Ovarian Cancer Clinical Trial

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

Summary

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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

Part 1: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.

Part 2:The respective cohorts for patient inclusion are:

Cohort A: Metastatic or advanced solid tumors that are HER2 IHC 3+ (excluding breast, gastric cancer, and colorectal cancer). Patients with non-small cell lung cancer can be included.
Cohort B: Metastatic or advanced solid tumors that are HER2 IHC 2+/ISH+ any tumor type (excluding breast, gastric cancer, and colorectal cancer). Patients with non-small cell lung cancer can be included.
Cohort C: Metastatic or advanced solid endometrial cancer that is HER2 IHC 2+ or 1+.
Cohort D: Metastatic or advanced ovarian cancer that is HER2 IHC 2+ or 1+.
Cohort E: Metastatic or advanced solid cervical cancer that is HER2 IHC 2+ or 1+.
Progressed following prior treatment or who have no satisfactory alternative treatment option.
Prior HER2 targeting therapy is permitted.

HER2 expression scored using current ASCO/CAP guidelines for scoring HER2 for gastric cancer.

Part 1: IHC 3+ or IHC 2+ by local or central assessment
Part 2: IHC and ISH results by central assessment as pre-defined for each cohort
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:

History of non-infectious pneumonitis/ILD that required steroids, 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 for Part 1. For Part 2, patients with primary diagnosis of adenocarcinoma of the breast, adenocarcinoma of the colon or rectum, adenocarcinoma of the gastric body or gastro-esophageal junction will be excluded.
Medical conditions that may interfere with the subject's participation in the study.

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

468

Study ID:

NCT04482309

Recruitment Status:

Recruiting

Sponsor:

AstraZeneca

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 112 Locations for this study

