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JAB-3068 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. Identifier: NCT04721223
Recruitment Status : Recruiting
First Posted : January 22, 2021
Last Update Posted : July 28, 2021
Information provided by (Responsible Party):
Jacobio Pharmaceuticals Co., Ltd.

Brief Summary:
To evaluate the safety and tolerability of JAB-3068 administered in investigational regimens in adult participants with advanced solid tumors.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Esophageal Squamous Cell Carcinoma Non Small Cell Lung Cancer Head and Neck Squamous Cell Carcinoma Drug: JAB-3068 Drug: PD1 inhibitor Phase 1 Phase 2

Detailed Description:
To assess the safety and tolerability and determine the recommended phase 2 dose (RP2D) of JAB-3068 in combination with PD1 inhibitor in patients with advanced solid tumors.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 118 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b/2a, Multi-Center, Open-Label,Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of JAB-3068 in Combination With JS001 in Patients With Advanced Solid Tumors
Actual Study Start Date : April 26, 2021
Estimated Primary Completion Date : February 28, 2022
Estimated Study Completion Date : October 28, 2022

Arm Intervention/treatment
Experimental: JAB-3068+PD1 inhibitor Part1
JAB-3068+JS001 dose escalation
Drug: JAB-3068
JAB-3068 administrated orally as a tablet.

Drug: PD1 inhibitor
JS001 administrated as an intravenous(IV) infusion.

Experimental: JAB-3068+PD1 inhibitor Part2
JAB-3068+JS001 dose expansion
Drug: JAB-3068
JAB-3068 administrated orally as a tablet.

Drug: PD1 inhibitor
JS001 administrated as an intravenous(IV) infusion.

Primary Outcome Measures :
  1. Number of participants with dose limiting toxicities [ Time Frame: 24 months ]
    Incidence of dose limiting toxicities (DLTs) . 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 with JAB-3068 and JS001.

  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).

Secondary Outcome Measures :
  1. Plasma concentration (Cmax) [ Time Frame: 24 months ]
    Highest observed plasma concentration of JAB-3068 and JS001

  2. Time to achieve Cmax (Tmax) [ Time Frame: 24 months ]
    Time of highest observed plasma concentration of JAB-3068 and JS001

  3. Area under the plasma concentration-time curve (AUC) [ Time Frame: 24 months ]
    Area under the plasma concentration time curve of JAB-3068 and JS001

  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).

  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.

  6. 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.

  7. 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.

  8. Number of Participants with Treatment-related Adverse Events(TRAE) [ Time Frame: 24 months ]
    TRAE is defined as the AES that the casual relationship of the AE is ralated to investigational drug.

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

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.

Exclusion Criteria:

  • History (≤3 years) of cancer that is histologically distinct from the cancers under study, except for cervical carcinoma in situ, superficial non-invasive bladder tumors, or curatively treated Stage I non-melanoma skin cancer
  • Known serious allergy to experimental drugs
  • Brain or spinal metastases, except if treated by surgery, surgery plus radiotherapy or radiotherapy alone, with no evidence of progression or hemorrhage for ≤21 days before the start of treatment with the study drugs, and has not received any systemic corticosteroids for ≥21 days before the start of treatment with the study drugs

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 identifier (NCT number): NCT04721223

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Contact: Jacobio Pharmaceuticals 86 10 56315466

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China, Beijing
Beijing Cancer Hospital Recruiting
Beijing, Beijing, China
Cancer Hospital Chinese Academy of Medical Sciences Recruiting
Beijing, Beijing, China
China, Henan
Henan Cancer Hospital Recruiting
Zhengzhou, Henan, China
Sponsors and Collaborators
Jacobio Pharmaceuticals Co., Ltd.
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Responsible Party: Jacobio Pharmaceuticals Co., Ltd. Identifier: NCT04721223    
Other Study ID Numbers: JAB-3068-03
First Posted: January 22, 2021    Key Record Dates
Last Update Posted: July 28, 2021
Last Verified: July 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
Additional relevant MeSH terms:
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Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Esophageal Squamous Cell Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents