Advanced Solid Tumors (Excluding Gastric Cancer and Breast Cancer)Phase 2NCT06271837
A Study of T-DXd as Monotherapy or in Combination With Anti-cancer Agents in Patients With Selected HER2-expressing Tumors
A Phase 2 study testing Trastuzumab deruxtecan and Bevacizumab in people with Advanced Solid Tumors (Excluding Gastric Cancer and Breast Cancer), run by AstraZeneca at 29 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Advanced Solid Tumors (Excluding Gastric Cancer and Breast Cancer)
- What is being tested?
- Trastuzumab deruxtecan and Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 29 sitesChina
- Study dates
- 22 Feb 2024to 10 Feb 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- Primary diagnosis of adenocarcinoma of the breast, adenocarcinoma of the gastric body or gastroesophageal junction.
- Has substance abuse or any other medical conditions that may interfere with the patient's participation in the clinical study or evaluation of the clinical study results.
- A pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and concentrated ascites reinfusion therapy.
- History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 3 years before the first dose of study intervention and of low potential risk for recurrence. Exceptions include adequately resected non melanoma skin cancer, curatively treated in situ disease, or other solid tumors curatively treated.
- Has unresolved toxicities from previous anti cancer therapy.
- Has any spinal cord compression, leptomeningeal disease, or clinically active CNS metastases.
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- Uncontrolled infection requiring IV injection of antibiotics, antivirals, or antifungals, or active infection including tuberculosis.
- Active primary immunodeficiency, known uncontrolled active HIV infection, or active Hepatitis B or C infection.
- Protocol-defined inadequate cardiac function.
- History of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
- Has a concomitant medical condition that would increase the risk of toxicity in the opinion of the investigator.
- Anti cancer chemotherapy without an adequate treatment washout period prior to enrollment.
- Major surgical procedure (excluding placement of vascular access) or significant traumatic injury within 4 weeks of the first dose of study intervention or an anticipated need for major surgery during the study.
- Known allergy or hypersensitivity to study treatment or any excipients of the product or other mAbs.
- Involvement in the planning and/or conduct of the study.
- Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements.
- Previous enrollment in the present study. Concurrent enrollment in another therapeutic clinical study (excluding observational studies).
- For females only: Currently pregnant or breast feeding, or who are planning to become pregnant.
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
China29 sites
Research Site
Beijing, 100142
Research Site
Beijing, 100191
Research Site
Changchun, 130021
Research Site
Changsha, 410013
Research Site
Chengdu, 610041
Research Site
Chongqing, 400030
Research Site
Dongyang, 322100
Research Site
Guangzhou, 510145
Research Site
Guangzhou, 510630
Research Site
Hangzhou, 310003
Research Site
Hangzhou, 310016
Research Site
Hangzhou, 310022
Research Site
Harbin, 150081
Research Site
Hefei, 230031
Research Site
Kunming, 650118
Research Site
Lishui, 323000
Research Site
Nanchang, 330029
Research Site
Shandong
Research Site
Shanghai, 200001
Research Site
Shanghai, 200011
Research Site
Shanghai, 200032
Research Site
Shenyang, 110016
Research Site
Taiyuan, 030001
Research Site
Wuhan, 430022
Research Site
Xi'an, 710061
Research Site
Xuzhou, 221009
Research Site
Yinchuan, 750004
Research Site
Zhengzhou, 450002
Research Site
Zhengzhou, 450008
About this study
Official title: 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)
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.
- Being tested
- Trastuzumab deruxtecan, Bevacizumab
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trastuzumab deruxtecanDrug
Also called DS-8201a, T-DXd
Trastuzumab deruxtecan by intravenous infusion
BevacizumabDrug
Bevacizumab by intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | Experimental | HER2 IHC 3+ solid tumors (excluding breast and gastric cancer) Receives: Drug: Trastuzumab deruxtecan |
| Part 2 Cohort A | Experimental | HER2 IHC 2+ solid tumors (excluding breast and gastric cancer) Receives: Drug: Trastuzumab deruxtecan |
| Part 2 Cohort B | Experimental | HER2 IHC 1+ gynecologic cancers Receives: Drug: Trastuzumab deruxtecan |
| Part 3 | Experimental | HER2 IHC 3+ or 2+ cervical cancer Receives: Drug: Trastuzumab deruxtecan; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confirmed Objective Response Rate (ORR)
Confirmed ORR is the proportion of patients who have a confirmed complete response or confirmed partial response per RECIST 1.1.
Measured: An average of approximately 12 months
Secondary outcomes (8)
Duration of Response (DoR)
DoR is defined as the time from the date of first documented response until the date of documented progression (per RECIST 1.1) or death in the absence of disease progression.
