SHR-A1904 Combinations in CLDN18.2-Positive Advanced Solid Tumor
NCT06350006
Phase
Phase 1
Recruitment status
Recruiting
Participants
Lead sponsor
Shanghai Hengrui Pharmaceutical Co., Ltd.
Start date
2024-05-29
Number of sites
- Summary
- This study consists of two research phases: Phase Ib (includes dose escalation stage and efficacy expansion stage): To explore the safety, tolerability and initial efficacy of SHR-A1904 in the treatment of CLDN18.2-positive advanced solid tumors, and to determine the recommended dose and recommended population for the Phase III combination study. Phase III: A randomized, Open-Label, multicenter clinical study of SHR-A1904 combined with chemotherapy and immunotherapy Versus chemotherapy combined with immunotherapy for CLDN18.2-positive advanced solid tumors.
- Short title
- SHR-A1904 Combinations in CLDN18.2-Positive Advanced Solid Tumor
- Official title
- A Phase Ib/III Study of SHR-A1904 Combinations in CLDN18.2-Positive Advanced Solid Tumor
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2028-12-30
- First posted
- 2024-04-05
- Registry last updated
- 2025-12-31
- Primary completion date
- 2027-12-30
- Start date
- 2024-05-29
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Registry sponsor category
- Industry
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06350006
- ClinicalTrials.gov ID
- NCT06350006
- Registry record
- Open registry record
- Allocation
- Not randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- No masking
Sources for study design
Incidence and severity of AE
Timeframe: Up to follow-up period, approximately 24 months
Phase 1b
Dose Limiting Toxicity (DLT)
Timeframe: approximately 24 months
Phase 1b
Maximal Tolerable Dose (MTD)
Timeframe: approximately 24 months
Phase 1b
Phase III Recommended Dose (RP3D)
Timeframe: approximately 24 months
Phase 1b
Progression-free survival (PFS) assessed by blind Independent Center Review (BICR) based on RECIST 1.1 criteria
Timeframe: approximately 36 months
Phase 3
SHR-A1904 toxin binding antibody
Timeframe: approximately 24 months
Phase 1b
SHR-A1904 Total antibody
Timeframe: approximately 24 months
Phase 1b
Immunogenicity indicators of SHR-A1904: drug resistant antibody (ADA) and neutralizing antibody (NAb)
Timeframe: approximately 24 months
Phase 1b
Expression level of CLDN18.2 in tumor tissues
Timeframe: approximately 24 months
Phase 1b
Overall survival (OS)
Timeframe: approximately 36 months
Phase 3
Incidence and severity of AE
Timeframe: approximately 36 months
Phase 3
Sources for outcomes
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Healthy volunteers
- No
- Age 18 to 75 years old (including boundary values);
- Volunteer to participate in this clinical study and sign informed consent;
- ECOG score 0-1;
- Expected survival ≥3 months;
- Pathologically confirmed locally advanced unresectable or metastatic solid tumors;
- positive CLDN18.2 expression in tumor tissue;
- There is at least one measurable lesion that meets the RECIST 1.1 criteria;
- Adequate bone marrow and organ function.
- Plan to receive any other antitumor therapy during this trial; Received other investigational drugs or treatments that are not on the market within 4 weeks prior to the first administration; Anti-tumor therapy, such as chemotherapy, radiotherapy, biotherapy, targeted therapy or immunotherapy, was received within 4 weeks before the first administration of the study drug. Palliative radiotherapy or local therapy within 2 weeks before the first administration of the study drug; Had major surgery other than diagnosis or biopsy within the 4 weeks prior to the first administration or randomization and required elective surgery during the trial.
- HER2 expression in tumor tissue is positive.
- The adverse reactions of previous anti-tumor therapy has not recovered to NCI-CTCAE v5.0 grade≤ 1.
- Has ≥ grade 2 peripheral sensory neuropathy.
- Has an allergic reaction to any of the components treated in this study, or are allergic to humanized monoclonal antibody products.
- Has a history or current history of meningeal metastasis; or active brain metastases.
- Presence of dysphagia or other factors affecting the use of oral medications.
- Additional malignancy within the five years prior to the first administration or randomization.
- Has an active autoimmune disease or a history of autoimmune disease.
- Received systemic use of corticosteroids or other immunosuppressants for immunosuppressive effects within 14 days prior to the first administration or randomization.
- Has a history of clinically significant lung disease.
- Has serosal effusion ≥ grade 3 (based on NCI CTCAE5.0 criteria).
- There was an active infection requiring systemic treatment within 2 weeks prior to the first administration or randomization.
- A history of immunodeficiency, including a positive HIV test; Presence of active hepatitis B or hepatitis C.
- People who have previously received allogeneic hematopoietic stem cell transplantation or organ transplantation.
- Has severe cardiovascular and cerebrovascular diseases.
- Gastrointestinal perforation and/or gastrointestinal fistula within the last 6 months prior to the first administration or randomization; Active gastrointestinal bleeding occurred 3 months before the first administration or randomization.
- In the investigator's judgment, the subject has other factors that could have affected the study results or led to the forced termination of the study.
Sources for eligibility
- Sun Yat-sen University Cancer CenterGuangzhou, ChinaRecruiting
Sources for sites