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A Study of RC88 Combined With JS001 for Advanced Solid Tumours

Sponsor
RemeGen Co., Ltd. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05804526
Collaborator
(none)
82
Enrollment
1
Arm
32
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This study will evaluate safety , clinical pharmacology and efficacy of intravenous RC88 combined with JS001 in advancedsolid tumours

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
82 participants
Allocation:
N/A
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-label, Non-randomised, Multi-center Study to Evaluate the Safety， and Efficacy Off RC888 Combined With JS001in AdvancedSolid Tumours
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
May 1, 2025
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: RC88+JS001

Drug: RC88+JS001
JS001 240mg by intravenous (IV) infusion

Outcome Measures

Primary Outcome Measures

  1. RP2D [28 days after first treatment]

    Incidence of DLT (dose limiting toxicity) of RC88 combined with JS001

Secondary Outcome Measures

  1. 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. 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.

Eligibility Criteria

Criteria

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

  1. Voluntary agreement to provide written informed consen

  2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

  3. Predicted survival ≥ 12 weeks

  4. Phase I (Phase I) was included and confirmed as MSLN positive (≥1+ after IHC test by central laboratory).Failure, intolerance, or lack of standard treatment has been identified by tissue or cytology The MSLN test is not required for patients with advanced malignant tumor and for subjects diagnosed with malignant mesothelioma;

  5. Adequate organ function required

  6. Male and female participants are eligible to participate if they agree to the contraception use as per study protocol.

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

No locations specified.

Sponsors and Collaborators

  • RemeGen Co., Ltd.

Investigators

  • Study Director: Shi Yuankai, M.D., Leading PI

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
RemeGen Co., Ltd.
ClinicalTrials.gov Identifier:
NCT05804526
Other Study ID Numbers:
  • RC88 C003
First Posted:
Apr 7, 2023
Last Update Posted:
Apr 7, 2023
Last Verified:
Mar 1, 2023
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

Study Results

No Results Posted as of Apr 7, 2023