RC88 in Platinum-Resistant Recurrent Epithelial Ovarian Cancer, Fallopian Tube Cancer, and Primar… (NCT06173037) | Clinical Trial Compass
CompletedPhase 2
RC88 in Platinum-Resistant Recurrent Epithelial Ovarian Cancer, Fallopian Tube Cancer, and Primary Peritoneal Cancer
China43 participantsStarted 2024-01-19
Plain-language summary
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of RC88 monotherapy in subjects with Platinum-Resistant Recurrent Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancer.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. Agree to participate in the study and sign an Informed Consent Form;
✓. Female subjects aged 18 years or older at the time of signing the Informed Consent Form;
✓. Histology confirmed high grade serous ovarian, fallopian tube or primary peritoneal cancer;
✓. Must be newly developed platinum-resistant (Must not have received systemic therapy after developing platinum resistance status);
✓. Received at least 3 prior lines of systemic therapies；
✓. Imaging evidence of disease progression during or at the end of last-line therapy;
✓. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
✓. Life expectancy of at least 12 weeks;
Exclusion criteria
✕. The presence of clinically uncontrollable third-space fluids, such as massive pleural effusion or pericardial effusion accompanied by clinical symptoms or requiring symptomatic management; and ascites that cannot be effectively controlled with treatment;
✕. Subjects with asymptomatic brain metastases who have received prior treatment may participate in this study if they meet all the following criteria:
✕. Subjects with a history of other invasive malignancies within 3 years prior to the first dose, except for adequately treated papillary thyroid carcinoma, basal cell or squamous cell skin cancers without evidence of recurrence, and other adequately treated carcinoma in situ without evidence of disease recurrence；
What they're measuring
1
Overall Response Rate (ORR) by Independent Review Committee (IRC)
✕. Subjects with ongoing clinically significant toxicity associated with prior treatment that has not resolved to Grade 0 or 1 by NCI CTCAE 5.0;
✕. Subjects who have received systemic anti-tumor therapy (including chemotherapy, targeted therapy, biologic therapy, hormonal therapy, etc.) within 28 days or 5 half-lives of prior therapy (whichever is shorter) prior to first dose;
✕. Subjects who have received herbal or proprietary Chinese medicines for tumor control within 14 days prior to the first dose;
✕. Subjects who have received previous mesothelin target-related drugs or MMAE, MMAF, DM1, DM4 and other microtubule inhibitor ADCs；
✕. Subjects with clinical symptoms or signs of gastrointestinal obstruction;