What is this study of RC118 plus Toripalimab/RC148 studying for advanced solid tumors?

This clinical trial is studying the safety and effectiveness of combining RC118 with Toripalimab or RC148 for patients with certain advanced cancers that express Claudin 18.2. Researchers aim to find safe doses and assess treatment response in patients with hard-to-treat gastric and related cancers. The study is sponsored by RemeGen Co., Ltd.

Who may be eligible for this advanced solid tumor clinical trial?

Adults aged 18 to 75 with locally advanced or metastatic gastric or gastroesophageal junction cancer who have failed standard treatments may be eligible. Participants need good overall health with an ECOG status of 0 or 1 and must provide tumor tissue samples. Please review eligibility criteria for more details.

Is there any cost to participate in this advanced solid tumor clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. However, personal travel and other expenses may vary and are not guaranteed to be covered. Participants should plan accordingly.

Actively Recruiting

Phase 1

Phase 2

Age: 18Years - 75Years

All Genders

ID06038396

Phase III Study of RC118 with Toripalimab or RC148 for Claudin 18.2-Positive Advanced or Metastatic Solid Tumors

Led by RemeGen Co., Ltd. · Updated on 2025-01-29

Participants Needed

Research Sites

26 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety, tolerability, and effectiveness of a combination of drugs including RC118, Toripalimab, and RC148 in patients with Claudin 18.2-positive, locally advanced unresectable or metastatic malignant solid tumors, especially focusing on gastric and gastro-esophageal junction cancers. This open, multi-center study includes Phase I to establish safe dosage levels and Phase II to assess treatment outcomes. The trial is sponsored by RemeGen Co., Ltd. and aims to improve options for patients who have failed standard therapies. Participants receive RC118 administered every two weeks at one of two dose levels, combined with a fixed dose of Toripalimab every three weeks. Based on initial dose escalation results in Phase I, an extension cohort will evaluate combinations of RC118 plus Toripalimab or RC148. The study involves careful dose adjustment to find the maximum tolerated dose and recommended Phase II dose. During the study, participants will undergo regular assessments including measurement of adverse events, tumor response, and survival outcomes over up to 15 months. Tumor tissue samples will be collected to confirm Claudin 18.2 expression and monitor biomarkers. Safety monitoring includes tracking dose-limiting toxicities early in treatment and overall tolerability. Participants must meet specific health criteria and will be followed closely throughout the trial duration, with study visits scheduled to assess treatment effects and side effects.

CONDITIONS

Brief Title

A Study of RC118 Plus Toripalimab / RC148 in Patients with Locally Advanced Unresectable or Metastatic Solid Tumors

Who Can Participate

Age: 18Years - 75Years

All Genders

Eligibility Criteria

You may qualify if you...

Able to voluntarily participate and provide written informed consent
Male or female aged between 18 and 75 years
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Expected survival of at least 12 weeks
Histologically confirmed locally advanced or metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma, having failed standard therapy
Received two or fewer prior systemic therapies
Agree to provide tumor tissue for Claudin 18.2 and PD-L1 expression testing, with moderate to high Claudin 18.2 expression
At least one measurable target lesion according to RECIST v1.1
Sufficient heart, bone marrow, liver, and kidney function
Fertile participants must agree to effective contraception during the study and for six months after last dose

You will not qualify if you...

Pregnant or breastfeeding women, or positive pregnancy test during screening (except non-fertile women as defined)
Active hepatitis B or C infection or positive HIV antibody during screening
History of immunodeficiency diseases or prior organ/bone marrow transplant
Previous treatment with Claudin 18.2-targeting therapies including monoclonal antibodies, ADC, CAR-T, or investigational drugs within 4 weeks
Vaccination with live vaccines within 4 weeks before first dose or planned during study
Allergy to study drug ingredients or excipients
Anti-tumor therapy within 4 weeks or less than 5 half-lives prior to first dose; traditional Chinese medicine or immunomodulators within 2 weeks prior
Unresolved toxicities from prior therapies above grade 1 except certain long-term effects
Clinical symptoms requiring drainage of pleural, abdominal, or pericardial effusion
Active infection within 2 weeks requiring systemic therapy
Serious concurrent diseases affecting safety or study completion including uncontrolled diabetes or organ failures
Tumor lesions with bleeding tendency or recent blood transfusion
Prolonged QTc interval or significant cardiac history
Recent myocardial infarction, severe angina, advanced heart failure, or uncontrolled hypertension
Recent thromboembolic events within 6 months
Active autoimmune disease requiring systemic treatment within 2 years (exceptions apply)
Brain metastases or meningitis not stable or recently treated (cancerous meningitis excluded)
Other malignancies within 5 years prior to consent
Major surgery or intervention within 4 weeks, except biopsy
For Phase II: recent immune checkpoint inhibitor or VEGF/PD-1 targeted therapy, prior immunotherapy toxicity causing discontinuation, current anticoagulant use (except prophylactic heparin)
Uncontrolled mental illness
Poor compliance expected to prevent study completion

Research Team

Xiaohong Su

Tianshu Liu, ph.D

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Phase III Study of RC118 with Toripalimab or RC148 for Claudin 18.2-Positive Advanced or Metastatic Solid Tumors

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria