Advanced Pancreatic CancerPhase 1NCT04928625
A Trial of SHR-A1904 in Patients With Advanced Pancreatic Cancer
A Phase 1 study testing SHR-A1904 in people with Advanced Pancreatic Cancer, run by Shanghai Hengrui Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The study is being conducted to assess the safety and tolerability of SHR-A1904 in patients with with advanced pancreatic cancer and to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD), and recommended phase II dose (RP2D) of SHR-A1904 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Pancreatic Cancer
- What is being tested?
- SHR-A1904
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteChina
- Study dates
- 6 Aug 2021to 31 Dec 2023
- Phase
- Phase 1
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study
- Males or females aged 18-75 years old
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Has a life expectancy of ≥ 3 months
- Has at least one measurable lesion as defined by RECIST v1.1
Who cannot join
- Plan to receive any other anti-tumor treatments during the study treatment period of this study
- Received other clinical investigational products or treatments within 4 weeks before the first dose of the study
- Underwent a major surgery other than diagnosis or biopsy within 4 weeks before the first dose of the study
- Previously received gastrectomy (only for subjects of the dose-escalation part)
- Subjects with known brain metastases
- Grade II-IV cardiac insufficiency as per the New York Heart Association (NYHA) criteria; arrhythmia requiring long-term drug control; unstable angina or acute myocardial infarction within 6 months before the first dose of the study
- Presence of accompanying diseases (such as poorly controlled hypertension, serious diabetes mellitus, thyroid disorder, psychosis, etc.) that may pose serious risks to the safety of the subject or may affect the subject's ability to complete the study, or any other situation as judged by the investigator
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 20000
xianjun Yu, Doctor
About this study
Official title: An Open-Label, Single-Arm, Multi-Center Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SHR-A1904 in Patients With Advanced Pancreatic Cancer
The study is being conducted to assess the safety and tolerability of SHR-A1904 in patients with with advanced pancreatic cancer and to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD), and recommended phase II dose (RP2D) of SHR-A1904
- Conditions
- Advanced Pancreatic Cancer
- Being tested
- SHR-A1904
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-A1904Drug
SHR-A1904
| Study group | Role | What they receive |
|---|---|---|
| SHR-A1904 | Experimental | Not described Receives: Drug: SHR-A1904 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (DLT) of SHR-A1904
Measured: UP to 2 months
Maximum tolerated dose (MTD) of SHR-A1904
Measured: UP to 2 months
Recommended Phase II Dose (RP2D)
Measured: Up to 1 year
Secondary outcomes (5)
Maximum concentration (Cmax)
Measured: Up to 1 year
Time to maximum concentration (Tmax)
Measured: up to 1 year
Area under the drug concentration-time curve from time 0 to the last measurable concentration time point (AUC0-t)
Measured: Up to 1 year
Anti-drug antibody (ADA) of SHR-A1904
Measured: Up to 1 year
Objective response rate (ORR)
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2021
- Study start6 Aug 2021
- Primary completion30 Jun 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Hengrui Pharmaceutical Co., Ltd.The 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open-Label, Single-Arm, Multi-Center Phase I Clinical Study TO EVALUATE the Safety
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04928625
- Sponsor's protocol ID
- SHR-A1904-I-102
- Status last verified
- May 2021
- First submitted
- 2 Jun 2021
- Last updated
- 24 Aug 2021
- 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 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Arm, Multi-Center Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SHR-A1904 in Patients With Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT04928625
- Acronym / sponsor ID
- SHR-A1904-I-102
- Conditions
- Advanced Pancreatic Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Aug 2021 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 16 Jun 2021 (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.
The study is being conducted to assess the safety and tolerability of SHR-A1904 in patients with with advanced pancreatic cancer and to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD), and recommended phase II dose (RP2D) of SHR-A1904
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-Label, Single-Arm, Multi-Center Phase I Clinical Study TO EVALUATE the Safety
| Arm | Type | Receives |
|---|---|---|
| SHR-A1904 | Experimental | Drug: SHR-A1904 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study
- Males or females aged 18-75 years old
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Has a life expectancy of ≥ 3 months
- Has at least one measurable lesion as defined by RECIST v1.1
Key exclusion criteria (7 listed)
- Plan to receive any other anti-tumor treatments during the study treatment period of this study
- Received other clinical investigational products or treatments within 4 weeks before the first dose of the study
- Underwent a major surgery other than diagnosis or biopsy within 4 weeks before the first dose of the study
- Previously received gastrectomy (only for subjects of the dose-escalation part)
- Subjects with known brain metastases
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 |
|---|---|---|
| SHR-A1904SHR-A1904 | Drug | SHR-A1904 |
Primary outcome
Dose-limiting toxicity (DLT) of SHR-A1904
Time frame: UP to 2 months
Maximum tolerated dose (MTD) of SHR-A1904
Time frame: UP to 2 months
Recommended Phase II Dose (RP2D)
Time frame: Up to 1 year
5 secondary outcomes
Maximum concentration (Cmax)
Time frame: Up to 1 year
Time to maximum concentration (Tmax)
Time frame: up to 1 year
Area under the drug concentration-time curve from time 0 to the last measurable concentration time point (AUC0-t)
Time frame: Up to 1 year
Anti-drug antibody (ADA) of SHR-A1904
Time frame: Up to 1 year
Objective response rate (ORR)
Time frame: Up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SHR-A1904 in people with Advanced Pancreatic Cancer, run by Shanghai Hengrui Pharmaceutical Co., Ltd. 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 5 inclusion and 7 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 24 Aug 2021. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chunlei Jin, Ph.D. (86-021-23511999, chunlei.jin@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity (DLT) of SHR-A1904 (time frame: UP to 2 months). The study lists 3 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 24 Aug 2021.