Clinical trial NCT06703177: A Study of SHR-1826 for Injection in Combination With Other Antitumor Therapies in Subjects With Solid Tumors
Official title: Phase IB/II Study of Safety, Tolerability and Efficacy of SHR-1826 for Injection in Combination With Other Antitumor Therapies in Subjects With Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Advanced Solid Tumors
Lead sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-11-25
Enrollment: 876
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open label, multi-center, multiple dose Phase IB/II study to evaluate the safety, tolerability and efficacy of SHR-1826 for injection in subjects with advanced solid tumors.


Eligibility criteria: Inclusion Criteria:

1. Voluntary participation and written informed consent;
2. 18-75 years older, no gender limitation;
3. Eastern Cooperative Oncology Group (ECOG) score: 0-1;
4. With a life expectancy ≥ 3 months;
5. Pathologically diagnosed advanced solid tumor;
6. Be able to provide fresh or archived tumour tissue;
7. At least one measurable lesion according to RECIST v1.1;
8. Adequate bone marrow reserve and organ function;
9. Contraception is required during clinical trials, and pregnancy tests must be negative for women of childbearing age within 7 days before the first dose.

Exclusion Criteria:

1. Meningeal metastasis history or clinical symptoms of central nervous system metastasis;
2. Previous or co-existing malignancies;
3. Spinal cord compression that was not treated radically by surgery and/or radiotherapy was excluded;
4. Uncontrollable tumor-related pain;
5. Previously received antiboy-coupled drug therapy with topoisomerase I inhibitor toxin; Previously received EGFR/c-Met double antibody;
6. Received systemic antitumor therapy before the first dose;
7. Have undergone major surgery other than diagnosis or biopsy within 28 days prior to initial dosing; Minor traumatic surgery within 7 days prior to first dosing;
8. For the first time, a study was conducted to treat patients with radiation therapy exceeding the prescribed dose before study treatment;
9. Received Other investigational drugs treatments 4 weeks prior to the initiation of the study treatment;
10. Unresolved CTCAE 5.0\>grade 2 toxicities from previous anticancer therapy;
11. A history of interstitial pneumonia/non-infectious pneumonia;
12. Accompanied by uncontrolled pleural effusion and pericardial effusion; Moderate or severe ascites with clinical symptoms;
13. Study the presence of intestinal obstruction or the presence of signs or symptoms of intestinal obstruction 6 months before first dosing;
14. With poorly controlled or severe cardiovascular disease;
15. Active hepatitis B, hepatitis C;
16. Patients with a history of immunodeficiency;
17. Severe infection 30 days before the first dose.

Primary outcomes:
measure: RP2D (Phase 1)
timeFrame: Screening up to study completion, an average of 1 year.
measure: AE (Phase 1)
timeFrame: Screening up to study completion, an average of 1 year.
measure: Objective response rate (ORR) (Phase 2)
timeFrame: Screening up to study completion, an average of 1 year.
Secondary outcomes:
measure: Objective response rate (ORR) (Phase 1)
timeFrame: Screening up to study completion, an average of 1 year.
measure: Disease control rate (DCR) (Phase 1)
timeFrame: Screening up to study completion, an average of 1 year.
measure: Duration of response (DoR) (Phase 1)
timeFrame: Screening up to study completion, an average of 1 year.
measure: Progression-free survival (PFS) (Phase 1)
timeFrame: Screening up to study completion, an average of 1 year.
measure: Overall survival (OS) (Phase 1)
timeFrame: Screening up to study completion, an average of 1 year.
measure: Drug Resistant Antibody (ADA) (Phase 1)
timeFrame: Screening up to study completion, an average of 1 year.
measure: Blood concentration of SHR-1826 (Phase 1)
timeFrame: Screening up to study completion, an average of 1 year.
measure: Blood concentration of free toxin SHR169265 (Phase 1)
timeFrame: Screening up to study completion, an average of 1 year.
measure: Disease control rate (DCR) (Phase 2)
timeFrame: Screening up to study completion, an average of 1 year.
measure: Duration of response (DoR) (Phase 2)
timeFrame: Screening up to study completion, an average of 1 year.
measure: Progression-free survival (PFS) (Phase 2)
timeFrame: Screening up to study completion, an average of 1 year.
measure: Overall survival (OS) (Phase 2)
timeFrame: Screening up to study completion, an average of 1 year.
measure: AE (Phase 2)
timeFrame: Screening up to study completion, an average of 1 year.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-Sen university cancer center
state: Guangdong
Study officials:
References: