B Cell LymphomaPhase 1NCT05113069
A Study of SHR-A1912 for Injection in Patients With B Cell Lymphomas
A Phase 1 study testing SHR-A1912 in people with B Cell Lymphoma, run by Shanghai Hengrui Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
To assess the safety and tolerability of SHR-A1912 in patients with B cell lymphoma, to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD), and recommended phase II dose (RP2D) of SHR-A1912. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- B Cell Lymphoma
- What is being tested?
- SHR-A1912
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteChina
- Study dates
- 22 Dec 2021to 30 Mar 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than or equal to18 years old, male or female;
- Eastern Cooperative Oncology Group (ECOG) performance status is 0 to 1;
- Life expectancy >12 weeks;
- Histologically or cytologically confirmed B cell lymphoma;
- Relapsed and/or refractory disease after at least 1 prior treatment regimen;
- At least one measurable nodal lesion, defined as > 1.5 cm in its longest dimension, or one measurable extra nodal lesion, defined as > 1.0 cm in its longest diameter (no need for dose escalation stage).
Who cannot join
- Received autologous stem cell transplantation within 12 weeks before the first study treatment; previously received allogeneic stem cell transplantation; received Car-T cell therapy within 12 weeks before the first study treatment;
- History of recent major surgery or severe trauma within 4 weeks before the first study treatment;
- Received anti-tumour treatment within 2 weeks before the first study treatment;
- Central nervous system (CNS) infiltration;
- Active infection with HBV or HCV;
- History of immunodeficiency, including HIV serotest positive, or other acquired or congenital immunodeficiency diseases, and active tuberculosis;
- Active infection or unexplained fever>38.5℃;
- History of severe cardiovascular disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SHR-A1912 for Injection as Monotherapy in Patients With B-cell Lymphoma
To assess the safety and tolerability of SHR-A1912 in patients with B cell lymphoma, to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD), and recommended phase II dose (RP2D) of SHR-A1912.
- Conditions
- B Cell Lymphoma
- Being tested
- SHR-A1912
- Medical subject headings
- Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-A1912Drug
SHR-A1912, dose escalation and expansion.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | SHR-A1912 Receives: Drug: SHR-A1912 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Measured: 21 Days after the 1st dosing (first cycle)
Dose Limited Toxicity (DLT)
Measured: 21 Days (first cycle)
Maximum tolerable dose (MTD)
Measured: 21 Days (first cycle)
Recommended phase II dose (RP2D)
Measured: Up to approximately 2 years
Secondary outcomes (11)
Adverse Events
Measured: 12 weeks after the last dose
Time of maximum observed plasma concentration (Tmax) of SHR-1912
Measured: 21 days after last dose
Maximum observed plasma concentration (Cmax) of SHR-1912
Measured: 21 days after last dose
Area under the plasma concentration time curve (AUC) of SHR-1912
Measured: 21 days after last dose
Anti-drug antibody (ADA) of SHR-A1912
Measured: 12 weeks after last dose
Complete Response Rate (CR)
Measured: Up to approximately 2 years
Objective Response Rate (ORR)
Measured: Up to approximately 2 years
Duration of Response (DoR)
Measured: Up to approximately 2 years
Disease Control Rate (DCR)
Measured: Up to approximately 2 years
Progression-Free Survival (PFS)
Measured: Up to approximately 2 years
Overall Survival (OS)
Measured: Up to approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start22 Dec 2021
- Primary completion31 Mar 2024 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B Cell LymphomaStudies 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
- single arm for SHR-A1912
- Masking
- None (open label)
- Enrolment
- 170 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
- NCT05113069
- Sponsor's protocol ID
- SHR-A1912-I-101
- Status last verified
- Nov 2023
- First submitted
- 5 Nov 2021
- Last updated
- 6 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SHR-A1912 for Injection as Monotherapy in Patients With B-cell Lymphoma
- ClinicalTrials.gov ID
- NCT05113069
- Acronym / sponsor ID
- SHR-A1912-I-101
- Conditions
- B Cell Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Dec 2021 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 9 Nov 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.
To assess the safety and tolerability of SHR-A1912 in patients with B cell lymphoma, to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD), and recommended phase II dose (RP2D) of SHR-A1912.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single arm for SHR-A1912
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: SHR-A1912SHR-A1912 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age greater than or equal to18 years old, male or female;
- Eastern Cooperative Oncology Group (ECOG) performance status is 0 to 1;
- Life expectancy >12 weeks;
- Histologically or cytologically confirmed B cell lymphoma;
- Relapsed and/or refractory disease after at least 1 prior treatment regimen;
Key exclusion criteria (8 listed)
- Received autologous stem cell transplantation within 12 weeks before the first study treatment; previously received allogeneic stem cell transplantation; received Car-T cell therapy within 12 weeks before the first study treatment;
- History of recent major surgery or severe trauma within 4 weeks before the first study treatment;
- Received anti-tumour treatment within 2 weeks before the first study treatment;
- Central nervous system (CNS) infiltration;
- Active infection with HBV or HCV;
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-A1912SHR-A1912, dose escalation and expansion. | Drug | Treatment group |
Primary outcome
Adverse Events
Time frame: 21 Days after the 1st dosing (first cycle)
Dose Limited Toxicity (DLT)
Time frame: 21 Days (first cycle)
Maximum tolerable dose (MTD)
Time frame: 21 Days (first cycle)
Recommended phase II dose (RP2D)
Time frame: Up to approximately 2 years
11 secondary outcomes
Adverse Events
Time frame: 12 weeks after the last dose
Time of maximum observed plasma concentration (Tmax) of SHR-1912
Time frame: 21 days after last dose
Maximum observed plasma concentration (Cmax) of SHR-1912
Time frame: 21 days after last dose
Area under the plasma concentration time curve (AUC) of SHR-1912
Time frame: 21 days after last dose
Anti-drug antibody (ADA) of SHR-A1912
Time frame: 12 weeks after last dose
Complete Response Rate (CR)
Time frame: Up to approximately 2 years
Objective Response Rate (ORR)
Time frame: Up to approximately 2 years
Duration of Response (DoR)
Time frame: Up to approximately 2 years
Disease Control Rate (DCR)
Time frame: Up to approximately 2 years
Progression-Free Survival (PFS)
Time frame: Up to approximately 2 years
Overall Survival (OS)
Time frame: Up to approximately 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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-A1912 in people with B Cell Lymphoma, 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 6 inclusion and 8 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 6 Dec 2023. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: 21 Days after the 1st dosing (first cycle)). The study lists 4 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 6 Dec 2023.