Measured: An average of approximately 12 months
Disease control rate (DCR)
The DCR is defined as the percentage of patients who have a confirmed complete response (CR) or partial response (PR) or stable disease (SD) per RECIST 1.1.
Measured: An average of approximately 12 months
Confirmed best objective response (BOR)
BOR is a patient's best response during their participation in the study up until RECIST 1.1-defined progression or the last evaluable assessment in the absence of RECIST 1.1-defined progression.
Measured: An average of approximately 12 months
Progression-free survival (PFS)
PFS is defined as the time from the date of enrollment until the date of objective progressive disease (PD) per RECIST 1.1 or death.
Measured: An average of approximately 12 months
Overall survival (OS)
OS is defined as the time from the date of enrollment until death due to any cause.
Measured: An average of approximately 12 months
Occurrence of adverse events (AEs) and serious adverse events (SAEs)
The grading scales found in the revised NCI CTCAE v5.0 will be utilized for all events.
Measured: An average of approximately 12 months
Pharmacokinetics (PK) of T-DXd
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.
Measured: An average of approximately 12 months
Immunogenicity of T-DXd
Incidence of anti-drug antibodies against T-DXd in serum at each time point.
Measured: An average of approximately 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start22 Feb 2024
- Primary completion10 Feb 2027 (estimated)
- Study completion10 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid Tumors (Excluding Gastric Cancer and Breast Cancer)Studies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Daiichi Sankyo Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06271837
- Sponsor's protocol ID
- D781AC00001
- Status last verified
- Aug 2026
- First submitted
- 19 Jan 2024
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests 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 approved.
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06271837
- Acronym / sponsor ID
- D781AC00001
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 127 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Daiichi Sankyo Co., Ltd.
- Study start
- 22 Feb 2024 (actual)
- Primary completion
- 10 Feb 2027 (estimated)
- Study completion
- 10 Feb 2027 (estimated)
- First posted
- 22 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part 1 | Experimental | Drug: Trastuzumab deruxtecanHER2 IHC 3+ solid tumors (excluding breast and gastric cancer) |
| Part 2 Cohort A | Experimental | Drug: Trastuzumab deruxtecanHER2 IHC 2+ solid tumors (excluding breast and gastric cancer) |
| Part 2 Cohort B | Experimental | Drug: Trastuzumab deruxtecanHER2 IHC 1+ gynecologic cancers |
| Part 3 | Experimental | Drug: Trastuzumab deruxtecan, Drug: BevacizumabHER2 IHC 3+ or 2+ cervical cancer |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (18 listed)
- Primary diagnosis of adenocarcinoma of the breast, adenocarcinoma of the gastric body or gastroesophageal junction.
- Has substance abuse or any other medical conditions that may interfere with the patient's participation in the clinical study or evaluation of the clinical study results.
- A pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and concentrated ascites reinfusion therapy.
- History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 3 years before the first dose of study intervention and of low potential risk for recurrence. Exceptions include adequately resected non melanoma skin cancer, curatively treated in situ disease, or other solid tumors curatively treated.
- Has unresolved toxicities from previous anti cancer therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trastuzumab deruxtecanAlso: DS-8201a, T-DXdTrastuzumab deruxtecan by intravenous infusion | Drug | Part 1, Part 2 Cohort A, Part 2 Cohort B, Part 3 |
| BevacizumabBevacizumab by intravenous infusion | Drug | Part 3 |
Primary outcome
Confirmed Objective Response Rate (ORR)
Time frame: An average of approximately 12 months
Confirmed ORR is the proportion of patients who have a confirmed complete response or confirmed partial response per RECIST 1.1.
8 secondary outcomes
Duration of Response (DoR)
Time frame: An average of approximately 12 months
Disease control rate (DCR)
Time frame: An average of approximately 12 months
Confirmed best objective response (BOR)
Time frame: An average of approximately 12 months
Progression-free survival (PFS)
Time frame: An average of approximately 12 months
Overall survival (OS)
Time frame: An average of approximately 12 months
Occurrence of adverse events (AEs) and serious adverse events (SAEs)
Time frame: An average of approximately 12 months
Pharmacokinetics (PK) of T-DXd
Time frame: An average of approximately 12 months
Immunogenicity of T-DXd
Time frame: An average of approximately 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests 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 approved.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trastuzumab deruxtecan and Bevacizumab in people with Advanced Solid Tumors (Excluding Gastric Cancer and Breast Cancer), run by AstraZeneca at 29 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Confirmed Objective Response Rate (ORR) (time frame: An average of approximately 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.