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Monoclonal Antibodies

RO7296682 + Atezolizumab for Advanced Cancer

Phase 1
Waitlist Available
Research Sponsored by Hoffmann-La Roche
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 31 months
Awards & highlights

Study Summary

This trial will test if a new drug is safe and works well with another drug to treat people with advanced solid tumors.

Who is the study for?
This trial is for adults with advanced solid tumors that have worsened after standard treatment or who can't tolerate it. They must be relatively healthy, able to perform daily activities (ECOG 0-1), and provide a tumor tissue sample. Participants need stable blood clotting if on anticoagulants and agree to use effective birth control. Exclusions include brain cancer, recent major surgery, active infections like Hepatitis B/C or HIV, pregnancy, certain allergies, recent radiotherapy outside of palliative care, dementia preventing consent.Check my eligibility
What is being tested?
The study tests the combination of RO7296682 with Atezolizumab in patients with advanced solid tumors. It aims to assess how safe and tolerable this mix is while also checking its initial effectiveness against the tumors.See study design
What are the potential side effects?
While specific side effects are not listed here, common ones related to drugs like RO7296682 and Atezolizumab may include immune-related reactions affecting organs, infusion reactions similar to allergic responses during drug administration, fatigue from treatment burden on the body's resources.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 31 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 31 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective Response Rate (ORR) (Part II and III only)
Percentage of Participants with Adverse Events (AEs)
Percentage of Participants with Dose-Limiting Toxicities (DLTs)
Secondary outcome measures
Area under the Curve (AUC) of RO7296682
Disease Control Rate (DCR)
Duration of Response (DoR)
+10 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%
Peripheral sensory neuropathy
7%
Pain in extremity
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

3Treatment groups
Experimental Treatment
Group I: Part III (Exploratory)Experimental Treatment2 Interventions
Dose-Expansion: Will start once MTD/RP2D dose of RO7296682 in combination with Atezolizumab is defined in Part I and if clinical activity is seen in this trial or in the single agent study (WP41188). Participants with selected tumor types will receive a fixed dose of RO7296682 in combination with Atezolizumab at the dosing regimen established in Part I.
Group II: Part IIExperimental Treatment2 Interventions
Dose-Expansion: Will start once MTD/RP2D dose of RO7296682 in combination with Atezolizumab is defined in Part I. Participants with selected tumor types will receive a fixed dose of RO7296682 in combination with Atezolizumab.
Group III: Part IExperimental Treatment2 Interventions
Dose-Escalation: Mixed solid tumors participants will receive ascending doses of RO7296682 with a fixed dose of Atezolizumab, every three weeks (Q3W) until either the Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) is defined.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RO7296682
2021
Completed Phase 1
~50
Atezolizumab
2017
Completed Phase 3
~5860

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,432 Previous Clinical Trials
1,089,837 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,201 Previous Clinical Trials
888,554 Total Patients Enrolled

Media Library

Atezolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04642365 — Phase 1
Solid Tumors Research Study Groups: Part I, Part II, Part III (Exploratory)
Solid Tumors Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT04642365 — Phase 1
Atezolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04642365 — Phase 1

Frequently Asked Questions

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

How many medical centers are enrolled in the clinical trial?

"As of now, the trial is enrolling participants from 5 clinical sites. Toronto, Vancouver and Ottawa are among them as well as 2 other locales. To reduce travelling needs should you choose to join this study, picking a centre closest to your residence would be most beneficial."

Answered by AI

What medical conditions has RO7296682 been demonstrated to be effective in addressing?

"RO7296682 is primarily used in the treatment of small cell lung cancer (sclc). Additionally, this drug can be deployed to treat a variety of malignancies and postoperative situations."

Answered by AI

What other research efforts have been made regarding RO7296682?

"The initial trials of RO7296682 began at SCRI Tennessee Oncology Chattanooga in 2008, with 82 studies already completed. Currently, 350 active experiments are being conducted across the world, many of which based out of Toronto, Ontario."

Answered by AI

In what size population is this research being conducted?

"The trial's sponsor, Hoffmann-La Roche, requires the recruitment of 180 individuals that meet the criteria outlined in their protocol. These patients will be recruited from various locations such as Princess Margaret Cancer Centre and MD Anderson Cancer Center."

Answered by AI

Does this research project bring something new to the table?

"Currently, there are 350 research projects related to RO7296682 operating in 74 nations and 1646 cities. Hoffmann-La Roche launched the initial trial in 2008 with 720 participants; since then, 82 further studies have been conducted up to Phase 2 drug approval stage."

Answered by AI

Does RO7296682 offer users any risks or side effects?

"RO7296682 has yet to go through extensive clinical testing, so it is given a score of 1 for safety. Thus far, only limited data exists outlining its efficacy and security."

Answered by AI

Are fresh participants still being accepted for this research endeavor?

"Affirmative, clinicaltrials.gov confirms that this medical trial began recruitment on April 1st 2021 and is still actively searching for participants as of November 16th 2022. 180 patients need to be enrolled from 5 different sites."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Safety and Tolerability of RO7296682 in Combination With Atezolizumab in Participants With Advanced Solid Tumors.
2021. "A Study to Evaluate the Safety and Tolerability of RO7296682 in Combination With Atezolizumab in Participants With Advanced Solid Tumors.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04642365.
~11 spots leftby May 2025
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