Advanced Urothelial CarcinomaPhase 1/2NCT06639347
A Trial of SHR-A2102 With Antitumor Therapy in Advanced Urothelial Carcinoma
A Phase 1/2 study testing SHR-A2102, Adebrelimab injection and SHR-8068 injection in people with Advanced Urothelial Carcinoma, run by Shanghai Hengrui Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-A2102 for injection with Antitumor Therapy in Advanced Urothelial Carcinoma. To explore the reasonable dosage of SHR-A2102 for Advanced Urothelial Carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Urothelial Carcinoma
- What is being tested?
- SHR-A2102, Adebrelimab injection and SHR-8068 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 4 Nov 2024to 31 May 2027
- Phase
- Phase 1/2
- 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
- Competent to comprehend, sign, and date an informed consent form.
- Male or female subjects must be age 18 or older.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Subjects must have histologically documented, unresectable locally advanced or
- Histologically confirmed locally advanced or metastatic urothelial cancer.Phase Ib, subjects must have failed, be intolerant or refused the standard treatment; Phase II, subjects must not have received systemic antitumor therapy for locally advanced unresectable or metastatic urothelial carcinoma.
- An archival tumor tissue sample or a fresh tissue sample should be provided.
- Subjects must have measurable disease according to RECIST (version 1.1).
Who cannot join
- Subjects with not adequately treated, or uncontrollable , or active CNS metastases.
- Subjects who have previously received TOPO1-based ADCs.
- Subjects who have received anti-cancer treatment within 4 weeks prior the first dose of study treatment.
- Subjects who have received radiotherapy within 14 days , or chest radiotherapy > 30Gy within 6 months prior to the first dose of study drug.
- Subjects with ongoing clinically significant toxicity associated with prior treatment that has not resolved to ≤ Grade 1.
- Subjects who have received systemic immunosuppressant treatment within 14 days prior the first dose of study treatment.
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- Subjects who have known or suspected interstitial pneumonitis.
- Phase Ib: Subjects who have had≥ Grade 3 irAEs during the previous treatment with ICIs.
- Subjects who have any active, known or suspected autoimmune diseases.
- Subjects who have moderate or severe ascites with clinical symptoms, or uncontrolled or moderate or above pleural effusion, or pericardial effusion.
- Subjects who have uncontrolled cardiac diseases or cardiac clinical symptoms.
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
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Fangjian Zhou, zhoufj@sysucc.org.cn
Yanxia Shi, shiyx@sysucc.org.cn
About this study
Official title: An Open Label, Multicenter, Phase Ib/Il Study to Evaluate the Safety, Tolerability, and Efficacy of SHR A2102 in Combination With Other Anti-cancer Agents in Patients With Advanced Urothelial Carcinoma
The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-A2102 for injection with Antitumor Therapy in Advanced Urothelial Carcinoma. To explore the reasonable dosage of SHR-A2102 for Advanced Urothelial Carcinoma.
- Conditions
- Advanced Urothelial Carcinoma
- Being tested
- SHR-A2102, Adebrelimab injection, SHR-8068 injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-A2102Drug
SHR-A2102
Adebrelimab injectionDrug
Adebrelimab injection
SHR-8068 injectionDrug
SHR-8068 injection
| Study group | Role | What they receive |
|---|---|---|
| SHR-A2102 + Adebrelimab injection+SHR-8068 injection | Experimental | Not described Receives: Drug: SHR-A2102; Drug: Adebrelimab injection; Drug: SHR-8068 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: RP2D of SHR-A2102 combined with Adebrelimab and SHR-8068 in patients with advanced urothelial cancer
Measured: Up to approximately 5 years
Phase I: Incidence and severity of adverse events
Measured: Up to approximately 5 years
Phase II: ORR by investigator assessment
Measured: Up to approximately 5 years
Secondary outcomes (14)
Phase I: ORR by investigator assessment
Measured: Up to approximately 5 years
Phase I: DCR by investigator assessment
Measured: Up to approximately 5 years
Phase I: DoR by investigator assessment
Measured: Up to approximately 5 years
Phase I: PFS by investigator assessment
Measured: Up to approximately 5 years
Phase I: OS by investigator assessment
Measured: Up to approximately 5 years
Phase I: Pharmacokinetic parameter for serum concentrations of SHR-A2102 and free toxin
Measured: Up to approximately 5 years
Phase I: Anti-SHR-A2102 antibody (ADA) and anti-SHR-A2102 neutralizing antibody (NAb)
Measured: Up to approximately 5 years
Phase II: DCR by investigator assessment
Measured: Up to approximately 5 years
Phase II: DoR by investigator assessment
Measured: Up to approximately 5 years
Phase II: PFS by investigator assessment
Measured: Up to approximately 5 years
Phase II: OS by investigator assessment
Measured: Up to approximately 5 years
Phase II: Incidence and severity of adverse events
Measured: up to 5 years
Phase II: Pharmacokinetic parameter for serum concentrations of SHR-A2102 and free toxin
Measured: Up to approximately 5 years
Phase II: Anti-SHR-A2102 antibody (ADA) and anti-SHR-A2102 neutralizing antibody (NAb)
