NCT05460273 · CITED IN SOURCE DOCUMENTS

A Study of Dato-DXd in Chinese Patients With Advanced Non-Small Cell Lung Cancer, Triple-negative Breast Cancer and Other Solid Tumors (TROPION-PanTumor02)

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase: PHASE1, PHASE2
Status at capture: ACTIVE NOT RECRUITING
Registry last update: 2026-08-31

Researchers are looking for a better way to treat advanced Triple-Negative Breast Cancer (TNBC) and Non-Small-Cell Lung Cancer (NSCLC). "Advanced" usually means that the cancer keeps growing even with treatment. The cancer may also be "metastatic", which means that it has spread to other parts of the body or the surrounding tissue. The study drug, Datopotamab deruxtecan, is designed to work by attaching to the tumor cells and stopping the tumor growth. Datopotamab deruxtecan is also known as Dato-DXd. In this study, the researchers want to find out how well Dato-DXd works to stop tumors from growing in Chinese participants with NCSLC or TNBC. This is the first time Dato-DXd is being studied in Chinese population. Participants in this study will get Dato-DXd through a needle as an injection. They will get 1 dose of Dato-DXd every 3 weeks until their cancer gets worse or they leave the study for another reason. Participants will visit their study sites at least once every 3 weeks for as long as they are in the study. The study doctors will take blood samples every 3 weeks and take images of the participants' tumors every 6 weeks until the participant leaves the study.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Confirmed Objective Response Rate(ORR) Assessed by Independent Central Review(ICR)

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outcome · POSTED

Confirmed Objective Response Rate(ORR) Assessed by Investigator

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outcome · POSTED

Duration of Response (DoR), Assessed by Investigator

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outcome · POSTED

Disease Control Rate (DCR), Assessed by ICR

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outcome · POSTED

Best Overall Response (BoR) , Assessed by ICR

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outcome · POSTED

Time To Response (TTR) , Assessed by ICR

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outcome · POSTED

Progression-Free Survival (PFS) , Assessed by ICR

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outcome · POSTED

Overall Survival (OS)

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outcome · POSTED

Progression-Free Survival (PFS) , Assessed by Investigator

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outcome · POSTED

Disease Control Rate (DCR), Assessed by Investigator

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outcome · POSTED

Best Overall Response (BoR) , Assessed by Investigator

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outcome · POSTED

Time To Response (TTR) , Assessed by Investigator

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outcome · POSTED

Pharmacokinetic Parameter: Area Under the Plasma Concentration- Time Curve (AUC) _ Total Anti-TROP2 Antibody

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outcome · POSTED

Pharmacokinetic Parameter: Maximum Plasma Concentration (Cmax) _ Total Anti-TROP2 Antibody

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outcome · POSTED

Pharmacokinetic Parameter: Area Under the Plasma Concentration- Time Curve (AUC) _Dato-DXd

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outcome · POSTED

Pharmacokinetic Parameter: Maximum Plasma Concentration (Cmax) _ Dato-DXd

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outcome · POSTED

Pharmacokinetic Parameter: Area Under the Plasma Concentration- Time Curve (AUC) _ MAAA-1181a

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outcome · POSTED

Pharmacokinetic Parameter: Maximum Plasma Concentration (Cmax) _ MAAA-1181a

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outcome · POSTED

Pharmacokinetic Parameter: Time to Maximum Plasma Concentration (Tmax) _Total Anti-TROP2 Antibody

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outcome · POSTED

Pharmacokinetic Parameter: Time to Maximum Plasma Concentration (Tmax) _Dato-DXd

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outcome · POSTED

Pharmacokinetic Parameter: Time to Maximum Plasma Concentration (Tmax) _ MAAA-1181a

