What side effects are associated with this type of intervention?

Common side effects of immune-modulating agents and checkpoint inhibitors used in the treatment of solid tumors include fatigue, rash, diarrhea, and pruritus. More severe adverse events can include pneumonitis, colitis, hepatitis, endocrinopathies, and infusion reactions. These side effects result from the immune system's heightened activity, which can sometimes target normal tissues in addition to cancer cells.

What prior FDA approvals exist?

The FDA has approved several immune-modulating agents for the treatment of solid tumors. Notable examples include pembrolizumab (Keytruda) and nivolumab (Opdivo), both of which are PD-1 inhibitors that enhance the immune system's ability to fight cancer by blocking the PD-1 pathway. Additionally, ipilimumab (Yervoy), a CTLA-4 inhibitor, has been approved for use in combination with nivolumab for certain types of solid tumors. These agents have shown efficacy in treating various cancers, including melanoma, non-small cell lung cancer, and renal cell carcinoma, by enhancing anti-tumor immunity.

What other types of research exist?

Promising novel alternatives to XmAb662 for solid tumor patients include: 1) Pembrolizumab (Keytruda) in combination with other agents such as lenvatinib or chemotherapy, which has shown efficacy in various solid tumors. 2) Atezolizumab (Tecentriq) combined with bevacizumab and chemotherapy, particularly for non-small cell lung cancer and renal cell carcinoma. 3) Nivolumab (Opdivo) in combination with relatlimab, which has shown promise in melanoma. These agents are part of ongoing research and have demonstrated potential in enhancing anti-tumor immunity.

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Monoclonal Antibodies

XmAb®662 + Pembrolizumab for Solid Cancers

Phase 1

Waitlist Available

Research Sponsored by Xencor, Inc.

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Summary

This trial is testing a new drug called XmAb662, either alone or with another drug called pembrolizumab. Pembrolizumab is used to treat various advanced solid tumors and has shown effectiveness in multiple cancer types. The study targets patients with advanced solid tumors that haven't responded to other treatments. The study aims to find out if XmAb662 is safe and how it works in the body.

Who is the study for?

This trial is for adults with advanced solid tumors that have grown after standard treatment. They must be able to measure the tumor's size, have a life expectancy of at least 3 months, and their body should be functioning well enough to participate. People can't join if they've had severe immune reactions from similar treatments or are currently on certain cancer therapies.

What is being tested?

The study tests XmAb662 alone or with Keytruda (pembrolizumab) in patients with various types of advanced cancers. It aims to find a safe and effective dose by observing how patients react and how the drug behaves in their bodies.

What are the potential side effects?

Possible side effects include reactions related to the immune system affecting different organs, infusion-related reactions like allergic responses during drug administration, and other common side effects associated with cancer immunotherapies.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 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

Incidence and severity of treatment emergent adverse events (TEAEs)

Incidence of dose-limiting toxicities (DLTs)

Secondary study objectives

Characterization of pharmacokinetics

Duration of response

Objective response rate

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Dose Escalation and Expansion XmAb662 administered in combination with pembrolizumabExperimental Treatment2 Interventions

Group II: Dose Escalation and Expansion XmAb662 administered as monotherapyExperimental Treatment1 Intervention

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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, such as immune-modulating agents like XmAb662 and PD-1 inhibitors like pembrolizumab, work by enhancing the body's immune response to target and destroy cancer cells. These agents block inhibitory pathways that tumors use to evade the immune system, thereby boosting the activity of T-cells against the tumor. This mechanism is particularly important for solid tumor patients as it can lead to more effective and durable responses, potentially improving survival rates and quality of life compared to conventional therapies.

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Who is running the clinical trial?

Xencor, Inc.Lead Sponsor

29 Previous Clinical Trials

2,441 Total Patients Enrolled

Chet Bohac, MDStudy DirectorExecutive Medical Director, Clinical Development

3 Previous Clinical Trials

336 Total Patients Enrolled

Media Library

Pembrolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05996445 — Phase 1

Solid Tumors Research Study Groups: Dose Escalation and Expansion XmAb662 administered in combination with pembrolizumab, Dose Escalation and Expansion XmAb662 administered as monotherapy

Solid Tumors Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT05996445 — Phase 1

Pembrolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05996445 — Phase 1

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