A Study of RC118 in Patients with Locally Advanced Unresectable or Metastatic Malignant Solid Tumors

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorRemeGen Co., Ltd.

About this trial

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。

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • RC118-ADC

Treatment groups

135 Participants
are divided into 1 treatment group

Sponsors and collaborators