RP-3500 for Solid Cancers
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing a new oral drug, RP-3500, alone and with other drugs in patients with advanced cancers that have specific genetic mutations. The drug aims to stop cancer cells from fixing themselves, potentially shrinking or stopping the growth of the cancer.
Do I need to stop my current medications to join the trial?
The trial requires that you stop chemotherapy, small molecule anticancer, or biologic anticancer therapy at least 14 days before starting the study drug. If you are on medications that prolong the QT interval, you may also need to stop those. Other medications are not specifically mentioned, so consult with the trial team for guidance.
Do I need to stop my current medications to join the trial?
The trial requires that you stop chemotherapy, small molecule anticancer, or biologic anticancer therapy at least 14 days before starting the study drug. Other medications are not specifically mentioned, so it's best to discuss your current medications with the trial team.
What safety data is available for RP-3500 (camonsertib) and related treatments?
The research provided focuses on the safety and efficacy of Gemcitabine (Gemzar) in various cancer treatments. Gemcitabine has been studied in combination with other agents like interferon alpha, doxorubicin, and platinum compounds for different cancers, including renal cell carcinoma, breast cancer, and non-small-cell lung cancer. The studies report moderate toxicity levels, with common side effects including leukopenia, neutropenia, febrile neutropenia, anemia, mucositis, and diarrhea. However, there is no specific safety data for RP-3500 (camonsertib) or Talazoparib (Talzenna) in the provided research.12345
What safety data exists for RP-3500 (camonsertib) and related treatments like Gemcitabine (Gemzar) in humans?
Gemcitabine (Gemzar) has been studied in various cancers and generally shows moderate safety, with some patients experiencing blood-related side effects like low white blood cell counts and anemia, as well as mouth sores and diarrhea. These side effects are considered manageable, and the treatment is often combined with other drugs to improve effectiveness while monitoring for toxicity.12345
Is the drug combination of Gemcitabine, RP-3500, and Talazoparib promising for treating solid cancers?
Yes, the combination of Gemcitabine, RP-3500, and Talazoparib is promising for treating solid cancers. Gemcitabine has shown effectiveness in various cancers like breast, lung, and ovarian cancer, often improving survival and response rates when combined with other drugs. This suggests that combining it with RP-3500 and Talazoparib could enhance its effectiveness in treating solid cancers.12678
What makes the drug RP-3500 for solid cancers unique?
The drug RP-3500 (camonsertib) is unique because it combines gemcitabine, which has shown effectiveness in various cancers, with talazoparib, a PARP inhibitor that targets cancer cells with specific DNA repair weaknesses, potentially offering a novel mechanism of action and improved outcomes for solid cancers.12678
What data supports the idea that RP-3500 for Solid Cancers is an effective drug?
The available research shows that Gemcitabine (Gemzar), which is part of the RP-3500 treatment, has shown effectiveness in treating various solid cancers. For breast cancer, it has demonstrated better outcomes without severe side effects, especially when combined with other drugs, leading to longer survival and delayed disease progression. In non-small cell lung cancer (NSCLC), Gemcitabine combined with other drugs has shown increased effectiveness and fewer side effects compared to standard treatments. These findings suggest that RP-3500, which includes Gemcitabine, can be an effective option for treating solid cancers.12689
What data supports the effectiveness of the drug Gemcitabine (Gemzar) for solid cancers?
Who Is on the Research Team?
Timothy Yap
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
Adults with advanced solid tumors and specific ATR inhibitor-sensitizing mutations can join this trial. They must have measurable disease, be in good physical condition (ECOG score of 0 or 1), and able to swallow pills. Participants need proper organ function, acceptable blood counts, and a negative pregnancy test if applicable. Contraception is required during the study and for six months after.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Evaluate the safety profile and MTD of RP-3500 (camonsertib) when administered orally, alone and in combination with talazoparib or gemcitabine
Expansion Cohorts
Expansion cohorts with RP-3500 (camonsertib) to study the anti-tumor effect and further examine the safety and PK at the RP2D
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Gemcitabine Injection [Gemzar]
- RP-3500 (camonsertib)
- Talazoparib
Gemcitabine Injection [Gemzar] is already approved in European Union, United States, Canada, Japan for the following indications:
- Pancreatic cancer
- Breast cancer
- Non-small cell lung cancer
- Ovarian cancer
- Pancreatic cancer
- Breast cancer
- Non-small cell lung cancer
- Ovarian cancer
- Pancreatic cancer
- Breast cancer
- Non-small cell lung cancer
- Ovarian cancer
- Pancreatic cancer
- Breast cancer
- Non-small cell lung cancer
- Ovarian cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Repare Therapeutics
Lead Sponsor
Roche Pharma AG
Industry Sponsor
Dr. Thomas Schinecker
Roche Pharma AG
Chief Executive Officer since 2023
PhD in Molecular Biology from New York University
Dr. Levi Garraway
Roche Pharma AG
Chief Medical Officer since 2019
MD from University of California, San Francisco