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RP-6306 Combination Therapy for Cancer
Phase 2
Recruiting
Research Sponsored by Canadian Cancer Trials Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Summary
This trial is testing RP-6306, a new drug, to see if it can help treat cancer when used with standard treatments. It focuses on patients with specific biomarkers to see if they respond better. The drug works by blocking a protein that helps cancer cells grow.
Who is the study for?
Adults with advanced cancers like endometrial, NSCLC, ovarian carcinosarcoma, TNBC, PDAC, colorectal cancer or HER-2+ gastroesophageal cancer. They must have tried some treatments already (like platinum-based chemotherapy), be in good physical condition and expected to live at least 3 months. Specific genetic markers are required for some cohorts. Pregnant women and those with certain health conditions or previous hypersensitivity to study drugs can't join.
What is being tested?
The trial is testing RP-6306's safety and effectiveness against various advanced cancers when combined with standard treatments such as Gemcitabine or FOLFIRI Protocol. It also examines if patients' biomarkers affect their response to the treatment compared to usual cancer care approaches.
What are the potential side effects?
Potential side effects of RP-6306 and other drugs used in this trial may include reactions related to drug infusion, impact on blood cells leading to increased infection risk, fatigue, digestive issues due to oral medication absorption problems, and possibly organ inflammation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Trial Design
3Treatment groups
Active Control
Group I: RP-6306 + TrastuzumabActive Control2 Interventions
Group II: RP-6306 + GemcitabineActive Control2 Interventions
Group III: RP-6306 + FOLFIRIActive Control2 Interventions
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
Cancer treatments work through various mechanisms to target and destroy cancer cells. Chemotherapy uses drugs to kill rapidly dividing cells, affecting both cancerous and some healthy cells.
Targeted therapies, like those being studied in trials such as RP-6306, focus on specific molecules or pathways crucial for cancer cell growth and survival, thereby minimizing damage to normal cells. Immunotherapy boosts the body's immune system to recognize and attack cancer cells.
Radiation therapy uses high-energy particles to damage the DNA of cancer cells, leading to cell death. Understanding these mechanisms helps patients and doctors choose the most effective treatment plan, manage side effects, and improve overall outcomes.
Emerging treatments in lung cancer - targeting the RLIP76 molecular transporter.Resistance to Targeted Therapies: Refining Anticancer Therapy in the Era of Molecular Oncology.Overcoming therapeutic resistance in malignant gliomas: current practices and future directions.
Emerging treatments in lung cancer - targeting the RLIP76 molecular transporter.Resistance to Targeted Therapies: Refining Anticancer Therapy in the Era of Molecular Oncology.Overcoming therapeutic resistance in malignant gliomas: current practices and future directions.
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Who is running the clinical trial?
Canadian Cancer Trials GroupLead Sponsor
127 Previous Clinical Trials
68,196 Total Patients Enrolled
Repare TherapeuticsIndustry Sponsor
9 Previous Clinical Trials
1,240 Total Patients Enrolled
Yvette DrewStudy ChairBCCA-Vancouver Cancer Centre, Vancouver BC Canada
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have never been treated with gemcitabine.My cancer has a TP53 mutation.My colorectal cancer is advanced, cannot be surgically removed, and cannot be cured.My cancer has a TP53 mutation.I have never been treated with gemcitabine.I am using a highly effective method of birth control.My tumor is HER-2 positive and has CCNE1 amplification.I am 18 years old or older.I am fully active or can carry out light work.I have had platinum-based chemotherapy but not gemcitabine for my condition.I have undergone standard treatments like chemotherapy and immunotherapy for my condition.I can take pills and don't have issues absorbing food or medicine.My cancer has a TP53 mutation.I cannot stop taking my proton pump inhibitors or certain other medications.I had radiation therapy but it ended at least 4 weeks ago.I have never been treated with gemcitabine.My cancer has a TP53 mutation.My cancer has a TP53 mutation.I have a tissue sample from my cancer and have agreed to its use.I have previously used WEE1 or PKMYT1 inhibitors.It's been over 3 weeks since my last major surgery and my wounds have healed.I do not have conditions that would make taking pills difficult.I have had cancer before, but it was either skin cancer treated successfully, cervical cancer treated without spreading, or any cancer treated over 2 years ago with no current signs of disease.My cancer is advanced, cannot be surgically removed, and cannot be cured.My disease was confirmed by a doctor or through imaging within the last 3 weeks.I have high-grade serous ovarian, fallopian tube, or peritoneal cancer that is resistant to platinum-based chemotherapy.My cancer worsened during or soon after first-line platinum-based treatment.My cancer in the stomach or esophagus cannot be surgically removed and has no cure.I have had FOLFOX chemotherapy for my cancer either as initial treatment or after it came back within 6 months.I had FOLFIRINOX treatment and my cancer returned within 6 months after.I have had platinum-based chemotherapy before but never gemcitabine.I have recovered from side effects of my last cancer treatment.I do not have any serious illnesses or infections that would prevent me from following the study's requirements.My cancer has both KRAS and TP53 mutations.I have had platinum-based chemotherapy but not gemcitabine for my condition.I can receive FOLFIRI treatment and do not have two copies of the UGT1A1*28 gene variant.I have not used growth factors in the last 28 days and won't need them during the trial.My liver and kidney functions are within the required limits.I have had brain or spinal cancer but am stable and not on steroids after treatment.I am not on any other cancer treatments except for stable bone-targeted therapy.I have received at least 2 treatments for my advanced cancer.My heart is healthy, and I don't have serious lung, brain diseases, or infections.I have advanced or recurrent high-grade serous endometrial cancer that cannot be surgically removed.
Research Study Groups:
This trial has the following groups:- Group 1: RP-6306 + Trastuzumab
- Group 2: RP-6306 + Gemcitabine
- Group 3: RP-6306 + FOLFIRI
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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