New drug RC88 shows promise in early trial for hard-to-treat cancers
NCT ID NCT04175847
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested an experimental drug called RC88 in 198 people with advanced solid tumors that had stopped responding to standard treatments. The goal was to find a safe dose and see if the drug could shrink tumors or slow their growth. The study was completed and looked at side effects, dosing limits, and early signs of effectiveness.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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198 people
The number who actually took part.
- Started
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Apr 2020
- Finished
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Dec 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Voluntary agreement to provide written informed consent. * Age requirements :phase I 18-70 (including 18 and 70) ,IIa ≥18 years old. * Predicted survival ≥ 12 weeks. * Phase I must be histologically or cytologically confirmed and have failed standard therapy (disease progression after treatment) or are intolerant, unable to receive, or nonexistent to standard care,Patients with partial advanced or metastatic malignant solid tumors; * Phase II: Cohort 1:Advanced malignant mesothelioma; Cohort2:advanced ovarian carcinoma ;Cohort2 Other cancers that may benefit include pancreatic cancer, gastric adenocarcinoma, triple negative breast cancer, and lung adenocarcinoma * Patients with malignant pleural mesothelioma were assessed using mRECIST criteria, and those with other cancers were assessed using RECIST V1.1 criteria. * 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: * Use of investigational drug or device within 4 weeks prior to study dosing * 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 live virus vaccine within 4 weeks prior to study administration or planned to receive live virus vaccine during study . * Currently known active infection with HIV or tuberculosis. * Diagnosed with HBsAg , HBcAb positive and HBV DNA copy positive, or HCVAb positive. * Has Unstable angina, coronary angioplasty, stent implantation,Coronary artery bypass grafting, serious arrhythmias requiring treatment (e.g., persistent ventricular tachycardia, ventricular fibrillation,Torsional ventricular tachycardia), QTc \> 470 ms and long QT syndrome * 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; * Pregnancy or lactation. * Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Drum Tower Hospital
Nanjing, Jiangsu, China
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Henan Cancer Hospital
Zhengzhou, Henan, 450008, China
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National Cancer Center/Cancer Hospital, Chinese Academy of Medical Science and Peking Union Medical College
Beijing, Beijing Municipality, 100021, China
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The First Hospital of Jilin University
Changchun, Jilin, 130021, China
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