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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04175847
Recruitment Status : Not yet recruiting
First Posted : November 25, 2019
Last Update Posted : January 7, 2020
Sponsor:
Information provided by (Responsible Party):
RemeGen

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

Condition or disease Intervention/treatment Phase
Solid Tumor Drug: RC88 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 31 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study to Evaluate the Safety, Pharmacokinetics and Effect of RC88-ADC For Injection in Subjects With Advanced Malignant Solid Tumors
Estimated Study Start Date : February 15, 2020
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : May 31, 2022

Arm Intervention/treatment
Experimental: RC88 Drug: RC88
Participants will be allocated to one of the following dose groups: 0.1, 0.5, 1.0, 1.5, 2.0 and 2.5 mg/kg, and receive a treatment of RC88-ADC followed by 21 days of dose limited toxicity (DLT) observation period.
Other Name: RC88 for Injection




Primary Outcome Measures :
  1. Adverse events [ Time Frame: From the day of ICF sign to 28 days after the day of the last treatment ]
    Adverse events was assessed by investigator(s) according to NCI-CTCAE v4.03

  2. Maximum Tolerated dose of RC88 [ Time Frame: 21 days after first treatment. ]
    The dose level in which >= 2 out of 6 patients have dose-limiting toxicity (DLT). The MTD is defined as the previous dose level.


Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: 24 months ]
    Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR)

  2. Progression Free Survival (PFS) [ Time Frame: 24 months ]
    Progression-free Survival (PFS) (median) was determined using the number of months measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression) of participants. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04175847


Contacts
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Contact: Jianmin Fang +0810-58075763 jianminfang@hotmail.com

Locations
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China, Beijing
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Science and Peking Union Medical College
Beijing, Beijing, China, 100021
Contact: Yuankai Shi, M.D.         
Sponsors and Collaborators
RemeGen

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Responsible Party: RemeGen
ClinicalTrials.gov Identifier: NCT04175847    
Other Study ID Numbers: RC88-C001
First Posted: November 25, 2019    Key Record Dates
Last Update Posted: January 7, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms