Advanced or Metastatic Pancreatic AdenocarcinomaPhase 2PROBENCT07825753
Protein-Matched ADC or PDC Umbrella Trial in Advanced Pancreatic and Breast Cancer
A Phase 2 study testing Trastuzumab emtansine (T-DM1), Trastuzumab deruxtecan (T-DXd) and Datopotamab deruxtecan (Dato-DXd) in people with Advanced or Metastatic Pancreatic Adenocarcinoma and Advanced or Metastatic Breast Cancer (BC), run by Fudan University at 1 site in China.
Trial summary
To evaluate the clinical efficacy (objective response rate, ORR) of mass spectrometry-based absolute quantification-guided selection and matching of ADC/PDC therapy in patients with locally advanced or metastatic pancreatic cancer/breast cancer, and to explore a quantitative threshold-based stratification strategy for… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced or Metastatic Pancreatic Adenocarcinoma, Advanced or Metastatic Breast Cancer (BC)
- What is being tested?
- Trastuzumab emtansine (T-DM1), Trastuzumab deruxtecan (T-DXd) and Datopotamab deruxtecan (Dato-DXd)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteChina
- Study dates
- 10 Sep 2026to 1 Feb 2030
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients aged ≥18 years and ≤75 years at the time of informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy of ≥3 months, as assessed by the investigator.
- Histologically confirmed recurrent (unresectable) or metastatic advanced pancreatic cancer or breast cancer.
- Radiographic or objective evidence of disease progression during or following the last systemic therapy administered prior to the first dose of study treatment.
- Documented failure of standard-of-care therapy in the recurrent/metastatic setting, with receipt of at least 2 prior lines of chemotherapy. If disease recurrence occurs within 6 months after completion of (neo)adjuvant chemotherapy, the adjuvant chemotherapy regimen shall be counted as 1 line of prior chemotherapy. Additionally:
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- For patients with hormone receptor-positive (estrogen receptor [ER]-positive and/or progesterone receptor [PR]-positive) and HER2-negative tumors: progression after at least 1 line of endocrine therapy, with the investigator's determination that the patient is unlikely to benefit from further endocrine therapy. Primary endocrine resistance in the adjuvant setting shall be counted as 1 line (disease recurrence within 24 months after completion of adjuvant endocrine therapy is considered 1 line). Prior treatment with CDK4/6 inhibitors is permitted.
- For patients with HER2-positive advanced breast cancer: receipt of at least 2 prior lines of anti-HER2 therapy.
- At least 1 extracranial measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Adequate organ and bone marrow function, as demonstrated by the following laboratory values obtained within 14 days prior to the first dose of study treatment:
- Hemoglobin ≥90 g/L (without transfusion within 14 days prior to screening).
- Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L.
- Platelet count ≥90 × 10⁹/L.
- Total bilirubin ≤1.5 × upper limit of normal (ULN).
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN; if hepatic metastases are present, ALT and AST ≤5 × ULN.
- Serum creatinine ≤1.5 × ULN, or creatinine clearance ≥60 mL/min as calculated by the Cockcroft-Gault formula.
- International normalized ratio (INR)/prothrombin time (PT) and activated partial thromboplastin time (aPTT) ≤1.5 × ULN.
- Left ventricular ejection fraction (LVEF) ≥50% as assessed by echocardiography or multigated acquisition (MUGA) scan; QTcF <470 ms for female patients.
- Women of childbearing potential (WOCBP) must agree to use highly effective contraceptive measures from the start of screening through 7 months after the last dose of study treatment, and must agree not to breastfeed. A negative serum pregnancy test is required within 7 days prior to the first dose of study treatment.
- Voluntary written informed consent signed prior to any study-specific procedures, with the expectation of good compliance and willingness to adhere to all protocol-specified study requirements.
Who cannot join
- Known history of severe hypersensitivity to the investigational drug substance, any excipients contained in the study drug formulation, or other monoclonal antibodies/peptides.
- Participation in any other interventional clinical trial (excluding observational studies) within 4 weeks (or 5 half-lives of the investigational product, whichever is shorter) prior to the first dose of study treatment. Receipt of any of the following within the specified time windows prior to the first dose of study treatment:
- oSurgery (major cancer-directed surgery), radiotherapy, chemotherapy, biological therapy, or participation in another interventional clinical study within 3 weeks.