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outcome · POSTED

Immunogenicity of Dato-DXd

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outcome · POSTED

Duration of Response (DoR), Assessed by ICR

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Key Inclusion Criteria: * Capable of giving signed informed consent. * Participant must be ≥ 18 years at the time of screening. * Eastern Cooperative Oncology Group performance status of 0 or 1. * At least one lesion not previously irradiated that qualifies as a RECIST 1.1 target lesion at baseline and can be accurately measured at baseline and is suitable for accurate repeated measurements. Additional Inclusion Criteria for Cohort 1 (NSCLC): \- Histologically or cytologically documented Stage IIIB or IIIC NSCLC disease not amenable for surgical resection or definitive chemoradiation or Stage IV NSCLC disease at the beginning of study intervention. For the subset of participants without AGAs: * Documented negative test results for EGFR and ALK genomic alterations. If test results for EGFR and ALK are not available, participants are required to undergo testing performed locally for these genomic alterations. * Participants must meet one of the required prior therapy requirements for advanced or metastatic NSCLC. For the subset of participants with AGAs: \- Documented positive test results for one or more actionable genomic alteration: EGFR, ALK, ROS1, METex14 skipping, RET or other AGAs with approved therapies \- Received one or two prior lines of applicable targeted therapy for the participant's genomic alteration at the time of screening. Additional Inclusion Criteria for Cohort 2 (TNBC) * Pathologically documented oestrogen and progesterone receptor-negative and HER2-negative expression. * Inoperable locally advanced or metastatic breast cancer. * Received at least 2 prior chemotherapy regimens for locally advanced or metastatic breast cancer and previously treated with a taxane in any setting. Key Exclusion Criteria: * Has leptomeningeal carcinomatosis or metastasis * Has clinically significant corneal disease * Has known active hepatitis or uncontrolled hepatitis B or C infection * Has a 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. * Prior exposure to specific therapies without an adequate treatment washout period prior to enrolment. Additional Exclusion Criteria for Cohort 1 (NSCLC): \- Has mixed SCLC and NSCLC histology.
healthy Volunteers: false
maximum Age: 130 Years
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
This single-arm study consists of multiple cohorts, divided by indication.
intervention Names
Drug: Datopotamab Deruxtecan (Dato-DXd)
label
Dato-DXd Arm
type
EXPERIMENTAL

interventions

arm Group Labels
Dato-DXd Arm
description
Dato-DXd is an antibody-drug conjugate (ADC) that binds to TROP2.
name
Datopotamab Deruxtecan (Dato-DXd)
other Names
DS-1062a
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

intervention Model Description

This is a Phase 1/Phase 2, multicentre, open-label, multiple-cohort study, which is designed to evaluate the efficacy, safety, PK, and immunogenicity of Dato-DXd in adult Chinese participants with advanced or metastatic solid tumours.

masking Info

masking: NONE
masking Description: It is a single-arm, multi-cohort study with no blinding.

primary Purpose

TREATMENT

Enrollment

count: 119
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Confirmed ORR is defined as the proportion of participants in each cohort who have a confirmed CR or confirmed PR, as assessed by ICR per RECIST 1.1.
measure
Confirmed Objective Response Rate(ORR) Assessed by Independent Central Review(ICR)
time Frame
TNBC cohort: from enrollment to 13 months post last subject dose with a median of 12 months follow up. NSCLC cohort: from enrollment to 20 months post last subject dose with a median of 16.7 months follow up.

secondary Outcomes

description
Confirmed ORR is defined as the proportion of participants in each cohort who have a confirmed CR or confirmed PR, as determined by investigator assessment per RECIST 1.1.
measure
Confirmed Objective Response Rate(ORR) Assessed by Investigator
time Frame
TNBC cohort: from enrollment to 13 months post last subject dose with a median of 12 months follow up. NSCLC cohort: from enrollment to 20 months post last subject dose with a median of 16.7 months follow up.
description
Duration of response is defined as the time from the date of first documented response (which is subsequently confirmed) until date of documented progression per RECIST 1.1, as assessed by investgator, or death due to any cause.
measure
Duration of Response (DoR), Assessed by Investigator
time Frame
TNBC cohort: from enrollment to 13 months post last subject dose with a median of 12 months follow up. NSCLC cohort: from enrollment to 20 months post last subject dose with a median of 16.7 months follow up.
description
Disease control rate is defined as the percentage of participants who have a confirmed CR or PR or who have SD per RECIST 1.1, as assessed by ICR
measure
Disease Control Rate (DCR), Assessed by ICR
time Frame
TNBC cohort: from enrollment to 13 months post last subject dose with a median of 12 months follow up. NSCLC cohort: from enrollment to 20 months post last subject dose with a median of 16.7 months follow up.
description
Best overall response is defined as participant's best confirmed response during their participation in the study, but prior to starting any subsequent anticancer therapy, up until RECIST 1.1-defined PD or the last evaluable assessment in the absence of RECIST 1.1-defined progression.
measure
Best Overall Response (BoR) , Assessed by ICR
time Frame
TNBC cohort: from enrollment to 13 months post last subject dose with a median of 12 months follow up. NSCLC cohort: from enrollment to 20 months post last subject dose with a median of 16.7 months follow up.
description
Time to response is defined as the time from the date of the first dose of study intervention until the date of first documented objective response, which is subsequently confirmed per RECIST 1.1
measure
Time To Response (TTR) , Assessed by ICR
time Frame
TNBC cohort: from enrollment to 13 months post last subject dose with a median of 12 months follow up. NSCLC cohort: from enrollment to 20 months post last subject dose with a median of 16.7 months follow up.
description
Progression-free survival is defined as time from the date of the first dose of study intervention until progression per RECIST 1.1, as assessed by ICR, or death due to any cause.
measure
Progression-Free Survival (PFS) , Assessed by ICR
time Frame
TNBC cohort: from enrollment to 13 months post last subject dose with a median of 12 months follow up. NSCLC cohort: from enrollment to 20 months post last subject dose with a median of 16.7 months follow up.
description
Overall survival is defined as the time from the date of the first dose of study intervention to the date of death due to any cause.
measure
Overall Survival (OS)
time Frame
TNBC cohort: from enrollment to 13 months post last subject dose with a median of 12 months follow up. NSCLC cohort: from enrollment to 20 months post last subject dose with a median of 16.7 months follow up.
description
Progression-free survival is defined as time from the date of the first dose of study intervention until progression per RECIST 1.1, as assessed by investigator, or death due to any cause.
measure
Progression-Free Survival (PFS) , Assessed by Investigator
time Frame
TNBC cohort: from enrollment to 13 months post last subject dose with a median of 12 months follow up. NSCLC cohort: from enrollment to 20 months post last subject dose with a median of 16.7 months follow up.
description
Duration of response is defined as the time from the date of first documented response (which is subsequently confirmed) until date of documented progression per RECIST 1.1, as assessed by investigator, or death due to any cause.
measure
Disease Control Rate (DCR), Assessed by Investigator
time Frame
TNBC cohort: from enrollment to 13 months post last subject dose with a median of 12 months follow up. NSCLC cohort: from enrollment to 20 months post last subject dose with a median of 16.7 months follow up.
description
Best overall response is defined as participant's best confirmed response during their participation in the study, but prior to starting any subsequent anticancer therapy, up until RECIST 1.1-defined PD or the last evaluable assessment in the absence of RECIST 1.1-defined progression.
measure
Best Overall Response (BoR) , Assessed by Investigator
time Frame
TNBC cohort: from enrollment to 13 months post last subject dose with a median of 12 months follow up. NSCLC cohort: from enrollment to 20 months post last subject dose with a median of 16.7 months follow up.
description
Time to response is defined as the time from the date of the first dose of study intervention until the date of first documented objective response, which is subsequently confirmed per RECIST 1.1.
measure
Time To Response (TTR) , Assessed by Investigator
time Frame
TNBC cohort: from enrollment to 13 months post last subject dose with a median of 12 months follow up. NSCLC cohort: from enrollment to 20 months post last subject dose with a median of 16.7 months follow up.
description
PK parameters of Total Anti-TROP2 Antibody\_Area under the curve
measure
Pharmacokinetic Parameter: Area Under the Plasma Concentration- Time Curve (AUC) _ Total Anti-TROP2 Antibody
time Frame
TNBC cohort: from enrollment to 13 months post last subject dose with a median of 12 months follow up. NSCLC cohort: from enrollment to 20 months post last subject dose with a median of 16.7 months follow up.

Full study description

brief Summary: Researchers are looking for a better way to treat advanced Triple-Negative Breast Cancer (TNBC) and Non-Small-Cell Lung Cancer (NSCLC). "Advanced" usually means that the cancer keeps growing even with treatment. The cancer may also be "metastatic", which means that it has spread to other parts of the body or the surrounding tissue. The study drug, Datopotamab deruxtecan, is designed to work by attaching to the tumor cells and stopping the tumor growth. Datopotamab deruxtecan is also known as Dato-DXd. In this study, the researchers want to find out how well Dato-DXd works to stop tumors from growing in Chinese participants with NCSLC or TNBC. This is the first time Dato-DXd is being studied in Chinese population. Participants in this study will get Dato-DXd through a needle as an injection. They will get 1 dose of Dato-DXd every 3 weeks until their cancer gets worse or they leave the study for another reason. Participants will visit their study sites at least once every 3 weeks for as long as they are in the study. The study doctors will take blood samples every 3 weeks and take images of the participants' tumors every 6 weeks until the participant leaves the study.
detailed Description: This is a Phase 1/Phase 2, multicentre, open-label, multiple-cohort study, which is designed to evaluate the efficacy, safety, Pharmacokinetic, and immunogenicity of Dato-DXd in adult Chinese participants with advanced or metastatic solid tumours. It is a single-arm study with no blinding. This study is divided into different cohorts. Participants of the same cohort are with the same tumour type. The starting cohorts are Cohort 1 (NSCLC) and Cohort 2 (TNBC). Future cohorts will consist of other advanced or metastatic solid tumour types, including, but not limited to, advanced/unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma or urothelial carcinoma that is refractory or intolerant to SoC therapy or for which no Standard of Care therapy is available. Cohort 1 and Cohort 2 will be prioritised for immediate enrolment and the protocol will be amended as needed for the future cohorts. Cohort 1: The target population of Cohort 1 is adult Chinese participants with advanced or metastatic NSCLC with or without actionable genomic alterations(AGAs) (ie, alterations in genes with approved therapies, such as EGFR, ALK, or other known AGAs). Eligible participants without AGAs will have been previously treated with platinum-based chemotherapy and anti-PD-1/anti-PD-L1 monoclonal antibody either in combination or sequentially. Participants without AGAs who received anti-PD-1/anti-PD-L1 monoclonal antibody as frontline therapy may have received the combination of platinum-based chemotherapy and anti-PD-1/anti-PD-L1 monoclonal antibody in the second-line setting. Eligible participants with AGAs will have been previously treated with one or two prior lines of applicable targeted therapy that is approved for the participant's genomic alteration and platinum-based chemotherapy as the only prior line of cytotoxic therapy. Participants with AGAs may have received up to one anti-PD-1/anti-PD-L1 monoclonal antibody treatment alone or in combination with chemotherapy. A total of approximately 40 eligible participants in China will be enrolled in this cohort, including approximately 6 participants with AGAs. Cohort 2: The target population of Cohort 2 is adult Chinese participants with inoperable locally advanced or metastatic TNBC who have received at least 2 prior chemotherapy regimens for advanced breast cancer, counting the (neo)adjuvant therapy as a prior chemotherapy regimen if progression occurred within 12 months after completion of the therapy (DFI ≤ 12 months). A total of approximately 78 eligible participants in China will be enrolled in this cohort. Cohort 2 will enroll at most around 20% (approximately N=15) of enrolled participants with a DFI ≤ 12 months. Enrolled participants will be treated with Dato-DXd at 6.0 mg/kg via an IV infusion on Day 1,every 3 weeks. The primary objective of the study is to estimate the effectiveness of Dato-DXd by assessment of confirmed ORR by independent central review.

Source references