Advanced Solid TumorsPhase 1NCT05701709
Phase I Study of SHR-A2102 in Patients With Advanced Solid Tumors
A Phase 1 study testing SHR-A2102 in people with Advanced Solid Tumors, run by Shanghai Hengrui Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The study was designed to evaluate the efficacy, safety, and pharmacokinetics of SHR2102 in patients with advanced solid tumors. The objective of this study was to determine the dose-limiting toxicity, maximum tolerance and recommended dose of SHR-A2102 in phase II study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- SHR-A2102
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 395 participants
- Where
- 1 siteChina
- Study dates
- 6 Apr 2023to 31 Aug 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Able and willing to provide a written informed consent;
- Age ≥18 years old, gender unlimited;
- The physical status score of the Eastern Tumor Cooperative Group (ECOG) was 0 ~ 1;
- Life expectancy Predicted survival ≥3 months;
- Histologically or cytologically confirmed advanced or metastatic malignant tumor; Patients with advanced solid tumors confirmed by pathology who have failed or been intolerant to standard treatment, have no standard treatment or refuse standard treatment;
- There is at least one measurable lesion that meets the RECIST 1.1 criteria.
Who cannot join
- Plan to receive any other antitumor therapy during this trial;
- Receiving other investigational drugs or treatments that are not on the market within 4 weeks prior to the initial administration of the study drug;
- Received antitumor therapy such as chemotherapy, radiotherapy, biotherapy, targeted therapy, or immunotherapy within 4 weeks prior to first administration of the study drug (nitrosourea or mitomycin C within 6 weeks prior to first administration; Oral fluorouracil within 2 weeks prior to initial first administration); Palliative radiotherapy or local therapy within 2 weeks before first administration use of the study drug;
- Had major surgery other than diagnosis or biopsy within 4 weeks prior to the study's initial dosing;
- Treatment with CYP3A4, CYP2D6, P-gp or BCRP booster or inducer is less than 5 drug half-life from the date of first administration;
- According to NCI-CTCAE v5.0, adverse events caused by previous antitumor therapy did not recover to ≤ grade 1 (except hair loss; In the judgment of the investigator, after consultation with the sponsor, some tolerable chronic grade 2 toxicity may be excluded);
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- Inadequately treated central nervous system (CNS) metastases, or the presence of uncontrolled or symptomatic active CNS metastases, may be characterized by the presence of clinical symptoms, cerebral edema, spinal cord compression, cancerous meningitis, pia meningeal disease, and/or rapid progression. Patients with CNS metastases that have been adequately treated and whose neurological symptoms return to baseline at least 4 weeks prior to randomization (except for residual signs or symptoms associated with CNS treatment) may be enrolled. In addition, subjects must either stop corticosteroids or receive prednisone (or an equivalent dose of another corticosteroid) at least 4 weeks prior to randomization;
- Any other malignancies, excluding cured basal cell carcinoma of the skin and carcinoma in situ of the cervix, etc. within 5 years prior to initial administration;
- A history of clinically significant lung disease (such as interstitial pneumonia, radiation pneumonia, pulmonary fibrosis) or chest imaging during screening suggests any such disease;
- Severe infections that require intravenous antibiotic, antiviral or antifungal control;
- Active HBV or HCV infection (HBsAg positive and viral copy number ≥2000 IU/mL, HCV antibody positive and HCV RNA higher than the lower limit of detection method);
- History of immunodeficiency (including HIV positive, other acquired or congenital immunodeficiency diseases) or organ transplantation;
- Concomitant diseases (such as severe diabetes, thyroid disease, and psychosis) or any other conditions that, in the investigator's judgment, seriously endanger the patient's safety or affect the patient's ability to complete the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
Hua Zhong
About this study
Official title: An Open-Label, Single-Arm, Multi-Center Phase I Clinical Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of SHR-A2102 in Patients With Advanced Solid Tumors
The study was designed to evaluate the efficacy, safety, and pharmacokinetics of SHR2102 in patients with advanced solid tumors. The objective of this study was to determine the dose-limiting toxicity, maximum tolerance and recommended dose of SHR-A2102 in phase II study.
- Conditions
- Advanced Solid Tumors
- 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
SHR-A2102 was given intravenously. Patients may continue to use SHR-A2102 until disease progression or unacceptable toxicity occurs.
| Study group | Role | What they receive |
|---|---|---|
| SHR-A2102 | Experimental | Not described Receives: Drug: SHR-A2102 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
Adverse events are assessed by CTCAE v5.0
Measured: 24 months
Maximum tolerated dose (MTD)
MTD is defined as the maximum dose within the first 3 weeks of multiple dosing that does not exceed the proportion of subjects who develop DLT as specified in the protocol's BOIN design.
Measured: 12 weeks
Recommended Phase 2 dose (RP2D)
RP2D will be determined based on the available data for toxicity and PK.
Measured: 24 months
Dose Limiting Toxicity (DLT)
Adverse events that occurred during the DLT observation period (the first period of study administration, a total of 21 days) that were determined to be related to the study drug (see protocol for details).
