Advanced Solid TumorsPhase 1/2NCT05508659
A Study of Duvelisib Combined With SG001 Injection in Patient With Advanced Solid Tumors
A Phase 1/2 study testing Duvelisib and SG001 in people with Advanced Solid Tumors, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd..
Trial summary
Study will be conducted with 2 stages. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- Duvelisib and SG001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- No sites listed yet
- Study dates
- 20 Sep 2022to 20 Mar 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years old;
- Histologically or cytologically proven metastatic or locally advanced solid tumors, including but not limited to esophageal cancer, gastric cancer, colorectal cancer and head and neck squamous cancer;
- Prior treatment with PD-1 inhibitor containing regimen and disease progression on imaging or cytohistopathology;
- Eastern Cooperative Oncology Group performance status (ECOG) performance status of 0 to 1;
- At least one measurable lesion per RECIST v1.1;
- Adequate laboratory function including hepatic function, renal function, and blood cell examination;
- Ability to provide archived tumour tissue samples or newly obtained puncture biopsies or excisional biopsies from tumour lesions that have not previously received radiotherapy;
- Life expectancy ≥12 weeks; Fully understand the study and voluntarily sign the informed consent form.
Who cannot join
- Have hypersensitivity experience with content of duvelisib capsule or tislelizumab;
- Has received prior therapy with other PI3K inhibitors or BTK inhibitors;
- Has received anti-tumour agent (including but not limited to chemotherapy, target therapy, anti-angiogenesis therapy, immune therapy, radiotherapy, and tumour embolism therapy etc.) within 28 days before the first dose administration;
- Has administrated with systemic immune inhibitors within 28 days prior to the first, except: topical glucocorticoids by nasal spray, inhalation or other routes, or physiological doses of systemic glucocorticoids (not beyond 10 mg/d of prednisone or equivalent dose);
- Has received a live virus vaccine within 28 days of firs dose or planned during the trial period. Seasonal influence vaccine without live virus vaccine is permitted;
- Has prior allograft solid or blood stem cell transplant;
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- Has had major surgery within 28 days prior to the first dose or un-healed wound, ulceration, or bone fraction at screening;
- Presence of toxicity not recovered to CTCAE v5.0 ≤ Grade 1 from previous anti-tumour therapy prior to first dose, except for alopecia or no clinically significant abnormalities in laboratory tests;
- Has hydrothorax or ascites or hydropericardium with symptom or need drainage therapy. Just radiological minor hydrothorax or ascites or hydropericardium without symptom was not excluded;
- Has an active autoimmune disease requiring systemic treatment or immunosuppressive agents within the past 2 years. Replacement therapy is permitted (e.g. thyroxine, insulin or physiological corticosteroids for adrenal or pituitary insufficiency);
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are stable, and meet the following criteria: neurological symptoms have recovered to CTCAE v5.0 ≤ Grade 1 at least 2 weeks prior to the first dose; no imaging evidence of new brain metastases or enlarged brain metastases within 4 weeks prior to the first dose; patients has not been treated with corticosteroids since at least 3 days prior to the first dose or is receiving a stable dose, or a tapered dose of ≥ 10 mg/day of prednisone (or equivalent);
- Has a history of any of the following cardiovascular conditions:
- Class Ⅱ or above congestive heart failure per New York Heart Association, unstable angina pectoris, myocardial infarction within 6 month prior to first dose, arrythmia require treatment, LVEF<50% during screening;
- Primary myocardiopathy (e.g. dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, undefined cardiomyopathy);
- History of clinically significant corrected for heart rate (QTc) interval prolongation, or screening QTc > 470 msec (female) or > 450 msec (male);
- Coronary heart disease requiring drug therapy during screening;
- Has cerebrovascular incidence (including transient cerebral ischemic attack);
- Poorly controlled hypertension with oral drugs, systolic blood pressure (SBP) ≥ 150 mm Hg and/or diastolic blood pressure (DBP) ≥ 100 mm Hg;
- Other cardio-cerebral vascular disease with investigator's judgement;
- Interstitial lung disease proved by CT or MRI during screening, or history of lung disease requiring oral or intravenous steroid hormone therapy within 6 months prior to first dose, or a previous history of severe lung function damage;
- Active lung tuberculosis or received anti-tuberculosis therapy within 1 years prior to first dose;
- Has a clinically significant gastrointestinal abnormality unable to oral take duvelisib capsule, such as major intestine resection, intra-intestinal plant, Crohn disease, ulcerative colitis, continuous diarrhoea, or gastro-intestinal perforation; gastrointestinal perforation and/or fistula, peptic ulcer, fully intestinal obstruction, or incomplete intestinal obstruction requiring full-extra intestinal nutrition within 6 months prior to first dose;
