SIM0505 for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test the safety and effectiveness of a new drug, SIM0505, for treating advanced solid tumors, focusing on cancers such as ovarian, renal (kidney), uterine, and non-small cell lung cancer. Participants will receive varying doses of SIM0505 every 21 days to determine the optimal dose and observe any anti-tumor effects. Ideal candidates are those with advanced forms of these cancers who have not responded to other treatments. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications, such as strong and moderate CYP3A4 inhibitors and drugs with a known risk of Torsades de Pointes, at least 14 days before starting the study treatment. If you are on any anti-cancer therapies, you may need to stop them within specific time frames before the trial begins.
Is there any evidence suggesting that SIM0505 is likely to be safe for humans?
Research has shown that SIM0505 is well tolerated by patients with various types of cancer. Current data indicates that SIM0505 has a good safety record, with most people not experiencing serious side effects. Studies are testing SIM0505 for its safety and effectiveness in treating cancers such as ovarian, kidney, uterine, and lung cancer.
Although detailed information on side effects from early trials is not available, the phase 1 trial primarily aims to determine safe dosage levels. This stage is crucial for assessing safety in humans. If SIM0505 has been approved for another condition, it suggests some level of safety. However, ongoing research focuses on ensuring its safety for cancer treatment.12345Why do researchers think this study treatment might be promising for cancer?
Researchers are excited about SIM0505 because it offers a new way to tackle cancer by optimizing its dosage for different types, including ovarian, renal, uterine, and lung cancers. Unlike traditional treatments like chemotherapy, which often have broad and harsh effects on the body, SIM0505 is designed to specifically target tumor activity with potentially fewer side effects. By exploring different dose levels, SIM0505 aims to find the most effective dose with the least toxicity, potentially offering a more tailored and effective treatment option for cancer patients. This approach could lead to better outcomes and improved quality of life for those undergoing cancer treatment.
What evidence suggests that this trial's treatment, SIM0505, could be effective for cancer?
Research has shown that SIM0505 holds promise in treating various cancers. In one study, SIM0505 shrank tumors in 46% of participants, meaning nearly half saw improvement. Additionally, the treatment prevented disease progression in 98% of patients. SIM0505 specifically targets cancer cells, aiming to minimize harm to healthy cells. This trial will explore different dose levels of SIM0505 in separate treatment arms for ovarian, kidney, uterine, and certain lung cancers. Early results are encouraging, but further research is needed to confirm these findings.16789
Are You a Good Fit for This Trial?
This trial is for adults with advanced solid tumors who have not responded to standard treatments or are ineligible for them. They must have had at least one prior anti-tumor treatment and a measurable lesion, an ECOG score of 0 or 1, life expectancy over 12 weeks, and proper organ function. Women must test negative for pregnancy and all participants agree to use effective contraception.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Multiple dose levels of SIM0505 will be explored in dose escalation to determine the maximum tolerated dose
Dose Optimization
2-3 dose levels of SIM0505 will be explored to determine the recommended dose and evaluate preliminary anti-tumor activity
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- SIM0505
Find a Clinic Near You
Who Is Running the Clinical Trial?
NextCure, Inc.
Lead Sponsor
Jiangsu Simcere Pharmaceutical Co., Ltd.
Lead Sponsor
Ren Jinsheng
Jiangsu Simcere Pharmaceutical Co., Ltd.
Chief Executive Officer since 2004
Bachelor's degree from Shanxi College of Finance and Economics, EMBA from China Europe International Business School
Tang Renhong
Jiangsu Simcere Pharmaceutical Co., Ltd.
Chief Medical Officer since 2022
MD
Shanghai Xianxiang Medical Technology Co., Ltd.
Industry Sponsor
Shanghai Xianxiang Medical Technology Co., Ltd.
Collaborator