Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/JPRN-jRCT2011210035
JPRN-jRCT2011210035Active, not recruitingPhase 2

Open-label study of tusamitamab ravtansine (SAR408701) in combination with ramucirumab in participants previously treated for advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma with CEACAM5-positive tumors

Tanaka Tomoyuki0 sites38 target enrollmentStarted: September 22, 2021Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions

Trial Snapshot

Phase
Phase 2
Status
Active, not recruiting
Sponsor
Enrollment
38
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
>= 18age old to ot applicable (—)
Sex
All

Inclusion Criteria

  • •Histologically or cytologically confirmed diagnosis of gastric or GEJ adenocarcinoma.
  • •- Metastatic disease or locally advanced, unresectable disease.
  • •- Participants who have measurable target lesion.
  • •- Participants with high carcinoembryonic antigen-related cell adhesion molecule (CEACAM5) expression as per central assessment on tumor biospsy
  • •- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  • •- Female participant who agrees to use effective contraceptive methods during and for at least 7 months after the last dose of treatment administration
  • •- Male participant who agrees to use effective contraception methods during and for at least 4 months after the last dose of treatment administration
  • •- Signed informed consent

Exclusion Criteria

  • •Participants are excluded from the study if any of the following criteria apply:
  • •- Untreated brain metastases, leptomeningeal disease, or uncontrolled spinal cord compression.
  • •- Significant concomitant illness.
  • •- History within the last 3 years of an invasive malignancy other than that treated in this study
  • •- Known uncontrolled infection
  • •- Nonresolution of any prior treatment-related toxicity
  • •- Unresolved corneal disorder or any previous corneal disorder considered by an ophthalmologist to predict higher risk of drug-induced keratopathy
  • •- Use of contact lenses
  • •- Radiographic evidence of major airway or blood vessel invasion or intratumor cavitation
  • •- History of uncontrolled hereditary or acquired thrombotic disorder or history of aneurism
  • •- Major surgery within 28 days prior to Day 1/first IMP infusion; subcutaneous venous access device placement within 7 days prior to Day 1; or postoperative bleeding complications or wound complications from a surgical procedure performed in the last 2 months
  • •- History of gross hemoptysis (defined as bright red blood or >=1/2 teaspoon) within 2 months before the first treatment administration
  • •- Any arterial thrombotic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 6 months before the first administration of treatment administration
  • •- Uncontrolled arterial hypertension (systolic >=150 mmHg or diastolic >=90 mmHg) despite standard medical management.
  • •- Serious or nonhealing wound, skin ulcer, or bone fracture within 28 days before the first administration of treatment administration
  • •- Gastrointestinal (GI) perforation and/or fistulae within 6 months prior to first administration of treatment administration
  • •- Significant bleeding disorders, vasculitis, or Grade 3-4 gastrointestinal (GI) bleeding within 3 months before the first administration of study intervention.
  • •- Bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection Crohn's disease, ulcerative colitis, or chronic diarrhea
  • •- Medical condition requiring concomitant administration of a medication with a narrow therapeutic window and metabolized by CYP450 or a strong CYP3A inhibitor
  • •- Concurrent treatment with any other anticancer therapy
  • •- Prior treatment targeting CEACAM5 or containing maytansinoid DM1 or DM4 or ramucirumab or taxane or targeting VEGF/VEGFR
  • •- Poor organ function

Investigators

Sponsor
Tanaka Tomoyuki

Similar Trials

Active, not recruiting
Phase 1
Tusamitamab ravtansine (SAR408701) in combination with ramucirumab in pretreated participants with gastric cancerMedDRA version: 20.1Level: PTClassification code 10062878Term: Gastrooesophageal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10001150Term: Adenocarcinoma gastricSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Cancer
EUCTR2021-001967-26-ESSanofi aventis recherche & développement38
Terminated
Phase 2
Tusamitamab Ravtansine (SAR408701) in Combination With Ramucirumab in Pretreated Participants With Gastric CancerAdenocarcinoma GastricGastrooesophageal Cancer
NCT05071053Sanofi35
Terminated
Phase 2
The Study of Tusamitamab Ravtansine (IBI126) Combined With Sintilimab and Tusamitamab Ravtansine (IBI126) Combined With Sintilimab Plus Platinum-based Chemotherapy and Pemetrexed in Subjects With CEACAM5 Positive Expression Advanced/Metastatic Non-squamous Non-small-cell Lung Cancer (NSQ NSCLC)Non-squamous Non-small-cell Lung Cancer
NCT05849246Innovent Biologics (Suzhou) Co. Ltd.4
Terminated
Phase 2
Tusamitamab Ravtansine (SAR408701) in Combination With Pembrolizumab and Tusamitamab Ravtansine (SAR408701) in Combination With Pembrolizumab and Platinum-based Chemotherapy With or Without Pemetrexed in Patients With NSQ NSCLCNon-squamous Non-small-cell Lung Cancer (NSQ NSCLC)
NCT04524689Sanofi57
Completed
Phase 1
Phase I Study of Anetumab Ravtansine in Hepatic or Renal ImpairmentNeoplasms
NCT02696642Bayer54