A Phase II, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd, DS-8201a) as Monotherapy or in Combination With Anti-cancer Agents for the Treatment of Patients With Selected HER2-expressing Tumors (DESTINY PanTumor03)

Status: Recruiting
Location: See all (31) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This is an open-label, multicenter, Phase II study to evaluate the efficacy and safety of trastuzumab deruxtecan as monotherapy or in combination with anti-cancer agents for the treatment in locally advanced, unresectable, or metastatic patients with selected HER2-expressing solid tumors which are not eligible for curative therapy.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 130
Healthy Volunteers: f
View:

• At least 18 years of age.

• Locally advanced, unresectable, or metastatic solid tumors based on most recent imaging.

• HER2 expression.

• ECOG performance status of 0-1.

• Must provide an adequate FFPE tumor sample to centrally determine HER2 status and other correlatives.

• Has measurable target disease assessed by the investigator based on RECIST 1.1.

• Adequate organ function and bone marrow within 14 days before enrollment.

• Contraceptive use by males or females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

• Capable of giving signed informed consent.

• Provision of signed and dated written ICF prior to mandatory study-specific procedures, sampling, or analyses.

• Evidence of post-menopausal status or negative serum pregnancy test for females of childbearing potential who are sexually active with a non-sterilized male partner.

Locations
Other Locations
China
Research Site
RECRUITING
Beijing
Research Site
RECRUITING
Beijing
Research Site
RECRUITING
Changchun
Research Site
RECRUITING
Changsha
Research Site
WITHDRAWN
Changzhou
Research Site
RECRUITING
Chengdu
Research Site
RECRUITING
Chongqing
Research Site
RECRUITING
Dongyang
Research Site
RECRUITING
Guangzhou
Research Site
RECRUITING
Guangzhou
Research Site
WITHDRAWN
Haikou
Research Site
RECRUITING
Hangzhou
Research Site
RECRUITING
Hangzhou
Research Site
RECRUITING
Hangzhou
Research Site
RECRUITING
Harbin
Research Site
RECRUITING
Hefei
Research Site
RECRUITING
Kunming
Research Site
RECRUITING
Lishui
Research Site
RECRUITING
Nanchang
Research Site
RECRUITING
Shandong
Research Site
RECRUITING
Shanghai
Research Site
RECRUITING
Shanghai
Research Site
RECRUITING
Shanghai
Research Site
RECRUITING
Shenyang
Research Site
RECRUITING
Taiyuan
Research Site
RECRUITING
Wuhan
Research Site
RECRUITING
Xi'an
Research Site
RECRUITING
Xuzhou
Research Site
RECRUITING
Yinchuan
Research Site
RECRUITING
Zhengzhou
Research Site
RECRUITING
Zhengzhou
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date: 2024-02-18
Estimated Completion Date: 2027-04-01
Participants
Target number of participants: 175
Treatments
Experimental: Part 1
HER2 IHC 3+ solid tumors (excluding breast and gastric cancer)
Experimental: Part 2 Cohort A
HER2 IHC 2+ solid tumors (excluding breast and gastric cancer)
Experimental: Part 2 Cohort B
HER2 IHC 1+ gynecologic cancers
Experimental: Part 3
HER2 IHC 3+ or 2+ cervical cancer
Related Therapeutic Areas
Sponsors
Leads: AstraZeneca
Collaborators: Daiichi Sankyo Co., Ltd.

This content was sourced from clinicaltrials.gov