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Monoclonal Antibodies

Tusamitamab Ravtansine for Metastatic Cancer (TusaRav-QT Trial)

Phase 1

Waitlist Available

Research Sponsored by Sanofi

Eligibility Criteria Checklist

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

Must have

Histologically or cytologically confirmed diagnosis of colorectal cancer (CRC) adenocarcinoma, nonsquamous non small cell lung cancer (NSQ NSCLC), or gastric/ gastroesophageal junction (GC/GEJ) adenocarcinoma, metastatic disease at study entry

Capable of giving signed informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the date of first infusion up to approximately 30 days after the last infusion i.e., up approximately 34 weeks

Awards & highlights

TusaRav-QT Trial Summary

This trialtests a new treatment for metastatic cancer in the colon, lungs, and stomach/esophagus. Patients have no other options.

Who is the study for?

This trial is for adults with metastatic colorectal, non-squamous non-small cell lung, or gastric/gastroesophageal junction cancers without standard treatment options. Participants must have measurable disease and be in good physical condition (ECOG 0-1). They should agree to use effective contraception and not have any significant illnesses or unresolved treatment-related toxicities that could affect their participation.Check my eligibility

What is being tested?

The study tests Tusamitamab Ravtansine's effect on the heart's electrical activity (QTc interval) in patients with specific advanced solid tumors. It's an open-label, single-arm Phase 1 trial conducted across multiple centers internationally, focusing on those who've exhausted other treatments.See study design

What are the potential side effects?

While specific side effects of Tusamitamab Ravtansine are not listed here, common side effects for cancer drugs like this may include nausea, fatigue, diarrhea, liver problems and potential heart issues such as changes in the QTc interval which will be closely monitored during the trial.

TusaRav-QT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with a specific type of advanced cancer in the colon, lung, or stomach.

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I am able to understand and sign the consent form.

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My tumor expresses CEACAM5.

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I am fully active or can carry out light work.

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My lung cancer shows CEACAM5 presence or high CEA levels if no tumor tissue is available.

TusaRav-QT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the date of first infusion up to approximately 30 days after the last infusion i.e., up approximately 34 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the date of first infusion up to approximately 30 days after the last infusion i.e., up approximately 34 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of first infusion up to approximately 30 days after the last infusion i.e., up approximately 34 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from baseline in QT-interval corrected (QTcF) centrally assessed

Secondary outcome measures

Area under the plasma concentration versus time curve from time 0 to 14 days (AUC0-14d)

Duration of response (DOR)

ECG parameter: PR interval

+7 more

Side effects data

From 2015 Phase 3 trial • 602 Patients • NCT01419197

18%

Thrombocytopenia

17%

Nausea

17%

Headache

16%

Decreased appetite

16%

Asthenia

15%

Pyrexia

14%

Aspartate aminotransferase increased

13%

Epistaxis

13%

Cough

11%

Fatigue

11%

Vomiting

11%

Diarrhoea

10%

Paraesthesia

10%

Abdominal pain

10%

Dry mouth

10%

Urinary tract infection

Insomnia

Upper respiratory tract infection

Blood alkaline phosphatase increased

Musculoskeletal pain

Neuropathy peripheral

Anaemia

Constipation

Mucosal inflammation

Alanine aminotransferase increased

Arthralgia

Abdominal pain upper

Myalgia

Back pain

Nasopharyngitis

Dizziness

Dyspnoea

Hypokalaemia

Blood bilirubin increased

Hyperglycaemia

Neutropenia

Lacrimation increased

Pain

Sinusitis

Pulmonary embolism

Pneumonia

Hypersensitivity

Upper gastrointestinal haemorrhage

Tumour necrosis

Abscess

Hepatotoxicity

Lymphoedema

Epilepsy

Upper limb fracture

Muscular weakness

Hemiplegia

Cellulitis

Seizure

Abdominal infection

Biliary tract infection

Toxicity to various agents

Pulmonary Fibrosis

Lung infection

100%

80%

60%

40%

20%

Study treatment Arm

Trastuzumab Emtansine - Post TPC Treatment Switch

Trastuzumab Emtansine

Treatment of Physician's Choice (TPC)

TusaRav-QT Trial Design

1Treatment groups

Experimental Treatment

Group I: Tusamitamab ravtansineExperimental Treatment1 Intervention

Participants will receive tusamitamab ravtansine intravenous (IV) infusion until disease progression, unacceptable toxicity, the start of a new anti-cancer therapy, or the participant's or Investigator's decision to stop the treatment, whichever comes first.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor

2,163 Previous Clinical Trials

3,512,424 Total Patients Enrolled

3 Trials studying Tumors

289 Patients Enrolled for Tumors

Clinical Sciences & OperationsStudy DirectorSanofi

857 Previous Clinical Trials

2,019,243 Total Patients Enrolled

1 Trials studying Tumors

59 Patients Enrolled for Tumors

Media Library

Tumors Research Study Groups: Tusamitamab ravtansine

Frequently Asked Questions

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

What is the aggregate population of participants in this clinical investigation?

"Affirmative. According to the data posted on clinicaltrials.gov, this medical study is proactively recruiting participants after being initially published on October 3rd 2022 and recently updated on November 29th 2022. The trial hopes to enrol 50 individuals from a single location."

Answered by AI

What risks do individuals face when utilizing Tusamitamab ravtansine?

"Due to the dearth of safety and efficacy data supporting Tusamitamab ravtansine, it was assigned a score of 1 on our risk assessment scale."

Answered by AI

Are there any openings left in this medical research endeavor?

"Yes, according to clinicaltrials.gov this medical trial is presently recruiting patients. The original posting was made on October 3rd 2022 and a recent update was posted on November 29th 2022; the research team seeks 50 participants from 1 location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effect of Tusamitamab Ravtansine on QTc Interval in Participants With Metastatic Solid Tumors

2022. "Effect of Tusamitamab Ravtansine on QTc Interval in Participants With Metastatic Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05429762.

All > Cancer > Oncology