- Has an active infection requiring systemic intravenous antibiotics contented therapy;
- Has known active Hepatitis B (Hepatitis B surface antigen positive with HBV-DNA ≥10^4copies/mL) or Hepatitis C virus (HCV antibody positive with HCV RNA ≥10^3copies/mL). HIV/AIDS positive or other severe infectious disease;
- Patients cannot receive prohibition therapy for Pneumocystis Kanosh's, herpes simplex virus (HSV), herpes zoster (VZV) during trial process base on investigator's judgement;
- Has a history of pulmonary embolism within 6 months prior to first dose, or deep vein thrombosis or any other serious venous thromboembolic event within 3 months prior to first dose;
- Has a known history of additional malignancy. Carcinoma in situ, non-melanoma cutaneous carcinoma which resolved at least 2 years prior to first dose and will not requiring additional treatment during the study period;
- Cannot or unwilling agree to use an adequate method of contraception, starting with the first dose of study therapy through 12 weeks after the last dose of duvelisib or 150 days after the lase dose of tislelizumab whichever occurs first. Or pregnant or breasting women;
- Other conditions that, in the opinion of the investigator, make participation in the study unsuitable, including but not limited with psychiatric or substance abuse disorders.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Multi-centre, Randomized, Open-label, Phase 1/2 Trial to Investigate the Safety, Tolerability, and Preliminary Anti-cancer Efficacy of Duvelisib Combined With SG001 Injection in Advanced Solid Tumours
Study will be conducted with 2 stages.
Read the detailed description
The first stage will explore the suitable dose of duvelisib when combined with SG001 injection in patients with advanced solid tumors who had failed with prior systemic therapy.
The second stage will explore the safety and tolerability, preliminary anti-tumor efficacy and PK data of duvelisib monotherapy and combo regime with SG001 injection in patients with advanced solid tumors which will including but not limited with esophageal carcinoma, gastric carcinoma, colorectal cancer and head and neck squamous carcinoma.
- Conditions
- Advanced Solid Tumors
- Being tested
- Duvelisib, SG001
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuvelisibDrug
Also called COPIKTRA
Duvelisib PR2D bid po. until progressive disease (PD), unacceptable toxicity, or any criterion for withdrawal from the trial.
SG001Drug
Also called Recombinant Anti-PD-1 Fully Human Monoclonal Antibody Injection
240mg, each two weeks,iv,until progressive disease (PD), unacceptable toxicity, or any criterion for withdrawal from the trial.
| Study group | Role | What they receive |
|---|---|---|
| Combined therapy (cohort A) | Experimental | Duvelisib combine with SG001 injection regimen in patients who had failed with prior PD-1/PD-L1 therapy Receives: Drug: Duvelisib; Drug: SG001 |
| Combined therapy (cohort C) | Experimental | Duvelisib combine with SG001 injection regimen in patients who had failed with prior systemic therapy but naïve with prior PD-1/PD-L1. Receives: Drug: Duvelisib; Drug: SG001 |
| SG001 injection monotherapy (cohort B) | Active comparator | SG001 monotherapy in patients who had failed with prior systemic therapy but naïve with prior PD-1/PD-L1 Receives: Drug: SG001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT
Number of patients with dose limiting toxicity
Measured: up to week 6
TEAEs
Number of patients with treatment-emergent adverse events
Measured: up to approximately 2 years
AEs
Number of patients with treatment-related Adverse Events
Measured: up to approximately 2 years
Secondary outcomes (5)
ORR
Objective Response Rate
Measured: up to approximately 2 years
DOR
Duration of response
Measured: up to approximately 2 years
DCR
Disease control rate
Measured: up to approximately 2 years
PFS
Progression Free survival
Measured: up to approximately 2 years
OS
Overall Survival
Measured: up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2022
- Study start20 Sep 2022 (estimated)
- Primary completion20 Sep 2024 (estimated)
- Study completion20 Mar 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 CSPC ZhongQi Pharmaceutical Technology 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lin Shen, Principal investigator, Overall Study Officials:
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05508659
- Sponsor's protocol ID
- HE1801-CSP-001
- Status last verified
- Aug 2022
- First submitted
- 13 Aug 2022
- Last updated
- 19 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: When the research is completed, we will publish the results in the form of conference reports and papers.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre, Randomized, Open-label, Phase 1/2 Trial to Investigate the Safety, Tolerability, and Preliminary Anti-cancer Efficacy of Duvelisib Combined With SG001 Injection in Advanced Solid Tumours
- ClinicalTrials.gov ID
- NCT05508659
- Acronym / sponsor ID
- HE1801-CSP-001
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Sep 2022 (estimated)
- Primary completion
- 20 Sep 2024 (estimated)
- Study completion
- 20 Mar 2025 (estimated)
- First posted
- 19 Aug 2022 (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.