- oEndocrine therapy, immunotherapy, molecularly targeted therapy, or anti-cancer traditional Chinese medicine within 2 weeks.
- Leptomeningeal metastases or active brain parenchymal metastases. Patients with clinically stable brain parenchymal metastases may be eligible, including those with asymptomatic brain metastases that have not received prior local therapy; or patients who have previously received treatment for CNS metastases (radiotherapy or surgery), provided that imaging-confirmed disease stability has been maintained for at least 4 weeks and symptomatic treatment (including corticosteroids and mannitol) has been discontinued for more than 2 weeks.
- Presence of or history of other malignancies, with the following exceptions: cured basal cell carcinoma or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, papillary thyroid carcinoma, ductal carcinoma in situ of the breast, or any other malignancy with disease-free survival exceeding 3 years.
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- Uncontrolled concurrent illness, including but not limited to: persistent or active infection, uncontrolled or clinically significant cardiovascular disease, severe chronic gastrointestinal disease associated with diarrhea, or any psychiatric illness or social situation that, in the investigator's judgment, would limit compliance with study requirements, significantly increase the risk of adverse events, or impair the ability to provide written informed consent.
- Uncontrolled or clinically significant cardiovascular disease, including any of the following:
- History of myocardial infarction or symptomatic congestive heart failure (CHF) (New York Heart Association [NYHA] Class II-IV) within 6 months prior to enrollment. Patients with troponin levels above the upper limit of normal (ULN) at screening, as defined by the manufacturer, in the absence of any myocardial infarction-related symptoms, must undergo cardiology consultation prior to enrollment to rule out myocardial infarction.
- Uncontrolled hypertension.
- Uncontrolled and/or clinically significant cardiac arrhythmias.
- QT interval corrected by the Fredericia method (QTcF) >470 ms for female patients, based on the mean of three 12-lead electrocardiogram (ECG) results obtained during the screening period.
- History of steroid-treated (non-infectious) interstitial lung disease (ILD)/pneumonitis, current ILD/pneumonitis, or suspected ILD/pneumonitis on screening imaging that cannot be ruled out.
- Clinically significant pulmonary comorbidities, including but not limited to: any underlying pulmonary disease (i.e., pulmonary embolism within 3 months prior to study enrollment, severe asthma, severe chronic obstructive pulmonary disease [COPD], restrictive lung disease, significant pleural effusion, etc.); any autoimmune, connective tissue, or inflammatory disease with pulmonary involvement (i.e., rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc.); and/or prior pneumonectomy (completed).
- Use of immunosuppressive agents or systemic corticosteroids for immunosuppressive purposes within 2 weeks prior to the first dose of study treatment (dose >10 mg/day prednisone or equivalent dose of other corticosteroids). Nasal spray or inhaled corticosteroids are excluded from this criterion.
- Any active autoimmune disease or history of autoimmune disease with potential for relapse. Patients with skin conditions not requiring systemic treatment (e.g., vitiligo, psoriasis, alopecia), well-controlled type 1 diabetes mellitus on insulin therapy, or asthma that has completely resolved since childhood and requires no intervention in adulthood may be enrolled. Patients with asthma requiring bronchodilator therapy are not eligible.
- Uncontrolled infection requiring intravenous antibiotics, antiviral agents, or antifungal agents.
- Active primary immunodeficiency, known human immunodeficiency virus (HIV) infection, active hepatitis B (HBsAg-positive with HBV DNA ≥500 IU/mL), or active hepatitis C infection. Among patients who are hepatitis C antibody-positive, only those with negative HCV RNA by polymerase chain reaction (PCR) are eligible for enrollment.
- Unresolved toxicity from prior anti-cancer therapy, defined as toxicity not resolved to Grade ≤1 or baseline (excluding alopecia). Patients with chronic, stable Grade 2 toxicity that the investigator considers related to prior anti-cancer therapy (defined as no worsening to Grade ≥2 for at least 3 months prior to enrollment and manageable with standard treatment) may be enrolled (e.g., chemotherapy-induced neuropathy, fatigue). Residual toxicity from prior immune-oncology (IO) therapy: Grade 1 or Grade 2 endocrinopathies, which may include: (a) hypothyroidism/hyperthyroidism; (b) type 1 diabetes mellitus; (c) hyperglycemia; (d) adrenal insufficiency; (e) adrenalitis; (f) skin depigmentation (vitiligo).
