Naptumomab Estafenatox in Combination with Durvalumab in Subjects with Selected Advanced or Metastatic Solid Tumor, Including a Cohort Expansion in Esophageal Cancer.

PHASE1RecruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

October 10, 2019

Primary Completion Date

March 1, 2027

Study Completion Date

March 1, 2027

Conditions
ER+ Breast CancerOvarian CancerCervical Squamous Cell CarcinomaPancreatic AdenocarcinomaEndometrial CancerRenal Cell CarcinomaUrothelial CancerHead and Neck Squamous Cell CarcinomaMesotheliomaMelanomaHepatocellular CarcinomaProstate CancerNSCLCHER2-negative Breast CancerTriple Negative Breast CancerBladder CancerColorectal Cancer MetastaticGastroEsophageal CancerNSCL2 Gene MutationEsophageal Cancer
Interventions
COMBINATION_PRODUCT

Obinutuzumab, naptumomab estafenatox and durvalumab

"Obinutuzumab is given intravenous (I.V.) 1,000 mg concentrate for solution for infusion, as pre-treatment.~Dose escalation and MTD Expansion: NAP is given as an intravenous (I.V.) bolus injection at multiple doses.~Durvalumab is given at a dose of 1120 mg, I.V, 1- 1.5 hours after completion of the administration of NAP on the second day of each 21-day cycle, and when administered as monotherapy at a dose of 1500 mg delivered once every 28 days.~Esophageal cohort expansion: NAP is given as an intravenous (I.V.) bolus injection at multiple doses on cycles 1-6 and one dose per cycle starting cycle 7. Durvalumab is given at a dose of 1120 mg, I.V, 1- 1.5 hours after completion of the administration of NAP on the second day of each 21-day cycle during cycles 1-6, and at a dose of 1500 mg delivered once every 28 days starting cycle 7."

COMBINATION_PRODUCT

Naptumomab estafenatox and durvalumab

NAP was given as an intravenous (I.V.) bolus injection at multiple doses. Durvalumab was given at a dose of 1120 mg, I.V, 1- 1.5 hours after completion of the administration of NAP on the second day of each 21-day cycle, and when administered as monotherapy at a dose of 1500 mg delivered once every 28 days.

Trial Locations (9)

52621

COMPLETED

Sheba Medical Center, Ramat Gan

110029

NOT_YET_RECRUITING

All India Institute of Medical Sciences, New Delhi

313001

NOT_YET_RECRUITING

PMCH (Pacific Medical College & Hospital), Udaipur

380015

RECRUITING

Shalby Hospital, Ahmedabad

500034

NOT_YET_RECRUITING

Basavatarakam Indo-American Cancer Hospital & Research Institute, Hyderabad

3109601

COMPLETED

Rambam Medical Center, Haifa

6423906

COMPLETED

Tel Aviv Sourasky Medical Center, Tel Aviv

124105124105

NOT_YET_RECRUITING

National Cancer Institute, Jhajjar

Unknown

COMPLETED

Rabin Medical Center, Petah Tikva

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

AstraZeneca

INDUSTRY

lead

NeoTX Therapeutics Ltd.

INDUSTRY