Measured: 3 weeks
Secondary outcomes (9)
Peak plasma concentration (Cmax)
Measured: 12 weeks
Area under the plasma concentration versus time curve (AUC）
Measured: 12 weeks
T1/2 (Half-life)
The time required for the plasma concentration of a drug to be reduced by 50%
Measured: 12 weeks
Immunogenicity: Number of subjects with anti-SHR-A2102 antibody (ADA), incidence, occurrence time, duration, etc
Measured: 12 weeks
Objective response rate (ORR)
Measured: 24 months
duration of response (DoR)
Measured: 24 months
disease control rate (DCR)
Measured: 24 months
progression-free survival (PFS)
Measured: 24 months
overall survival (OS)
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 posted27 Jan 2023
- Study start6 Apr 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Solid TumorsStudies 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
- SHR-A2102 single arm
- Masking
- None (open label)
- Enrolment
- 395 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
- NCT05701709
- Sponsor's protocol ID
- SHR-A2102-I-102
- Status last verified
- Mar 2025
- First submitted
- 18 Jan 2023
- Last updated
- 22 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zhong R, Hong H, Yan M, Wang Q, Zhang Y, Lan Q, Luo Y, Zhang L, Xu H, Guo S, Guo W, Ma J, Zhang L, Wu L, Liu Z, He W, Sun Y, Chen K, Huang J, Han G, Nian W, Zhang M, Ren S, Qiao R, Li X, Yu M, Hu J, Huang Y, Song L, Shi W, Zhong H. SHR-A2102, a nectin-4 directed antibody-drug conjugate, in patients with pretreated advanced solid tumours: a multicentre, single-arm, phase 1 trial. Lancet Oncol. 2026 Sep;27(9):1146-1157. doi: 10.1016/S1470-2045(26)00238-X.
PubMed 42636836
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. 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, Efficacy and Pharmacokinetics of SHR-A2102 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05701709
- Acronym / sponsor ID
- SHR-A2102-I-102
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 395 participants (estimated)
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Apr 2023 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 27 Jan 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.
The study was designed to evaluate the efficacy, safety, and pharmacokinetics of SHR2102 in patients with advanced solid tumors. The objective of this study was to determine the dose-limiting toxicity, maximum tolerance and recommended dose of SHR-A2102 in phase II study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- SHR-A2102 single arm
| Arm | Type | Receives |
|---|---|---|
| SHR-A2102 | 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 (6 listed)
- Able and willing to provide a written informed consent;
- Age ≥18 years old, gender unlimited;
- The physical status score of the Eastern Tumor Cooperative Group (ECOG) was 0 ~ 1;
- Life expectancy Predicted survival ≥3 months;
- Histologically or cytologically confirmed advanced or metastatic malignant tumor; Patients with advanced solid tumors confirmed by pathology who have failed or been intolerant to standard treatment, have no standard treatment or refuse standard treatment;
Key exclusion criteria (13 listed)
- Plan to receive any other antitumor therapy during this trial;
- Receiving other investigational drugs or treatments that are not on the market within 4 weeks prior to the initial administration of the study drug;
- Received antitumor therapy such as chemotherapy, radiotherapy, biotherapy, targeted therapy, or immunotherapy within 4 weeks prior to first administration of the study drug (nitrosourea or mitomycin C within 6 weeks prior to first administration; Oral fluorouracil within 2 weeks prior to initial first administration); Palliative radiotherapy or local therapy within 2 weeks before first administration use of the study drug;
- Had major surgery other than diagnosis or biopsy within 4 weeks prior to the study's initial dosing;
- Treatment with CYP3A4, CYP2D6, P-gp or BCRP booster or inducer is less than 5 drug half-life from the date of first administration;
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-A2102SHR-A2102 was given intravenously. Patients may continue to use SHR-A2102 until disease progression or unacceptable toxicity occurs. | Drug | SHR-A2102 |
Primary outcome
Number of participants with adverse events
Time frame: 24 months
Adverse events are assessed by CTCAE v5.0
Maximum tolerated dose (MTD)
Time frame: 12 weeks
MTD is defined as the maximum dose within the first 3 weeks of multiple dosing that does not exceed the proportion of subjects who develop DLT as specified in the protocol's BOIN design.
Recommended Phase 2 dose (RP2D)
Time frame: 24 months
RP2D will be determined based on the available data for toxicity and PK.
Dose Limiting Toxicity (DLT)
Time frame: 3 weeks
Adverse events that occurred during the DLT observation period (the first period of study administration, a total of 21 days) that were determined to be related to the study drug (see protocol for details).
9 secondary outcomes
Peak plasma concentration (Cmax)
Time frame: 12 weeks
Area under the plasma concentration versus time curve (AUC）
Time frame: 12 weeks
T1/2 (Half-life)
Time frame: 12 weeks
Immunogenicity: Number of subjects with anti-SHR-A2102 antibody (ADA), incidence, occurrence time, duration, etc
Time frame: 12 weeks
Objective response rate (ORR)
Time frame: 24 months
duration of response (DoR)
Time frame: 24 months
disease control rate (DCR)
Time frame: 24 months
progression-free survival (PFS)
Time frame: 24 months
overall survival (OS)
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
- Derived from this study: PubMed 42636836Zhong R, Hong H, Yan M, Wang Q, Zhang Y, Lan Q, Luo Y, Zhang L, Xu H, Guo S, Guo W, Ma J, Zhang L, Wu L, Liu Z, He W, Sun Y, Chen K, Huang J, Han G, Nian W, Zhang M, Ren S, Qiao R, Li X, Yu M, Hu J, Huang Y, Song L, Shi W, Zhong H. SHR-A2102, a nectin-4 directed antibody-drug conjugate, in patients with pretreated advanced solid tumours: a multicentre, single-arm, phase 1 trial. Lancet Oncol. 2026 Sep;27(9):1146-1157. doi: 10.1016/S1470-2045(26)00238-X.
- 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.
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 Solid Tumors, 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 13 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: looking for participants now, as of the sponsor's last update on 22 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fei Luo (+0518-81220121, fei.luo@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events (time frame: 24 months). 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?
On the ClinicalTrials.gov record for NCT05701709, which also lists 1 linked publication.
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 22 Jul 2025.