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JAB-21822 Activity in Adult Patients With Advanced Solid Tumors Harboring KRAS G12C Mutation

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ClinicalTrials.gov Identifier: NCT05002270
Recruitment Status : Recruiting
First Posted : August 12, 2021
Last Update Posted : September 9, 2021
Sponsor:
Information provided by (Responsible Party):
Jacobio Pharmaceuticals Co., Ltd.

Tracking Information
First Submitted Date  ICMJE July 26, 2021
First Posted Date  ICMJE August 12, 2021
Last Update Posted Date September 9, 2021
Actual Study Start Date  ICMJE September 3, 2021
Estimated Primary Completion Date July 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 4, 2021)
  • Dose Escalation phase: Number of participants with dose limiting toxicities (DLTs) [ Time Frame: At the end of Cycle 1 (each cycle is 21 days) ]
  • Dose Escalation and Dose Expansion phase: Number of participants with adverse events [ Time Frame: Up to 4 years ]
    Patients will be assessed for incidence and severity of adverse events (AEs) according to NCI-CTCAE criteria
  • Dose Expansion phase: Overall response rate (ORR) [ Time Frame: Up to 4 years - from baseline to RECIST confirmed Progressive Disease ]
    ORR is defined as the percentage of participants with complete response (CR) or partial response (PR) per RECIST v 1.1
  • Dose Expansion phase: Duration of response ( DOR ) [ Time Frame: Up to 4 years ]
    DOR is defined as the time from the participant's initial objective response (CR or PR) to disease progression per CTCAE v1.1 or death due to any cause, whichever occurs first.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 4, 2021)
  • Dose Escalation and Dose Expansion phase: Peak Plasma Concentration (Cmax) [ Time Frame: Up to 4 years ]
    Cmax of JAB-21822 alone or JAB-21822 plus cetuximabn will be measured by using plasma PK samples
  • Dose Escalation and Dose Expansion phase: Area under the plasma concentration versus time curve (AUC) [ Time Frame: Up to 4 years ]
    AUC of JAB-21822 alone or JAB-21822 plus cetuximab will be measured by using plasma PK samples
  • Dose Escalation phase: Overall response rate (ORR) [ Time Frame: Up to 4 years - from baseline to RECIST confirmed Progressive Disease ]
    The percentage of participants with complete response (CR) or partial response (PR) on RECIST v 1.1.
  • Dose Escalation phase: Duration of response ( DOR ) [ Time Frame: Up to 4 years ]
    DOR is defined as the time from the participant's initial objective response (CR or PR) to disease progression per CTCAE v1.1 or death due to any cause, whichever occurs first.
  • Dose Escalation and Dose Expansion phase: Disease Control Rate ( DCR ) [ Time Frame: Up to 4 years ]
    DCR is defined as percentage of participants with complete response (CR), partial response (PR), or stable disease(SD) per CTCAE v1.1
  • Dose Escalation and Dose Expansion phase: Progression-free survival (PFS) [ Time Frame: Up to 4 years ]
    PFS is defined as the interval of time between the date of first treatment to the earliest date of disease progression per CTCAE v1.1 or death which occurs first
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE JAB-21822 Activity in Adult Patients With Advanced Solid Tumors Harboring KRAS G12C Mutation
Official Title  ICMJE A Phase 1/2, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-21822 Monotherapy and Combination Therapy in Adult Patients With Advanced Solid Tumors Harboring KRAS G12C Mutation
Brief Summary This study is to evaluate the safety and tolerability of JAB-21822 monotherapy and combination therapy in adult participants with advanced solid tumors harboring KRAS G12C mutation.
Detailed Description The primary objective of this study is to evaluate the safety and tolerability of JAB-21822 monotherapy to determine the MTD and PR2D during Dose Escalation phase; then to evaluate preliminary antitumor activity when JAB-21822 administered alone and combination with cetuximab during Dose Expansion phase in adult participants with advanced solid tumors harboring KRAS G12C mutation.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Advanced Solid Tumor
  • NSCLC
  • CRC
Intervention  ICMJE
  • Drug: JAB-21822 (KRAS G12C inhibitor)
    Administered orally
  • Drug: Cetuximab (EGFR inhibitor)
    Administered IV
Study Arms  ICMJE
  • Experimental: Arm A0, JAB-21822 monotherapy, Phase 1, Dose Escalation
    Dose escalation of JAB-21822 will be administered alone to determine the MTD and RP2D
    Intervention: Drug: JAB-21822 (KRAS G12C inhibitor)
  • Experimental: Arm A1, JAB-21822 monotherapy, Phare 2, Dose Expansion
    JAB-21822 will be administered alone at RP2D in selected cancer type patients to evaluate the preliminary antitumor activity.
    Intervention: Drug: JAB-21822 (KRAS G12C inhibitor)
  • Experimental: Experimental: Arm B, JAB-21822 combination with Cetuximab, Phase 2, Dose Expansion
    JAB-21822 will be administered together with Cetuximab in mCRC patients to evaluate the preliminary antitumor activity.
    Interventions:
    • Drug: JAB-21822 (KRAS G12C inhibitor)
    • Drug: Cetuximab (EGFR inhibitor)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 4, 2021)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2025
Estimated Primary Completion Date July 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participants must be able to provide an archived tumor sample
  • Histologically or cytologically confirmed solid tumors with KRAS G12C mutation
  • Must have received at least 1 prior standard therapy
  • Must have at least 1 measurable lesion per RECIST v1.1
  • Must have adequate organ function
  • Must be able to swallow and retain orally administered medication

Exclusion Criteria:

  • Has brain or spinal metastases, except if treated and no evidence of radiographic progression or hemorrhage for at least 28 days
  • Active infection requiring systemic treatment within 7 days
  • Active HBV or HCV
  • Any severe and/or uncontrolled medical conditions
  • LVEF ≤50% assessed by ECHO or QTcF
  • QT interval >470 msec
  • Experiencing unresolved CTCAE 5.0 Grade >1 toxicities
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Huiqiang Wang, PhD 86 10 56315466 Huiqiang.wang@jacobiopharma.com
Contact: Ramina Mikailova ramina.mikailova@jacobiopharma.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05002270
Other Study ID Numbers  ICMJE JAB-21822-1001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Jacobio Pharmaceuticals Co., Ltd.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Jacobio Pharmaceuticals Co., Ltd.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Jacobio Pharmaceuticals Co., Ltd.
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP