Pancreatic CancerPhase 2NCT06233864
A Study of the Treatment of Disitamab Vedotin in Patients With Locally Advanced or Metastatic Pancreatic Cancer
A Phase 2 study testing Disitamab Vedotin and Gemcitabine in people with Pancreatic Cancer, run by Sun Yat-sen University.
Trial summary
This is a phase 2 clinical study,to explore the efficacy and safety of Disitamab Vedotin in patients with locally advanced or metastatic pancreatic cancer expressing HER2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Disitamab Vedotin and Gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- No sites listed yet
- Study dates
- 17 Apr 2024to 17 Apr 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- 1. Age: 18 (inclusive) or above, regardless of gender.
- 2. histologically or cytologically confirmed patients with locally advanced or metastatic pancreatic cancer who cannot undergo radical surgery
- 3. HER2 expressing(Immunohistochemical IHC 1+,2+ or 3+)
- 4. Number of treatment lines: Cohort 1: Prior first-line gemcitabine-free regimen or intolerant to gemcitabine-containing regimen; Cohort 2: Previous treatment with second-line standard or intolerance
- 5. Patients who have previously received neoadjuvant chemotherapy, adjuvant chemotherapy, radiotherapy or chemoradiotherapy for the purpose of curing non-metastatic disease must have a disease-free interval of 6 months from the last chemotherapy and/or radiotherapy to the random date
- 6. There is at least one measurable lesion that meets the definition of the RECIST 1.1 standard at baseline.
Show all 11Show fewer
- 7. ECOG fitness status score: 0 or 1 point.
- 8. Estimated survival time ≥ 3 months.
- 9. Adequate organ function.
- 10. Male and female participants are eligible to participate if they agree to the contraception use as per study protocol.
- 11. Voluntary agreement to provide written informed consent.
Who cannot join
- 1. Central nervous system metastasis or meningeal metastasis with clinical symptoms.
- 2. Have a history of autoimmune diseases, immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.
- 3. Active hepatitis B (hepatitis B virus titer>1000 copies/ml or 200 IU/ml); Hepatitis C virus and syphilis infection.
- 4. Have undergone major organ surgery (excluding puncture biopsy) or have experienced significant trauma within 3 weeks before the first use of the study drug.
- 5. Known hypersensitivity or intolerance to any component of the study protocol drug or its excipients.
- 6. Strong inducers and inhibitors of P-gp, a strong or moderate inducer of CYP3A4, used within 14 days prior to the first use of the study drug
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Phase II Clinical Study of the Treatment of Disitamab Vedotin（RC48) in Patients With Locally Advanced or Metastatic Pancreatic Cancer Expressing HER2
This is a phase 2 clinical study,to explore the efficacy and safety of Disitamab Vedotin in patients with locally advanced or metastatic pancreatic cancer expressing HER2.
Read the detailed description
63 patients with locally advanced or metastatic pancreatic cancer will participate in this study. HER2 expression in locally advanced or metastatic pancreatic cancer patients is defined as the expression of HER2 in tumor tissues detected by immunohistochemistry (IHC) as IHC 1+, 2+, or 3+. The arm 1 recruits 43 patients and the arm 2 recruits 20 patients.
- Conditions
- Pancreatic Cancer
- Being tested
- Disitamab Vedotin, Gemcitabine
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disitamab VedotinDrug
Also called RC48
Disitamab Vedotin
GemcitabineDrug
Gemcitabine
| Study group | Role | What they receive |
|---|---|---|
| Disitamab Vedotin combined with Gemcitabine，2L | Experimental | Disitamab Vedotin 2.5 mg/kg，iv，Q3W; Gemcitabine 1g/m2，iv，d1, d8 Q3W; Disitamab Vedotin+Gemcitabine is used as second-line treatment for HER2-expressive patients who have failed first-line gemcitabine-free regimen or are intolerant to gemcitabine-containing regimen. Receives: Drug: Disitamab Vedotin; Drug: Gemcitabine |
| Disitamab Vedotin，3L | Experimental | Disitamab Vedotin 2.5 mg/kg，iv，Q3W; Disitamab Vedotin in HER2-expressive patients who have failed at second-line standard treatment or are intolerant Receives: Drug: Disitamab Vedotin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Object Response Rate, ORR
Defined as the percentage of participants with a complete response (CR) or partial response (PR)
Measured: up to 12 months
Secondary outcomes (4)
Disease Control Rate, DCR
Defined as the proportion of participants who have a complete response (CR), partial response (PR) or standard disease (SD) as assessed by investigator according to RECIST 1.1
Measured: up to 12 months
Progress Free Survival, PFS
Defined as time from randomization until progression per RECIST 1.1 as assessed by investigator, or death due to any cause.
Measured: up to 12 months
Over Survival, OS
Defined as time from randomization until the date of death due to any cause.
