Status:

COMPLETED

JAB-3068 Activity in Adult Patients With Advanced Solid Tumors

Lead Sponsor:

Jacobio Pharmaceuticals Co., Ltd.

Collaborating Sponsors:

AbbVie

Conditions:

Advanced Solid Tumor

Esophageal Squamous Cell Carcinoma

Eligibility:

All Genders

18+ years

Phase:

PHASE1

PHASE2

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.

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

April 26 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 29 2023

Estimated Enrollment :

12 Patients enrolled

Trial Details

Trial ID

NCT04721223

Start Date

April 26 2021

End Date

December 29 2023

Last Update

September 19 2024

Active Locations (3)

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Page 1 of 1 (3 locations)

1

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

2

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

3

Henan Cancer Hospital

Zhengzhou, Henan, China