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Monoclonal Antibodies

Runimotamab 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
HER2-Expressing Breast Cancer-Specific Inclusion Criteria: Locally tested, Human Epidermal Growth Factor Receptor 2 (HER2)-expressing BC; Locally advanced or metastatic BC that has relapsed or is refractory to established therapies
HER2-Expressing Gastric/Gastroesophageal (GEJ) Cancer-Specific Inclusion Criteria: Adenocarcinoma of the stomach or GEJ with inoperable locally advanced or recurrent and/or metastatic disease, not amenable to curative therapy; HER2-expressing tumor (primary tumor or metastasis) as assessed by local lab testing; HER2-positive gastric/GEJ cancer must have received prior trastuzumab, cisplatin (or carboplatin or oxaliplatin or investigational platinum agent) and 5-fluorouracil (5-FU)/capecitabine
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through the end of study (approximately 78 months)
Awards & highlights

Study Summary

This trial will study the safety and effectiveness of a new drug for HER2-positive cancers. The drug will be given alone and with another cancer drug.

Who is the study for?
This trial is for people with advanced or metastatic HER2-expressing cancers who have tried at least one standard therapy without success, or can't tolerate it. They should expect to live at least 12 weeks, be in good physical condition (ECOG 0-1), and have a heart pumping function (LVEF) of at least 50%. People with untreated brain metastases, significant heart/lung problems, certain infections like HIV/HCV, uncontrolled diabetes, or those pregnant cannot join.Check my eligibility
What is being tested?
The study tests Runimotamab alone and combined with Trastuzumab on participants with HER2-positive cancers. It aims to understand the safety and how the body processes these drugs when given through an IV.See study design
What are the potential side effects?
Potential side effects may include reactions related to infusion such as fever or chills, organ inflammation due to immune response from the treatment, fatigue from drug action on cancer cells and normal tissues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My breast cancer is HER2 positive and has either returned or didn't respond to treatment.
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My stomach cancer is advanced, cannot be surgically removed, and has been treated with specific drugs including trastuzumab.
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I am fully active or restricted in physically strenuous activity but can do light work.
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Any major side effects from my previous treatments have mostly gone away.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through the end of study (approximately 78 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through the end of study (approximately 78 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
Percentage of Participants with Adverse Events
Secondary outcome measures
Anti-Drug Antibody (ADA) Levels of Runimotamab
Area Under the Serum Concentration vs. Time Curve (AUC) of Runimotamab
Clearance (CL) of Runimotamab
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Dose ExpansionExperimental Treatment3 Interventions
Participants will receive runimotamab based on the MTD or maximum allowed dose (MAD) identified during dose escalation.
Group II: Dose EscalationExperimental Treatment3 Interventions
Participants will be assigned sequentially to escalating doses of runimotamab up to the maximum tolerated dose (MTD).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trastuzumab
2014
Completed Phase 4
~5190
Tocilizumab
2012
Completed Phase 4
~1840

Find a Location

Who is running the clinical trial?

Genentech, Inc.Lead Sponsor
1,539 Previous Clinical Trials
567,218 Total Patients Enrolled
Clinical TrialsStudy DirectorGenentech, Inc.
2,198 Previous Clinical Trials
887,911 Total Patients Enrolled

Media Library

Runimotamab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03448042 — Phase 1
Solid Tumors Research Study Groups: Dose Escalation, Dose Expansion
Solid Tumors Clinical Trial 2023: Runimotamab Highlights & Side Effects. Trial Name: NCT03448042 — Phase 1
Runimotamab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03448042 — Phase 1

Frequently Asked Questions

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

What is the upper limit for participant numbers in this trial?

"That is correct. An examination of the clinicaltrials.gov website reveals that this experiment, which was first publicized on June 6th 2018, is currently recruiting patients to participate. In total, 537 people will be accepted at two different medical sites."

Answered by AI

Are any new volunteers currently being accepted for this research program?

"Clinicaltrials.gov maintains that this medical trial, which was inaugurated on 6/6/2018 and subsequently revised on 11/1/2022, is currently recruiting participants."

Answered by AI

Has BTRC4017A met the regulatory criteria for approval by the FDA?

"The safety of BTRC4017A has been rated a 1 on our scale from 1 to 3 due to the limited data available resulting from this being a Phase 1 trial."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of Runimotamab in Participants With Locally Advanced or Metastatic HER2-Expressing Cancers
2018. "A Study of Runimotamab in Participants With Locally Advanced or Metastatic HER2-Expressing Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03448042.
~0 spots leftby Apr 2024
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