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Bavituximab

Phase 2

Gastric Cancer | Small molecule | Oncology |Merck & Company, Inc.|Last Updated: Feb 8, 2023

Success Probability

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment80

FDA Designations

No designations recorded

Clinical trial landscape

Bavituximab · 1 trial · 2 indications

Phase 2 1
NCT04099641An Open Label Study of Bavituximab and Pembrolizumab in Advanced Gastric and GEJ Cancer PatientsGastric Cancer
COMPLETED80 Analytics
PHASE2COMPLETED
An Open Label Study of Bavituximab and Pembrolizumab in Advanced Gastric and GEJ Cancer Patients
Gastric CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Patients With Treatment Emergent Adverse Events (TEAE)
From first dose through 30 days after last dose. Maximum exposure: 567 days.

Incidence of TEAEs graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0, including changes in clinical laboratory parameters. TEAEs: any AE that emerged on or after first dose, and within 30 days of the last dose.

Severity of Treatment Emergent Adverse Events (TEAE)
From first dose through 30 days after last dose. Maximum exposure: 567 days.

Severity of TEAEs graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0, including changes in clinical laboratory parameters. TEAEs: any AE that emerged on or after first dose, and within 30 days of the last dose.

Objective Response Rate (ORR)
From date of first dose until the date of CR, PR, first documented progression or date of death from any cause, whichever came first. Maximum exposure: 567 days.

ORR was based on RECIST version 1.1 criteria for target lesions, where a patient may achieve as best overall response (BOR) either complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD). CR was defined as the disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline summary of diameters. ORR is calculated as the number of patients achieving a CR or PR (objective response) divided by the number of efficacy patients.

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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
bavituximab and pembrolizumabEXPERIMENTALBavituximab 3mg/kg IV weekly in combination with pembrolizumab 200mg IV given once every 3 weeks

Interventions

NameTypeDescription
BavituximabDRUGBavituximab IV infusion
Pembrolizumab InjectionDRUGPembrolizumab IV Infusion
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites21

Inclusion Criteria: * Signed written informed consent * Men and women ≥ 18 years old; ≥ 20 years old in South Korea and Taiwan * Unresectable metastatic or locally advanced gastric or GEJ adenocarcinoma * Progressed on and/or after at least 1 prior regimen for metastatic disease or achieved stable ...

Countries:United StatesSouth KoreaTaiwanUnited Kingdom
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Competitive Landscape -Gastric Cancer 112 trials

Top 20 of 45 competitors

CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN16PHASE3AZD0901, Ramucirumab, paclitaxel, Paclitaxel, Docetaxel
BeOne Medicines Ltd. Sponsored ADRONC4PHASE3Tislelizumab, Cisplatin, Leucovorin, 5-fluorouracil, Oxaliplatin
Jazz Pharmaceuticals Public Limited CompanyJAZZ3PHASE3Zanidatamab, Tislelizumab, Trastuzumab, Capecitabine, Oxaliplatin
Arcus Biosciences, Inc.RCUS2PHASE3Domvanalimab, Zimberelimab, Capecitabine, Fluorouracil, Leucovorin
Bristol-Myers Squibb CompanyBMY6PHASE2Pumitamig, Folfox, Capox, Nivolumab
Pfizer Inc.PFE7PHASE2disitamab vedotin, tucatinib
Agenus Inc.AGEN2PHASE3Balstilimab, Botensilimab, Folfox Protocol, XELOX, Nivolumab
AbbVie, Inc.ABBV2PHASE2Telisotuzumab Adizutecan, Budigalimab, Fluorouracil, Leucovorin, Oxaliplatin
Eli Lilly and CompanyLLY2PHASE2Ramucirumab, Paclitaxel
Compass Therapeutics, Inc.CMPX1PHASE2CTX-009, Paclitaxel
ALX Oncology Holdings, Inc.ALXO1PHASE2Evorpacept, Trastuzumab, Ramucirumab, Paclitaxel
GE Healthcare Technologies Inc.GEHC1PHASE2GEH300079 Positron-Emission Tomography/Computed Tomography
ImmunityBio IncIBRX1PHASE2N-803, Pembrolizumab
Apollomics Inc. Class AAPLM1PHASE2APL-101
Exelixis, Inc.EXEL2PHASE1cabozantinib, atezolizumab
Tango Therapeutics, Inc.TNGX2PHASE2Trifluridine/Tipiracil, Oxaliplatin, FOLFOX regimen, Nivolumab
Inhibrx Biosciences, Inc.INBX1PHASE1INBRX-106- Hexavalent OX40 agonist antibody, pembrolizumab, Carboplatin AUC-5, Pemetrexed/m2, Cisplatin/m2
Incyte CorporationINCY1PHASE2Capecitabine, Oxaliplatin, Retifanlimab
I-Mab Biopharma US LimitedIMAB2PHASE2Givastomig, Nivolumab, 5Fluorouracil, Leucovorin, Oxaliplatin
Enliven Therapeutics, Inc.ELVN1PHASE1ELVN-002, Trastuzumab, 5-Fluorouracil, Oxaliplatin, Capecitabine
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Frequently asked questions about Bavituximab

What is Bavituximab used for in gastric cancer?

Bavituximab is an investigational antibody being studied for the treatment of gastric cancer and gastroesophageal junction cancer. It is being evaluated in combination with pembrolizumab in patients with advanced disease. The drug is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.

What does Bavituximab target?

Bavituximab is a monoclonal antibody, indicated by the '-mab' suffix in its name. As an antibody-based therapy, it is designed to bind to specific targets involved in cancer progression. However, its precise molecular target has not been specified in the available clinical trial information.

Who is developing Bavituximab?

Bavituximab is being developed by Merck & Company, Inc., a global pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with gastric cancer.

What phase is Bavituximab in?

Bavituximab is currently in Phase 2 clinical development. It has completed one Phase 2 trial, which was an open-label study in patients with advanced gastric and gastroesophageal junction cancer. The drug remains investigational and has not received FDA approval.

What clinical trials is Bavituximab in?

Bavituximab has been studied in one completed clinical trial, registered as NCT04099641. This Phase 2 study was an open-label trial evaluating Bavituximab in combination with pembrolizumab in 80 patients with advanced gastric and gastroesophageal cancer. The trial was conducted in the United States, South Korea, Taiwan, and the United Kingdom.

Is Bavituximab the same as pembrolizumab?

No, Bavituximab is not the same as pembrolizumab. Bavituximab is an investigational antibody being developed by Merck, while pembrolizumab is a separate immunotherapy drug. In the clinical trial NCT04099641, Bavituximab was studied in combination with pembrolizumab to assess their combined effect in treating gastric cancer.