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New treatment option for Advanced Solid Tumor
Official title A Study of RC118 in Patients with Locally Advanced Unresectable or Metastatic Malignant Solid Tumors
ClinicalTrials.gov ID: NCT05205850
What this study is testing
What is RC118-ADC?
RC118-ADC is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for advanced solid tumor.
Also referred to as RC118 for injection.
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
- In Phase I, This study will explore the tolerability and safety of RC118 in patients with locally advanced unresectable or metastatic malignant solid tumors with positive Claudin 18.2 expression, and determine the maximum tolerated dose (MTD) and the recommended dose in phase II clinical trials (RP2D); In Phase IIa, to explore the clinical effectiveness and safety of long-term use of RC118 at RP2D doses for patients with different tumor types。
- 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 to 75
You may be able to join if
- Volunteer to participate in this study and sign written informed consent
- 18 years old ≤ age ≤ 75 years old, no gender limit
- ECOG physical status score is 0 or 1 point
- The expected survival time exceeds 12 weeks
- Standard treatment is ineffective (disease progression or no remission after treatment), patients who cannot tolerate standard treatment, locally...
You likely can't join if
- Women who are pregnant or breastfeeding, or women whose blood pregnancy test results are positive during the screening period (female people who are...
- people with positive test results for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), and human immunodeficiency virus antibody...
- people with a prior history of other acquired, congenital immunodeficiency diseases; people who are preparing for or have previously undergone organ...
- Those who have previously received targeted therapy drugs for Claudin 18.2; or participated in clinical trials of other drugs within 4 weeks before...
- Have vaccinated within 4 weeks before the first dose or plan to vaccinate any vaccine during the study period
- Allergic to known research drug ingredients or excipients
See the full eligibility criteria
Who can join
- Volunteer to participate in this study and sign written informed consent
- 18 years old ≤ age ≤ 75 years old, no gender limit
- ECOG physical status score is 0 or 1 point
- The expected survival time exceeds 12 weeks
- Standard treatment is ineffective (disease progression or no remission after treatment), patients who cannot tolerate standard treatment, locally advanced unresectable or metastatic malignant solid tumors
- The subject agrees to provide freshly collected tumor tissue specimens or collected and preserved tumor tissue specimens within 2 years during the screening period for CLDN 18.2 testing, and must meet the following...
- According to the RECIST v1.1 standard, based on imaging examination (CT/MRI), there is at least one measurable or evaluable target lesion
- Sufficient bone marrow, liver, and kidney functions (subject to the normal value of the clinical trial center): absolute neutrophil count (ANC) ≥ 1.5×109/L, platelet ≥ 100×109/L, hemoglobin ≥ 90 g/ L, serum total...
- Male or female people with fertility must agree to take effective contraceptive measures during the study period and within 6 months after the end of the last medication, such as double-barrier contraceptive methods...
What rules you out
- Women who are pregnant or breastfeeding, or women whose blood pregnancy test results are positive during the screening period (female people who are infertile do not need to undergo a pregnancy test, such as...
- people with positive test results for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), and human immunodeficiency virus antibody (HIV-Ab) during the screening period
- people with a prior history of other acquired, congenital immunodeficiency diseases; people who are preparing for or have previously undergone organ or bone marrow transplantation;
- Those who have previously received targeted therapy drugs for Claudin 18.2; or participated in clinical trials of other drugs within 4 weeks before the first administration and received trial drugs
- Have vaccinated within 4 weeks before the first dose or plan to vaccinate any vaccine during the study period
- Allergic to known research drug ingredients or excipients
- Combined use of vitamin K antagonist anticoagulant drugs; combined use of therapeutic doses of heparin (people using preventive doses of heparin can be included in the study)
- Received anti-tumor therapy (surgery, chemotherapy, radiotherapy, biological therapy) within 4 weeks before the first administration, and received palliative radiotherapy for bone metastases within 2 weeks
- The toxicity of previous anti-tumor treatments has not returned to the level 0 or 1 of NCI-CTCAE v5.0 (except for hair loss)
- There are clinical symptoms of pleural fluid, ascites, and pericardial effusions require drainage (patients who do not require drainage or whose drainage is discontinued and who do not have a significant increase in...
- According to the judgment of the investigator, an active infection with clinical significance
- Combined with other diseases that seriously endanger the safety of the subject or affect the completion of the test, such as gastrointestinal bleeding (within 4 weeks before the first dose), peptic ulcer, intestinal...
- QTc interval during the screening period\>480 ms (based on the average of 3 screening electrocardiograms); previous family or personal history of long/short QT interval syndrome; ventricular arrhythmia deemed clinically...
- Past myocardial infarction (within 6 months before the first administration), severe or unstable angina, coronary or peripheral artery bypass grafting, New York Heart Association (NYHA) grade 3\~4 heart failure, no...
- People who have had alcohol dependence or drug abuse in the past
- Those who have received systemic steroid therapy for a long period of time (Note: Short-term use (≤ 7 days) and withdrawal\> 2 weeks can be selected)
- Patients who have previously or currently suffered from uncontrolled primary or metastatic brain tumors, and the investigator believes that patients who have been stabilized or whose local treatment has ended may be...
- Past or current peripheral neuropathy ≥ Grade 2
- Past or current mental illness that is difficult to control
- people who have poor compliance and are not expected to cooperate to complete the test procedure
- Other people deemed unsuitable to participate in clinical research by the investigator
- Serious arterial/venous thrombosis or cardiovascular accident within 6 months prior to dose administration, such pulmonary embolism, cerebral infarction, cerebral hemorrhage, except for asymptomatic lacunar infarction...
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
- Hangzhou, Zhejiang, China
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 to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China; Hangzhou, Zhejiang, China. 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.