Advanced Solid TumorPhase 1/2NCT05794477
A Study of SHR-1802 in Combination With Adebrelimab in Patients With Advanced Solid Tumors
A Phase 1/2 study testing Adebrelimab, SHR-1802 and Carboplatin/Cisplatin in people with Advanced Solid Tumor, run by Shanghai Hengrui Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The aim of this study is to observe and evaluate the tolerability, safety, pharmacokinetics and immunogenicity of SHR-1802 combined with adebrelimab in patients with advanced solid tumors, determine the RP2D of SHR-1802 combined with adebrelimab ± chemotherapy, and evaluate the efficacy of SHR-1802 combined with… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- Adebrelimab, SHR-1802 and Carboplatin/Cisplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteChina
- Study dates
- 28 Apr 2023to 31 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
- Able and willing to provide a written informed consent；
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- Has a life expectancy≥ 12 weeks；
- At least one measurable lesion according to RECIST v1.1；
- Pathologically confirmed advanced solid tumor；
- Adequate bone marrow reserve and organ function.
Who cannot join
- Have received anti-PD-1 or PD-L1 antibody therapy;
- Subjects with other malignant tumors in the past 3 years;
- Have uncontrolled clinically symptomatic pleural effusion, pericardial effusion, or ascites;
- Previous or current interstitial pneumonia/interstitial lung disease ;
- History of autoimmune disease with the possibility of recurrence or active autoimmune disease;
- Severe infection within 1 month before the first study drug administration;
- The presence of other serious physical or mental disorders or abnormalities in laboratory tests that may increase the risk of study participation or interfere with study results, as well as patients deemed unsuitable for study participation by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410013
Hui Wang, Doctor, +86-13973135460, wanghui@hnca.org.cn
About this study
Official title: An Open Label, Multicenter, Phase Ib/II Study of SHR-1802 in Combination With Adebrelimab in Patients With Advanced Solid Tumors
The aim of this study is to observe and evaluate the tolerability, safety, pharmacokinetics and immunogenicity of SHR-1802 combined with adebrelimab in patients with advanced solid tumors, determine the RP2D of SHR-1802 combined with adebrelimab ± chemotherapy, and evaluate the efficacy of SHR-1802 combined with adebrelimab ± chemotherapy in patients with advanced solid tumors.
- Conditions
- Advanced Solid Tumor
- Being tested
- Adebrelimab, SHR-1802, Carboplatin/Cisplatin, Paclitaxel/Nab-Paclitaxel/Pemetrexed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdebrelimabBiological
Specified dose on specified days
SHR-1802Biological
Specified dose on specified days
Carboplatin/CisplatinDrug
Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.
Paclitaxel/Nab-Paclitaxel/PemetrexedDrug
Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.
| Study group | Role | What they receive |
|---|---|---|
| phase Ib：SHR-1802+Adebrelimab | Experimental | Not described Receives: Biological: Adebrelimab; Biological: SHR-1802 |
| phase II cohort 1: SHR-1802+Adebrelimab | Experimental | Not described Receives: Biological: Adebrelimab; Biological: SHR-1802 |
| phase II cohort 2: SHR-1802+Adebrelimab + Platinum Doublet Chemotherapy (PDCT) | Experimental | Not described Receives: Biological: Adebrelimab; Biological: SHR-1802; Drug: Carboplatin/Cisplatin; Drug: Paclitaxel/Nab-Paclitaxel/Pemetrexed |
| phase II cohort 3: SHR-1802+Adebrelimab + PDCT | Experimental | Not described Receives: Biological: Adebrelimab; Biological: SHR-1802; Drug: Carboplatin/Cisplatin; Drug: Paclitaxel/Nab-Paclitaxel/Pemetrexed |
| phase II cohort 4: SHR-1802+Adebrelimab | Experimental | Not described Receives: Biological: Adebrelimab; Biological: SHR-1802 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity (DLT)
Measured: 3 weeks
Recommended phase II dose (RP2D)
Measured: up to 2 months
ORR
Objective Response Rate, determined according to RECIST v1.1 criteria
Measured: up to 2 years
Secondary outcomes (6)
DOR
Duration of Response, determined according to RECIST v1.1 criteria
Measured: up to 2 years
DCR
Disease Control Rate, determined according to RECIST v1.1 criteria
Measured: up to 2 years
PFS assessed by investigator
Progression Free Survival, determined according to RECIST v1.1 criteria
Measured: up to 2 years
TTR
Time to Response，determined according to RECIST v1.1 criteria
Measured: up to 2 years
OS (overall survival)
From date of treatment start to any cause death or last follow-up
Measured: up to 2 years
12-month OS rate
Measured: from the date of the first dose up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start28 Apr 2023
- Primary completion1 Jul 2025 (estimated)
- Study completion31 Dec 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 TumorStudies 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
- Non-randomised
- Intervention model
- Single group
- Model description
- Dose-exploration：Six patients will be enrolled for tolerability observation. If ≥2 subjects in the previous dose level experienced DLTS, an additional 6 subjects in the other dose level were enrolled. Efficacy-expansion: After determination of the recommended dose for Phase II (RP2D), selected cohorts with different tumor types will be expanded.
- Masking
- None (open label)
- Enrolment
- 132 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
- NCT05794477
- Sponsor's protocol ID
- SHR-1802-II-202
- Status last verified
- May 2023
- First submitted
- 20 Mar 2023
- Last updated
- 2 Jun 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 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Multicenter, Phase Ib/II Study of SHR-1802 in Combination With Adebrelimab in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05794477
- Acronym / sponsor ID
- SHR-1802-II-202
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Apr 2023 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 3 Apr 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 aim of this study is to observe and evaluate the tolerability, safety, pharmacokinetics and immunogenicity of SHR-1802 combined with adebrelimab in patients with advanced solid tumors, determine the RP2D of SHR-1802 combined with adebrelimab ± chemotherapy, and evaluate the efficacy of SHR-1802 combined with adebrelimab ± chemotherapy in patients with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Dose-exploration：Six patients will be enrolled for tolerability observation. If ≥2 subjects in the previous dose level experienced DLTS, an additional 6 subjects in the other dose level were enrolled. Efficacy-expansion: After determination of the recommended dose for Phase II (RP2D), selected cohorts with different tumor types will be expanded.
| Arm | Type | Receives |
|---|---|---|
| phase Ib：SHR-1802+Adebrelimab | Experimental | Biological: Adebrelimab, Biological: SHR-1802 |
| phase II cohort 1: SHR-1802+Adebrelimab | Experimental | Biological: Adebrelimab, Biological: SHR-1802 |
| phase II cohort 2: SHR-1802+Adebrelimab + Platinum Doublet Chemotherapy (PDCT) | Experimental | Biological: Adebrelimab, Biological: SHR-1802, Drug: Carboplatin/Cisplatin, Drug: Paclitaxel/Nab-Paclitaxel/Pemetrexed |
| phase II cohort 3: SHR-1802+Adebrelimab + PDCT | Experimental | Biological: Adebrelimab, Biological: SHR-1802, Drug: Carboplatin/Cisplatin, Drug: Paclitaxel/Nab-Paclitaxel/Pemetrexed |
| phase II cohort 4: SHR-1802+Adebrelimab | Experimental | Biological: Adebrelimab, Biological: SHR-1802 |
Who may qualify
- Ages
- 18 to 75 years
- 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；
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- Has a life expectancy≥ 12 weeks；
- At least one measurable lesion according to RECIST v1.1；
- Pathologically confirmed advanced solid tumor；
Key exclusion criteria (7 listed)
- Have received anti-PD-1 or PD-L1 antibody therapy;
- Subjects with other malignant tumors in the past 3 years;
- Have uncontrolled clinically symptomatic pleural effusion, pericardial effusion, or ascites;
- Previous or current interstitial pneumonia/interstitial lung disease ;
- History of autoimmune disease with the possibility of recurrence or active 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 |
|---|---|---|
| AdebrelimabSpecified dose on specified days | Biological | phase II cohort 1: SHR-1802+Adebrelimab, phase II cohort 2: SHR-1802+Adebrelimab + Platinum Doublet Chemotherapy (PDCT), phase II cohort 3: SHR-1802+Adebrelimab + PDCT, phase II cohort 4: SHR-1802+Adebrelimab, phase Ib：SHR-1802+Adebrelimab |
| SHR-1802Specified dose on specified days | Biological | phase II cohort 1: SHR-1802+Adebrelimab, phase II cohort 2: SHR-1802+Adebrelimab + Platinum Doublet Chemotherapy (PDCT), phase II cohort 3: SHR-1802+Adebrelimab + PDCT, phase II cohort 4: SHR-1802+Adebrelimab, phase Ib：SHR-1802+Adebrelimab |
| Carboplatin/CisplatinSpecified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy. | Drug | phase II cohort 2: SHR-1802+Adebrelimab + Platinum Doublet Chemotherapy (PDCT), phase II cohort 3: SHR-1802+Adebrelimab + PDCT |
| Paclitaxel/Nab-Paclitaxel/PemetrexedSpecified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy. | Drug | phase II cohort 2: SHR-1802+Adebrelimab + Platinum Doublet Chemotherapy (PDCT), phase II cohort 3: SHR-1802+Adebrelimab + PDCT |
Primary outcome
Dose limiting toxicity (DLT)
Time frame: 3 weeks
Recommended phase II dose (RP2D)
Time frame: up to 2 months
ORR
Time frame: up to 2 years
Objective Response Rate, determined according to RECIST v1.1 criteria
6 secondary outcomes
DOR
Time frame: up to 2 years
DCR
Time frame: up to 2 years
PFS assessed by investigator
Time frame: up to 2 years
TTR
Time frame: up to 2 years
OS (overall survival)
Time frame: up to 2 years
12-month OS rate
Time frame: from the date of the first dose up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 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 1/2 study testing Adebrelimab, SHR-1802 and Carboplatin/Cisplatin in people with Advanced Solid Tumor, 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 7 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 2 Jun 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 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 Shuni Wang, M.M (+86 15921207253, shuni.wang@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limiting toxicity (DLT) (time frame: 3 weeks). 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 2 Jun 2023.