See Locations Near You

Research Site
Burbank California, 91505, United States
Research Site
Duarte California, 91010, United States
Research Site
Fullerton California, 92835, United States
Research Site
La Jolla California, 92093, United States
Research Site
Los Angeles California, 90095, United States
Research Site
Santa Rosa California, 95403, United States
Research Site
Chicago Illinois, 60637, United States
Research Site
Muncie Indiana, 47303, United States
Research Site
Boston Massachusetts, 02215, United States
Research Site
Detroit Michigan, 48201, United States
Research Site
Saint Louis Missouri, 63110, United States
Research Site
Middletown New Jersey, 07748, United States
Research Site
Harrison New York, 10604, United States
Research Site
New York New York, 10029, United States
Research Site
New York New York, 10065, United States
Research Site
Rochester New York, 14642, United States
Research Site
Durham North Carolina, 27710, United States
Research Site
Columbus Ohio, 43210, United States
Research Site
Nashville Tennessee, 37203, United States
Research Site
Houston Texas, 77030, United States
Research Site
Fairfax Virginia, 22031, United States
Research Site
Seattle Washington, 98195, United States
Research Site
Auchenflower , 4066, Australia
Research Site
Blacktown , 2148, Australia
Research Site
Camperdown , 2050, Australia
Research Site
Heidelberg , 3084, Australia
Research Site
Melbourne , 3000, Australia
Research Site
Nedlands , 6009, Australia
Research Site
Brussels , 1090, Belgium
Research Site
Bruxelles , 1200, Belgium
Research Site
Leuven , 3000, Belgium
Research Site
Liège , 4000, Belgium
Research Site
Curitiba , 81520, Brazil
Research Site
Porto Alegre , 90035, Brazil
Research Site
Porto Alegre , 91350, Brazil
Research Site
Ribeirão Preto , 14051, Brazil
Research Site
Kelowna British Columbia, V1Y 5, Canada
Research Site
Hamilton Ontario, L8V 5, Canada
Research Site
London Ontario, N6A 5, Canada
Research Site
Ottawa Ontario, K1H 8, Canada
Research Site
Montreal Quebec, H2X 0, Canada
Research Site
Montreal , H3T 1, Canada
Research Site
Quebec , G1J 1, Canada
Research Site
Brno , 656 5, Czechia
Research Site
Hradec Kralove , 500 0, Czechia
Research Site
Olomouc , 77900, Czechia
Research Site
Ostrava , 708 5, Czechia
Research Site
Praha 5 , 150 0, Czechia
Research Site
Praha 8 , 180 8, Czechia
Research Site
Delhi , 11008, India
Research Site
Gurgaon , 12200, India
Research Site
Kolkata , 70016, India
Research Site
Madurai , 62510, India
Research Site
Mumbai , 40001, India
Research Site
Mumbai , 40005, India
Research Site
Nashik , 42200, India
Research Site
Milan , 20141, Italy
Research Site
Milan , 20162, Italy
Research Site
Napoli , 80131, Italy
Research Site
Roma , 00128, Italy
Research Site
Rome , 168, Italy
Research Site
Suita-shi , 565-0, Japan
Research Site
Seoul , 03080, Korea, Republic of
Research Site
Seoul , 03722, Korea, Republic of
Research Site
Seoul , 06351, Korea, Republic of
Research Site
Seoul , 5505, Korea, Republic of
Research Site
Amsterdam , 1066C, Netherlands
Research Site
Delft , 2625 , Netherlands
Research Site
Groningen , 9700, Netherlands
Research Site
Bydgoszcz , 85-79, Poland
Research Site
Gdańsk , 80-21, Poland
Research Site
Gliwice , 44-10, Poland
Research Site
Kraków , 31-50, Poland
Research Site
Poznan , 60-78, Poland
Research Site
Warszawa , 02-78, Poland
Research Site
Kaluga , 24800, Russian Federation
Research Site
Moscow , 11541, Russian Federation
Research Site
Moscow , 11547, Russian Federation
Research Site
Moscow , 11799, Russian Federation
Research Site
Moscow , 12120, Russian Federation
Research Site
Moscow , 14342, Russian Federation
Research Site
Moscow , 14344, Russian Federation
Research Site
Saint Petersburg , 19527, Russian Federation
Research Site
Saint-Petersburg , 19775, Russian Federation
Research Site
Barcelona , 8035, Spain
Research Site
Córdoba , 14004, Spain
Research Site
Madrid , 28027, Spain
Research Site
Madrid , 28040, Spain
Research Site
Madrid , 28041, Spain
Research Site
Madrid , 28046, Spain
Research Site
Valencia , 46014, Spain
Research Site
Taichung , 40705, Taiwan
Research Site
Tainan , 736, Taiwan
Research Site
Taipei , 100, Taiwan
Research Site
Taipei , 10449, Taiwan
Research Site
Taipei , 11217, Taiwan
Research Site
Tao-Yuan , 333, Taiwan
Research Site
Bangkok , 10210, Thailand
Research Site
Bangkok , 10300, Thailand
Research Site
Bangkok , 10330, Thailand
Research Site
Bangkok , 10330, Thailand
Research Site
Bangkok , 10400, Thailand
Research Site
Bangkok , 10400, Thailand
Research Site
Bangkok , 10700, Thailand
Research Site
Chiang Mai , 50200, Thailand
Research Site
Hat Yai , 90110, Thailand
Research Site
Khon Kaen , 40002, Thailand
Research Site
Muang , 34000, Thailand
Research Site
Muang , 50200, Thailand
Research Site
Ongkharak , 26120, Thailand
Research Site
Sisaket , 33000, Thailand
Research Site
Glasgow , G12 0, United Kingdom
Research Site
London , SW2 6, United Kingdom
Research Site
Manchester , M20 4, United Kingdom
Research Site
Northwood Middlesex , HA6 2, United Kingdom
Research Site
Sutton , SM2 5, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

468

Study ID:

NCT04482309

Recruitment Status:

Recruiting

Sponsor:


AstraZeneca

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.