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A Study to Assess the Safety and Tolerability of RC88 for Patients With Advanced Solid Tumours

Sponsor
RemeGen Co., Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05508334
Collaborator
(none)
81
Enrollment
2
Locations
1
Arm
18
Anticipated Duration (Months)
40.5
Patients Per Site
2.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to allow RC88 treatment of patients with advanced solid tumours to assess the safety and tolerability of clinical pharmacology studies

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

The main purpose of this Phase I study is to test RC88 at different dose levels to see if it is safe and well tolerated when given once every 2 weeks.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
81 participants
Allocation:
N/A
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-label, Non-randomised, Multicentre Study to Allow Continued Access to and Assess the Safety and Tolerability of RC88 for Patients With Advanced Solid Tumours
Anticipated Study Start Date :
Sep 30, 2022
Anticipated Primary Completion Date :
Dec 30, 2023
Anticipated Study Completion Date :
Mar 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental: RC88

Subjects will receive intravenous infusion of RC88 once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or investigational medicinal product (IMP) occurs

Drug: RC88
Every 2 weeks for a maximum of 2 years
Other Names:
  • The injectable RC88

    		•

    Outcome Measures

    Primary Outcome Measures

    1. RP2D [28 days after first treatment]

      Incidence of DLT (dose limiting toxicity) of RC88

    Secondary Outcome Measures

    1. Objective Response Rate (ORR) [24 months]

      Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR)

    2. Maximum Concentration (Cmax) of RC88 [pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 24, 48, 96, 168 hours]

      Dose Escalation and Expansion Part

    3. Terminal Half Life (t1/2) of RC88 [pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 24, 48, 96, 168 hours]

      Dose Escalation and Expansion Part

    4. Progression Free Survival (PFS) [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. All subjects must be ≥ 18 years at the first screening examination / visit.

    2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.

    3. Life expectancy of at least 12 weeks

    4. 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;

    5. Phase II-Advanced malignant solid tumor with MSLN expression

    6. Patients with malignant pleural mesothelioma were assessed using mRECIST criteria, and those with other cancers were assessed using RECIST V1.1 criteria

    7. Phase II-Mesothelin (MSLN) positive as confirmed by the central laboratory.

    8. Adequate organ function

    9. Voluntarily sign an informed consent form

    Exclusion Criteria:

    1. Cancer metastases in the brain

    2. Active infection or past hepatitis B or C infection

    3. Major surgery less than 1 month before the start of the study

    4. Uncontrolled heart disease

    5. History of allergy to mesothelin-directed antibodies, tubulysin, monoclonal antibodies related compounds

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Remegen Beijing Beijing China
    2 Remgenen Beijing Beijing China

    Sponsors and Collaborators

    • RemeGen Co., Ltd.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    RemeGen Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT05508334
    Other Study ID Numbers:
    • RC88 C002
    First Posted:
    Aug 19, 2022
    Last Update Posted:
    Aug 19, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Neoplasms

    Study Results

    No Results Posted as of Aug 19, 2022