HER-2 Positive Advanced Solid TumorsPhase 1NCT05957536
A Study of D3L-001 as Monotherapy in Subjects With HER2-Positive Advanced Solid Tumors
A Phase 1 study testing D3L-001 in people with HER-2 Positive Advanced Solid Tumors, run by D3 Bio (Wuxi) Co., Ltd at 9 sites in 3 countries.
Trial summary
This first-in-human (FIH) study, multi-center, open-label, dose escalation and dose expansion Phase I study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary anti-tumor activity of D3L-001 in subjects with HER2-positive advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HER-2 Positive Advanced Solid Tumors
- What is being tested?
- D3L-001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 9 sitesin 3 countries
- Study dates
- 19 Sep 2023to 19 Dec 2028
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must have documented HER2 positivity (determined by immunohistochemistry [IHC], in situ hybridization [ISH], Next Generation Sequencing [NGS] or other analysis techniques as appropriate).
- Subject must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Subject must have left ventricular ejection fraction (LVEF) ≥50% by either echocardiography (ECHO) or multiple-gated acquisition (MUGA) within the screening period.
- Subject must have adequate organ and marrow function within the screening period.
Who cannot join
- Subject has any prior treatment with anti-CD47 or SIRPα agent.
- Subject has any prior treatment without adequate washout periods as defined in the protocol.
- Subject has immunosuppressive medication that is not completed 14 days before the first dose of study medication.
- Subject has uncontrolled intercurrent illness that would limit compliance with study requirements, substantially increase risk of incurring AEs, or compromise the ability of the subject to give written informed consent.
- Subject has unresolved treatment-related toxicities from previous anticancer therapy of NCI CTCAE Grade ≥2 (with exception of vitiligo or alopecia).
- Judgment by the Investigator that the subject should not participate in the study if the subject is unlikely to comply with study procedures, restrictions, and requirements.
Trial locations and contacts
9 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
9 sites in 3 countries
United States4 sites, 1 recruiting
- Terminated
D3 Bio Investigative Site
Boston, Massachusetts, 02215
- Recruiting
D3 Bio Investigative Site
New York, New York, 10065
- Terminated
D3 Bio Investigative Site
San Antonio, Texas, 78229
- Terminated
D3 Bio Investigative Site
Stanford, California, 94305
China3 sites, 3 recruiting
- Recruiting
D3 Bio Investigative Site
Hangzhou, Zhejiang, 310022
- Recruiting
D3 Bio Investigative Site
Harbin, Heilongjiang, 150088
- Recruiting
D3 Bio Investigative Site
Shanghai, Shanghai Municipality, 200025
Australia2 sites, 2 recruiting
- Recruiting
D3 Bio Investigative Site
Malvern, Victoria, 3144
- Recruiting
D3 Bio Investigative Site
Sydney, New South Wales, 2109
About this study
Official title: A Phase 1, Open-label Dose Escalation and Dose-Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of D3L-001 Monotherapy in Subjects With HER2-Positive Advanced Solid Tumors.
This first-in-human (FIH) study, multi-center, open-label, dose escalation and dose expansion Phase I study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary anti-tumor activity of D3L-001 in subjects with HER2-positive advanced solid tumors.
- Conditions
- HER-2 Positive Advanced Solid Tumors
- Being tested
- D3L-001
- Keywords
- HER-2 Positive, Advanced Solid Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D3L-001Biological
Intravenous administration
| Study group | Role | What they receive |
|---|---|---|
| D3L-001 | Experimental | Part 1 Dose Escalation in subjects with HER2-positive advanced solid tumors
* Cohort 1 (starting dose)
* Cohort 2
* Cohort 3
* Cohort 4
* Cohort 5
* Cohort 6
* Cohort 7
* Cohort 8
Part 2 Dose Expansion
* Cohort A for subjects with HER2-positive advanced breast cancer
* Cohort B for subjects with HER2-positive advanced gastric cancer/gastroesophageal junction cancer Receives: Biological: D3L-001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events (AEs)
Measured: Screening until Safety Follow Up visit (30 days after the last dose)
Maximum Tolerated Dose based on Dose-Limiting Toxicities (DLTs)
Measured: At the end of Cycle 1 (each cycle is 21 days).
Secondary outcomes (10)
D3L-001 minimum serum concentration (Ctrough)
Measured: First dose up to 6 months
D3L-001 maximum observed plasma concentration (Cmax)
Measured: First dose up to 6 months
D3L-001 time to maximum plasma concentration (tmax)
Measured: First dose up to 6 months
D3L-001 half-life (t1/2)
Measured: First dose up to 6 months
D3L-001 area under the concentration-time curve (AUC)
Measured: First dose up to 6 months
Incidence of anti-drug antibodies (ADA) to D3L-001
Measured: First dose up to 6 months
Objective response rate (ORR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Measured: Until disease progression or end of treatment (up to approximately 6 months)
Duration of Response (DOR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Measured: Until disease progression or end of treatment (up to approximately 6 months)
Disease control rate (DCR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1
Measured: Until disease progression or end of treatment (up to approximately 6 months)
Progression-free survival (PFS) as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Measured: Until disease progression or end of treatment (up to approximately 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study start19 Sep 2023
- Primary completion19 Dec 2028 (estimated)
- Study completion19 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER-2 Positive Advanced Solid TumorsStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- D3 Bio (Wuxi) Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05957536
- Sponsor's protocol ID
- D3L-001-100
- Status last verified
- Aug 2026
- First submitted
- 7 Jul 2023
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label Dose Escalation and Dose-Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of D3L-001 Monotherapy in Subjects With HER2-Positive Advanced Solid Tumors.
