JAB-3068 Activity in Adult Patients With Advanced Solid Tumors

NCT ID: NCT04721223

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-26

Study Completion Date

2023-12-29

Brief Summary

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

Detailed Description

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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.

Conditions

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Advanced Solid Tumor Esophageal Squamous Cell Carcinoma Non Small Cell Lung Cancer Head and Neck Squamous Cell Carcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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JAB-3068+PD1 inhibitor Part1

JAB-3068+JS001 dose escalation

Group Type EXPERIMENTAL

JAB-3068

Intervention Type DRUG

JAB-3068 administrated orally as a tablet.

PD1 inhibitor

Intervention Type DRUG

JS001 administrated as an intravenous(IV) infusion.

JAB-3068+PD1 inhibitor Part2

JAB-3068+JS001 dose expansion

Group Type EXPERIMENTAL

JAB-3068

Intervention Type DRUG

JAB-3068 administrated orally as a tablet.

PD1 inhibitor

Intervention Type DRUG

JS001 administrated as an intravenous(IV) infusion.

Interventions

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JAB-3068

JAB-3068 administrated orally as a tablet.

Intervention Type DRUG

PD1 inhibitor

JS001 administrated as an intravenous(IV) infusion.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role collaborator

Jacobio Pharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Site Status

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Site Status

Henan Cancer Hospital

Zhengzhou, Henan, China

Site Status

Countries

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China

Other Identifiers

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JAB-3068-03

Identifier Type: -

Identifier Source: org_study_id

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