Advanced Or Metastatic Solid Tumor MalignanciesPhase 1NCT05735275
A Phase 1 Study of SHR-A2102 in Subjects With Advanced Solid Tumors.
A Phase 1 study testing SHR-A2102 in people with Advanced Or Metastatic Solid Tumor Malignancies, run by Shanghai Hengrui Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This is a first in human, open-label, single-arm, multicenter dose escalation and expansion Phase 1 study of SHR-A2102 in patients with advanced or metastatic solid tumors. The purpose of this study is to assess the tolerability, safety, pharmacokinetics and immunogenicity of SHR-A2102 and preliminary anti-tumor… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Or Metastatic Solid Tumor Malignancies
- What is being tested?
- SHR-A2102
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 1 siteChina
- Study dates
- 3 Mar 2023to 31 Aug 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
- Ability to understand and the willingness to sign a written informed consent document；
- Aged ≥18 years old;
- Histologically or cytologically confirmed advanced or metastatic malignant tumor;
- Presence of at least one measurable lesion in agreement to RECIST criteria;
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1;
- Life expectancy ≥3 months;
- Adequate organ performance based on laboratory blood tests;
- Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.
Who cannot join
- Previous received anti-cancer systemic therapy including chemo-therapy, radiation therapy, target therapy or immuno-therapy within 4 weeks before the first dose;
- Previous received experimental medication or therapy within 4 weeks before the first dose;
- Previous therapeutic surgery within 4 weeks;
- Has unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to NCI-CTCAE version 5.0 grade ≤ 1.
- Known allergic to any compound of SHR-A2102;
- Patients with uncontrolled or active brain metastasis；
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- Patients with clinical significant lung disease;
- Patients with history of autoimmune diseases;
- Known active hepatitis B or C infection;
- Other serious accompanying illnesses, which, in the investigator's assessment, could seriously adversely affect the safety of the treatment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Jun Guo
About this study
Official title: Safety, Tolerability, Pharmacokinetics, and Efficacy of SHR-A2102, In Subjects With Locally Advanced Or Metastatic Solid Tumor Malignancies: A Phase I Open-Label, One-Arm, Multicenter Study.
This is a first in human, open-label, single-arm, multicenter dose escalation and expansion Phase 1 study of SHR-A2102 in patients with advanced or metastatic solid tumors. The purpose of this study is to assess the tolerability, safety, pharmacokinetics and immunogenicity of SHR-A2102 and preliminary anti-tumor efficacy
- Being tested
- SHR-A2102
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-A2102Drug
All participants receive SHR-A2102 alone.
| Study group | Role | What they receive |
|---|---|---|
| SHR-A2102 Does Escalation and Expansion | Experimental | Not described Receives: Drug: SHR-A2102 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limited Toxicity (DLT)
Measured: 21 Days (first cycle)
Maximum tolerable dose (MTD)
Measured: 21 Days (first cycle)
Recommended dose for phase II (RP2D)
Measured: Up to 8 months
Secondary outcomes (9)
Area under the plasma concentration time curve in the dosing interval AUC(TAU) of SHR-A2102
Measured: 30 days after last dose
Maximum observed plasma concentration (Cmax) of SHR-A2102
Measured: 30 days after last dose
Time of maximum observed plasma concentration (Tmax) of SHR-A2102
Measured: 30 days after last dose
Immunogenicity Analysis
ADA
Measured: 30 days after last dose
ORR
Objective Response Rate
Measured: 24 months
DCR
Disease Control Rate
Measured: 24 months
DoR
Duration of Response
Measured: 24 months
PFS
Progression-Free-Survival
Measured: 24 months
OS
Overall survival
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start3 Mar 2023
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 2025 (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 Solid Tumor MalignanciesStudies 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, multicenter, Single Group
- Masking
- None (open label)
- Enrolment
- 252 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
- NCT05735275
- Sponsor's protocol ID
- SHR-A2102-I-101
- Status last verified
- Jan 2023
- First submitted
- 29 Jan 2023
- Last updated
- 28 Mar 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 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, Pharmacokinetics, and Efficacy of SHR-A2102, In Subjects With Locally Advanced Or Metastatic Solid Tumor Malignancies: A Phase I Open-Label, One-Arm, Multicenter Study.
- ClinicalTrials.gov ID
- NCT05735275
- Acronym / sponsor ID
- SHR-A2102-I-101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Mar 2023 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 21 Feb 2023 (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 first in human, open-label, single-arm, multicenter dose escalation and expansion Phase 1 study of SHR-A2102 in patients with advanced or metastatic solid tumors. The purpose of this study is to assess the tolerability, safety, pharmacokinetics and immunogenicity of SHR-A2102 and preliminary anti-tumor efficacy
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- open, multicenter, Single Group
| Arm | Type | Receives |
|---|---|---|
| SHR-A2102 Does Escalation and Expansion | Experimental | Drug: SHR-A2102 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Ability to understand and the willingness to sign a written informed consent document；
- Aged ≥18 years old;
- Histologically or cytologically confirmed advanced or metastatic malignant tumor;
- Presence of at least one measurable lesion in agreement to RECIST criteria;
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1;
Key exclusion criteria (10 listed)
- Previous received anti-cancer systemic therapy including chemo-therapy, radiation therapy, target therapy or immuno-therapy within 4 weeks before the first dose;
- Previous received experimental medication or therapy within 4 weeks before the first dose;
- Previous therapeutic surgery within 4 weeks;
- Has unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to NCI-CTCAE version 5.0 grade ≤ 1.
- Known allergic to any compound of SHR-A2102;
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-A2102All participants receive SHR-A2102 alone. | Drug | SHR-A2102 Does Escalation and Expansion |
Primary outcome
Dose Limited Toxicity (DLT)
Time frame: 21 Days (first cycle)
Maximum tolerable dose (MTD)
Time frame: 21 Days (first cycle)
Recommended dose for phase II (RP2D)
Time frame: Up to 8 months
9 secondary outcomes
Area under the plasma concentration time curve in the dosing interval AUC(TAU) of SHR-A2102
Time frame: 30 days after last dose
Maximum observed plasma concentration (Cmax) of SHR-A2102
Time frame: 30 days after last dose
Time of maximum observed plasma concentration (Tmax) of SHR-A2102
Time frame: 30 days after last dose
Immunogenicity Analysis
Time frame: 30 days after last dose
ORR
Time frame: 24 months
DCR
Time frame: 24 months
DoR
Time frame: 24 months
PFS
Time frame: 24 months
OS
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 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.
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-A2102 in people with Advanced Or Metastatic Solid Tumor Malignancies, 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 8 inclusion and 10 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 28 Mar 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?
Contact Qi Zhang (+0518-81220121, qi.zhang@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limited Toxicity (DLT) (time frame: 21 Days (first cycle)). 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 28 Mar 2023.