- Imaging evidence of tumor invasion into major blood vessels, or, in the investigator's judgment, a very high likelihood of tumor invasion into major blood vessels during treatment that could result in fatal hemorrhage.
- Major surgical procedure, severe traumatic injury, fracture, or ulcer within 4 weeks prior to the first dose of study treatment.
- Pregnant or breastfeeding women; women of childbearing potential who are unwilling or unable to use highly effective contraceptive measures.
- Any other condition that, in the investigator's judgment, may interfere with the conduct of the study or the interpretation of study results.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Fudan University Shanghai Cancer Cancer
Shanghai, Shanghai Municipality, 200043
About this study
Official title: An Umbrella Clinical Trial of Antibody/Peptide-Drug Conjugates Matched by Mass Spectrometry-Based Absolute Quantitation of Proteins in Locally Advanced or Metastatic Pancreatic or Breast Cancer
To evaluate the clinical efficacy (objective response rate, ORR) of mass spectrometry-based absolute quantification-guided selection and matching of ADC/PDC therapy in patients with locally advanced or metastatic pancreatic cancer/breast cancer, and to explore a quantitative threshold-based stratification strategy for identifying a "hidden benefit population
Read the detailed description
This is a single-center, open-label, single-arm, umbrella clinical trial comprising dual cohorts for pancreatic cancer and breast cancer, with multiple sub-cohorts within each cohort. A Bayesian optimal two-stage design will be employed for dynamic decision-making.
The study consists of a screening period, a treatment period, and a follow-up period. Two cohorts are established: the Pancreatic Cancer cohort (PC) and the Breast Cancer cohort (BC).
During the screening period, all enrolled patients will provide fresh or archived tumor tissue for absolute quantification of membrane proteins via a mass spectrometry platform, generating an individualized "target expression profile" (expressed as molecules per cell). Targets will be ranked by expression level in descending order to identify the top 1-5 candidate targets.
- Conditions
- Advanced or Metastatic Pancreatic Adenocarcinoma, Advanced or Metastatic Breast Cancer (BC)
- Being tested
- Trastuzumab emtansine (T-DM1), Trastuzumab deruxtecan (T-DXd), Datopotamab deruxtecan (Dato-DXd), Sacituzumab govitecan (SG), Enfortumab vedotin (EV)
- Keywords
- Pancreatic Cancer, Breast Cancer
- Medical subject headings
- Breast Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trastuzumab emtansine (T-DM1)Drug
Trastuzumab emtansine (T-DM1) is an antibody-drug conjugate (ADC) consisting of the humanized anti-HER2 monoclonal antibody trastuzumab covalently linked to the cytotoxic maytansinoid DM1 via a non-cleavable thioether linker (SMCC). T-DM1 is administered intravenously at a dose of 3.6 mg/kg every 3 weeks (Q3W).
Trastuzumab deruxtecan (T-DXd)Drug
Trastuzumab deruxtecan (T-DXd) is an antibody-drug conjugate (ADC) consisting of the humanized anti-HER2 monoclonal antibody trastuzumab covalently linked to the topoisomerase I inhibitor payload DXd via a cleavable tetrapeptide-based linker (GGFG). T-DXd is administered intravenously at a dose of 5.4 mg/kg every 3 weeks (Q3W).
Datopotamab deruxtecan (Dato-DXd)Drug
Datopotamab deruxtecan (Dato-DXd) is an antibody-drug conjugate (ADC) consisting of a humanized anti-TROP2 IgG1 monoclonal antibody covalently linked to the topoisomerase I inhibitor payload DXd via a cleavable tetrapeptide-based linker (GGFG). Dato-DXd is administered intravenously at a dose of 6 mg/kg every 3 weeks (Q3W).
