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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04482309




Registration number
NCT04482309
Ethics application status
Date submitted
20/07/2020
Date registered
22/07/2020

Titles & IDs
Public title
A Phase 2 Study of T-DXd in Patients With Selected HER2 Expressing Tumors
Scientific 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)
Secondary ID [1] 0 0
2020-001574-29
Secondary ID [2] 0 0
D967VC00001
Universal Trial Number (UTN)
Trial acronym
DPT02
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Part 1: Bladder, Biliary Tract, Cervical, Endometrial, Ovarian, Pancreatic Cancer, Rare Tumors, Any Tumor Type Excluding Breast, Gastric, Colorectal Cancer 0 0
Part 2: HER2 Expressing/Amplified Solid Tumors Excluding Breast, Gastric, Colorectal Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Trastuzumab deruxtecan

Experimental: Part 1 Cohort 1 - Biliary tract cancer

Experimental: Part 1 Cohort 2 - Bladder cancer

Experimental: Part 1 Cohort 3 - Cervical cancer

Experimental: Part 1 Cohort 4 - Endometrial cancer

Experimental: Part 1 Cohort 5 - Ovarian cancer

Experimental: Part 1 Cohort 6 - Pancreatic cancer

Experimental: Part 1 Cohort 7 - Rare tumors

Experimental: Part 2 Cohort A - Any tumor type that is HER2 IHC 3+ (excluding breast, gastric cancer, and colorectal cancer)

Experimental: Part 2 Cohort B - Any tumor type that is HER2 IHC 2+/ISH+ (excluding breast, gastric cancer, and colorectal cancer)

