A Study of Duvelisib Combined With SG001 Injection in Patient With Advanced Solid Tumors

NCT05508659 | Unknown Phase 1

• 1 other identifier: HE1801-CSP-001
• Study Type: interventional
• Target: 128
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study will be conducted with 2 stages.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (3)

• DLT

  Number of patients with dose limiting toxicity

  up to week 6

• TEAEs

  Number of patients with treatment-emergent adverse events

  up to approximately 2 years

• AEs

  Number of patients with treatment-related Adverse Events

  up to approximately 2 years

Secondary Outcomes (5)

• ORR

  up to approximately 2 years

• DOR

  up to approximately 2 years

• DCR

  up to approximately 2 years

• PFS

  up to approximately 2 years

• OS

  up to approximately 2 years

Other Outcomes (3)

• AUC

  up to approximately 2 years

• Cmax

  up to approximately 2 years

• The correlation of biomarkers with efficacy

  up to approximately 2 years

Study Arms (3)

Combined therapy (cohort A)

EXPERIMENTAL

Duvelisib combine with SG001 injection regimen in patients who had failed with prior PD-1/PD-L1 therapy

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.

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

Drug: SG001

Interventions

Duvelisib DRUG

Duvelisib PR2D bid po. until progressive disease (PD), unacceptable toxicity, or any criterion for withdrawal from the trial.

Also known as: COPIKTRA

Combined therapy (cohort A); Combined therapy (cohort C)

SG001 DRUG

240mg, each two weeks,iv,until progressive disease (PD), unacceptable toxicity, or any criterion for withdrawal from the trial.

Also known as: Recombinant Anti-PD-1 Fully Human Monoclonal Antibody Injection

Combined therapy (cohort A); Combined therapy (cohort C); SG001 injection monotherapy (cohort B)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);
• 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);

Sponsors & Collaborators

• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: lead

MeSH Terms

Interventions

duvelisib

Study Officials

• Lin Shen

  Overall Study Officials:

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lin Shen

CONTACT

+86-10-88196561; linshenpku@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2022
• First Posted: August 19, 2022
• Study Start: September 20, 2022
• Primary Completion: September 20, 2024
• Study Completion: March 20, 2025
• Last Updated: August 19, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share