What side effects are associated with this type of intervention?

Common treatments for colorectal cancer, including chemotherapy regimens like FOLFOX and FOLFIRI, EGFR inhibitors such as cetuximab and panitumumab, and targeted therapies like KRAS G12C inhibitors, have various side effects. Chemotherapy can cause diarrhea, rash, and skin toxicity. EGFR inhibitors are associated with skin reactions, hypomagnesemia, and infusion-related reactions. NSAIDs, including aspirin, used for prevention, may lead to cardiovascular events and ototoxicity. These side effects should be carefully considered when choosing a treatment plan.

What prior FDA approvals exist?

The FDA has approved several targeted therapies for colorectal cancer, particularly for patients with specific genetic mutations. For instance, cetuximab and panitumumab are approved for KRAS wild-type colorectal cancer. However, for KRAS G12C mutations, which are less common in colorectal cancer, the focus has been on investigational drugs like JAB-21822. While there are no FDA-approved KRAS G12C inhibitors specifically for colorectal cancer as of now, ongoing clinical trials are exploring their efficacy and safety. Broadly, targeted therapies such as bevacizumab (anti-VEGF) and regorafenib (multi-kinase inhibitor) are also used in the treatment of metastatic colorectal cancer.

What other types of research exist?

Promising alternatives to JAB-21822 for colorectal cancer patients include cetuximab and panitumumab for KRAS wild-type mCRC. Additionally, ongoing research into other targeted therapies and immunotherapies, such as those involving EGFR inhibitors and combination therapies with agents like niraparib and nivolumab, may offer novel treatment options in 2024.

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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

Must not have

Any severe and/or uncontrolled medical conditions

Active infection requiring systemic treatment within 7 days

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial is testing a new drug, JAB-21822, alone and with cetuximab in adults with advanced cancers that have a specific genetic change called KRAS G12C. The goal is to see if these treatments are safe and can stop the cancer from growing. Adagrasib is a related molecule that also has FDA approval for patients with KRAS G12C-mutated locally advanced or metastatic NSCLC who have received at least one prior systemic therapy.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any severe or uncontrolled health conditions.

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I have not been on treatment for an infection in the last week.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dose Escalation and Dose Expansion phase: Number of participants with adverse events

Dose Expansion phase: Duration of response ( DOR )

Dose Expansion phase: Overall response rate (ORR)

Secondary study objectives

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

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Colorectal cancer treatments often target specific genetic mutations to improve efficacy. For instance, KRAS G12C inhibitors, like those studied in the JAB-21822 trial, block the mutated KRAS protein, preventing it from promoting cancer cell growth. This is crucial for patients with KRAS mutations, as traditional EGFR inhibitors like cetuximab are ineffective in these cases. Other common treatments include chemotherapy agents like oxaliplatin and fluorouracil, which damage DNA and inhibit cell division, and targeted therapies like bevacizumab, which inhibits angiogenesis. Understanding these mechanisms helps tailor treatments to individual genetic profiles, potentially improving outcomes and minimizing ineffective therapies.

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