Sacituzumab govitecan (SG)Drug
Sacituzumab govitecan (SG) is an antibody-drug conjugate (ADC) consisting of a humanized anti-TROP2 IgG1 monoclonal antibody covalently linked to the topoisomerase I inhibitor payload SN-38 via a cleavable pH-sensitive carbonate linker (CL2A). SG is administered intravenously at a dose of 10 mg/kg on Days 1 and 8 of each 21-day cycle.
Enfortumab vedotin (EV)Drug
Enfortumab vedotin (EV) is an antibody-drug conjugate (ADC) consisting of a humanized anti-Nectin-4 IgG1 monoclonal antibody covalently linked to the microtubule-disrupting agent monomethyl auristatin E (MMAE) via a cleavable protease-sensitive linker (vc, valine-citrulline). EV is administered intravenously at a dose of 1.25 mg/kg on Days 1, 8, and 15 of each 28-day cycle.
Becotatug vedotin (MRG003)Drug
Becotatug vedotin (MRG003) is an antibody-drug conjugate (ADC) consisting of a humanized anti-EGFR IgG1 monoclonal antibody covalently linked to the microtubule-disrupting agent monomethyl auristatin E (MMAE) via a cleavable protease-sensitive linker (vc, valine-citrulline). MRG003 is administered intravenously every 3 weeks (Q3W).
Izalontamab brengitecan (iza-bren / BL-B01D1)Drug
Izalontamab brengitecan (iza-bren; BL-B01D1) is a bispecific antibody-drug conjugate (ADC) targeting both EGFR and HER3, covalently linked to a topoisomerase I inhibitor payload. BL-B01D1 is administered intravenously.
Mirvetuximab soravtansine (MIRV)Drug
Mirvetuximab soravtansine (MIRV) is an antibody-drug conjugate (ADC) consisting of the humanized anti-FRα monoclonal antibody M9346A covalently linked to the cytotoxic maytansinoid DM4 via a cleavable disulfide linker. MIRV is administered intravenously at a dose of 6 mg/kg adjusted ideal body weight (AIBW) on Day 1 of every 3-week cycle (Q3W).
| Study group | Role | What they receive |
|---|---|---|
| HER2-directed molecular cohort | Experimental | Participants with elevated HER2 protein expression, as assessed by membrane protein assay, were treated with HER2-directed antibody-drug conjugates (ADCs), such as trastuzumab emtansine (T-DM1) or trastuzumab deruxtecan (T-DXd). Receives: Drug: Trastuzumab emtansine (T-DM1); Drug: Trastuzumab deruxtecan (T-DXd) |
| TROP2-directed molecular cohort | Experimental | Participants with elevated TROP2 protein expression, as assessed by membrane protein assay, were treated with TROP2-targeted antibody-drug conjugates (ADCs), such as datopotamab deruxtecan (Dato-DXd) or sacituzumab govitecan (SG). Receives: Drug: Datopotamab deruxtecan (Dato-DXd); Drug: Sacituzumab govitecan (SG) |
| Nectin-4-directed molecular cohort | Experimental | Participants with elevated Nectin-4 protein expression, as assessed by membrane protein assay, were treated with Nectin-4-targeted antibody-drug conjugates (ADCs), such as enfortumab vedotin (EV). Receives: Drug: Enfortumab vedotin (EV) |
| EGFR-directed molecular cohort | Experimental | Participants with elevated EGFR protein expression, as assessed by membrane protein assay, were treated with EGFR-targeted ADCs, including becotatug vedotin (MRG003), and EGFR/HER3 bispecific ADCs, such as izalontamab brengitecan (iza-bren). Receives: Drug: Becotatug vedotin (MRG003); Drug: Izalontamab brengitecan (iza-bren / BL-B01D1) |
| FRα-directed molecular cohort | Experimental | Participants with elevated FRα protein expression, as assessed by membrane protein assay, were treated with FRα-targeted ADCs, such as mirvetuximab soravtansine (MIRV). Receives: Drug: Mirvetuximab soravtansine (MIRV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR) as Assessed by RECIST 1.1
ORR is defined as the proportion of participants achieving a best overall response of complete response (CR) or partial response (PR) per RECIST 1.1 criteria, as assessed by the investigator.
