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FIH Study of JAB-21822 in Adult Patients With Advanced Solid Tumors Harboring KRAS G12C Mutation in China

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: NCT05009329
Recruitment Status : Recruiting
First Posted : August 17, 2021
Last Update Posted : August 17, 2021
Sponsor:
Information provided by (Responsible Party):
Jacobio Pharmaceuticals Co., Ltd.

Brief Summary:
To assess safety, tolerability, PK, preliminary efficacy and determine recommended phase 2 dose (RP2D) of JAB-21822 administered in adult participants with KRAS p.G12C-mutant advanced solid tumors.

Condition or disease Intervention/treatment Phase
NSCLC CRC Solid Tumor Drug: JAB-21822 Phase 1 Phase 2

Detailed Description:
This is a phase 1/2a, first-in-human, open-label study of JAB-21822, this study has two parts: dose escalation phase and dose expansion phase.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multi-center, Open, Dose-escalation, and Expanded Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of JAB-21822 in Advanced Solid Tumors With KRAS p.G12c Mutations
Actual Study Start Date : July 26, 2021
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025

Arm Intervention/treatment
Experimental: Phase 1 Dose Exploration
Dose escalation of JAB-21822 to determine maximum tolerated dose
Drug: JAB-21822
JAB-21822 will be administered orally

Experimental: Phase 1 Dose Expansion
Conditionally required
Drug: JAB-21822
JAB-21822 will be administered orally




Primary Outcome Measures :
  1. Incidence of dose limiting toxicities (DLTs) in the dose escalation phase [ Time Frame: first 21 days ]
    Number of participants with dose limiting toxicities

  2. 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


Secondary Outcome Measures :
  1. Peak Plasma Concentration (Cmax) [ Time Frame: up to 4 years ]
    Cmax of JAB-21822 will be measured by using plasma PK samples

  2. Area under plasma concentration versus time curve (AUC) [ Time Frame: up to 4 years ]
  3. Objective response rate ( ORR ) [ Time Frame: up to 4 years ]
    ORR is defined as the proportion of participants with complete response or partial response (CR+PR) per RECIST v 1.1

  4. 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 study drug therapy, to disease progression or death due to any cause, whichever occurs first.

  5. 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. 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



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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:

  1. Written informed consent
  2. Advanced (metastatic or unresectable) KRAS G12C mutant solid tumors, with failure or absence of standard treatment
  3. Subject must be ≥18 years
  4. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
  5. Subjects with life expectancy ≥3 months.
  6. Subjects must have at least one measurable lesion as defined by RECIST v1.1.
  7. There was no serious organ dysfunction in the screening stage
  8. Male or female subjects of reproductive age agree to use adequate contraception

Exclusion Criteria:

  1. History of intestinal disease or major gastric surgery or inability to swallow oral medications
  2. Other active cancer
  3. Previously treated with KRAS G12C inhibitor
  4. Active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV)
  5. Impaired heart function or clinically significant heart disease
  6. Pregnant or breast-feeding
  7. Previous allogeneic bone marrow transplant or organ transplant
  8. Intended study subjects who were unable to abstain from alcohol during medication
  9. Other unqualified conditions judged by the investigators

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): NCT05009329


Contacts
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Contact: Jacobio Pharmaceuticals 86 10 56315466 clinicaltrials@jacobiopharma.com

Locations
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China, Beijing
Beijing Cancer Hospital Recruiting
Beijing, Beijing, China, 100142
Sponsors and Collaborators
Jacobio Pharmaceuticals Co., Ltd.
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Responsible Party: Jacobio Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier: NCT05009329    
Other Study ID Numbers: JAB-21822-1002
First Posted: August 17, 2021    Key Record Dates
Last Update Posted: August 17, 2021
Last Verified: August 2021
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
Keywords provided by Jacobio Pharmaceuticals Co., Ltd.:
KRAS G12C Mutant Advanced Solid Tumor; NSCLC; CRC
Additional relevant MeSH terms:
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Neoplasms