- ClinicalTrials.gov ID
- NCT05957536
- Acronym / sponsor ID
- D3L-001-100
- Conditions
- HER-2 Positive Advanced Solid Tumors
- Keywords
- HER-2 Positive, Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- D3 Bio (Wuxi) Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 19 Sep 2023 (actual)
- Primary completion
- 19 Dec 2028 (estimated)
- Study completion
- 19 Dec 2028 (estimated)
- First posted
- 24 Jul 2023 (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 first-in-human (FIH) study, multi-center, open-label, dose escalation and dose expansion Phase I study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary anti-tumor activity of D3L-001 in subjects with HER2-positive advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| D3L-001 | Experimental | Biological: D3L-001Part 1 Dose Escalation in subjects with HER2-positive advanced solid tumors * Cohort 1 (starting dose) * Cohort 2 * Cohort 3 * Cohort 4 * Cohort 5 * Cohort 6 * Cohort 7 * Cohort 8 Part 2 Dose Expansion * Cohort A for subjects with HER2-positive advanced breast cancer * Cohort B for subjects with HER2-positive advanced gastric cancer/gastroesophageal junction cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject must have documented HER2 positivity (determined by immunohistochemistry [IHC], in situ hybridization [ISH], Next Generation Sequencing [NGS] or other analysis techniques as appropriate).
- Subject must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Subject must have left ventricular ejection fraction (LVEF) ≥50% by either echocardiography (ECHO) or multiple-gated acquisition (MUGA) within the screening period.
- Subject must have adequate organ and marrow function within the screening period.
Key exclusion criteria (6 listed)
- Subject has any prior treatment with anti-CD47 or SIRPα agent.
- Subject has any prior treatment without adequate washout periods as defined in the protocol.
- Subject has immunosuppressive medication that is not completed 14 days before the first dose of study medication.
- Subject has uncontrolled intercurrent illness that would limit compliance with study requirements, substantially increase risk of incurring AEs, or compromise the ability of the subject to give written informed consent.
- Subject has unresolved treatment-related toxicities from previous anticancer therapy of NCI CTCAE Grade ≥2 (with exception of vitiligo or alopecia).
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 |
|---|---|---|
| D3L-001Intravenous administration | Biological | D3L-001 |
Primary outcome
Number of Participants With Adverse Events (AEs)
Time frame: Screening until Safety Follow Up visit (30 days after the last dose)
Maximum Tolerated Dose based on Dose-Limiting Toxicities (DLTs)
Time frame: At the end of Cycle 1 (each cycle is 21 days).
10 secondary outcomes
D3L-001 minimum serum concentration (Ctrough)
Time frame: First dose up to 6 months
D3L-001 maximum observed plasma concentration (Cmax)
Time frame: First dose up to 6 months
D3L-001 time to maximum plasma concentration (tmax)
Time frame: First dose up to 6 months
D3L-001 half-life (t1/2)
Time frame: First dose up to 6 months
D3L-001 area under the concentration-time curve (AUC)
Time frame: First dose up to 6 months
Incidence of anti-drug antibodies (ADA) to D3L-001
Time frame: First dose up to 6 months
Objective response rate (ORR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Time frame: Until disease progression or end of treatment (up to approximately 6 months)
Duration of Response (DOR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Time frame: Until disease progression or end of treatment (up to approximately 6 months)
Disease control rate (DCR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1
Time frame: Until disease progression or end of treatment (up to approximately 6 months)
Progression-free survival (PFS) as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Time frame: Until disease progression or end of treatment (up to approximately 6 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 28 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for HER-2 Positive Advanced Solid Tumors
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08032562 in People With Advanced or Metastatic Solid Tumors
Advanced Breast Cancer, Metastatic Breast Cancer (HR+/ HER2-)
Active, not recruitingPhase 2
Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
RecruitingPhase 1
A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors
HR+ Breast Cancer, Triple Negative Breast Cancer (TNBC)
RecruitingPhase 1/2
Rinatabart Sesutecan (Rina-S, PRO1184, GEN1184) for Advanced Solid Tumors (GCT1184-01/ PRO1184-001)
High Grade Epithelial Ovarian Cancer, High Grade Serous Ovarian Cancer
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.
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing D3L-001 in people with HER-2 Positive Advanced Solid Tumors, run by D3 Bio (Wuxi) Co., Ltd at 9 sites in 3 countries.
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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, China, Australia. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Contact Medical Director (+86 21 61635900, D3bio_CT@d3bio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (AEs) (time frame: Screening until Safety Follow Up visit (30 days after the last dose)). The study lists 2 primary outcomes in all. 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 28 Aug 2026.