JAB-3068 Activity in Adult Patients With Advanced Solid Tumors

Last updated: September 17, 2024
Sponsor: Jacobio Pharmaceuticals Co., Ltd.
Overall Status: Completed

Phase

1/2

Condition

Carcinoma

Lung Cancer

Squamous Cell Carcinoma

Treatment

JAB-3068

PD1 inhibitor

Clinical Study ID

NCT04721223
JAB-3068-03
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Written informed consent, according to local guidelines, signed and dated by theparticipant prior to the performance of any study-specific procedures, sampling, oranalyses.

  • Participant must be ≥18 years of age at the time of signature of the informedconsent form (ICF).

  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.

Exclusion

Exclusion Criteria:

  • History (≤3 years) of cancer that is histologically distinct from the cancers understudy, except for cervical carcinoma in situ, superficial non-invasive bladdertumors, 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 radiotherapyor radiotherapy alone, with no evidence of progression or hemorrhage for ≤21 daysbefore the start of treatment with the study drugs, and has not received anysystemic corticosteroids for ≥21 days before the start of treatment with the studydrugs

Study Design

Total Participants: 12
Treatment Group(s): 2
Primary Treatment: JAB-3068
Phase: 1/2
Study Start date:
April 26, 2021
Estimated Completion Date:
December 29, 2023

Study 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.

Connect with a study center

  • Beijing Cancer Hospital

    Beijing, Beijing
    China

    Site Not Available

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing
    China

    Site Not Available

  • Henan Cancer Hospital

    Zhengzhou, Henan
    China

    Site Not Available

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