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Tests treatment safety and results for Advanced Solid Tumors
Official title A TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND EFFICACY OF SHR-A1904 IN SUBJECTS WITH ADVANCED SOLID TUMORS
ClinicalTrials.gov ID: NCT05277168
What this study is testing
What is SHR-A1904?
SHR-A1904 is an investigational medicine, being studied as a potential treatment for advanced solid tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study (dose escalation/expansion) is being conducted to assess the safety and tolerability of SHR-A1904 in subjects with advanced solid tumors, and to determine maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D), to assess preliminary efficacy of SHR-A1904, pharmacokinetic (PK) profile and immunogenicity of SHR-A1904 in subjects with advanced solid tumors.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Evidence of a personally signed and dated ICF indicating that the subject has been informed of all pertinent aspects of the study.
- Age \> 18.
- ECOG performance status of 0-1.
- Life expectancy of ≥ 3 months.
- people with pathologically diagnosed advanced relapsed or refractory solid tumors, either gastric and gastroesophageal junction (GEJ) cancer, or...
You likely can't join if
- Plan to receive any other anti-tumor treatments during the treatment period of this study.
- people participated in a prior investigational study or received anticancer treatment, and have not recovered from side effects of such therapy.
- Underwent major surgical operation within 4 weeks before the first dose of this IP.
- Received treatments with strong CYP3A4, CYP2D6, P-gp, or BCRP inhibitors or inducers within \< 5 half-lives of the drug before the first dose of the...
- Previously received total gastrectomy (only for people of the dose-escalation part.
- Adverse events caused by previous anti-tumor treatments have not recovered to Grade ≤ 1 according to NCI-CTCAE 5.0 (except for alopecia; some...
See the full eligibility criteria
- Evidence of a personally signed and dated ICF indicating that the subject has been informed of all pertinent aspects of the study.
- Age \> 18.
- ECOG performance status of 0-1.
- Life expectancy of ≥ 3 months.
- people with pathologically diagnosed advanced relapsed or refractory solid tumors, either gastric and gastroesophageal junction (GEJ) cancer, or pancreatic cancer, who are intolerable to SoC, have progressed through all...
- Positive expression of Claudin 18.2 (\>= 50% of cells with 2+ or 3+ expression, either from fresh or archival tissue) is required prior to enrollment and participation in this study. Positivity for Claudin 18.2 is...
- Has at least one measurable lesion as defined by RECIST v1.1.
- Has adequate organ and bone marrow function within 7 days prior to administration of study treatment defined below: with no blood transfusion or hematopoietic growth factor support within 2 weeks prior to screening)...
- Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 3 days before the first dose. WOCBP and male people whose partners are WOCBP must agree to use effective contraception method...
- Plan to receive any other anti-tumor treatments during the treatment period of this study.
- people participated in a prior investigational study or received anticancer treatment, and have not recovered from side effects of such therapy.
- Underwent major surgical operation within 4 weeks before the first dose of this IP.
- Received treatments with strong CYP3A4, CYP2D6, P-gp, or BCRP inhibitors or inducers within \< 5 half-lives of the drug before the first dose of the study.
- Previously received total gastrectomy (only for people of the dose-escalation part.
- Adverse events caused by previous anti-tumor treatments have not recovered to Grade ≤ 1 according to NCI-CTCAE 5.0 (except for alopecia; some tolerable chronic Grade 2 toxicities may also be excluded as judged by the...
- Known to be allergic to any component of SHR-A1904 product (antibody conjugated toxin, antibody), or allergic to humanized monoclonal antibody products.
- people with known brain metastases, unless the participant is \> 1 month from definitive therapy (surgery or radiotherapy), has no evidence of tumor growth on an imaging study and is clinically stable with respect to...
- people with a second primary cancer, except adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, and other solid tumors curatively treated with no evidence of disease for ≥ 3...
- Class III-IV cardiac insufficiency as per the New York Heart Association (NYHA) criteria; arrhythmia requiring long-term drug control; unstable angina or acute myocardial infarction within 6 months before the first dose...
- people with a history of clinically significant lung diseases (e.g., interstitial pneumonia, radiation pneumonia, and pulmonary fibrosis) or who are suspected to have these diseases by chest imaging at screening period.
- Serious infections that require use of intravenous antibiotics, antiviral drugs, or antifungal drugs during the study period.
- Hepatitis B (HBV, chronic or acute; defined as having a known positive hepatitis B surface antigen [HbsAg] test at the time of screening) or hepatitis C (HCV) infection requiring treatment.
- Has a history of immunodeficiency (including positive results of HIV test in screening, and other acquired and congenital immunodeficiencies) or organ transplant.
- Presence of accompanying diseases (such as poorly controlled hypertension, serious diabetes mellitus, thyroid disorder, psychosis, etc.) that may pose serious risks to the safety of the subject or may affect the...
The study team makes the final eligibility decision.
Where it's taking place
- Miami Beach, Florida, United States
- St. Petersburg, Florida, United States
- New Orleans, Louisiana, United States
- Cleveland, Ohio, United States
- Providence, Rhode Island, United States
- Greenville, South Carolina, United States
- Houston, Texas, United States
- Gosford, New South Wales, Australia
- Liverpool, New South Wales, Australia
- Randwick, New South Wales, Australia
- St Leonards, New South Wales, Australia
- Sydney, New South Wales, Australia
- Westmead, New South Wales, Australia
- Southport, Queensland, Australia
- Frankston, Victoria, Australia
- Nedlands, Western Australia, Australia
- Chisinau, Moldova
- Busan, South Korea
- Cheongju-si, South Korea
- Gyeonggi-do, South Korea
+ 3 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami Beach, Florida, United States; St. Petersburg, Florida, United States; New Orleans, Louisiana, United States; Cleveland, Ohio, United States; Providence, Rhode Island, United States; Greenville, South Carolina, United States and 17 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.