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

Launched by JACOBIO PHARMACEUTICALS CO., LTD. · Aug 4, 2021

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment called JAB-21822 for adults with advanced solid tumors that have a specific genetic mutation known as the KRAS G12C mutation. The main goal of the study is to see if this treatment is safe and how well it works, both on its own and when combined with other therapies. If you or someone you know has been diagnosed with advanced solid tumors, such as non-small cell lung cancer (NSCLC) or colorectal cancer (CRC), and has already tried at least one standard treatment, you may qualify to participate in this trial.

To be eligible, participants need to provide a sample of their tumor and have measurable tumors that can be tracked during the study. They should also have good organ function and be able to take medication by mouth. However, individuals with active brain or spinal cancer, recent serious infections, or certain heart conditions may not be able to join. If you participate, you can expect careful monitoring by medical professionals to ensure your safety and to assess how well the treatment is working. This trial is currently recruiting participants, and your involvement could contribute to important research in cancer treatment.

Gender

ALL

Eligibility criteria

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