Advanced Malignant CancerPhase 1NCT05162469
A Study of SHR-A1909 in Subjects With Advanced Malignant Tumors
A Phase 1 study testing SHR-1909 injection in people with Advanced Malignant Cancer, run by Shanghai Hengrui Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This is an, open-label, multi-center, three-part phase I trial to evaluate the safety, pharmacokinetics and immunogenicity of SHR-1909 and preliminary anti-tumor efficacy of SHR-1909 in advanced malignant cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Malignant Cancer
- What is being tested?
- SHR-1909 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 23 Feb 2022to 13 Jun 2024
- 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
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- Patients must have cytologically or histologically confirmed advanced malignant tumor, and must have failed standard treatment;
- Toxicities caused by prior anti-tumor treatments must have resolved to CTCAE Grade ≤ 1 prior to the first dose (except for alopecia or hypothyroidism treated with hormone replacement therapy or diabetes controlled with insulin);
- Adequate organ function.
Who cannot join
- With CNS infiltration, or ascites requiring paracentesis or symptomatic pleural effusion;
- Received prior CAR T-cell therapy;
- Received allogeneic hematopoietic stem cell transplantation within 3 months prior to the start of study treatment, or with acute/chronic graft versus host disease;
- With active infection or fever of unknown origin (> 38.5 °C).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SHR-1909 Injection in Patients With Advanced Malignant Tumors
This is an, open-label, multi-center, three-part phase I trial to evaluate the safety, pharmacokinetics and immunogenicity of SHR-1909 and preliminary anti-tumor efficacy of SHR-1909 in advanced malignant cancer.
- Conditions
- Advanced Malignant Cancer
- Being tested
- SHR-1909 injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1909 injectionDrug
SHR-1909 for intravenous injection;Strength:6ml:0.3g/vial. Dose escalation (non randomized, 6 dose-levels); Dose-expansion and efficacy-expansion(non-randomized,1-3 dose-level(s)).
| Study group | Role | What they receive |
|---|---|---|
| SHR-1909 monotherapy | Experimental | Not described Receives: Drug: SHR-1909 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD of SHR-1909
Maximum tolerated dose (MTD) based on dose-limiting toxicities (DLTs)
Measured: From Day 1 to 4 weeks
RP2D of SHR-1909
Recommended Phase 2 Dose(RP2D) of SHR-1909 will be determined during the dose-escalation and dose-expansion parts of the study. RP2D will be determined using available safety, pharmacokinetics and pharmacodynamics data.
Measured: From Day 1 to 90 days after last dose
Secondary outcomes (3)
Adverse Events
Adverse Events documented by CTCAE 5.0
Measured: 90 days after the last dose
Objective Response Rate (ORR)
Baseline to documented disease progression or study discontinuation
Measured: Up to approximately 2 years
Progression-Free Survival (PFS)
From Day 1 to Radiographic Progression or Death Due to Any Cause
Measured: Up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2021
- Study start23 Feb 2022
- Primary completion28 Mar 2024
- Study completion13 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant 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
- Dose escalation (non randomized， 6 arms); Dose-expansion and efficacy-expansion(non-randomized,1-3 arms)
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
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
- NCT05162469
- Sponsor's protocol ID
- SHR-1909-I-101
- Status last verified
- Jul 2025
- First submitted
- 5 Dec 2021
- Last updated
- 28 Jul 2025
- 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 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SHR-1909 Injection in Patients With Advanced Malignant Tumors
- ClinicalTrials.gov ID
- NCT05162469
- Acronym / sponsor ID
- SHR-1909-I-101
- Conditions
- Advanced Malignant Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Feb 2022 (actual)
- Primary completion
- 28 Mar 2024 (actual)
- Study completion
- 13 Jun 2024 (actual)
- First posted
- 17 Dec 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.
This is an, open-label, multi-center, three-part phase I trial to evaluate the safety, pharmacokinetics and immunogenicity of SHR-1909 and preliminary anti-tumor efficacy of SHR-1909 in advanced malignant cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Dose escalation (non randomized， 6 arms); Dose-expansion and efficacy-expansion(non-randomized,1-3 arms)
| Arm | Type | Receives |
|---|---|---|
| SHR-1909 monotherapy | Experimental | Drug: SHR-1909 injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- Patients must have cytologically or histologically confirmed advanced malignant tumor, and must have failed standard treatment;
- Toxicities caused by prior anti-tumor treatments must have resolved to CTCAE Grade ≤ 1 prior to the first dose (except for alopecia or hypothyroidism treated with hormone replacement therapy or diabetes controlled with insulin);
- Adequate organ function.
Key exclusion criteria (4 listed)
- With CNS infiltration, or ascites requiring paracentesis or symptomatic pleural effusion;
- Received prior CAR T-cell therapy;
- Received allogeneic hematopoietic stem cell transplantation within 3 months prior to the start of study treatment, or with acute/chronic graft versus host disease;
- With active infection or fever of unknown origin (> 38.5 °C).
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-1909 injectionSHR-1909 for intravenous injection;Strength:6ml:0.3g/vial. Dose escalation (non randomized, 6 dose-levels); Dose-expansion and efficacy-expansion(non-randomized,1-3 dose-level(s)). | Drug | SHR-1909 monotherapy |
Primary outcome
MTD of SHR-1909
Time frame: From Day 1 to 4 weeks
Maximum tolerated dose (MTD) based on dose-limiting toxicities (DLTs)
RP2D of SHR-1909
Time frame: From Day 1 to 90 days after last dose
Recommended Phase 2 Dose(RP2D) of SHR-1909 will be determined during the dose-escalation and dose-expansion parts of the study. RP2D will be determined using available safety, pharmacokinetics and pharmacodynamics data.
3 secondary outcomes
Adverse Events
Time frame: 90 days after the last dose
Objective Response Rate (ORR)
Time frame: Up to approximately 2 years
Progression-Free Survival (PFS)
Time frame: Up to approximately 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
- 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-1909 injection in people with Advanced Malignant 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 28 Jul 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
MTD of SHR-1909 (time frame: From Day 1 to 4 weeks). 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 Jul 2025.