JDQ443 for Cancer
(KontRASt-01 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the safety and effectiveness of a new treatment called JDQ443 (also known as Opnurasib) for individuals with advanced solid tumors that have a specific mutation known as KRAS G12C. The study tests JDQ443 both alone and in combination with other treatments, TNO155 and tislelizumab, to evaluate their combined effectiveness against these cancers. Suitable candidates for this trial are adults with advanced cancers featuring the KRAS G12C mutation who have either not responded to standard treatments or cannot tolerate them. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering patients a chance to be among the first to benefit from this innovative therapy.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that JDQ443, when used alone, is generally safe and well-tolerated. In studies, patients managed a dose of 200 mg twice a day. Some experienced side effects, but most could handle them. When JDQ443 was combined with TNO155, the safety profile remained similar, and patients with advanced solid tumors tolerated it well.
For JDQ443 with tislelizumab, less detailed safety information is available, but studies included this combination without major concerns. When all three drugs—JDQ443, TNO155, and tislelizumab—were used together, they were still considered safe. Although specific details on side effects aren't available, testing these combinations suggests they were not unexpectedly harmful.
In summary, research indicates that JDQ443 and its combinations are generally well-tolerated. However, individual experiences may vary, and participants should discuss potential risks with their healthcare providers.12345Why are researchers excited about this trial's treatments?
JDQ443 is unique because it targets a specific mutation in cancer cells known as KRAS G12C, which is not directly targeted by most existing treatments. Researchers are excited about JDQ443 as it offers a new mechanism of action that could potentially overcome resistance seen with other therapies. In combination arms, JDQ443 is paired with TNO155 and tislelizumab, which could enhance its effectiveness by also targeting different pathways in cancer cells, providing a multi-faceted approach to treatment. This has the potential to improve outcomes for patients who have limited options with current standard therapies.
What evidence suggests that this trial's treatments could be effective for cancer?
In this trial, participants will receive different treatments involving JDQ443. Previous studies have shown that JDQ443 alone produces promising results in treating cancers with the KRAS G12C mutation, particularly benefiting patients with non-small cell lung cancer (NSCLC). One arm of this trial will test JDQ443 alone. Another arm will explore the combination of JDQ443 with TNO155, which has also shown initial success in treating similar KRAS G12C-mutated tumors. Additionally, an arm will test JDQ443 with tislelizumab, which led to positive responses in past research. The combination of JDQ443 with both TNO155 and tislelizumab, tested in another arm, further supports its potential to shrink tumors in advanced solid cancers. These findings suggest that JDQ443, whether used alone or with other treatments, could be effective against certain advanced cancers.23456
Are You a Good Fit for This Trial?
This trial is for adults with advanced solid tumors that have a specific mutation called KRAS G12C. They should have tried standard treatments or be unable to take them, and may have had previous KRAS G12C inhibitor treatment. Participants need at least one tumor that can be measured and must be fairly active and able to care for themselves.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Characterize the safety and tolerability of JDQ443 single agent and in combination with other treatments
Dose Expansion
Assess anti-tumor activity and further assess safety, tolerability, and PK/PD of each regimen
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- JDQ443
Find a Clinic Near You
Who Is Running the Clinical Trial?
Novartis Pharmaceuticals
Lead Sponsor
Dr. Vas Narasimhan
Novartis Pharmaceuticals
Chief Executive Officer since 2018
MD from Harvard Medical School
Dr. Shreeram Aradhye
Novartis Pharmaceuticals
Chief Medical Officer since 2021
MD