across different types of these diseases under a unified protocol.

What are the potential side effects?

While not explicitly listed here, side effects may include typical reactions associated with immunotherapy such as fatigue, skin reactions, digestive issues; immune-related conditions affecting organs; infusion-related symptoms; and potential increased risk of infections.

Eligibility Criteria

Inclusion Criteria

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

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My cervical cancer has returned, spread, or persists despite treatment and cannot be cured.

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I am 18 years old or older.

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I am fully active or can carry out light work.

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My cancer is MSI-H and I haven't had specific immune therapies.

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My advanced peritoneal mesothelioma didn't respond to or couldn't tolerate the standard chemotherapy, or I haven't been treated but can't receive it.

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My blood and organ tests meet the required health standards.

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I have extensive-stage small-cell lung cancer and was treated with platinum-based therapy.

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I have a high-grade neuroendocrine carcinoma outside the lungs and was treated with platinum-based chemotherapy.

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My Hodgkin lymphoma has returned or didn't respond to first-line chemotherapy.

Exclusion Criteria

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

Select...

I have brain metastases that haven't been treated or are unstable.

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I haven't taken any targeted or experimental cancer treatments in the last 21 days.

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I have not received a live-virus vaccine in the last 30 days.

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I have or had lung inflammation that needed strong steroids.

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I haven't taken steroids or immunosuppressants in the last 14 days.

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I have been treated with drugs targeting PD1/PDL1 or CTLA-4.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

To establish the efficacy of XmAb20717 as measured by overall response rate.

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: XmAb20717Experimental Treatment1 Intervention

Participants will receive XmAb20717 by vein over 1 hour on Days 1 and 15 of each cycle.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

XmAb20717

2018

Completed Phase 1

~150

0 / 15Eligibility 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 cancer treatments include immunotherapy, chemotherapy, and targeted therapy. Immunotherapy, like XmAb20717, enhances the immune system's ability to recognize and attack cancer cells by blocking immune checkpoints such as PD-1 and CTLA-4. Chemotherapy kills rapidly dividing cells, while targeted therapies inhibit specific molecules involved in cancer growth and survival. Understanding these mechanisms helps in selecting the most appropriate treatment based on the cancer type and individual patient characteristics, potentially improving outcomes and reducing side effects.

Combining targeted therapy with immunotherapy in BRAF-mutant melanoma: promise and challenges.