A Study of SHR-1826 for Injection in Combination With Other Antitumor Therapies in Subjects With Solid Tumors
- 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.
- Short title
- 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
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 1/Phase 2
- Study type
- Interventional
- Completion date
- 2027-07-01
- First posted
- 2024-11-25
- Registry last updated
- 2025-12-03
- Primary completion date
- 2026-01-01
- Start date
- 2025-02-18
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Registry sponsor category
- Industry
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06703177
- ClinicalTrials.gov ID
- NCT06703177
- Registry record
- Open registry record
- Allocation
- Not applicable
- Model
- Single group
- Purpose
- Treatment
- Masking
- No masking
RP2D (Phase 1)
Timeframe: Screening up to study completion, an average of 1 year.
AE (Phase 1)
Timeframe: Screening up to study completion, an average of 1 year.
Objective response rate (ORR) (Phase 2)
Timeframe: Screening up to study completion, an average of 1 year.
Objective response rate (ORR) (Phase 1)
Timeframe: Screening up to study completion, an average of 1 year.
Disease control rate (DCR) (Phase 1)
Timeframe: Screening up to study completion, an average of 1 year.
Duration of response (DoR) (Phase 1)
Timeframe: Screening up to study completion, an average of 1 year.
Progression-free survival (PFS) (Phase 1)
Timeframe: Screening up to study completion, an average of 1 year.
Overall survival (OS) (Phase 1)
Timeframe: Screening up to study completion, an average of 1 year.
Drug Resistant Antibody (ADA) (Phase 1)
Timeframe: Screening up to study completion, an average of 1 year.
Blood concentration of SHR-1826 (Phase 1)
Timeframe: Screening up to study completion, an average of 1 year.
Blood concentration of free toxin SHR169265 (Phase 1)
Timeframe: Screening up to study completion, an average of 1 year.
Disease control rate (DCR) (Phase 2)
Timeframe: Screening up to study completion, an average of 1 year.
Duration of response (DoR) (Phase 2)
Timeframe: Screening up to study completion, an average of 1 year.
Progression-free survival (PFS) (Phase 2)
Timeframe: Screening up to study completion, an average of 1 year.
Overall survival (OS) (Phase 2)
Timeframe: Screening up to study completion, an average of 1 year.
AE (Phase 2)
Timeframe: Screening up to study completion, an average of 1 year.
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Healthy volunteers
- No
- Voluntary participation and written informed consent;
- 18-75 years older, no gender limitation;
- Eastern Cooperative Oncology Group (ECOG) score: 0-1;
- With a life expectancy ≥ 3 months;
- Pathologically diagnosed advanced solid tumor;
- Be able to provide fresh or archived tumour tissue;
- At least one measurable lesion according to RECIST v1.1;
- Adequate bone marrow reserve and organ function;
- Contraception is required during clinical trials, and pregnancy tests must be negative for women of childbearing age within 7 days before the first dose.
- Meningeal metastasis history or clinical symptoms of central nervous system metastasis;
- Previous or co-existing malignancies;
- Spinal cord compression that was not treated radically by surgery and/or radiotherapy was excluded;
- Uncontrollable tumor-related pain;
- Previously received antiboy-coupled drug therapy with topoisomerase I inhibitor toxin; Previously received EGFR/c-Met double antibody;
- Received systemic antitumor therapy before the first dose;
- 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;
- For the first time, a study was conducted to treat patients with radiation therapy exceeding the prescribed dose before study treatment;
- Received Other investigational drugs treatments 4 weeks prior to the initiation of the study treatment;
- Unresolved CTCAE 5.0>grade 2 toxicities from previous anticancer therapy;
- A history of interstitial pneumonia/non-infectious pneumonia;
- Accompanied by uncontrolled pleural effusion and pericardial effusion; Moderate or severe ascites with clinical symptoms;
- Study the presence of intestinal obstruction or the presence of signs or symptoms of intestinal obstruction 6 months before first dosing;
- With poorly controlled or severe cardiovascular disease;
- Active hepatitis B, hepatitis C;
- Patients with a history of immunodeficiency;
- Severe infection 30 days before the first dose.
- Sun Yat-Sen university cancer centerGuangzhou, ChinaRecruiting