Measured: Up to 104 Weeks
Secondary outcomes (4)
Disease Control Rate (DCR) as Assessed by RECIST 1.1
Disease Control Rate (DCR), defined as the proportion of patients achieving a best overall response of complete response (CR), partial response (PR), or stable disease (SD), as assessed by RECIST 1.1.
Measured: Up to 104 Weeks
Duration of Response (DoR)
DoR is defined as the time from the first documented response (CR or PR) to the first documented disease progression or death from any cause, as assessed by RECIST 1.1.
Measured: Up to 104 Weeks
Progression-Free Survival (PFS)
Progression-Free Survival (PFS), defined as the time from the start of treatment to the first documented disease progression or death from any cause, whichever occurs first, as assessed by RECIST 1.1.
Measured: Up to 104 Weeks
Overall Survival (OS)
Overall Survival (OS), defined as the time from the start of treatment to death from any cause.
Measured: Up to 104 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start10 Sep 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced or Metastatic Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- Model description
- This umbrella trial employs an adaptive platform design. Treatment arms may be dynamically added or dropped during the course of the study based on pre-specified decision rules. The Number of Arms and Arms section will be updated accordingly whenever new arms are introduced or existing arms are discontinued.Patients with locally advanced or metastatic pancreatic or breast cancer are stratified by mass spectrometry-based absolute protein quantitation and assigned to matched antibody/peptide-drug conjugate (ADC) arms in parallel.
- Masking
- None (open label)
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian Zhang,MD, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07825753
- Sponsor's protocol ID
- 2607349-13
- Acronym
- PROBE
- Status last verified
- Sep 2026
- First submitted
- 7 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Umbrella Clinical Trial of Antibody/Peptide-Drug Conjugates Matched by Mass Spectrometry-Based Absolute Quantitation of Proteins in Locally Advanced or Metastatic Pancreatic or Breast Cancer
- ClinicalTrials.gov ID
- NCT07825753
- Acronym / sponsor ID
- PROBE / 2607349-13
- Conditions
- Advanced or Metastatic Pancreatic Adenocarcinoma, Advanced or Metastatic Breast Cancer (BC)
- Keywords
- Pancreatic Cancer, Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 10 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Feb 2030 (estimated)
- First posted
- 17 Sep 2026 (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.
To evaluate the clinical efficacy (objective response rate, ORR) of mass spectrometry-based absolute quantification-guided selection and matching of ADC/PDC therapy in patients with locally advanced or metastatic pancreatic cancer/breast cancer, and to explore a quantitative threshold-based stratification strategy for identifying a "hidden benefit population
Detailed description
This is a single-center, open-label, single-arm, umbrella clinical trial comprising dual cohorts for pancreatic cancer and breast cancer, with multiple sub-cohorts within each cohort. A Bayesian optimal two-stage design will be employed for dynamic decision-making.
The study consists of a screening period, a treatment period, and a follow-up period. Two cohorts are established: the Pancreatic Cancer cohort (PC) and the Breast Cancer cohort (BC).
During the screening period, all enrolled patients will provide fresh or archived tumor tissue for absolute quantification of membrane proteins via a mass spectrometry platform, generating an individualized "target expression profile" (expressed as molecules per cell). Targets will be ranked by expression level in descending order to identify the top 1-5 candidate targets.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- This umbrella trial employs an adaptive platform design. Treatment arms may be dynamically added or dropped during the course of the study based on pre-specified decision rules. The Number of Arms and Arms section will be updated accordingly whenever new arms are introduced or existing arms are discontinued.Patients with locally advanced or metastatic pancreatic or breast cancer are stratified by mass spectrometry-based absolute protein quantitation and assigned to matched antibody/peptide-drug conjugate (ADC) arms in parallel.
