COMPLETED

JAB-21822 Activity in Adult Patients With Advanced Solid Tumors Harboring KRAS G12C Mutation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study is to evaluate the safety and tolerability of JAB-21822 monotherapy and combination therapy in adult participants with advanced solid tumors harboring KRAS G12C mutation.

Official Title

A Phase 1/2, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-21822 Monotherapy and Combination Therapy in Adult Patients With Advanced Solid Tumors Harboring KRAS G12C Mutation

Quick Facts

Study Start:2021-09-03
Study Completion:2025-02-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05002270

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants must be able to provide an archived tumor sample
  2. * Histologically or cytologically confirmed solid tumors with KRAS G12C mutation
  3. * Must have received at least 1 prior standard therapy
  4. * Must have at least 1 measurable lesion per RECIST v1.1
  5. * Must have adequate organ function
  6. * Must be able to swallow and retain orally administered medication
  1. * Has brain or spinal metastases, except if treated and no evidence of radiographic progression or hemorrhage for at least 28 days
  2. * Active infection requiring systemic treatment within 7 days
  3. * Active HBV or HCV
  4. * Any severe and/or uncontrolled medical conditions
  5. * LVEF ≤50% assessed by ECHO or QTcF
  6. * QT interval \>470 msec
  7. * Experiencing unresolved CTCAE 5.0 Grade \>1 toxicities

Contacts and Locations

Study Locations (Sites)

Mayo Clinc
Phoenix, Arizona, 85054
United States
Mayo Clinc
Scottsdale, Arizona, 85259
United States
Mayo Clinc
Jacksonville, Florida, 32224
United States
University of Utah
Salt Lake City, Utah, 84112
United States

Collaborators and Investigators

Sponsor: Jacobio Pharmaceuticals Co., Ltd.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-09-03
Study Completion Date2025-02-12

Study Record Updates

Study Start Date2021-09-03
Study Completion Date2025-02-12

Terms related to this study

Keywords Provided by Researchers

  • KRAS G12C Mutant Advanced Solid Tumor; NSCLC; CRC

Additional Relevant MeSH Terms

  • Advanced Solid Tumor
  • NSCLC
  • CRC