Advanced Solid TumorsPhase 1/2NCT06439589
Phase Ib/II Study of HRS2398 in Combination With Adebrelimab in Patients With Advanced Solid Tumors
A Phase 1/2 study testing HRS2398 and Adebrelimab in people with Advanced Solid Tumors, run by Shanghai Hengrui Pharmaceutical Co., Ltd. at 2 sites in China.
Trial summary
This study is a multicenter, open-label, dose-finding/efficacy-expanding phase Ib/II clinical trial, which aims to observe and evaluate the tolerability, safety, pharmacokinetic characteristics and immunogenicity of HRS2398 combined with Adebrelimab injection in patients with advanced solid tumors, determine the RP2D… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- HRS2398 and Adebrelimab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 2 sitesChina
- Study dates
- 12 Jun 2024to Dec 2025
- Phase
- Phase 1/2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects are able to give voluntary informed consent, understand the study and are willing to follow and complete all the test procedures.
- Age 18~75 years old.
- Dose escalation phase: patients with clinically diagnosed or pathologically confirmed advanced solid tumors who have failed standard therapy (disease progression during or after treatment) or for whom no effective standard treatment regimen exists.
- Dose Expansion and Efficacy Expansion Phase: Patients with advanced solid tumors who have received systemic immunotherapy and platinum-containing chemotherapy in the recurrent/metastatic settings.
- At least one measurable lesion per RECIST v1.1 criteria.
- ECOG PS score: 0-1.
Who cannot join
- Patients with meningeal metastases; or with brain metastases that have not been treated with surgery or radiotherapy.
- Cancerous ascites and pleural effusion with clinical symptoms, requiring puncture and drainage; or those who have received ascites, pleural effusion drainage within 14 days before the first dose.
- Presence of any active, known autoimmune disease.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Not yet recruiting
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
Hua Zhong
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450003
Yanyan Liu
About this study
Official title: An Open-label, Multi-center Phase Ib/II Study of HRS2398 in Combination With Adebrelimab in Patients With Advanced Solid Tumors
This study is a multicenter, open-label, dose-finding/efficacy-expanding phase Ib/II clinical trial, which aims to observe and evaluate the tolerability, safety, pharmacokinetic characteristics and immunogenicity of HRS2398 combined with Adebrelimab injection in patients with advanced solid tumors, determine the RP2D, and preliminarily evaluate the efficacy of HRS2398 combined with Adebrelimab in patients with advanced solid tumors.
- Conditions
- Advanced Solid Tumors
- Being tested
- HRS2398, Adebrelimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS2398Drug
HRS2398: Tablets, 40mg/tablet, oral
AdebrelimabDrug
Adebrelimab (SHR-1316): injection, 600mg(12mL), intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| HRS2398 given in combination with adebrelimab | Experimental | Not described Receives: Drug: HRS2398; Drug: Adebrelimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of subjects with dose-limiting toxicity (DLT)
Measured: From first dose of study treatment until the end of Cycle 1（up to 28 days）
Determination of Recommended Phase II dose (RP2D)
Measured: From first dose of study treatment until the end of Cycle 1（up to 28 days）
Objective Response Rate (ORR)
Measured: From time of first dose of HRS2398 or Adebrelimab until the date of objective disease progression or death (up to 6 months)
Secondary outcomes (5)
Disease Control Rate (DCR)
Measured: From time of first dose of HRS2398 or Adebrelimab until the date of objective disease progression or death (up to 6 months)
Duration of Response (DoR)
Measured: From time of first dose of objective disease progression until the date of objective disease progression or death (up to 6 months)
Progression free Survival (PFS)
Measured: From time of first dose of objective disease progression until the date of objective disease progression or death (up to 6 months)
Overall Survival (OS)
Measured: From time of first dose of objective disease progression until the date of death (up to 24 months)
Time To Response(TTR)
Measured: From time of first dose of objective disease progression until the date of objective disease progression or death (up to 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start12 Jun 2024
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 88 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
- NCT06439589
- Sponsor's protocol ID
- HRS2398-201-PD-L1
- Status last verified
- Jul 2024
- First submitted
- 28 May 2024
- Last updated
- 5 Jul 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 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multi-center Phase Ib/II Study of HRS2398 in Combination With Adebrelimab in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06439589
- Acronym / sponsor ID
- HRS2398-201-PD-L1
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Jun 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 3 Jun 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.
This study is a multicenter, open-label, dose-finding/efficacy-expanding phase Ib/II clinical trial, which aims to observe and evaluate the tolerability, safety, pharmacokinetic characteristics and immunogenicity of HRS2398 combined with Adebrelimab injection in patients with advanced solid tumors, determine the RP2D, and preliminarily evaluate the efficacy of HRS2398 combined with Adebrelimab in patients with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HRS2398 given in combination with adebrelimab | Experimental | Drug: HRS2398, Drug: Adebrelimab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects are able to give voluntary informed consent, understand the study and are willing to follow and complete all the test procedures.
- Age 18~75 years old.
- Dose escalation phase: patients with clinically diagnosed or pathologically confirmed advanced solid tumors who have failed standard therapy (disease progression during or after treatment) or for whom no effective standard treatment regimen exists.
- Dose Expansion and Efficacy Expansion Phase: Patients with advanced solid tumors who have received systemic immunotherapy and platinum-containing chemotherapy in the recurrent/metastatic settings.
- At least one measurable lesion per RECIST v1.1 criteria.
Key exclusion criteria (3 listed)
- Patients with meningeal metastases; or with brain metastases that have not been treated with surgery or radiotherapy.
- Cancerous ascites and pleural effusion with clinical symptoms, requiring puncture and drainage; or those who have received ascites, pleural effusion drainage within 14 days before the first dose.
- Presence of any active, known autoimmune disease.
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 |
|---|---|---|
| HRS2398HRS2398: Tablets, 40mg/tablet, oral | Drug | HRS2398 given in combination with adebrelimab |
| AdebrelimabAdebrelimab (SHR-1316): injection, 600mg(12mL), intravenous infusion | Drug | HRS2398 given in combination with adebrelimab |
Primary outcome
The number of subjects with dose-limiting toxicity (DLT)
Time frame: From first dose of study treatment until the end of Cycle 1（up to 28 days）
Determination of Recommended Phase II dose (RP2D)
Time frame: From first dose of study treatment until the end of Cycle 1（up to 28 days）
Objective Response Rate (ORR)
Time frame: From time of first dose of HRS2398 or Adebrelimab until the date of objective disease progression or death (up to 6 months)
5 secondary outcomes
Disease Control Rate (DCR)
Time frame: From time of first dose of HRS2398 or Adebrelimab until the date of objective disease progression or death (up to 6 months)
Duration of Response (DoR)
Time frame: From time of first dose of objective disease progression until the date of objective disease progression or death (up to 6 months)
Progression free Survival (PFS)
Time frame: From time of first dose of objective disease progression until the date of objective disease progression or death (up to 6 months)
Overall Survival (OS)
Time frame: From time of first dose of objective disease progression until the date of death (up to 24 months)
Time To Response(TTR)
Time frame: From time of first dose of objective disease progression until the date of objective disease progression or death (up to 6 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 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. This study is not recruiting at the moment.
2 sites 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 HRS2398 and Adebrelimab in people with Advanced Solid Tumors, run by Shanghai Hengrui Pharmaceutical Co., Ltd. at 2 sites 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 3 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 5 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xin Xu (0518-82342973, xin.xu@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of subjects with dose-limiting toxicity (DLT) (time frame: From first dose of study treatment until the end of Cycle 1（up to 28 days）). 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 5 Jul 2024.