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A Phase 2 Study of T-DXd in Patients With Selected HER2 Expressing Tumors (DPT02)

Primary Purpose

Bladder Cancer, Biliary Tract Cancer, Cervical Cancer, Endometrial Cancer, Ovarian Cancer, Pancreatic Cancer, Rare Tumors

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Trastuzumab deruxtecan
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Cancer, Biliary Tract Cancer, Cervical Cancer, Endometrial Cancer, Ovarian Cancer, Pancreatic Cancer, Rare Tumors focused on measuring T-DXd, DS-8201a, Trastuzumab Deruxtecan, HER2

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

  • 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.
  • Medical conditions that may interfere with the subject's participation in the study.

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Description

Cohort 1: Biliary tract cancer

Cohort 2: Bladder cancer

Cohort 3: Cervical cancer

Cohort 4: Endometrial cancer

Cohort 5: Ovarian cancer

Cohort 6: Pancreatic cancer

Cohort 7: Rare tumors

Outcomes

Primary Outcome Measures

Objective Response Rate (ORR)
Confirmed ORR per RECIST 1.1 is the percentage of patients with Complete Response or Partial Response that is subsequently confirmed.

Secondary Outcome Measures

Duration of response (DoR)
DOR is defined as the time from the date of first documented response until the date of documented progression or death.
Disease control rate (DCR)
DCR is the percentage of subjects who have a best overall response of complete response (CR) or partial response (PR) or stable disease (SD).
Progression free survival (PFS)
PFS is the time from date of first dose of study treatment until the date of objective disease progression or death.
Proportion of patients alive and progression-free at 6 months and 12 months
The proportion of patients alive and progression-free at 6 and 12 months (Kaplan-Meier estimates).
Overall survival (OS)
OS is the time from date of first dose of study treatment until death due to any cause.
Proportion of patients alive at 6 and 12 months
The proportion of patients alive at 6 and 12 months (Kaplan-Meier estimates).
Occurrence of adverse events (AEs) and serious adverse events (SAEs)
Occurrence of AEs and SAEs graded according to NCI CTCAE v5.0.
Pharmacokinetics (PK) assessed by serum concentration of T-DXd, total anti-HER2 antibody and MAAA-1181
Individual patient data and descriptive statistics will be provided for serum concentration data at each time point for T-DXd, total anti-HER2 antibody and MAAA-1181a
The immunogenicity of T-DXd assessed by the presence of ADAs for T-DXd
Individual participant data and descriptive statistics will be provided for data at each time point.