Measured: Up to approximately 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start4 Nov 2024
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Urothelial CarcinomaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- SHR-A2102 with antitumor therapy
- Masking
- None (open label)
- Enrolment
- 90 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
- NCT06639347
- Sponsor's protocol ID
- SHR-A2102-207
- Status last verified
- Oct 2024
- First submitted
- 10 Oct 2024
- Last updated
- 18 Nov 2024
- 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 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Multicenter, Phase Ib/Il Study to Evaluate the Safety, Tolerability, and Efficacy of SHR A2102 in Combination With Other Anti-cancer Agents in Patients With Advanced Urothelial Carcinoma
- ClinicalTrials.gov ID
- NCT06639347
- Acronym / sponsor ID
- SHR-A2102-207
- Conditions
- Advanced Urothelial Carcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Nov 2024 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 15 Oct 2024 (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 evaluate the safety, tolerability and efficacy of SHR-A2102 for injection with Antitumor Therapy in Advanced Urothelial Carcinoma. To explore the reasonable dosage of SHR-A2102 for Advanced Urothelial Carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- SHR-A2102 with antitumor therapy
| Arm | Type | Receives |
|---|---|---|
| SHR-A2102 + Adebrelimab injection+SHR-8068 injection | Experimental | Drug: SHR-A2102, Drug: Adebrelimab injection, Drug: SHR-8068 injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Competent to comprehend, sign, and date an informed consent form.
- Male or female subjects must be age 18 or older.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Subjects must have histologically documented, unresectable locally advanced or
- Histologically confirmed locally advanced or metastatic urothelial cancer.Phase Ib, subjects must have failed, be intolerant or refused the standard treatment; Phase II, subjects must not have received systemic antitumor therapy for locally advanced unresectable or metastatic urothelial carcinoma.
Key exclusion criteria (11 listed)
- Subjects with not adequately treated, or uncontrollable , or active CNS metastases.
- Subjects who have previously received TOPO1-based ADCs.
- Subjects who have received anti-cancer treatment within 4 weeks prior the first dose of study treatment.
- Subjects who have received radiotherapy within 14 days , or chest radiotherapy > 30Gy within 6 months prior to the first dose of study drug.
- Subjects with ongoing clinically significant toxicity associated with prior treatment that has not resolved to ≤ Grade 1.
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 | Drug | SHR-A2102 + Adebrelimab injection+SHR-8068 injection |
| Adebrelimab injectionAdebrelimab injection | Drug | SHR-A2102 + Adebrelimab injection+SHR-8068 injection |
| SHR-8068 injectionSHR-8068 injection | Drug | SHR-A2102 + Adebrelimab injection+SHR-8068 injection |
Primary outcome
Phase I: RP2D of SHR-A2102 combined with Adebrelimab and SHR-8068 in patients with advanced urothelial cancer
Time frame: Up to approximately 5 years
Phase I: Incidence and severity of adverse events
Time frame: Up to approximately 5 years
Phase II: ORR by investigator assessment
Time frame: Up to approximately 5 years
14 secondary outcomes
Phase I: ORR by investigator assessment
Time frame: Up to approximately 5 years
Phase I: DCR by investigator assessment
Time frame: Up to approximately 5 years
Phase I: DoR by investigator assessment
Time frame: Up to approximately 5 years
Phase I: PFS by investigator assessment
Time frame: Up to approximately 5 years
Phase I: OS by investigator assessment
Time frame: Up to approximately 5 years
Phase I: Pharmacokinetic parameter for serum concentrations of SHR-A2102 and free toxin
Time frame: Up to approximately 5 years
Phase I: Anti-SHR-A2102 antibody (ADA) and anti-SHR-A2102 neutralizing antibody (NAb)
Time frame: Up to approximately 5 years
Phase II: DCR by investigator assessment
Time frame: Up to approximately 5 years
Phase II: DoR by investigator assessment
Time frame: Up to approximately 5 years
Phase II: PFS by investigator assessment
Time frame: Up to approximately 5 years
Phase II: OS by investigator assessment
Time frame: Up to approximately 5 years
Phase II: Incidence and severity of adverse events
Time frame: up to 5 years
Phase II: Pharmacokinetic parameter for serum concentrations of SHR-A2102 and free toxin
Time frame: Up to approximately 5 years
Phase II: Anti-SHR-A2102 antibody (ADA) and anti-SHR-A2102 neutralizing antibody (NAb)
Time frame: Up to approximately 5 years
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 18 Nov 2024.
- 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 1/2 study testing SHR-A2102, Adebrelimab injection and SHR-8068 injection in people with Advanced Urothelial Carcinoma, 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 7 inclusion and 11 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 18 Nov 2024. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Chun Yang (+86 15001953916, chun.yang.cy35@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I: RP2D of SHR-A2102 combined with Adebrelimab and SHR-8068 in patients with advanced urothelial cancer (time frame: Up to approximately 5 years). 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 18 Nov 2024.