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。
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
Women who are pregnant or breastfeeding, or women whose blood pregnancy test results are positive during the screening period (female subjects who are infertile do not need to undergo a pregnancy test, such as hysterectomy and/or bilateral ovaries in the past Women with resection or amenorrhea ≥12 months)
Subjects 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
Subjects with a prior history of other acquired, congenital immunodeficiency diseases; subjects 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
Single group
RC118-ADC
DrugRC118 for injection is a novel antibody-drug conjugate, with a Claudin 18.2-targeting antibody and a microtube inhibitor
Dose limiting toxicity (DLT)
In the DLT evaluation window (observation period 1-28 days after the first administration), according to the NCI-CTCAE v5.0 grading standard, the investigator or the sponsor believes that toxic reaction which are reasonably related to RC118 treatment
The incidence and severity of adverse events (AE)
Adverse events was assessed by investigator(s) according to NCI-CTCAE v5.0
Objective response rate (ORR)
Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR)
Disease Control Rate (DCR)
Disease Control Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR) or stable disease(SD)
Progression-free survival (PFS)
Progression-free Survival (PFS) (median) was determined using the number of months measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression) of participants. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Duration of Remission (DOR)
Duration of response is the length of time that a tumor continues to respond to treatment without the cancer growing or spreading
Pharmacokinetic index
Tmax ，etc.
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