CompletedPhase 2

A Study of RC108-ADC in Subjects With Advanced Digestive System Malignant Tumor

China29 participantsStarted 2022-11-11

Plain-language summary

A multi-center, open-label, study designed to evaluate the preliminary efficacy, safety and pharmacokinetics of RC108 in patients with c-Me-positive advanced digestive system malignancies.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Voluntary agreement to provide written informed consent.
✓. Male or female, aged between 18 to 75 years.
✓. Predicted survival for ≥ 12 weeks. Diagnosed with histologically or cytologically confirmed locally advanced or metastatic Digestive System Malignant Tumor.
✓. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
✓. 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.
✓. bone marrow function: Hemoglobin ≥ 9g/dL; Absolute neutrophil count ≥ 1.5×10\^9 /L Platelets ≥ 100×10\^9 /L.
✓. hepatic function: Total bilirubin ≤ 1.5× ULN; AST and ALT ≤ 2.5×ULN and ≤ 5 x ULN with hepatic metastasis

Exclusion criteria

✕. Known hypersensitivity to the components of RC108-ADC.
✕. Toxicity of previous anti-tumor treatment not recovered to CTCAE (v5.0) Grade 0-1 (with exception of Grade 2 alopecia).
✕. Uncontrolled pericardial effusion or cardiac tamponade, or pleural or abdominal effusion with clinical symptoms.
✕. 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.

What they're measuring

Objective Response Rate (ORR)

Timeframe: Up to 24 Months

Trial details

NCT IDNCT05628857

SponsorRemeGen Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12-31

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