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NCT Number: NCT04721223

JAB-3068 Activity in Adult Patients With Advanced Solid Tumors

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

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Key information

Conditions

Advanced Solid Tumor Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Carcinoma, Squamous Cell Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Esophageal Squamous Cell Carcinoma Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Head and Neck Squamous Cell Carcinoma Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell Non Small Cell Lung Cancer Respiratory Tract Diseases Respiratory Tract Neoplasms Squamous Cell Carcinoma of Head and Neck Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Beijing Cancer Hospital, Beijing, Beijing Municipality, China

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

JAB-3068

Drug

JAB-3068 administrated orally as a tablet.

PD1 Inhibitor

Drug

JS001 administrated as an intravenous(IV) infusion.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Jacobio Pharmaceuticals Co., Ltd.

Industry

Collaborators

  • AbbVie

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 22, 2021
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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