JAB-21822 (KRAS G12C inhibitor) for Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Mayo Clinc, Scottsdale, AZ
Cancer+3 More
JAB-21822 (KRAS G12C inhibitor) - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This study is evaluating whether a drug called JAB-21822 can be used to treat cancer.

See full description

Eligible Conditions

  • Cancer
  • Solid Tumors, Advanced Solid Tumors
  • CRC
  • Non-Small Cell Lung Carcinoma (NSCLC)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether JAB-21822 (KRAS G12C inhibitor) will improve 4 primary outcomes and 6 secondary outcomes in patients with Cancer. Measurement will happen over the course of At the end of Cycle 1 (each cycle is 21 days).

Day 21
Dose Escalation phase: Number of participants with dose limiting toxicities (DLTs)
Up to 4 years
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: Number of participants with adverse events
Dose Escalation and Dose Expansion phase: Peak Plasma Concentration (Cmax)
Dose Escalation and Dose Expansion phase: Progression-free survival (PFS)
Dose Escalation phase: Duration of response ( DOR )
Dose Expansion phase: Duration of response ( DOR )
Year 4
Dose Escalation phase: Overall response rate (ORR)
Dose Expansion phase: Overall response rate (ORR)

Trial Safety

Safety Progress

1 of 3

Trial Design

3 Treatment Groups

Experimental: Arm B, JAB-21822 combination with Cetuximab, Phase 2, Dose Expansi...
1 of 3
Arm A1, JAB-21822 monotherapy, Phare 2, Dose Expansion
1 of 3
Arm A0, JAB-21822 monotherapy, Phase 1, Dose Escalation
1 of 3
Experimental Treatment

This trial requires 100 total participants across 3 different treatment groups

This trial involves 3 different treatments. JAB-21822 (KRAS G12C Inhibitor) is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Experimental: Arm B, JAB-21822 combination with Cetuximab, Phase 2, Dose ExpansionJAB-21822 will be administered together with Cetuximab in mCRC patients to evaluate the preliminary antitumor activity.
Arm A1, JAB-21822 monotherapy, Phare 2, Dose Expansion
Drug
JAB-21822 will be administered alone at RP2D in selected cancer type patients to evaluate the preliminary antitumor activity.
Arm A0, JAB-21822 monotherapy, Phase 1, Dose Escalation
Drug
Dose escalation of JAB-21822 will be administered alone to determine the MTD and RP2D

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 4 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 4 years for reporting.

Closest Location

Mayo Clinc - Scottsdale, AZ

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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

Patient Q&A Section

What does jab-21822 (kras g12c inhibitor) usually treat?

"Jab-21822 should be prescribed after other treatment options are considered. Jab-21822 should be used only as a last resort. After treatment has failed or undesirable side effects are observed, one should reconsider the use of jab-21822." - Anonymous Online Contributor

Unverified Answer

How many people get cancer a year in the United States?

"Cancer incidence rates in the US are projected to decrease by about 5-7% between the 2000 and 2020 years after the present. Given the fact that cancer prevalence has declined substantially during the last four decades, this pattern of decreasing cancer incidence is the most plausible explanation for the significant increase in cancer mortality in the United States in recent decades. Data from a recent study suggests that even if the US has been successful in improving cancer survival and decreasing cancer incidence rates over the past 50 years, the incidence rates are still lower than those seen in developed countries in the last 25 years. A combination of decreasing cancer incidence, improved cancer survival, and declining cancer incidence rates is not likely to occur in the future, and it poses a growing concern for the US health care system." - Anonymous Online Contributor

Unverified Answer

Can cancer be cured?

"The current standard therapy of cancer management (surgery, radiotherapy, chemotherapy, and targeted agents) shows no cure for cancer. However, the quality of life, prognosis, and survival of patients can all be improved." - Anonymous Online Contributor

Unverified Answer

What causes cancer?

"About 1 in 10 cancers have a strong genetic link to exposure to the carcinogen. People are most affected by cancer in the same parts of the lung or colon at the same time of their lives. And there are multiple factors which increase a person's risk of developing cancer. There are many genes involved." - Anonymous Online Contributor

Unverified Answer

What are common treatments for cancer?

