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JAB-3312 Activity in Adult Patients With Advanced Solid Tumors

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: NCT04720976
Recruitment Status : Recruiting
First Posted : January 22, 2021
Last Update Posted : January 19, 2022
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Jacobio Pharmaceuticals Co., Ltd.

Study Description
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Brief Summary:
To evaluate the safety and tolerability of JAB-3312 administered in investigational regimens in adult participants with advanced solid tumors.

Condition or disease Intervention/treatment Phase
Solid Tumor, Adult Drug: JAB-3312 Drug: Binimetinib Drug: Pembrolizumab Drug: Sotorasib Drug: Osimertinib Phase 1 Phase 2

Detailed Description:
To assess the safety and tolerability and determine the Recommended phase 2 dose (RP2D) of JAB-3312 in combination with PD1 inhibitor or MEK inhibitor in patients with advanced solid tumors.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2a, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-3312 Based Combination Therapies in Adult Patients With Advanced Solid Tumors
Actual Study Start Date : March 23, 2021
Estimated Primary Completion Date : March 31, 2023
Estimated Study Completion Date : June 30, 2023
Arms and Interventions
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Arm Intervention/treatment
Experimental: JAB-3312+Pembrolizumab dose escalation
Dose escalation part 1
 Drug: JAB-3312
JAB-3312 will be administered orally, variable dose.

Drug: Pembrolizumab
Pembrolizumab will be administered as an intravenous infusion.
Experimental: JAB-3312+ Binimetinib dose escalation
Dose escalation part2
 Drug: JAB-3312
JAB-3312 will be administered orally, variable dose.

Drug: Binimetinib
Binimetinib will be administered orally.
Experimental: JAB-3312+Pembrolizumab dose expansion
Dose expansion part1
 Drug: JAB-3312
JAB-3312 will be administered orally, variable dose.

Drug: Pembrolizumab
Pembrolizumab will be administered as an intravenous infusion.
Experimental: JAB-3312+Binimetinib dose expansion
Dose expansion part2
 Drug: JAB-3312
JAB-3312 will be administered orally, variable dose.

Drug: Binimetinib
Binimetinib will be administered orally.
Experimental: JAB-3312+Sotorasib dose escalation
Dose escalation part3
 Drug: JAB-3312
JAB-3312 will be administered orally, variable dose.

Drug: Sotorasib
Sotorasib will be administered orally.
Experimental: JAB-3312+ Osimertinib dose escalation
Dose escalation part4
 Drug: JAB-3312
JAB-3312 will be administered orally, variable dose.

Drug: Osimertinib
Osimertinib will be administered orally.
Experimental: JAB-3312+ Sotorasib dose expansion
Dose expansion part3
 Drug: JAB-3312
JAB-3312 will be administered orally, variable dose.

Drug: Sotorasib
Sotorasib will be administered orally.
Experimental: JAB-3312+ Osimertinib dose expansion
Dose expansion part4
 Drug: JAB-3312
JAB-3312 will be administered orally, variable dose.

Drug: Osimertinib
Osimertinib will be administered orally.


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with dose limiting toxicities [ Time Frame: 24 months ]
    Incidence of dose limiting toxicities (DLTs) in the dose escalation phase. A DLT is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first treatment cycle. (Dose escalation phase)

  2. Objective response rate (ORR) [ Time Frame: 24 months ]
    ORR is defined as the proportion of participants with complete response or partial response (CR+PR). (Dose expansion phase)

  3. Duration of response (DOR) [ Time Frame: 24 months ]
    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. (Dose expansion phase)

  4. Duration of response (DCR) [ Time Frame: 24 months ]
    DCR is defined as proportion of participants with complete response, partial response, stable disease(CR+PR+SD). (Dose expansion phase)

  5. Progression-free survival (PFS) [ Time Frame: 24 months ]
    PFS is defined as the interval of time between the date of first treatment to the earliest date of disease progression or death which occurs first. (Dose expansion phase)

  6. Overall survival (OS) [ Time Frame: 24 months ]
    OS is defined as the interval of time between the date of first treatment until death, loss to follow up or termination of the study by the sponsor. (Dose expansion phase)

  7. Number of participants with adverse events [ Time Frame: 24 months ]
    All patients participating in this study will be assessed for incidence and severity of adverse events (AEs) and serious AEs, including changes in laboratory values, vital signs, electrocardiograms, cardiac imaging and ophthalmological assessments


Secondary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: 24 months ]
    ORR is defined as the proportion of participants with complete response or partial response (CR+PR). (Dose escalation phase)

  2. Duration of response ( DOR ) [ Time Frame: 24 months ]
    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. (Dose escalation phase)

  3. Duration of response ( DCR ) [ Time Frame: 24 months ]
    DCR is defined as proportion of participants with complete response, partial response, stable disease(CR+PR+SD). (Dose escalation phase)

  4. Progression-free survival (PFS) [ Time Frame: 24 months ]
    PFS is defined as the interval of time between the date of first treatment to the earliest date of disease progression or death which occurs first. (Dose escalation phase)

  5. Overall survival (OS) [ Time Frame: 24 months ]
    OS is defined as the interval of time between the date of first treatment until death, loss to follow up or termination of the study by the sponsor(Dose escalation phase)

  6. Plasma concentration (Cmax) [ Time Frame: 24 months ]
    Highest observed plasma concentration of JAB-3312(dose escalation phase)

  7. Time to achieve Cmax (Tmax) [ Time Frame: 24 months ]
    Time of highest observed plasma concentration of JAB-3312(dose escalation phase)

  8. Area under the plasma concentration-time curve (AUC) [ Time Frame: 24 months ]
    Area under the plasma concentration time curve of JAB-3312(dose escalation phase)


Eligibility Criteria
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Information from the National Library of Medicine

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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:

  • Written informed consent, according to local guidelines, signed and dated by the participant prior to the performance of any study-specific procedures, sampling, or analyses.
  • Participant must be ≥18 years of age at the time of signature of the informed consent form (ICF).
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
  • Sufficient organ function
  • Participants with a life expectancy ≥3 months
  • Participants must have at least 1 measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Exclusion Criteria:

  • History of cancer that is histologically distinct from the cancers under study
  • Brain or spinal metastases
  • History of severe autoimmune disease or autoimmune disorder that requires chronic systemic corticosteroid treatment.
  • Has active hepatitis B, or hepatitis C infection
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): NCT04720976


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

Locations
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United States, Arizona
Research Site Not yet recruiting
Phoenix, Arizona, United States, 85054
Research Site Not yet recruiting
Scottsdale, Arizona, United States, 85259
United States, Florida
Research Site Not yet recruiting
Jacksonville, Florida, United States, 32224
United States, Michigan
Research Site Not yet recruiting
Detroit, Michigan, United States, 48202
United States, Missouri
Research Site Not yet recruiting
Saint Louis, Missouri, United States, 63130
United States, Texas
Research Site Not yet recruiting
Houston, Texas, United States, 77030
United States, Utah
Research Site Recruiting
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
Jacobio Pharmaceuticals Co., Ltd.
AbbVie
More Information
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Responsible Party: Jacobio Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier: NCT04720976    
Other Study ID Numbers: JAB-3312-1003
First Posted: January 22, 2021    Key Record Dates
Last Update Posted: January 19, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms
Pembrolizumab
Osimertinib
Antineoplastic Agents, Immunological
 Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action