Measured: up to 12 months
Adverse Events (AE)
NCI-CTCAE v5.0
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start17 Apr 2024 (estimated)
- Primary completion17 Apr 2025 (estimated)
- Study completion17 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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
- Masking
- None (open label)
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong sheng Zhang, Sun Yat-sen University
- Investigators
- Dong sheng Zhang, PhD, Principal investigator, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06233864
- Sponsor's protocol ID
- M01-RC48
- Status last verified
- Feb 2024
- First submitted
- 22 Jan 2024
- Last updated
- 17 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Study of the Treatment of Disitamab Vedotin（RC48) in Patients With Locally Advanced or Metastatic Pancreatic Cancer Expressing HER2
- ClinicalTrials.gov ID
- NCT06233864
- Acronym / sponsor ID
- M01-RC48
- Conditions
- Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 17 Apr 2024 (estimated)
- Primary completion
- 17 Apr 2025 (estimated)
- Study completion
- 17 Apr 2026 (estimated)
- First posted
- 31 Jan 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 a phase 2 clinical study,to explore the efficacy and safety of Disitamab Vedotin in patients with locally advanced or metastatic pancreatic cancer expressing HER2.
Detailed description
63 patients with locally advanced or metastatic pancreatic cancer will participate in this study. HER2 expression in locally advanced or metastatic pancreatic cancer patients is defined as the expression of HER2 in tumor tissues detected by immunohistochemistry (IHC) as IHC 1+, 2+, or 3+. The arm 1 recruits 43 patients and the arm 2 recruits 20 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Disitamab Vedotin combined with Gemcitabine，2L | Experimental | Drug: Disitamab Vedotin, Drug: GemcitabineDisitamab Vedotin 2.5 mg/kg，iv，Q3W; Gemcitabine 1g/m2，iv，d1, d8 Q3W; Disitamab Vedotin+Gemcitabine is used as second-line treatment for HER2-expressive patients who have failed first-line gemcitabine-free regimen or are intolerant to gemcitabine-containing regimen. |
| Disitamab Vedotin，3L | Experimental | Drug: Disitamab VedotinDisitamab Vedotin 2.5 mg/kg，iv，Q3W; Disitamab Vedotin in HER2-expressive patients who have failed at second-line standard treatment or are intolerant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 1. Age: 18 (inclusive) or above, regardless of gender.
- 2. histologically or cytologically confirmed patients with locally advanced or metastatic pancreatic cancer who cannot undergo radical surgery
- 3. HER2 expressing(Immunohistochemical IHC 1+,2+ or 3+)
- 4. Number of treatment lines: Cohort 1: Prior first-line gemcitabine-free regimen or intolerant to gemcitabine-containing regimen; Cohort 2: Previous treatment with second-line standard or intolerance
- 5. Patients who have previously received neoadjuvant chemotherapy, adjuvant chemotherapy, radiotherapy or chemoradiotherapy for the purpose of curing non-metastatic disease must have a disease-free interval of 6 months from the last chemotherapy and/or radiotherapy to the random date
Key exclusion criteria (6 listed)
- 1. Central nervous system metastasis or meningeal metastasis with clinical symptoms.
- 2. Have a history of autoimmune diseases, immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.
- 3. Active hepatitis B (hepatitis B virus titer>1000 copies/ml or 200 IU/ml); Hepatitis C virus and syphilis infection.
- 4. Have undergone major organ surgery (excluding puncture biopsy) or have experienced significant trauma within 3 weeks before the first use of the study drug.
- 5. Known hypersensitivity or intolerance to any component of the study protocol drug or its excipients.
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 |
|---|---|---|
| Disitamab VedotinAlso: RC48Disitamab Vedotin | Drug | Disitamab Vedotin combined with Gemcitabine，2L, Disitamab Vedotin，3L |
| GemcitabineGemcitabine | Drug | Disitamab Vedotin combined with Gemcitabine，2L |
Primary outcome
Object Response Rate, ORR
Time frame: up to 12 months
Defined as the percentage of participants with a complete response (CR) or partial response (PR)
4 secondary outcomes
Disease Control Rate, DCR
Time frame: up to 12 months
Progress Free Survival, PFS
Time frame: up to 12 months
Over Survival, OS
Time frame: up to 12 months
Adverse Events (AE)
Time frame: up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
Related trials for Pancreatic Cancer
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
Pancreatic Carcinoma, Pancreatic Neoplasm
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.
Dong sheng Zhang, PhD principal investigator
Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Disitamab Vedotin and Gemcitabine in people with Pancreatic Cancer, run by Sun Yat-sen University.
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 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: status not confirmed, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dong sheng Zhang, PhD (86-020-87342479, zhangdsh@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Object Response Rate, ORR (time frame: up to 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 17 Apr 2024.