Recruiting NCT06703177
A Study of SHR-1826 for Injection in Combination With Other Antitumor Therapies in Subjects With Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SHR-1826, SHR-4642, SHR-9839, SHR-8068.
- Who it may be relevant to
- Registry conditions: Advanced Solid Tumors. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Drug SHR-1826
SHR-1826 - Drug SHR-4642
SHR-4642 - Drug SHR-9839
SHR-9839 - Drug SHR-8068
SHR-8068 - Drug Bevacizumab Injection
Bevacizumab Injection - Drug Fluorouracil Injection
Fluorouracil Injection - Drug Calcium Folinate Injection
Calcium Folinate Injection - Drug Adebrelimab Injection
Adebrelimab Injection - Drug Capecitabine tablets
Capecitabine tablets, oral.
Primary outcome measures
- RP2D (Phase 1) [Time frame: Screening up to study completion, an average of 1 year.]
- AE (Phase 1) [Time frame: Screening up to study completion, an average of 1 year.]
- Objective response rate (ORR) (Phase 2) [Time frame: Screening up to study completion, an average of 1 year.]
Secondary outcome measures (12)
- Objective response rate (ORR) (Phase 1) [Time frame: Screening up to study completion, an average of 1 year.]
- Disease control rate (DCR) (Phase 1) [Time frame: Screening up to study completion, an average of 1 year.]
- Duration of response (DoR) (Phase 1) [Time frame: Screening up to study completion, an average of 1 year.]
- Progression-free survival (PFS) (Phase 1) [Time frame: Screening up to study completion, an average of 1 year.]
- Overall survival (OS) (Phase 1) [Time frame: Screening up to study completion, an average of 1 year.]
- Drug Resistant Antibody (ADA) (Phase 1) [Time frame: Screening up to study completion, an average of 1 year.]
- Blood concentration of SHR-1826 (Phase 1) [Time frame: Screening up to study completion, an average of 1 year.]
- Blood concentration of free toxin SHR169265 (Phase 1) [Time frame: Screening up to study completion, an average of 1 year.]
- Disease control rate (DCR) (Phase 2) [Time frame: Screening up to study completion, an average of 1 year.]
- Duration of response (DoR) (Phase 2) [Time frame: Screening up to study completion, an average of 1 year.]
- Progression-free survival (PFS) (Phase 2) [Time frame: Screening up to study completion, an average of 1 year.]
- Overall survival (OS) (Phase 2) [Time frame: Screening up to study completion, an average of 1 year.]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Sun Yat-Sen university cancer center — Guangzhou
Identifiers
NCT: NCT06703177 · SHR-1826-201