What side effects are associated with this type of intervention?

Immune checkpoint inhibitors, such as those targeting PD-1, PD-L1, and CTLA-4, are commonly used in the treatment of solid tumors and can cause a variety of side effects. The most frequently reported adverse events include fatigue, diarrhea, rash, and pruritus. More severe immune-related toxicities can involve pneumonitis, colitis, hepatitis, endocrinopathies (such as hypothyroidism or hyperthyroidism), and nephritis. These side effects result from the immune system's heightened activity against not only cancer cells but also normal tissues.

What prior FDA approvals exist?

The FDA has approved several immune checkpoint inhibitors for the treatment of solid tumors, focusing on immune system modulation. Notable drugs include nivolumab (Opdivo) and pembrolizumab (Keytruda), both of which target the PD-1 pathway and have shown efficacy in various cancers such as melanoma, non-small cell lung cancer, and head and neck cancers. Atezolizumab (Tecentriq), targeting the PD-L1 pathway, is also approved for use in urothelial carcinoma and non-small cell lung cancer. These approvals highlight the growing role of immunotherapy in treating solid tumors by enhancing the body's immune response against cancer cells.

What other types of research exist?

Promising novel alternatives to XmAb24306 for solid tumors include Pembrolizumab (Keytruda) and Nivolumab (Opdivo), both of which are immune checkpoint inhibitors that have demonstrated significant efficacy in various solid tumors. Additionally, combination therapies such as Pembrolizumab with chemotherapy or Nivolumab with Ipilimumab (Yervoy) are also showing promising results in clinical trials.

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Checkpoint Inhibitor

XmAb24306 + Atezolizumab for Solid Tumors

Phase 1

Recruiting

Research Sponsored by Genentech, Inc.

Eligibility Criteria Checklist

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

Must have

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

Life expectancy >/= 12 weeks

Must not have

History of leptomeningeal disease

Poorly controlled Type 2 diabetes mellitus

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Summary

This trial is testing a new drug, XmAb24306, alone or with another drug to help the immune system fight advanced or spreading cancers. It aims to see if this combination can better target and destroy cancer cells.

Who is the study for?

This trial is for adults with advanced solid tumors who are in fairly good health (ECOG 0 or 1), have a life expectancy of at least 12 weeks, and functioning major organs. They must not be pregnant, breastfeeding, or planning to become pregnant. Participants should not have significant heart disease, uncontrolled diabetes, active infections like TB or hepatitis B/C, autoimmune diseases, HIV, or a history of other cancers within the last three years.

What is being tested?

The study tests XmAb24306 alone and combined with Atezolizumab in patients with advanced solid tumors. It aims to assess safety and how well the body handles these treatments (pharmacokinetics) as well as their effectiveness against tumor growth.

What are the potential side effects?

Potential side effects may include reactions related to the immune system attacking normal cells leading to inflammation in various organs (immune-related adverse events), infusion reactions from receiving drugs through a vein, fatigue, liver issues due to medication interactions affecting organ function.

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 can carry out light work.

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My doctor expects me to live for at least 12 more weeks.

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My cancer is advanced, has come back, or spread and cannot be cured.

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My blood thinner medication dose has been stable.

Exclusion Criteria

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

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I have had cancer spread to the lining of my brain and spinal cord.

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My Type 2 diabetes is not well-managed.

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I have had a previous transplant of stem cells or an organ.

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I have a significant liver condition.

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I do not have active tuberculosis, hepatitis B or C, or Epstein Barr virus.

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I have brain metastases that are causing symptoms or getting worse.

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I have not had any cancer other than the one I'm being treated for in the last 3 years.

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I am taking medication that affects my heart's rhythm.

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I have a serious heart condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2019 Phase 3 trial • 1225 Patients • NCT02008227

36%

Fatigue

35%

Alopecia

24%

Diarrhoea

23%

Nausea

23%

Decreased appetite

22%

Anaemia

20%

Asthenia

19%

Cough

19%

Dyspnoea

16%

Myalgia

15%

Neutropenia

14%

Constipation

14%

Oedema peripheral

12%

Pyrexia

11%

Stomatitis

11%

Vomiting

11%

Neuropathy peripheral

10%

Arthralgia

Neutrophil count decreased

Rash

Headache

Dysgeusia

Paraesthesia

Pain in extremity

Mucosal inflammation

Back pain

Peripheral sensory neuropathy

Insomnia

Abdominal pain

Febrile neutropenia

Lacrimation increased

Dry skin

Pneumonia

Dizziness

Malaise

Urinary tract infection

Weight decreased

Haemoptysis

Nail disorder

Chest pain

Nasopharyngitis

Musculoskeletal pain

Bronchitis

Productive cough

Upper respiratory tract infection

Pruritus

Influenza like illness

Alanine aminotransferase increased

Aspartate aminotransferase increased

Syncope

Dehydration

Atrial fibrillation

Lower respiratory tract infection

Lung infection

Respiratory tract infection

Acute kidney injury

Chronic obstructive pulmonary disease

Pleural effusion

Depression

Musculoskeletal chest pain

100%

80%

60%

40%

20%

Study treatment Arm

Docetaxel

Atezolizumab

Trial Design

4Treatment groups

Experimental Treatment

Group I: Phase 1b Dose ExpansionExperimental Treatment2 Interventions

Participants will receive XmAb24306 and atezolizumab until study treatment discontinuation or study termination.

Group II: Phase 1b Dose EscalationExperimental Treatment2 Interventions

Participants will receive XmAb24306 and atezolizumab until study treatment discontinuation or study termination.

Group III: Phase 1a Dose ExpansionExperimental Treatment1 Intervention

Participants will receive XmAb24306 until study treatment discontinuation or study termination.

Group IV: Phase 1a Dose EscalationExperimental Treatment1 Intervention

Participants will receive XmAb24306 until study treatment discontinuation or study termination.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atezolizumab

2017

Completed Phase 3

~5850

XmAb24306

2022

Completed Phase 1

~20

0 / 13Eligibility 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 solid tumors often include immune system modulators, such as checkpoint inhibitors and monoclonal antibodies. These treatments work by enhancing the body's immune response against cancer cells. Checkpoint inhibitors, like atezolizumab, block proteins that prevent immune cells from attacking cancer cells, thereby boosting the immune response. Monoclonal antibodies, such as XmAb24306, can target specific antigens on cancer cells, marking them for destruction by the immune system. These mechanisms are crucial for solid tumor patients as they offer a targeted approach to treatment, potentially leading to better outcomes and fewer side effects compared to traditional therapies like chemotherapy.

Emerging and mechanism-based therapies for recurrent or metastatic Merkel cell carcinoma.