Experimental: Part 2 Cohort C - HER2 IHC 2+ or 1+ endometrial cancer

Experimental: Part 2 Cohort D - HER2 IHC 2+ or 1+ ovarian cancer

Experimental: Part 2 Cohort E - HER2 IHC 2+ or 1+ cervical cancer


Treatment: Drugs: Trastuzumab deruxtecan
Trastuzumab deruxtecan by intravenous infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective Response Rate (ORR)
Timepoint [1] 0 0
An average of approximately 6 months
Secondary outcome [1] 0 0
Duration of response (DoR)
Timepoint [1] 0 0
An average of approximately 6 months
Secondary outcome [2] 0 0
Disease control rate (DCR)
Timepoint [2] 0 0
An average of approximately 6 months
Secondary outcome [3] 0 0
Progression free survival (PFS)
Timepoint [3] 0 0
An average of approximately 6 months
Secondary outcome [4] 0 0
Proportion of patients alive and progression-free at 6 months and 12 months
Timepoint [4] 0 0
Up to 12 months
Secondary outcome [5] 0 0
Overall survival (OS)
Timepoint [5] 0 0
An average of approximately 14 months
Secondary outcome [6] 0 0
Proportion of patients alive at 6 and 12 months
Timepoint [6] 0 0
Up to 12 months
Secondary outcome [7] 0 0
Occurrence of adverse events (AEs) and serious adverse events (SAEs)
Timepoint [7] 0 0
An average of approximately 8 months
Secondary outcome [8] 0 0
Pharmacokinetics (PK) assessed by serum concentration of T-DXd, total anti-HER2 antibody and MAAA-1181
Timepoint [8] 0 0
An average of approximately 8 months
Secondary outcome [9] 0 0
The immunogenicity of T-DXd assessed by the presence of ADAs for T-DXd
Timepoint [9] 0 0
An average of approximately 6 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
120 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/08/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/07/2027
Actual
Sample size
Target
468
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Auchenflower
Recruitment hospital [2] 0 0
Research Site - Blacktown
Recruitment hospital [3] 0 0
Research Site - Camperdown
Recruitment hospital [4] 0 0
Research Site - Heidelberg
Recruitment hospital [5] 0 0
Research Site - Melbourne
Recruitment hospital [6] 0 0
Research Site - Nedlands
Recruitment postcode(s) [1] 0 0
4066 - Auchenflower
Recruitment postcode(s) [2] 0 0
2148 - Blacktown
Recruitment postcode(s) [3] 0 0
2050 - Camperdown
Recruitment postcode(s) [4] 0 0
3084 - Heidelberg
Recruitment postcode(s) [5] 0 0
3000 - Melbourne
Recruitment postcode(s) [6] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Indiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
New Jersey
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
United States of America
State/province [11] 0 0
Tennessee
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
United States of America
State/province [13] 0 0
Virginia
Country [14] 0 0
United States of America
State/province [14] 0 0
Washington
Country [15] 0 0
Belgium
State/province [15] 0 0
Brussels
Country [16] 0 0
Belgium
State/province [16] 0 0
Bruxelles
Country [17] 0 0
Belgium
State/province [17] 0 0
Leuven
Country [18] 0 0
Belgium
State/province [18] 0 0
Liège
Country [19] 0 0
Brazil
State/province [19] 0 0
Barretos
Country [20] 0 0
Brazil
State/province [20] 0 0
Curitiba
Country [21] 0 0
Brazil
State/province [21] 0 0
Natal
Country [22] 0 0
Brazil
State/province [22] 0 0
Porto Alegre
Country [23] 0 0
Brazil
State/province [23] 0 0
Ribeirão Preto
Country [24] 0 0
Brazil
State/province [24] 0 0
São Paulo
Country [25] 0 0
Brazil
State/province [25] 0 0
Vitória
Country [26] 0 0
Canada
State/province [26] 0 0
British Columbia
Country [27] 0 0
Canada
State/province [27] 0 0
Ontario
Country [28] 0 0
Canada
State/province [28] 0 0
Quebec
Country [29] 0 0
Canada
State/province [29] 0 0
Montreal
Country [30] 0 0
Czechia
State/province [30] 0 0
Brno
Country [31] 0 0
Czechia
State/province [31] 0 0
Hradec Kralove
Country [32] 0 0
Czechia
State/province [32] 0 0
Olomouc
Country [33] 0 0
Czechia
State/province [33] 0 0
Ostrava
Country [34] 0 0
Czechia
State/province [34] 0 0
Praha 5
Country [35] 0 0
Czechia
State/province [35] 0 0
Praha 8
Country [36] 0 0
India
State/province [36] 0 0
Delhi
Country [37] 0 0
India
State/province [37] 0 0
Gurgaon
Country [38] 0 0
India
State/province [38] 0 0
Kolkata
Country [39] 0 0
India
State/province [39] 0 0
Madurai
Country [40] 0 0
India
State/province [40] 0 0
Mumbai
Country [41] 0 0
India
State/province [41] 0 0
Nashik
Country [42] 0 0
Italy
State/province [42] 0 0
Milan
Country [43] 0 0
Italy
State/province [43] 0 0
Napoli
Country [44] 0 0
Italy
State/province [44] 0 0
Roma
Country [45] 0 0
Italy
State/province [45] 0 0
Rome
Country [46] 0 0
Japan
State/province [46] 0 0
Chuo-ku
Country [47] 0 0
Japan
State/province [47] 0 0
Kashiwa
Country [48] 0 0
Japan
State/province [48] 0 0
Suita-shi
Country [49] 0 0
Korea, Republic of
State/province [49] 0 0
Seoul
Country [50] 0 0
Netherlands
State/province [50] 0 0
Amsterdam
Country [51] 0 0
Netherlands
State/province [51] 0 0
Delft
Country [52] 0 0
Netherlands
State/province [52] 0 0
Groningen
Country [53] 0 0
Poland
State/province [53] 0 0
Bydgoszcz
Country [54] 0 0
Poland
State/province [54] 0 0
Gdansk
Country [55] 0 0
Poland
State/province [55] 0 0
Gliwice
Country [56] 0 0
Poland
State/province [56] 0 0
Kraków
Country [57] 0 0
Poland
State/province [57] 0 0
Poznan
Country [58] 0 0
Poland
State/province [58] 0 0
Warszawa
Country [59] 0 0
Russian Federation
State/province [59] 0 0
Kaluga
Country [60] 0 0
Russian Federation
State/province [60] 0 0
Moscow
Country [61] 0 0
Russian Federation
State/province [61] 0 0
Saint Petersburg
Country [62] 0 0
Russian Federation
State/province [62] 0 0
Saint-Petersburg
Country [63] 0 0
Spain
State/province [63] 0 0
Barcelona
Country [64] 0 0
Spain
State/province [64] 0 0
Córdoba
Country [65] 0 0
Spain
State/province [65] 0 0
Madrid
Country [66] 0 0
Spain
State/province [66] 0 0
Valencia
Country [67] 0 0
Taiwan
State/province [67] 0 0
Taichung
Country [68] 0 0
Taiwan
State/province [68] 0 0
Tainan
Country [69] 0 0
Taiwan
State/province [69] 0 0
Taipei
Country [70] 0 0
Taiwan
State/province [70] 0 0
Tao-Yuan
Country [71] 0 0
Thailand
State/province [71] 0 0
Bangkok
Country [72] 0 0
Thailand
State/province [72] 0 0
Chiang Mai
Country [73] 0 0
Thailand
State/province [73] 0 0
Hat Yai
Country [74] 0 0
Thailand
State/province [74] 0 0
Khon Kaen
Country [75] 0 0
Thailand
State/province [75] 0 0
Muang
Country [76] 0 0
Thailand
State/province [76] 0 0
Ongkharak
Country [77] 0 0
Thailand
State/province [77] 0 0
Sisaket
Country [78] 0 0
United Kingdom
State/province [78] 0 0
Glasgow
Country [79] 0 0
United Kingdom
State/province [79] 0 0
London
Country [80] 0 0
United Kingdom
State/province [80] 0 0
Manchester
Country [81] 0 0
United Kingdom
State/province [81] 0 0
Northwood Middlesex
Country [82] 0 0
United Kingdom
State/province [82] 0 0
Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Daiichi Sankyo Co., Ltd.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
AstraZeneca Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-877-240-9479
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
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.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04482309