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

Summary

This Phase 1b is a dose escalation, MTD expansion and cohort expansions study to assess the safety and tolerability of a combination of NAP with durvalumab in subjects with selected advanced or metastatic solid tumors.

Conditions

• ER+ Breast Cancer
• Ovarian Cancer
• Cervical Squamous Cell Carcinoma
• Pancreatic Adenocarcinoma
• Endometrial Cancer
• Renal Cell Carcinoma
• Urothelial Cancer
• Head and Neck Squamous Cell Carcinoma
• Mesothelioma
• Melanoma
• Hepatocellular Carcinoma
• Prostate Cancer
• NSCLC
• HER2-negative Breast Cancer
• Triple Negative Breast Cancer
• Bladder Cancer
• Colorectal Cancer Metastatic
• GastroEsophageal Cancer
• NSCL2 Gene Mutation
• Esophageal 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.

Sponsors & Collaborators

• NeoTX Therapeutics Ltd.

  lead INDUSTRY

• AstraZeneca

  collaborator INDUSTRY

Principal Investigators

• Tal Hetzroni Kedem · NeoTX Therapeutics Ltd.

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-10-10

Primary Completion

2027-03-01

Completion

2027-03-01

FDA Drug

Yes

Countries

• India
• Israel

Study Locations