Nasopharyngeal CarcinomaPhase 1NCT04282070
SHR-1701 in Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma
A Phase 1 study testing SHR-1701, Gemcitabine and Cisplatin in people with Nasopharyngeal Carcinoma, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
This is an open label, phase Ib Study of SHR-1701 in patients with recurrent/metastatic nasopharyngeal carcinoma(R/M NPC). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- SHR-1701, Gemcitabine and Cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteChina
- Study dates
- 27 Mar 2020to 15 Dec 2022
- Phase
- Phase 1
- 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 confirmed Recurrent/Metastatic Nasopharyngeal Carcinoma
- Subjects failure after platinum-based chemotherapy; failure from anti-PD-1/PD-L1 antibody therapy; Primarily metastatic (stage IVB as defined by the International Union against Cancer and American Joint Committee on Cancer staging system for NPC, eighth edition) or recurrent NPC that is not amenable for local regional treatment or curative treatment; failure from first line anti-PD-1/PD-L1 antibody therapy.
- Able and willing to provide signed informed consent form, and able to comply with all procedures.
- Histologically or cytologically proven metastatic or locally advanced solid tumors.
- Life expectancy >= 12 weeks as judged by the Investigator.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at trial entry.
- Disease must be measurable with at least 1 uni dimensional measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Adequate hematological, hepatic and renal function as defined in the protocol Other protocol-defined inclusion criteria could apply.
Who cannot join
- Prior therapy with an anti-PD1, anti-PD-L1, anti-CTLA-4 or a TGFb inhibitor.
- Anticancer treatment within 28 days before the first dose of study drug.
- Major surgery within 28 days before start of trial treatment.
- Systemic therapy with immunosuppressive agents within 7 days prior to the first dose of study drug; or use any investigational drug within 28 days before the start of trial treatment.
- With any active autoimmune disease or history of autoimmune disease.
- With active central nervous system (CNS) metastases causing clinical symptoms or requiring therapeutic intervention.
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- Clinically significant cardiovascular and cerebrovascular diseases
- History of immunodeficiency including seropositive for human immunodeficiency virus (HIV), or other acquired or congenital immunedeficient disease, or any active systemic viral infection requiring therapy.
- Previous malignant disease (other than the target malignancy to be investigated in the trial) within the last 2 years. Subjects with history of cervical carcinoma in situ, superficial or non-invasive bladder cancer or basal cell or squamous cell cancer in situ previously treated with curative intent are NOT excluded.
- Receipt of any organ transplantation, including allogeneic stem-cell transplantation Other protocol-defined exclusion criteria could apply
Trial locations and contacts
1 site in 1 country.
China1 site
Cancer Hospital of Guangzhou Sun Yat-sen University
Guangzhou, Guangdong, 510060
About this study
Official title: A Phase Ib, Open-label Trial to Investigate the Safety and Tolerability of SHR-1701 in Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma
This is an open label, phase Ib Study of SHR-1701 in patients with recurrent/metastatic nasopharyngeal carcinoma(R/M NPC).
Read the detailed description
The main purpose of this study is to assess the safety and tolerability of SHR-1701 in patients with R/M NPC. The secondary purpose is to assess the anti-tumor activity and immunogenicity of SHR-1701 in R/M NPC.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- SHR-1701, Gemcitabine, Cisplatin, Albumin Paclitaxel
- Keywords
- Nasopharyngeal Carcinoma
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1701Drug
Also called SHR-1701 Injection
Subjects will receive an intravenous infusion of SHR-1701 until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the trial.
GemcitabineDrug
Also called Gemcitabine Hydrochloride for Injection
Maximum 6 cycles for combined therapy.
CisplatinDrug
Also called Cisplatin Injection
Maximum 6 cycles for combined therapy.
Albumin PaclitaxelDrug
Also called nab-Paclitaxel
Maximum 6 cycles for combined therapy.
| Study group | Role | What they receive |
|---|---|---|
| SHR-1701 (Arm A) | Experimental | SHR-1701 for R/M NPC failure after platinum-based chemotherapy Receives: Drug: SHR-1701 |
| SHR-1701 (Arm B) | Experimental | SHR-1701 for R/M NPC failure after anti PD-1/PD-L1 antibody therapy Receives: Drug: SHR-1701 |
| SHR-1701 plus Gemcitabine and Cisplatin (Arm C) | Experimental | SHR-1701+Gemcitabine+Cisplatin for first line treatment of R/M NPC Receives: Drug: SHR-1701; Drug: Gemcitabine; Drug: Cisplatin |
| SHR-1701 plus Albumin Paclitaxel (Arm D) | Experimental | SHR-1701+Albumin Paclitaxel for R/M NPC failure after first line anti PD-1/PD-L1 antibody therapy Receives: Drug: SHR-1701; Drug: Albumin Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity Toxicity
Number of participants with adverse events as assessed by CTCAE v5.0
Measured: up to 2 years
Secondary outcomes (5)
Objective Response Rate (ORR) per RECIST 1.1
ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: at least 30% decrease in the sum of diameters of target lesions) per RECIST 1.1.
Measured: up to 2 years
Progression-free Survival (PFS) per RECIST 1.1
PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on blinded independent central review or death due to any cause, whichever occurs first.
Measured: up to 2 years
Disease Control Rate (DCR) per RECIST 1.1
DCR is defined as the percentage of participants in the analysis population who have a CR, PR or SD per RECIST 1.1.