Study will be conducted with 2 stages.
Detailed description
The first stage will explore the suitable dose of duvelisib when combined with SG001 injection in patients with advanced solid tumors who had failed with prior systemic therapy.
The second stage will explore the safety and tolerability, preliminary anti-tumor efficacy and PK data of duvelisib monotherapy and combo regime with SG001 injection in patients with advanced solid tumors which will including but not limited with esophageal carcinoma, gastric carcinoma, colorectal cancer and head and neck squamous carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Combined therapy (cohort A) | Experimental | Drug: Duvelisib, Drug: SG001Duvelisib combine with SG001 injection regimen in patients who had failed with prior PD-1/PD-L1 therapy |
| Combined therapy (cohort C) | Experimental | Drug: Duvelisib, Drug: SG001Duvelisib combine with SG001 injection regimen in patients who had failed with prior systemic therapy but naïve with prior PD-1/PD-L1. |
| SG001 injection monotherapy (cohort B) | Active comparator | Drug: SG001SG001 monotherapy in patients who had failed with prior systemic therapy but naïve with prior PD-1/PD-L1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥18 years old;
- Histologically or cytologically proven metastatic or locally advanced solid tumors, including but not limited to esophageal cancer, gastric cancer, colorectal cancer and head and neck squamous cancer;
- Prior treatment with PD-1 inhibitor containing regimen and disease progression on imaging or cytohistopathology;
- Eastern Cooperative Oncology Group performance status (ECOG) performance status of 0 to 1;
- At least one measurable lesion per RECIST v1.1;
Key exclusion criteria (29 listed)
- Have hypersensitivity experience with content of duvelisib capsule or tislelizumab;
- Has received prior therapy with other PI3K inhibitors or BTK inhibitors;
- Has received anti-tumour agent (including but not limited to chemotherapy, target therapy, anti-angiogenesis therapy, immune therapy, radiotherapy, and tumour embolism therapy etc.) within 28 days before the first dose administration;
- Has administrated with systemic immune inhibitors within 28 days prior to the first, except: topical glucocorticoids by nasal spray, inhalation or other routes, or physiological doses of systemic glucocorticoids (not beyond 10 mg/d of prednisone or equivalent dose);
- Has received a live virus vaccine within 28 days of firs dose or planned during the trial period. Seasonal influence vaccine without live virus vaccine is permitted;
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 |
|---|---|---|
| DuvelisibAlso: COPIKTRADuvelisib PR2D bid po. until progressive disease (PD), unacceptable toxicity, or any criterion for withdrawal from the trial. | Drug | Combined therapy (cohort A), Combined therapy (cohort C) |
| SG001Also: Recombinant Anti-PD-1 Fully Human Monoclonal Antibody Injection240mg, each two weeks,iv,until progressive disease (PD), unacceptable toxicity, or any criterion for withdrawal from the trial. | Drug | Combined therapy (cohort A), Combined therapy (cohort C), SG001 injection monotherapy (cohort B) |
Primary outcome
DLT
Time frame: up to week 6
Number of patients with dose limiting toxicity
TEAEs
Time frame: up to approximately 2 years
Number of patients with treatment-emergent adverse events
AEs
Time frame: up to approximately 2 years
Number of patients with treatment-related Adverse Events
5 secondary outcomes
ORR
Time frame: up to approximately 2 years
DOR
Time frame: up to approximately 2 years
DCR
Time frame: up to approximately 2 years
PFS
Time frame: up to approximately 2 years
OS
Time frame: up to approximately 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2022.
- Individual participant dataSharing planned: No. When the research is completed, we will publish the results in the form of conference reports and papers.
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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.
Lin Shen principal investigator
Overall Study Officials:
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Duvelisib and SG001 in people with Advanced Solid Tumors, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd..
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 29 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 19 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Lin Shen (+86-10-88196561, linshenpku@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLT (time frame: up to week 6). 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 19 Aug 2022.