"Cancer treatments are based on factors such as type of cancer, tumor size, and how deep the malignancy goes into the body. Common treatments for cancer are surgery, radiation therapy, chemotherapy, targeted therapy, and a combination of these. For each treatment, there are specific side effects. These side effects may be temporary or permanent depending on the treatment.\n\nThe International Agency for Research on Cancer classifies cancers as either "cancer" or "other"." - Anonymous Online Contributor

Unverified Answer

What are the signs of cancer?

"Cancers may present with unexplained weight loss, unexplained blood in the urine, unexplained pain, unexplained unexplained changes in appetite (such as weight loss) and unexplained tingling in fingers and toes.\n\nThere is a common misconception that most signs of cancer are caused by cancer. Signs of cancer are not necessarily caused by cancer, but can be caused by other diseases, including diabetes.\n\nThe four major signs of cancer are cancer being present, the seriousness of the disease, signs and symptoms of the disease, and the seriousness of the patient.\n\nThe four major signs of cancer are:\n1. Someone with cancer will eventually develop cancer." - Anonymous Online Contributor

Unverified Answer

What is cancer?

"Cancer is the sixth leading cause of death and is one of the common forms of cancer found worldwide. It results from accumulated damage to cells and tissue. Cancer begins as a single cell, but can spread to other cells. Cancer can be divided into five main types: skin, colon, breast, lung, and prostate cancer. Each of these types of cancer has different risk factors and the most common risk factors are smoking, excess weight, lack of physical exercise and exposure to ultraviolet (UV) radiation, and certain inherited disorders, among others. The most commonly diagnosed cancers among men are prostate cancer, skin cancer and colorectal cancer." - Anonymous Online Contributor

Unverified Answer

How does jab-21822 (kras g12c inhibitor) work?

"The data demonstrate that jab-21822 is effective in overcoming the g12c mutant checkpoint pathway, reducing growth to the cells expressing the g12c mutation and enhancing their antitumor activity in vitro and in vivo. Jab-21822 may be a promising drug candidate for treating g12c mutant tumors in patients with advanced cancers." - Anonymous Online Contributor

Unverified Answer

Is jab-21822 (kras g12c inhibitor) safe for people?

"jab-21822 is a promising new small molecule KrasG12c (G13K) inhibitor that can enter cell lines, induce cell death and inhibit growth. jab-21822, when given to patients with advanced cancer in phase 1 trial, resulted in a 5-fold increase in patient progression-free survival compared to chemotherapy without jab-21822. jab-21822 has also shown significant antitumor activity in cultured cell lines. jab-21822 is well tolerated in clinical trials and in preclinical in vivo models; has a broad therapeutic window in vivo and in vitro and induces apoptosis in cancer stem cells through the extrinsic apoptotic cell pathway." - Anonymous Online Contributor

Unverified Answer

Does cancer run in families?

"Cancer is found almost as often in first-degree relatives as in nonrelatives and has high concordance among multiple cancers, indicating some commonality among the genetic modifiers." - Anonymous Online Contributor

Unverified Answer

What is the latest research for cancer?

"Results from a recent paper of the current latest studies cannot be assumed and only the results of the randomized controlled trials can be used. More studies have been done on [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) than on lung cancer. A larger number of randomized controlled trials, or meta-analyses have also been done on prostate cancer. Results in [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) for breast, and colon cancer show inconclusive results. In 2007, the British Cancer Foundation (United Kingdom) published results of a large multinational study on colon and rectal cancer. The study was undertaken to investigate whether vitamin D levels, folate and selenium supplements, and red wine may reduce the risk of colorectal cancer." - Anonymous Online Contributor

Unverified Answer

Is jab-21822 (kras g12c inhibitor) typically used in combination with any other treatments?

"Combination therapies, which included jab-21822 and other agents, were effective in inhibiting growth of most lung cancers and a panel of solid tumors. The addition of jab-21822 to other agents has been feasible in various patient populations." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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