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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 4 years
Awards & highlights

Study Summary

This trial will test a new antibody drug, XmAb24306, to see if it is safe and effective in treating solid tumors. The trial will also test combining XmAb24306 with a checkpoint inhibitor treatment.

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.Check my eligibility
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.See study design
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants with Adverse Events
Secondary outcome measures
DOR as Based on Radiographic Assessment by the Investigator Using iRECIST
Duration of Response (DOR) as Determined by the Investigator According to RECIST v1.1
ORR as Based on Radiographic Assessment by the Investigator Using Modified RECIST v1.1 for Immune-Based Therapeutics (iRECIST)
+5 more

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%
Neuropathy peripheral
11%
Vomiting
11%
Stomatitis
10%
Arthralgia
9%
Rash
9%
Neutrophil count decreased
8%
Dysgeusia
8%
Paraesthesia
8%
Headache
7%
Pain in extremity
7%
Peripheral sensory neuropathy
7%
Insomnia
7%
Mucosal inflammation
7%
Back pain
6%
Pneumonia
6%
Febrile neutropenia
6%
Abdominal pain
6%
Dry skin
6%
Lacrimation increased
6%
Dizziness
5%
Haemoptysis
5%
Weight decreased
5%
Malaise
5%
Urinary tract infection
5%
Nail disorder
4%
Productive cough
4%
Chest pain
4%
Nasopharyngitis
4%
Musculoskeletal pain
4%
Bronchitis
3%
Pruritus
3%
Upper respiratory tract infection
2%
Alanine aminotransferase increased
2%
Aspartate aminotransferase increased
2%
Influenza like illness
1%
Respiratory tract infection
1%
Musculoskeletal chest pain
1%
Lower respiratory tract infection
1%
Acute kidney injury
1%
Depression
1%
Lung infection
1%
Dehydration
1%
Chronic obstructive pulmonary disease
1%
Atrial fibrillation
1%
Syncope
1%
Pleural effusion
100%
80%
60%
40%
20%
0%
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
~5860

Find a Location

Who is running the clinical trial?

Genentech, Inc.Lead Sponsor
1,540 Previous Clinical Trials
567,649 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,201 Previous Clinical Trials
888,482 Total Patients Enrolled

Media Library

Atezolizumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04250155 — Phase 1
Solid Tumors Research Study Groups: Phase 1a Dose Escalation, Phase 1a Dose Expansion, Phase 1b Dose Escalation, Phase 1b Dose Expansion
Solid Tumors Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT04250155 — Phase 1
Atezolizumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04250155 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still an opportunity to participate in this research endeavor?

"Affirmative. The information on clinicaltrials.gov confirms that this research trial, which was first posted on March 9th 2020, is still seeking participants. A total of 250 individuals need to be recruited from 14 distinct medical centres."

Answered by AI

For what medical conditions is XmAb24306 commonly prescribed?

"XmAb24306 is traditionally employed to address small cell lung cancer (SCLC) but has been used for malignant neoplasms, non-small cell lung carcinoma and postoperative care."

Answered by AI

How many locations are conducting this experiment?

"Participants in this study can select from a wide range of 14 medical sites, such as Ottawa Hospital and Sir Mortimer B Davis Jewish General Hospital. Two additional options are available for those wishing to join the trial in San Francisco: UCSF Helen Diller Family CCC."

Answered by AI

What is the current enrollment count for this medical research endeavor?

"This trial, which is sponsored by Genentech Inc., necessitates the recruitment of 250 patients that meet its prerequisites. It will be conducted at multiple venues such as Ottawa Hospital in Canada and UCSF Helen Diller Family CCC in San Francisco, USA."

Answered by AI

Is this research endeavor a pioneering exploration?

"XmAb24306 has been under observation since 2008, when Hoffmann-La Roche first sponsored a trial with 720 participants. After being approved by the FDA for Phase 2 trials, XmAB24306 is now involved in 350 live studies conducted across 74 countries and 1646 cities."

Answered by AI

Has XmAb24306 been studied in any other clinical research trials?

"XmAb24306 was first examined in 2008 at SCRI Tennessee Oncology Chattanooga. As of now, 80 trials have been concluded and 350 others are presently seeking participants with a concentration located in Ottawa, Ontario."

Answered by AI

What potential risks do people exposed to XmAb24306 face?

"With limited evidence regarding its safety profile and efficacy, XmAb24306 received a score of 1 based on our team's assessment."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
An Open-Label Dose-Escalation Study to Evaluate XmAb24306 as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors
2020. "An Open-Label Dose-Escalation Study to Evaluate XmAb24306 as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04250155.
~5 spots leftby Jun 2024
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