Full Information

First Posted
July 20, 2020
Last Updated
July 7, 2023
Sponsor
AstraZeneca
Collaborators
Daiichi Sankyo Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04482309
Brief Title
A Phase 2 Study of T-DXd in Patients With Selected HER2 Expressing Tumors
Acronym
DPT02
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 18, 2020 (Actual)
Primary Completion Date
June 8, 2023 (Actual)
Study Completion Date
March 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
Collaborators
Daiichi Sankyo Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer, Biliary Tract Cancer, Cervical Cancer, Endometrial Cancer, Ovarian Cancer, Pancreatic Cancer, Rare Tumors
Keywords
T-DXd, DS-8201a, Trastuzumab Deruxtecan, HER2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
This study will consist of seven cohorts of urothelial bladder cancer, biliary tract cancer, cervical cancer, endometrial cancer, ovarian cancer, Pancreatic cancer, and rare tumors.
Masking
None (Open Label)
Masking Description
This study is Open-Label Study.
Allocation
Non-Randomized
Enrollment
468 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Cohort 1: Biliary tract cancer
Arm Title
Arm 2
Arm Type
Experimental
Arm Description
Cohort 2: Bladder cancer
Arm Title
Arm 3
Arm Type
Experimental
Arm Description
Cohort 3: Cervical cancer
Arm Title
Arm 4
Arm Type
Experimental
Arm Description
Cohort 4: Endometrial cancer
Arm Title
Arm 5
Arm Type
Experimental
Arm Description
Cohort 5: Ovarian cancer
Arm Title
Arm 6
Arm Type
Experimental
Arm Description
Cohort 6: Pancreatic cancer
Arm Title
Arm 7
Arm Type
Experimental
Arm Description
Cohort 7: Rare tumors
Intervention Type
Drug
Intervention Name(s)
Trastuzumab deruxtecan
Other Intervention Name(s)
DS-8201a, T-DXd
Intervention Description
Trastuzumab deruxtecan by intravenous infusion
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
Confirmed ORR per RECIST 1.1 is the percentage of patients with Complete Response or Partial Response that is subsequently confirmed.
Time Frame
An average of approximately 41 months
Secondary Outcome Measure Information:
Title
Duration of response (DoR)
Description
DOR is defined as the time from the date of first documented response until the date of documented progression or death.
Time Frame
An average of approximately 41 months
Title
Disease control rate (DCR)
Description
DCR is the percentage of subjects who have a best overall response of complete response (CR) or partial response (PR) or stable disease (SD).
Time Frame
An average of approximately 41 months
Title
Progression free survival (PFS)
Description
PFS is the time from date of first dose of study treatment until the date of objective disease progression or death.
Time Frame
An average of approximately 41 months
Title
Proportion of patients alive and progression-free at 6 months and 12 months
Description
The proportion of patients alive and progression-free at 6 and 12 months (Kaplan-Meier estimates).
Time Frame
Up to 12 months
Title
Overall survival (OS)
Description
OS is the time from date of first dose of study treatment until death due to any cause.
Time Frame
An average of approximately 41 months
Title
Proportion of patients alive at 6 and 12 months
Description
The proportion of patients alive at 6 and 12 months (Kaplan-Meier estimates).
Time Frame
Up to 12 months
Title
Occurrence of adverse events (AEs) and serious adverse events (SAEs)
Description
Occurrence of AEs and SAEs graded according to NCI CTCAE v5.0.
Time Frame
An average of approximately 41 months
Title
Pharmacokinetics (PK) assessed by serum concentration of T-DXd, total anti-HER2 antibody and MAAA-1181
Description
Individual patient data and descriptive statistics will be provided for serum concentration data at each time point for T-DXd, total anti-HER2 antibody and MAAA-1181a
Time Frame
An average of approximately 41 months
Title
The immunogenicity of T-DXd assessed by the presence of ADAs for T-DXd
Description
Individual participant data and descriptive statistics will be provided for data at each time point.
Time Frame
An average of approximately 41 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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. Medical conditions that may interfere with the subject's participation in the study.
Facility Information:
Facility Name
Research Site
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Research Site
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Facility Name
Research Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Research Site
City
Muncie
State/Province
Indiana
ZIP/Postal Code
47303
Country
United States
Facility Name
Research Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Research Site
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Facility Name
Research Site
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Research Site
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Facility Name
Research Site
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Research Site
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Research Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Research Site
City
Auchenflower
ZIP/Postal Code
4066
Country
Australia
Facility Name
Research Site
City
Camperdown
ZIP/Postal Code
2050
Country
Australia
Facility Name
Research Site
City
Heidelberg
ZIP/Postal Code
3084
Country
Australia
Facility Name
Research Site
City
Nedlands
ZIP/Postal Code
6009
Country
Australia
Facility Name
Research Site
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Research Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Research Site
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Research Site
City
Montreal
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Research Site
City
Quebec
ZIP/Postal Code
G1J 1Z4
Country
Canada
Facility Name
Research Site
City
Brno
ZIP/Postal Code
656 53
Country
Czechia
Facility Name
Research Site
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Research Site
City
Olomouc
ZIP/Postal Code
775 20
Country
Czechia
Facility Name
Research Site
City
Praha 5
ZIP/Postal Code
150 06
Country
Czechia
Facility Name
Research Site
City
Praha 8
ZIP/Postal Code
180 81
Country
Czechia
Facility Name
Research Site
City
Delhi
ZIP/Postal Code
110085
Country
India
Facility Name
Research Site
City
Gurgaon
ZIP/Postal Code
122001
Country
India
Facility Name
Research Site
City
Kolkata
ZIP/Postal Code
700160
Country
India
Facility Name
Research Site
City
Mumbai
ZIP/Postal Code
400012
Country
India
Facility Name
Research Site
City
Milan
ZIP/Postal Code
20141
Country
Italy
Facility Name
Research Site
City
Milan
ZIP/Postal Code
20162
Country
Italy
Facility Name
Research Site
City
Roma
ZIP/Postal Code
00128
Country
Italy
Facility Name
Research Site
City
Rome
ZIP/Postal Code
168
Country
Italy
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
5505
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
6351
Country
Korea, Republic of
Facility Name
Research Site
City
Amsterdam
ZIP/Postal Code
1066CX
Country
Netherlands
Facility Name
Research Site
City
Delft
ZIP/Postal Code
2625 AD
Country
Netherlands
Facility Name
Research Site
City
Groningen
ZIP/Postal Code
9700
Country
Netherlands
Facility Name
Research Site
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
Facility Name
Research Site
City
Gdańsk
ZIP/Postal Code
80-214
Country
Poland
Facility Name
Research Site
City
Kraków
ZIP/Postal Code
30-688
Country
Poland
Facility Name
Research Site
City
Poznan
ZIP/Postal Code
60-780
Country
Poland
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Research Site
City
Kaluga
ZIP/Postal Code
248007
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
115419
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
117997
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
121205
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
143423
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
143442
Country
Russian Federation
Facility Name
Research Site
City
Saint Petersburg
ZIP/Postal Code
195271
Country
Russian Federation
Facility Name
Research Site
City
Saint-Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
8035
Country
Spain
Facility Name
Research Site
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28027
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Research Site
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Research Site
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
Research Site
City
Tainan
ZIP/Postal Code
736
Country
Taiwan
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Research Site
City
Tao-Yuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Research Site
City
Bangkok
ZIP/Postal Code
10210
Country
Thailand
Facility Name
Research Site
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Research Site
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Research Site
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Research Site
City
Hat Yai
ZIP/Postal Code
90110
Country
Thailand
Facility Name
Research Site
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Facility Name
Research Site
City
Muang
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Research Site
City
Ongkharak
ZIP/Postal Code
26120
Country
Thailand
Facility Name
Research Site
City
London
ZIP/Postal Code
SW2 6JJ
Country
United Kingdom
Facility Name
Research Site
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Research Site
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
IPD Sharing Time Frame
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD Sharing Access Criteria
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD Sharing URL
https://astrazenecagroup-dt.pharmacm.com/DT/Home

Learn more about this trial

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

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