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KRAS G12C inhibitor

JAB-21822 + Cetuximab for Solid Tumors

Phase 1 & 2
Recruiting
Research Sponsored by Jacobio Pharmaceuticals Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must be able to swallow and retain orally administered medication
Histologically or cytologically confirmed solid tumors with KRAS G12C mutation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights

Study Summary

This trial is to study the safety of JAB-21822 as a single treatment and in combination with other treatments for adults with solid tumors that have a KRAS G12C mutation.

Who is the study for?
Adults with advanced solid tumors that have a specific mutation called KRAS G12C can join this trial. They must have tried at least one standard treatment before, be able to take pills, and their organs need to work well. People with brain or spinal metastases, active infections, certain heart conditions, or unresolved severe side effects from previous treatments cannot participate.Check my eligibility
What is being tested?
The trial is testing JAB-21822 alone and in combination with Cetuximab in patients. Both drugs target different parts of the cancer cells' growth mechanisms. The goal is to see how safe they are and how well patients tolerate them.See study design
What are the potential side effects?
Potential side effects may include typical reactions related to targeted cancer therapies such as skin rash, diarrhea, liver enzyme changes leading to fatigue or yellowing of the skin/eyes (jaundice), and other organ-specific inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can swallow and keep down pills.
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My cancer has a KRAS G12C mutation.
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I have undergone at least one standard treatment.
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I can provide a sample of my tumor from a previous procedure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose Escalation and Dose Expansion phase: Number of participants with adverse events
Dose Escalation phase: Number of participants with dose limiting toxicities (DLTs)
Dose Expansion phase: Duration of response ( DOR )
+1 more
Secondary outcome measures
Dose Escalation and Dose Expansion phase: Area under the plasma concentration versus time curve (AUC)
Dose Escalation and Dose Expansion phase: Disease Control Rate ( DCR )
Dose Escalation and Dose Expansion phase: Peak Plasma Concentration (Cmax)
+3 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Experimental: Arm B, JAB-21822 combination with Cetuximab, Phase 2, Dose ExpansionExperimental Treatment2 Interventions
JAB-21822 will be administered together with Cetuximab in mCRC patients to evaluate the preliminary antitumor activity.
Group II: Arm A1, JAB-21822 monotherapy, Phare 2, Dose ExpansionExperimental Treatment1 Intervention
JAB-21822 will be administered alone at RP2D in selected cancer type patients to evaluate the preliminary antitumor activity.
Group III: Arm A0, JAB-21822 monotherapy, Phase 1, Dose EscalationExperimental Treatment1 Intervention
Dose escalation of JAB-21822 will be administered alone to determine the MTD and RP2D

Find a Location

Who is running the clinical trial?

Jacobio Pharmaceuticals Co., Ltd.Lead Sponsor
18 Previous Clinical Trials
1,470 Total Patients Enrolled

Media Library

JAB-21822 (KRAS G12C inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05002270 — Phase 1 & 2
Colorectal Cancer Research Study Groups: Experimental: Arm B, JAB-21822 combination with Cetuximab, Phase 2, Dose Expansion, Arm A0, JAB-21822 monotherapy, Phase 1, Dose Escalation, Arm A1, JAB-21822 monotherapy, Phare 2, Dose Expansion
Colorectal Cancer Clinical Trial 2023: JAB-21822 Highlights & Side Effects. Trial Name: NCT05002270 — Phase 1 & 2
JAB-21822 (KRAS G12C inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05002270 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the purpose of this experiment?

"The primary goal of this study, which will last approximately 4 years, is to assess the number of adverse events in patients that receive escalating doses of the medication. Additionally, disease control rate, progression-free survival, and area under the plasma concentration versus time curve will be monitored as secondary objectives."

Answered by AI

How many different physical locations are conducting this clinical trial?

"4 clinical trial sites are presently looking for patients to enroll. The locations of these centres are: Salt Lake City, Jacksonville, Phoenix and 4 other undisclosed locations. If you enroll in this study, it would be advantageous to choose the centre that is closest to your residence to limit travel."

Answered by AI

Is JAB-21822 (KRAS G12C inhibitor) a new medication?

"The first trial for JAB-21822 (KRAS G12C inhibitor) was completed in 2005 at the Mamie McFaddin Ward Cancer Center. In the 15 years since, there have been 368 more completed trials. As of now, 136 clinical trials are actively recruiting patients; many of these out of Salt Lake City, Utah."

Answered by AI

Why is JAB-21822 (KRAS G12C inhibitor) used?

"JAB-21822 (KRAS G12C inhibitor) is most frequently used as an intervention for pharmacotherapy. However, it can also be used to treat various conditions such as regionally advanced squamous cell carcinoma of the head and neck, metastatic squamous cell carcinoma of the head and neck (hnscc), and squamous cell carcinoma."

Answered by AI

Are there any openings for new participants in this trial?

"The clinical trial indicated on clinicaltrials.gov is currently looking for patients that match its inclusion criteria. The study was first posted on September 3rd, 2021 and 100 patients are needed to be enrolled at 4 different locations."

Answered by AI

How many trial participants are being treated with the experimental medication?

"That is correct, the clinical trial mentioned is still recruiting patients. According to the same website, 100 individuals are needed for the study which began on September 3rd 2021. The 4 locations have not been specified as of this edit (September 7th, 2021)."

Answered by AI

Has this type of clinical trial been conducted before?

"JAB-21822 (KRAS G12C inhibitor) has been under investigation since 2005 when the first trial, sponsored by Bristol-Myers Squibb, took place. Phase 2 approval was granted after the initial study's positive results in 2005. To date, there are 136 active studies involving JAB-21822 being conducted across 51 countries and 1363 cities."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
JAB-21822 Activity in Adult Patients With Advanced Solid Tumors Harboring KRAS G12C Mutation
2021. "JAB-21822 Activity in Adult Patients With Advanced Solid Tumors Harboring KRAS G12C Mutation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05002270.
All > Colorectal Cancer Glendale
~28 spots leftby Apr 2025
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