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
Overview
- Phase
- Phase 1
- Intervention
- SG001
- Conditions
- Advanced Solid Tumors
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Enrollment
- 128
- Primary Endpoint
- AEs
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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;
- •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);
Arms & Interventions
Combined therapy (cohort A)
Duvelisib combine with SG001 injection regimen in patients who had failed with prior PD-1/PD-L1 therapy
Intervention: SG001
Combined therapy (cohort A)
Duvelisib combine with SG001 injection regimen in patients who had failed with prior PD-1/PD-L1 therapy
Intervention: Duvelisib
Combined therapy (cohort C)
Duvelisib combine with SG001 injection regimen in patients who had failed with prior systemic therapy but naïve with prior PD-1/PD-L1.
Intervention: Duvelisib
Combined therapy (cohort C)
Duvelisib combine with SG001 injection regimen in patients who had failed with prior systemic therapy but naïve with prior PD-1/PD-L1.
Intervention: SG001
SG001 injection monotherapy (cohort B)
SG001 monotherapy in patients who had failed with prior systemic therapy but naïve with prior PD-1/PD-L1
Intervention: SG001
Outcomes
Primary Outcomes
AEs
Time Frame: up to approximately 2 years
Number of patients with treatment-related Adverse Events
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
Secondary Outcomes
- DOR(up to approximately 2 years)
- DCR(up to approximately 2 years)
- PFS(up to approximately 2 years)
- OS(up to approximately 2 years)
- ORR(up to approximately 2 years)