Measured: up to 2 years
Immunogenicity of SHR-1701
anti SHR-1603 antibodies (ADA)
Measured: up to 2 years
Overall Survival (OS)
Overall Survival is defined as the time from registration to death due to any cause, or censored at date last known alive. OS will be measured by the Method of Kaplan and Meier.
Measured: 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 posted24 Feb 2020
- Study start27 Mar 2020
- Primary completion16 Apr 2022 (estimated)
- Study completion15 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04282070
- Sponsor's protocol ID
- SHR-1701-I-103
- Status last verified
- Mar 2021
- First submitted
- 18 Feb 2020
- Last updated
- 21 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib, Open-label Trial to Investigate the Safety and Tolerability of SHR-1701 in Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT04282070
- Acronym / sponsor ID
- SHR-1701-I-103
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- Nasopharyngeal Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Mar 2020 (actual)
- Primary completion
- 16 Apr 2022 (estimated)
- Study completion
- 15 Dec 2022 (estimated)
- First posted
- 24 Feb 2020 (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 is an open label, phase Ib Study of SHR-1701 in patients with recurrent/metastatic nasopharyngeal carcinoma(R/M NPC).
Detailed description
The main purpose of this study is to assess the safety and tolerability of SHR-1701 in patients with R/M NPC. The secondary purpose is to assess the anti-tumor activity and immunogenicity of SHR-1701 in R/M NPC.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SHR-1701 (Arm A) | Experimental | Drug: SHR-1701SHR-1701 for R/M NPC failure after platinum-based chemotherapy |
| SHR-1701 (Arm B) | Experimental | Drug: SHR-1701SHR-1701 for R/M NPC failure after anti PD-1/PD-L1 antibody therapy |
| SHR-1701 plus Gemcitabine and Cisplatin (Arm C) | Experimental | Drug: SHR-1701, Drug: Gemcitabine, Drug: CisplatinSHR-1701+Gemcitabine+Cisplatin for first line treatment of R/M NPC |
| SHR-1701 plus Albumin Paclitaxel (Arm D) | Experimental | Drug: SHR-1701, Drug: Albumin PaclitaxelSHR-1701+Albumin Paclitaxel for R/M NPC failure after first line anti PD-1/PD-L1 antibody therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically confirmed Recurrent/Metastatic Nasopharyngeal Carcinoma
- Subjects failure after platinum-based chemotherapy; failure from anti-PD-1/PD-L1 antibody therapy; Primarily metastatic (stage IVB as defined by the International Union against Cancer and American Joint Committee on Cancer staging system for NPC, eighth edition) or recurrent NPC that is not amenable for local regional treatment or curative treatment; failure from first line anti-PD-1/PD-L1 antibody therapy.
- Able and willing to provide signed informed consent form, and able to comply with all procedures.
- Histologically or cytologically proven metastatic or locally advanced solid tumors.
- Life expectancy >= 12 weeks as judged by the Investigator.
Key exclusion criteria (10 listed)
- Prior therapy with an anti-PD1, anti-PD-L1, anti-CTLA-4 or a TGFb inhibitor.
- Anticancer treatment within 28 days before the first dose of study drug.
- Major surgery within 28 days before start of trial treatment.
- Systemic therapy with immunosuppressive agents within 7 days prior to the first dose of study drug; or use any investigational drug within 28 days before the start of trial treatment.
- With any active autoimmune disease or history of 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 |
|---|---|---|
| SHR-1701Also: SHR-1701 InjectionSubjects will receive an intravenous infusion of SHR-1701 until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the trial. | Drug | SHR-1701 (Arm A), SHR-1701 (Arm B), SHR-1701 plus Albumin Paclitaxel (Arm D), SHR-1701 plus Gemcitabine and Cisplatin (Arm C) |
| GemcitabineAlso: Gemcitabine Hydrochloride for InjectionMaximum 6 cycles for combined therapy. | Drug | SHR-1701 plus Gemcitabine and Cisplatin (Arm C) |
| CisplatinAlso: Cisplatin InjectionMaximum 6 cycles for combined therapy. | Drug | SHR-1701 plus Gemcitabine and Cisplatin (Arm C) |
| Albumin PaclitaxelAlso: nab-PaclitaxelMaximum 6 cycles for combined therapy. | Drug | SHR-1701 plus Albumin Paclitaxel (Arm D) |
Primary outcome
Toxicity Toxicity
Time frame: up to 2 years
Number of participants with adverse events as assessed by CTCAE v5.0
5 secondary outcomes
Objective Response Rate (ORR) per RECIST 1.1
Time frame: up to 2 years
Progression-free Survival (PFS) per RECIST 1.1
Time frame: up to 2 years
Disease Control Rate (DCR) per RECIST 1.1
Time frame: up to 2 years
Immunogenicity of SHR-1701
Time frame: up to 2 years
Overall Survival (OS)
Time frame: 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 21 Dec 2021.
- Individual participant dataSharing planned: No
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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 study testing SHR-1701, Gemcitabine and Cisplatin in people with Nasopharyngeal Carcinoma, run by Jiangsu HengRui Medicine 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 8 inclusion and 10 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 21 Dec 2021. 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?
Results are not available in the source record.
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?
Toxicity Toxicity (time frame: up to 2 years). 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 21 Dec 2021.