Evaluating MIL93 for treating advanced solid tumors

A Phase I Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy of MIL93 in Advanced or Metastatic Solid Tumors.

This study is testing a new treatment called MIL93 to see if it can safely help people with advanced solid tumors, both on its own and when combined with standard chemotherapy.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 228 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Beijing Mabworks Biotech Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Beijing)
• Trial ID: NCT04671875 on ClinicalTrials.gov

What this trial studies

This clinical study investigates the safety, tolerability, pharmacokinetics, and efficacy of MIL93, a monoclonal antibody targeting Claudin 18.2, in patients with advanced or metastatic solid tumors. The study consists of two parts: the first part focuses on dose escalation and expansion for mono-therapy, while the second part examines the combination of MIL93 with standard chemotherapy in patients with specific types of cancer. Participants will receive doses of MIL93 every three weeks, with adjustments based on observed safety and efficacy. The study aims to identify optimal dosing and assess the potential benefits of MIL93 in treating these malignancies.

Who should consider this trial

Good fit: Ideal candidates include adults with advanced unresectable or metastatic solid tumors that are positive for Claudin 18.2 and have limited treatment options.

Not a fit: Patients with tumors that do not express Claudin 18.2 or those who have already received standard treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors that express Claudin 18.2.

How similar studies have performed: While this approach is novel in targeting Claudin 18.2, similar studies with monoclonal antibodies have shown promise in treating various cancers.

Eligibility criteria

Inclusion Criteria:

1. Adult patients, \>=18 years of age;
2. Suffer from advanced unresectable or metastatic malignant solid tumors confirmed by histological diagnosis and meet the criteria of the enrolled group as follows:

   Mono-therapy dose escalation study: The subjects for whom no standard treatment regimens are available or who is intolerable to standard treatments.

   Mono-therapy dose expansion study: The subjects with positive CDLN18.2 expression in tumor tissue (through immunohistochemistry (IHC) test) confirmed by the central laboratory at enrollment.

   Combination study is composed of 2 cohorts.Cohort 1:Subjects with untreated CLDN18.2 positive G/GEJAC; Cohort 2:Subjects with untreated CLDN18.2 positive pancreatic cancer.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
4. Life expectancy \>=3 months;
5. Sufficient organ and bone marrow function;
6. At least one measurable lesion or evaluable lesion (recist v1.1);
7. Able and willing to provide written informed consent and to comply with the study protocol.

Exclusion Criteria:

1. Prior use of any anti-cancer therapy(including chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc) within 4 weeks of study start;
2. Previous exposure to any drug targeting CLDN 18.2;
3. Major surgery within 8 weeks prior to the first administration or expected to undergo major surgery during the study treatment;
4. Systemic immunosuppressive therapy was required within 14 days prior to the first administration;
5. Central nervous system metastasis;
6. History of other primary malignant tumors in 5 years;
7. Evidence of significant, uncontrolled concomitant disease;
8. Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C(including HBsAg,HBcAb positive with abnormal HBV DNA or HCV RNA );
9. Suffering from serious or uncontrollable gastro-intestinal tract bleed;
10. Known severe allergic reaction or/and infusion reaction to monoclonal antibody;
11. Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual contact during the following time periods related to this study: 1) while participating in the study; 2) for at least 6 months after discontinuation of all study treatments.

Where this trial is running

Beijing

• Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Jing Huang, doctor

Conditions Advanced Malignancies