| Arm | Type | Receives |
|---|---|---|
| HER2-directed molecular cohort | Experimental | Drug: Trastuzumab emtansine (T-DM1), Drug: Trastuzumab deruxtecan (T-DXd)Participants with elevated HER2 protein expression, as assessed by membrane protein assay, were treated with HER2-directed antibody-drug conjugates (ADCs), such as trastuzumab emtansine (T-DM1) or trastuzumab deruxtecan (T-DXd). |
| TROP2-directed molecular cohort | Experimental | Drug: Datopotamab deruxtecan (Dato-DXd), Drug: Sacituzumab govitecan (SG)Participants with elevated TROP2 protein expression, as assessed by membrane protein assay, were treated with TROP2-targeted antibody-drug conjugates (ADCs), such as datopotamab deruxtecan (Dato-DXd) or sacituzumab govitecan (SG). |
| Nectin-4-directed molecular cohort | Experimental | Drug: Enfortumab vedotin (EV)Participants with elevated Nectin-4 protein expression, as assessed by membrane protein assay, were treated with Nectin-4-targeted antibody-drug conjugates (ADCs), such as enfortumab vedotin (EV). |
| EGFR-directed molecular cohort | Experimental | Drug: Becotatug vedotin (MRG003), Drug: Izalontamab brengitecan (iza-bren / BL-B01D1)Participants with elevated EGFR protein expression, as assessed by membrane protein assay, were treated with EGFR-targeted ADCs, including becotatug vedotin (MRG003), and EGFR/HER3 bispecific ADCs, such as izalontamab brengitecan (iza-bren). |
| FRα-directed molecular cohort | Experimental | Drug: Mirvetuximab soravtansine (MIRV)Participants with elevated FRα protein expression, as assessed by membrane protein assay, were treated with FRα-targeted ADCs, such as mirvetuximab soravtansine (MIRV). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Male or female patients aged ≥18 years and ≤75 years at the time of informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy of ≥3 months, as assessed by the investigator.
- Histologically confirmed recurrent (unresectable) or metastatic advanced pancreatic cancer or breast cancer.
- Radiographic or objective evidence of disease progression during or following the last systemic therapy administered prior to the first dose of study treatment.
Key exclusion criteria (23 listed)
- Known history of severe hypersensitivity to the investigational drug substance, any excipients contained in the study drug formulation, or other monoclonal antibodies/peptides.
- Participation in any other interventional clinical trial (excluding observational studies) within 4 weeks (or 5 half-lives of the investigational product, whichever is shorter) prior to the first dose of study treatment. Receipt of any of the following within the specified time windows prior to the first dose of study treatment:
- oSurgery (major cancer-directed surgery), radiotherapy, chemotherapy, biological therapy, or participation in another interventional clinical study within 3 weeks.
- oEndocrine therapy, immunotherapy, molecularly targeted therapy, or anti-cancer traditional Chinese medicine within 2 weeks.
- Leptomeningeal metastases or active brain parenchymal metastases. Patients with clinically stable brain parenchymal metastases may be eligible, including those with asymptomatic brain metastases that have not received prior local therapy; or patients who have previously received treatment for CNS metastases (radiotherapy or surgery), provided that imaging-confirmed disease stability has been maintained for at least 4 weeks and symptomatic treatment (including corticosteroids and mannitol) has been discontinued for more than 2 weeks.
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 emtansine (T-DM1)Trastuzumab emtansine (T-DM1) is an antibody-drug conjugate (ADC) consisting of the humanized anti-HER2 monoclonal antibody trastuzumab covalently linked to the cytotoxic maytansinoid DM1 via a non-cleavable thioether linker (SMCC). T-DM1 is administered intravenously at a dose of 3.6 mg/kg every 3 weeks (Q3W). | Drug | HER2-directed molecular cohort |
| Trastuzumab deruxtecan (T-DXd)Trastuzumab deruxtecan (T-DXd) is an antibody-drug conjugate (ADC) consisting of the humanized anti-HER2 monoclonal antibody trastuzumab covalently linked to the topoisomerase I inhibitor payload DXd via a cleavable tetrapeptide-based linker (GGFG). T-DXd is administered intravenously at a dose of 5.4 mg/kg every 3 weeks (Q3W). | Drug | HER2-directed molecular cohort |
