Tusamitamab ravtansine for Tumors

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
TumorsTusamitamab ravtansine - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This is a Phase1, single-arm study for treatment. This is a prospective multicenter, multinational, open-label study to assess the effect of tusamitamab ravtansine on the QT interval in participants with metastatic colorectal cancer (CRC), nonsquamous non small cell lung cancer (NSQ NSCLC), or gastric/ gastroesophageal junction (GEJ) adenocarcinoma for which in the judgement of the Investigator, no standard alternative therapy is available.

Treatment Effectiveness

Study Objectives

1 Primary · 10 Secondary · Reporting Duration: From the date of first infusion up to approximately 30 days after the last infusion i.e., up approximately 34 weeks

Week 2
Change from baseline in QT-interval corrected (QTcF) centrally assessed
ECG parameter: PR interval
ECG parameter: QRS interval
ECG parameter: QT interval
ECG parameter: QT interval corrected according to the Bazett's formula (QTcB)
Electrocardiogram (ECG) parameter: heart rate (HR)
Week 34
Incidence of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and laboratory abnormalities
Week 2
Area under the plasma concentration versus time curve from time 0 to 14 days (AUC0-14d)
Maximum concentration observed (Cmax)
Week 30
Duration of response (DOR)
Overall response rate (ORR)

Trial Safety

Side Effects for

Trastuzumab Emtansine - Post TPC Treatment Switch
18%Thrombocytopenia
17%Nausea
17%Headache
16%Asthenia
16%Decreased appetite
15%Pyrexia
14%Aspartate aminotransferase increased
13%Cough
13%Epistaxis
11%Fatigue
11%Vomiting
11%Diarrhoea
10%Paraesthesia
10%Dry mouth
10%Urinary tract infection
10%Abdominal pain
9%Upper respiratory tract infection
9%Insomnia
7%Anaemia
7%Alanine aminotransferase increased
7%Mucosal inflammation
7%Arthralgia
7%Musculoskeletal pain
7%Blood alkaline phosphatase increased
7%Constipation
7%Neuropathy peripheral
7%Abdominal pain upper
6%Hypokalaemia
6%Back pain
6%Nasopharyngitis
6%Myalgia
6%Dizziness
6%Dyspnoea
5%Blood bilirubin increased
5%Pain
5%Neutropenia
5%Lacrimation increased
5%Hyperglycaemia
5%Sinusitis
1%Muscular weakness
1%Epilepsy
1%Pulmonary Fibrosis
1%Pneumonia
1%Biliary tract infection
1%Lymphoedema
1%Hepatotoxicity
1%Hemiplegia
1%Upper limb fracture
1%Abdominal infection
1%Toxicity to various agents
1%Pulmonary embolism
1%Tumour necrosis
1%Abscess
1%Cellulitis
1%Lung infection
1%Seizure
1%Upper gastrointestinal haemorrhage
1%Hypersensitivity
This histogram enumerates side effects from a completed 2015 Phase 3 trial (NCT01419197) in the Trastuzumab Emtansine - Post TPC Treatment Switch ARM group. Side effects include: Thrombocytopenia with 18%, Nausea with 17%, Headache with 17%, Asthenia with 16%, Decreased appetite with 16%.

Trial Design

1 Treatment Group

Tusamitamab ravtansine
1 of 1

Experimental Treatment

50 Total Participants · 1 Treatment Group

Primary Treatment: Tusamitamab ravtansine · No Placebo Group · Phase 1

Tusamitamab ravtansine
Drug
Experimental Group · 1 Intervention: Tusamitamab ravtansine · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from the date of first infusion up to approximately 30 days after the last infusion i.e., up approximately 34 weeks

Who is running the clinical trial?

SanofiLead Sponsor
2,041 Previous Clinical Trials
2,959,032 Total Patients Enrolled
3 Trials studying Tumors
289 Patients Enrolled for Tumors
Clinical Sciences & OperationsStudy DirectorSanofi
800 Previous Clinical Trials
1,634,131 Total Patients Enrolled
1 Trials studying Tumors
59 Patients Enrolled for Tumors

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have documented disease progression, for which, in the judgment of the Investigator, no alternative medical therapy is available.
You have a tumor that expresses CEACAM5.
You have measurable disease by RECIST v1.1, as determined by the Investigator.
You have a performance status of 0 to 1.
You are male and agree to use effective contraception methods during and for at least 4 months after the last dose of treatment administration.