78 Participants Needed

RP-6306 Combination Therapy for Cancer

Recruiting at 9 trial locations
LS
Overseen ByLesley Seymour
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications, but you cannot take proton pump inhibitors, strong CYP3A inhibitors, or inducers during the trial. There is also a washout period (time without taking certain medications) required for previous chemotherapy or systemic therapy.

What makes the drug RP-6306 unique for cancer treatment?

The drug RP-6306 is unique because it is being studied in combination with other therapies to potentially enhance their effectiveness against cancer, which may offer a novel approach compared to standard treatments that often target single pathways or mechanisms.12345

Research Team

SL

Stephanie Lheureux

Principal Investigator

University Health Network, Princess Margaret Hospital, Toronto ON Canada

YD

Yvette Drew

Principal Investigator

BCCA-Vancouver Cancer Centre, Vancouver BC Canada

EC

Eric Chen

Principal Investigator

University Health Network, Princess Margaret Hospital, Toronto ON Canada

Eligibility Criteria

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.

Inclusion Criteria

I have never been treated with gemcitabine.
Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to screening (if applicable)/enrollment in the trial to document their willingness to participate
My cancer has a TP53 mutation.
See 36 more

Exclusion Criteria

Patients are not eligible if they have a known hypersensitivity to the study drug(s) or their components
Pregnant or breastfeeding women
I cannot stop taking my proton pump inhibitors or certain other medications.
See 8 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive RP-6306 in combination with standard treatments such as Trastuzumab, RP-3500, Gemcitabine, or FOLFIRI

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • RP-6306
Trial OverviewThe 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.
Participant Groups
4Treatment groups
Active Control
Group I: RP-6306 + TrastuzumabActive Control2 Interventions
Group II: RP-6306 + RP-3500Active Control2 Interventions
Group III: RP-6306 + GemcitabineActive Control2 Interventions
Group IV: RP-6306 + FOLFIRIActive Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Canadian Cancer Trials Group

Lead Sponsor

Trials
135
Recruited
70,300+

Repare Therapeutics

Industry Sponsor

Trials
10
Recruited
1,300+

Findings from Research

Palomid 529 (P529), a TORC1/TORC2 inhibitor, effectively reduces cell proliferation and induces apoptosis in hormone-refractory prostate cancer (HRPC) cells, especially in those lacking the PTEN gene, indicating its potential as a targeted therapy.
Combining P529 with conventional chemotherapy drugs like docetaxel and cisplatin shows strong synergistic effects, leading to increased complete responses and reduced tumor progression in in vivo models, suggesting a promising new treatment strategy for HRPC.
The TORC1/TORC2 inhibitor, Palomid 529, reduces tumor growth and sensitizes to docetaxel and cisplatin in aggressive and hormone-refractory prostate cancer cells.Gravina, GL., Marampon, F., Petini, F., et al.[2022]
In a study involving 43 patients with castrate-resistant prostate cancer (CRPC), the combination of docetaxel, bevacizumab, and everolimus showed significant anticancer activity, with 79% of patients achieving a prostate-specific antigen decline of ≥30%.
While the combination therapy was found to be safe, with manageable toxicities, it did not demonstrate improved outcomes compared to docetaxel alone, highlighting the need to weigh potential benefits against the risk of increased side effects.
Safety and Efficacy of Docetaxel, Bevacizumab, and Everolimus for Castration-resistant Prostate Cancer (CRPC).Gross, ME., Dorff, TB., Quinn, DI., et al.[2020]
The maximum tolerated dose (MTD) of MK-2206 was determined to be 45 mg every other day or 200 mg every three weeks, with common side effects including fatigue, nausea, and skin rash.
In this phase 1 study involving 72 patients with advanced solid tumors, MK-2206 showed promising antitumor activity when combined with chemotherapy and targeted therapies, with some patients experiencing complete or partial responses.
Phase 1 trial of the oral AKT inhibitor MK-2206 plus carboplatin/paclitaxel, docetaxel, or erlotinib in patients with advanced solid tumors.Molife, LR., Yan, L., Vitfell-Rasmussen, J., et al.[2021]

References

The TORC1/TORC2 inhibitor, Palomid 529, reduces tumor growth and sensitizes to docetaxel and cisplatin in aggressive and hormone-refractory prostate cancer cells. [2022]
Safety and Efficacy of Docetaxel, Bevacizumab, and Everolimus for Castration-resistant Prostate Cancer (CRPC). [2020]
Phase 1 trial of the oral AKT inhibitor MK-2206 plus carboplatin/paclitaxel, docetaxel, or erlotinib in patients with advanced solid tumors. [2021]
mTOR signaling and drug development in cancer. [2021]
MK-2206, an allosteric Akt inhibitor, enhances antitumor efficacy by standard chemotherapeutic agents or molecular targeted drugs in vitro and in vivo. [2022]