A Phase 2 Study of T-DXd in Patients With Selected HER2 Expressing Tumors

  • Interventional
  • Recruiting
  • NCT04482309
Eligibility Details Visit Clinicaltrials.gov

A Phase 2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd, DS-8201a) for the Treatment of Selected HER2 Expressing Tumors (DESTINY-PanTumor02)

This is an open-label, multi-center, multi-cohort, Phase 2 study to evaluate the efficacy and safety of trastuzumab deruxtecan (T-DXd) for the treatment of selected HER2-expressing tumors. This study will enroll 7 tumor-specific cohorts: urothelial bladder cancer, biliary tract cancer, cervical cancer, endometrial cancer, ovarian cancer, pancreatic cancer, and rare tumors. Study hypothesis: Trastuzumab deruxtecan will show meaningful clinical activity and a favorable risk benefit profile in selected HER2-expressing solid tumors.

Gender
All

Age Group
18 Years to 120 Years

Accepting Healthy Volunteers?
No

Inclusion Criteria:

         - Locally advanced, unresectable, or metastatic disease based on most recent imaging.

         - The respective cohorts for patient inclusion are:

             - Cohort 1: Biliary tract cancer

             - Cohort 2: Bladder cancer

             - Cohort 3: Cervical cancer

             - Cohort 4: Endometrial cancer

             - Cohort 5: Epithelial ovarian cancer

             - Cohort 6: Pancreatic cancer

             - Cohort 7: Rare tumors: This cohort will consist of patients with tumors that express HER2, excluding the tumors mentioned above, and breast, non-small cell lung cancer, gastric cancer, and colorectal cancer.

         - Progressed following prior treatment or who have no satisfactory alternative treatment option.

         - Prior HER2 targeting therapy is permitted.

         - HER2 expression for eligibility may be based on local or central assessment.

         - Has measurable target disease assessed by the Investigator based on RECIST version 1.1.

         - Has protocol- defined adequate organ function including cardiac, renal and hepatic function.

        Exclusion Criteria:

         - Uncontrolled intercurrent illness

         - History of non-infectious pneumonitis/ILD, current ILD, or where suspected ILD that cannot be ruled out by imaging at screening

         - Lung-specific intercurrent clinically significant severe illnesses

         - Uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals

         - Pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART

         - Known Somatic DNA mutation of HER2 (ERBB2) without tumoral HER2 protein expression.

         - Primary diagnosis of adenocarcinoma of the breast, adenocarcinoma of the colon or rectum, adenocarcinoma of the gastric body or gastro-esophageal junction, or non-small cell lung cancer.

At a Glance

National Government IDNCT04482309

IRB#IRB20-1940

Lead SponsorAstraZeneca

Lead PhysicianGini Fleming

Collaborator(s)N/A

EligibilityAll
18 Years to 120 Years
Recruiting