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JAB-3068 Activity in Adult Patients With Advanced Solid Tumors

Primary Purpose

Advanced Solid Tumor, Esophageal Squamous Cell Carcinoma, Non Small Cell Lung Cancer

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
JAB-3068
PD1 inhibitor
Sponsored by
Jacobio Pharmaceuticals Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Solid Tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beijing Cancer HospitalRecruiting
  • Cancer Hospital Chinese Academy of Medical SciencesRecruiting
  • Henan Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

JAB-3068+PD1 inhibitor Part1

JAB-3068+PD1 inhibitor Part2

Arm Description

JAB-3068+JS001 dose escalation

JAB-3068+JS001 dose expansion

Outcomes

Primary Outcome Measures

Number of participants with dose limiting toxicities
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.
Objective response rate (ORR)
ORR is defined as the proportion of participants with complete response or partial response (CR+PR).

Secondary Outcome Measures

Plasma concentration (Cmax)
Highest observed plasma concentration of JAB-3068 and JS001
Time to achieve Cmax (Tmax)
Time of highest observed plasma concentration of JAB-3068 and JS001
Area under the plasma concentration-time curve (AUC)
Area under the plasma concentration time curve of JAB-3068 and JS001
Duration of response ( DCR )
DCR is defined as proportion of participants with complete response, partial response, stable disease(CR+PR+SD).
Progression-free survival (PFS)
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.
Duration of response ( DOR )
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.
Overall survival (OS)
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.
Number of Participants with Treatment-related Adverse Events(TRAE)
TRAE is defined as the AES that the casual relationship of the AE is ralated to investigational drug.

Full Information

First Posted
January 14, 2021
Last Updated
July 26, 2021
Sponsor
Jacobio Pharmaceuticals Co., Ltd.
Collaborators
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT04721223
Brief Title
JAB-3068 Activity in Adult Patients With Advanced Solid Tumors
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 26, 2021 (Actual)
Primary Completion Date
February 28, 2022 (Anticipated)
Study Completion Date
October 28, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jacobio Pharmaceuticals Co., Ltd.
Collaborators
AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Solid Tumor, Esophageal Squamous Cell Carcinoma, Non Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
118 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
JAB-3068+PD1 inhibitor Part1
Arm Type
Experimental
Arm Description
JAB-3068+JS001 dose escalation
Arm Title
JAB-3068+PD1 inhibitor Part2
Arm Type
Experimental
Arm Description
JAB-3068+JS001 dose expansion
Intervention Type
Drug
Intervention Name(s)
JAB-3068
Intervention Description
JAB-3068 administrated orally as a tablet.
Intervention Type
Drug
Intervention Name(s)
PD1 inhibitor
Intervention Description
JS001 administrated as an intravenous(IV) infusion.
Primary Outcome Measure Information:
Title
Number of participants with dose limiting toxicities
Description
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.
Time Frame
24 months
Title
Objective response rate (ORR)
Description
ORR is defined as the proportion of participants with complete response or partial response (CR+PR).
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Plasma concentration (Cmax)
Description
Highest observed plasma concentration of JAB-3068 and JS001
Time Frame
24 months
Title
Time to achieve Cmax (Tmax)
Description
Time of highest observed plasma concentration of JAB-3068 and JS001
Time Frame
24 months
Title
Area under the plasma concentration-time curve (AUC)
Description
Area under the plasma concentration time curve of JAB-3068 and JS001
Time Frame
24 months
Title
Duration of response ( DCR )
Description
DCR is defined as proportion of participants with complete response, partial response, stable disease(CR+PR+SD).
Time Frame
24 months
Title
Progression-free survival (PFS)
Description
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.
Time Frame
24 months
Title
Duration of response ( DOR )
Description
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.
Time Frame
24 months
Title
Overall survival (OS)
Description
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.
Time Frame
24 months
Title
Number of Participants with Treatment-related Adverse Events(TRAE)
Description
TRAE is defined as the AES that the casual relationship of the AE is ralated to investigational drug.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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. 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jacobio Pharmaceuticals
Phone
86 10 56315466
Email
clinicaltrials@jacobiopharma.com
Facility Information:
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Name
Cancer Hospital Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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JAB-3068 Activity in Adult Patients With Advanced Solid Tumors

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