Advanced Solid TumorsPhase 1/2NCT04856774
Trial of SHR-1701 Plus BP102 in Subjects With Selected Solid Tumors
A Phase 1/2 study testing SHR-1701；BP102 in people with Advanced Solid Tumors, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
The main purpose of this study was to assess the safety, tolerability, and efficacy when combining SHR-1701 and BP102 in participants with certain cancers. This study was conducted in 2 phases, Phase Ib and Phase II. 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?
- SHR-1701；BP102
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2021to 30 Mar 2024
- 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
- Histologically or cytologically confirmed solid malignancy that is metastatic or unresectable for which standard curative or palliative measures do not exist or are no longer effective (phase Ib)
- Histologically or cytologically confirmed metastatic or locally advanced solid tumors of the selected indications. (Phase II).
- .Life expectancy exceeds 12 weeeks;
- The Eastern Cancer Cooperative Group (ECOG) has a performance score of 0 or 1;
- Normal organ and marrow function;
Who cannot join
- Has known active central nervous system (CNS) metastases. Subjects with previously treated brain metastases may participate provided they are stable.
- A history of human immunodeficiency virus (HIV) infection is known, or has an active autoimmune disease.
- History of interstitial lung disease or pneumonia requiring oral or intravenous steroids.
- Has moderate or severe cardiovascular disease;
- Active HBV(hepatitis B) or HCV (Hepatitis C virus)-infected subjects;
- Any other malignancies within 5 years except for those with negligible risk of metastasis or death.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Open-Label, Phase Ib/II Trial of SHR-1701 Plus BP102 in Subjects With Selected Solid Tumors
The main purpose of this study was to assess the safety, tolerability, and efficacy when combining SHR-1701 and BP102 in participants with certain cancers. This study was conducted in 2 phases, Phase Ib and Phase II.
- Conditions
- Advanced Solid Tumors
- Being tested
- SHR-1701；BP102
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1701；BP102Drug
Drug: SHR-1701 IV infusion
Drug: BP102 IV infusion
Phase Ib: SHR-1701 30mg/kg + BP102 15mg/kg Q3w as starting dose, until recommended phase 2 dose is determined.
| Study group | Role | What they receive |
|---|---|---|
| SHR -1701 + BP102 | Experimental | Not described Receives: Drug: SHR-1701；BP102 |
What is being measured
The primary outcome is the main question the study is designed to answer.
recommended phase 2 dose (Phase Ib)
Measured: At the end of Cycle 2 (each cycle is 21 days)
Objective response rate (ORR)
Measured: 2 years
Secondary outcomes (9)
Dose Limiting Toxicity (DLT) (Phase 1b)
Measured: At the end of Cycle 2 (each cycle is 21 days)
Number of participants with treatment emergent adverse events (TEAEs)
Measured: For each participant, from the first dose till 90 days after the last dose
Number of participants with treatment emergent serious adverse events (SAEs)
Measured: For each participant, from the first dose till 90 days after the last dose
ORR
Measured: 2 years
Duration of response (DOR)
Measured: 2 years
Disease control rate (DCR)
Measured: 2 years
Time to response(TTR)
Measured: 2 years
Progression-free survival (PFS)
Measured: 2 years
Overall survival (OS)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start1 Jun 2021
- Primary completion30 Mar 2024
- Study completion30 Mar 2024
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 Suzhou Suncadia Biopharmaceuticals 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
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04856774
- Sponsor's protocol ID
- SHR-1701-II-207
- Status last verified
- Jun 2024
- First submitted
- 19 Apr 2021
- Last updated
- 27 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label, Phase Ib/II Trial of SHR-1701 Plus BP102 in Subjects With Selected Solid Tumors
- ClinicalTrials.gov ID
- NCT04856774
- Acronym / sponsor ID
- SHR-1701-II-207
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 23 Apr 2021 (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 main purpose of this study was to assess the safety, tolerability, and efficacy when combining SHR-1701 and BP102 in participants with certain cancers. This study was conducted in 2 phases, Phase Ib and Phase II.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SHR -1701 + BP102 | Experimental | Drug: SHR-1701；BP102 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically or cytologically confirmed solid malignancy that is metastatic or unresectable for which standard curative or palliative measures do not exist or are no longer effective (phase Ib)
- Histologically or cytologically confirmed metastatic or locally advanced solid tumors of the selected indications. (Phase II).
- .Life expectancy exceeds 12 weeeks;
- The Eastern Cancer Cooperative Group (ECOG) has a performance score of 0 or 1;
- Normal organ and marrow function;
Key exclusion criteria (6 listed)
- Has known active central nervous system (CNS) metastases. Subjects with previously treated brain metastases may participate provided they are stable.
- A history of human immunodeficiency virus (HIV) infection is known, or has an active autoimmune disease.
- History of interstitial lung disease or pneumonia requiring oral or intravenous steroids.
- Has moderate or severe cardiovascular disease;
- Active HBV(hepatitis B) or HCV (Hepatitis C virus)-infected subjects;
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-1701；BP102Drug: SHR-1701 IV infusion Drug: BP102 IV infusion Phase Ib: SHR-1701 30mg/kg + BP102 15mg/kg Q3w as starting dose, until recommended phase 2 dose is determined. | Drug | SHR -1701 + BP102 |
Primary outcome
recommended phase 2 dose (Phase Ib)
Time frame: At the end of Cycle 2 (each cycle is 21 days)
Objective response rate (ORR)
Time frame: 2 years
9 secondary outcomes
Dose Limiting Toxicity (DLT) (Phase 1b)
Time frame: At the end of Cycle 2 (each cycle is 21 days)
Number of participants with treatment emergent adverse events (TEAEs)
Time frame: For each participant, from the first dose till 90 days after the last dose
Number of participants with treatment emergent serious adverse events (SAEs)
Time frame: For each participant, from the first dose till 90 days after the last dose
ORR
Time frame: 2 years
Duration of response (DOR)
Time frame: 2 years
Disease control rate (DCR)
Time frame: 2 years
Time to response(TTR)
Time frame: 2 years
Progression-free survival (PFS)
Time frame: 2 years
Overall survival (OS)
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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-1701；BP102 in people with Advanced Solid Tumors, run by Suzhou Suncadia Biopharmaceuticals 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 27 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recommended phase 2 dose (Phase Ib) (time frame: At the end of Cycle 2 (each cycle is 21 days)). The study lists 2 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 27 Jun 2024.