| Datopotamab deruxtecan (Dato-DXd)Datopotamab deruxtecan (Dato-DXd) is an antibody-drug conjugate (ADC) consisting of a humanized anti-TROP2 IgG1 monoclonal antibody covalently linked to the topoisomerase I inhibitor payload DXd via a cleavable tetrapeptide-based linker (GGFG). Dato-DXd is administered intravenously at a dose of 6 mg/kg every 3 weeks (Q3W). | Drug | TROP2-directed molecular cohort |
| Sacituzumab govitecan (SG)Sacituzumab govitecan (SG) is an antibody-drug conjugate (ADC) consisting of a humanized anti-TROP2 IgG1 monoclonal antibody covalently linked to the topoisomerase I inhibitor payload SN-38 via a cleavable pH-sensitive carbonate linker (CL2A). SG is administered intravenously at a dose of 10 mg/kg on Days 1 and 8 of each 21-day cycle. | Drug | TROP2-directed molecular cohort |
| Enfortumab vedotin (EV)Enfortumab vedotin (EV) is an antibody-drug conjugate (ADC) consisting of a humanized anti-Nectin-4 IgG1 monoclonal antibody covalently linked to the microtubule-disrupting agent monomethyl auristatin E (MMAE) via a cleavable protease-sensitive linker (vc, valine-citrulline). EV is administered intravenously at a dose of 1.25 mg/kg on Days 1, 8, and 15 of each 28-day cycle. | Drug | Nectin-4-directed molecular cohort |
| Becotatug vedotin (MRG003)Becotatug vedotin (MRG003) is an antibody-drug conjugate (ADC) consisting of a humanized anti-EGFR IgG1 monoclonal antibody covalently linked to the microtubule-disrupting agent monomethyl auristatin E (MMAE) via a cleavable protease-sensitive linker (vc, valine-citrulline). MRG003 is administered intravenously every 3 weeks (Q3W). | Drug | EGFR-directed molecular cohort |
| Izalontamab brengitecan (iza-bren / BL-B01D1)Izalontamab brengitecan (iza-bren; BL-B01D1) is a bispecific antibody-drug conjugate (ADC) targeting both EGFR and HER3, covalently linked to a topoisomerase I inhibitor payload. BL-B01D1 is administered intravenously. | Drug | EGFR-directed molecular cohort |
| Mirvetuximab soravtansine (MIRV)Mirvetuximab soravtansine (MIRV) is an antibody-drug conjugate (ADC) consisting of the humanized anti-FRα monoclonal antibody M9346A covalently linked to the cytotoxic maytansinoid DM4 via a cleavable disulfide linker. MIRV is administered intravenously at a dose of 6 mg/kg adjusted ideal body weight (AIBW) on Day 1 of every 3-week cycle (Q3W). | Drug | FRα-directed molecular cohort |
Primary outcome
Objective Response Rate (ORR) as Assessed by RECIST 1.1
Time frame: Up to 104 Weeks
ORR is defined as the proportion of participants achieving a best overall response of complete response (CR) or partial response (PR) per RECIST 1.1 criteria, as assessed by the investigator.
4 secondary outcomes
Disease Control Rate (DCR) as Assessed by RECIST 1.1
Time frame: Up to 104 Weeks
Duration of Response (DoR)
Time frame: Up to 104 Weeks
Progression-Free Survival (PFS)
Time frame: Up to 104 Weeks
Overall Survival (OS)
Time frame: Up to 104 Weeks
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 17 Sep 2026.
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Pancreatic Ductal Adenocarcinoma (PDAC)
Active, not recruitingPhase 1
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
Breast Cancer, Ovarian Cancer
RecruitingPhase 1/2
VMD-928 Monotherapy and in Combination With Pembrolizumab to Treat TrkA Overexpression Driven Solid Tumors or Lymphoma
Head and Neck Carcinoma, Adenoid Cystic Carcinoma
RecruitingPhase 2
A Study of Navlimetostat (BMS-986504) Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Homozygous MTAP Deletion (MountainTAP-5)
Solid Tumors
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.
1 site 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 emtansine (T-DM1), Trastuzumab deruxtecan (T-DXd) and Datopotamab deruxtecan (Dato-DXd) in people with Advanced or Metastatic Pancreatic Adenocarcinoma and Advanced or Metastatic Breast Cancer (BC), run by Fudan University at 1 site 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 20 inclusion and 23 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: opening soon, as of the sponsor's last update on 17 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 1 site 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?
Contact Jian Zhang, MD (+8664175590 ext. 85000, syner2000@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) as Assessed by RECIST 1.1 (time frame: Up to 104 Weeks). 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 17 Sep 2026.