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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.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor NSCLC CRC Drug: JAB-21822 (KRAS G12C inhibitor) Drug: Cetuximab (EGFR inhibitor) Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 3, 2021
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2025
Arms and Interventions
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Arm Intervention/treatment
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
 Drug: JAB-21822 (KRAS G12C inhibitor)
Administered orally
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.
 Drug: JAB-21822 (KRAS G12C inhibitor)
Administered orally
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.
 Drug: JAB-21822 (KRAS G12C inhibitor)
Administered orally

Drug: Cetuximab (EGFR inhibitor)
Administered IV


Outcome Measures
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Primary Outcome Measures :
  1. Dose Escalation phase: Number of participants with dose limiting toxicities (DLTs) [ Time Frame: At the end of Cycle 1 (each cycle is 21 days) ]
  2. 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

  3. 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

  4. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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.

  4. 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.

  5. 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

  6. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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): NCT05002270


Contacts
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Contact: Huiqiang Wang, PhD 86 10 56315466 Huiqiang.wang@jacobiopharma.com
Contact: Ramina Mikailova ramina.mikailova@jacobiopharma.com

Locations
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United States, Arizona
Mayo Clinc Not yet recruiting
Phoenix, Arizona, United States, 85054
Mayo Clinc Not yet recruiting
Scottsdale, Arizona, United States, 85259
United States, Florida
Mayo Clinc Not yet recruiting
Jacksonville, Florida, United States, 32224
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
Jacobio Pharmaceuticals Co., Ltd.
More Information
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Responsible Party: Jacobio Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier: NCT05002270    
Other Study ID Numbers: JAB-21822-1001
First Posted: August 12, 2021    Key Record Dates
Last Update Posted: September 9, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jacobio Pharmaceuticals Co., Ltd.:
KRAS G12C Mutant Advanced Solid Tumor; NSCLC; CRC
Additional relevant MeSH terms:
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Neoplasms
Cetuximab
Antineoplastic Agents, Immunological
Antineoplastic Agents