A Phase I Study of RC88-ADC in Subjects With Advanced Malignant Solid Tumors

• Status: Recruiting
• Trial end date: 2022-05-31
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the safety, pharmacokinetics and effect of RC88-ADC for injeciton in subjects with advanced malignant solid tumors.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: RemeGen; RemeGen Co., Ltd.

Criteria

Inclusion Criteria:

• Voluntary agreement to provide written informed consent.

• Male or female, Aged between 18 to 70 years.

• Predicted survival ≥ 12 weeks.

• Diagnosed with histologically or cytologically-confirmed locally advanced or metastatic solid tumors.

• Measurable lesion according to RECIST 1.1.

• Mesothelin (MSLN) positive as confirmed by the central laboratory. Subject is able to provide specimens from primary or metastatic lesions for MSLN tests.

• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.

• Adequate organ function, evidenced by the following laboratory results within 7 days prior to the study treatment:

• Cardiac ejection fraction ≥ 50 %. Hemoglobin ≥ 9g/dL; Absolute neutrophil count ≥ 1.5×10^9 /L Platelets ≥ 100×10^9 /L; Total bilirubin ≤ 1.5× ULN; AST and ALT ≤ 2.5×ULN and ≤ 5 x ULN with hepatic metastasis; Serum creatinine ≤1.5×ULN.

• All female subjects will be considered to be of child-bearing potential unless they are postmenopausal, or have been sterilized surgically.Female subjects of child-bearing potential must agree to use two forms of highly effective contraception. Male subjects and their female partner who are of child-bearing potential must agree to use two forms of highly effective contraception.

• Willing to adhere to the study visit schedule and the prohibitions and restrictions specified in this protocol.

Exclusion Criteria:

• Known hypersensitivity to the components of RC88-ADC.

• Toxicity of previous anti-tumor treatment not recovered to CTCAE Grade 0-1 (with exception of Grade 2 alopecia).

• Pericardial effusion or cardiac tamponade, or pleural or abdominal effusion with clinical symptoms that requires ongoing treatment.

• Has a history or current history of explosive, acute, chronic, recurrent or persistent myocarditis or pericarditis caused by any cause (eg, virus, tuberculosis, autoimmune disease, etc.)

• Ophthalmic screening is required: has a history of ocular lesions such as the cornea, limbus, conjunctiva, or eyelids (including but not limited to: corneal inflammation, corneal dystrophy, dry eye, meibomian gland dysfunction, uveitis, corneal endothelium Decompensation, glaucoma, iris corneal endothelial syndrome (ICE), etc.) can not be enrolled; has a ophthalmologists-confirmed current medical history of the cornea, limbus, conjunctiva, orbital lesions cannot be included;

• History of receiving any anti-cancer drug/biologic treatment within 4 weeks prior to trial treatment.

• History of major surgery within 4 weeks of planned start of trial treatment.

• Has received a live virus vaccine within 4 weeks of planned start of trial treatment.

• Currently known active infection with HIV or tuberculosis.

• Diagnosed with HBsAg , HBcAb positive and HBV DNA copy positive, or HCVAb positive.

• Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.

• History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or cancers with a similar curative outcome as those mentioned above.

• known central nervous system metastases.

• Uncontrolled hypertension, diabetes, Interstitial lung Disease, or COPD;

• NYHA Class III heart failure

• Pregnancy or lactation.

• Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.