What side effects are associated with this type of intervention?

Common treatments for solid tumors, such as the combination of RP-6306 with FOLFIRI, often result in side effects including gastrointestinal issues like diarrhea, nausea, and vomiting, as well as hematologic toxicities such as neutropenia and anemia. Other frequent side effects include fatigue, mucositis, and alopecia. These side effects are typical of chemotherapeutic regimens and require careful monitoring.

What prior FDA approvals exist?

Several FDA-approved drugs have been used in the treatment of solid tumors, often in combination with established chemotherapy regimens like FOLFIRI. For instance, bevacizumab, a monoclonal antibody targeting VEGF, has been approved for use with FOLFIRI in metastatic colorectal cancer. Ramucirumab, another VEGF receptor 2 antagonist, has also been approved for various solid tumors, including colorectal cancer, often in combination with chemotherapy. Additionally, agents like cetuximab and panitumumab, which target the EGFR pathway, have been approved for use in combination with chemotherapy for colorectal cancer. These approvals highlight the trend of combining targeted therapies with traditional chemotherapy to enhance treatment efficacy in solid tumors.

What other types of research exist?

Promising novel alternatives for treating advanced solid tumors in 2024 include: 1) Larotrectinib, a TRK inhibitor effective in TRK fusion-positive cancers. 2) Cabozantinib, a tyrosine kinase inhibitor showing activity in various solid tumors. 3) Pembrolizumab, an immune checkpoint inhibitor with efficacy in multiple solid tumor types. 4) Bevacizumab, an angiogenesis inhibitor used in combination with other therapies. 5) Futibatinib, an FGFR inhibitor recently approved for cholangiocarcinoma with FGFR2 fusions/rearrangements.

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PKMYT1 inhibitor

RP-6306 for Advanced Cancer (MINOTAUR Trial)

Q: What is the mechanism of action of this treatment?

The most common treatments for solid tumors often involve combination therapies like FOLFIRI, which includes folinic acid, fluorouracil, and irinotecan. Folinic acid boosts the efficacy of fluorouracil, which disrupts DNA synthesis, while irinotecan inhibits topoisomerase I, preventing DNA replication. These mechanisms target different aspects of cancer cell survival, making the treatment more effective. This is particularly important for solid tumor patients as it can help overcome drug resistance and improve overall treatment outcomes.

Phase 1

Waitlist Available

Research Sponsored by Repare Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Confirmed advanced solid tumors resistant or refractory to standard treatment

Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1

Must not have

Inability to swallow and retain oral medications

Chemotherapy or small molecule antineoplastic agent given within 21 days or <5 half-lives, whichever is shorter, prior to first dose of study treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up objective response rate, best overall response rate, duration of response, clinical benefit rate, progression-free survival at 6 months, and overall survival at 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests the safety and effectiveness of combining a new drug, RP-6306, with standard chemotherapy (FOLFIRI) in patients with advanced cancers. The goal is to find the best dose and schedule while checking for side effects and early signs of effectiveness.

Who is the study for?

Adults over 18 with advanced solid tumors like colorectal, gastrointestinal, or esophageal cancer that's getting worse despite treatment. They must be able to perform daily activities with ease or only have minor limitations (ECOG score of 0-1), and women who can have children need a negative pregnancy test.

What is being tested?

The trial is testing RP-6306 combined with FOLFIRI chemotherapy in patients with certain advanced solid tumors. It aims to find the safest dose, see how well it works against the cancer, and figure out the best dosage schedule.

What are the potential side effects?

Possible side effects include those commonly associated with chemotherapy such as nausea, fatigue, low blood counts leading to increased infection risk or bleeding problems. Specific side effects of RP-6306 are not detailed but may include typical reactions to oral cancer drugs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My advanced cancer has not responded to standard treatments.

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I am fully active or can carry out light work.

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My cancer is advanced or has spread, and recent scans show it's getting worse.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot swallow or keep down pills.

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I haven't had chemotherapy or targeted cancer drugs within the last 3 weeks.

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I have not had major surgery in the last 4 weeks.

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My liver is not working well.

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I do not have any active, uncontrolled infections including HBV, HCV, HIV, or AIDS.

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My high blood pressure is not under control.

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I have brain metastases that are not under control and cause symptoms.

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I have not had serious heart problems in the last 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ objective response rate, best overall response rate, duration of response, clinical benefit rate, progression-free survival at 6 months, and overall survival at 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~objective response rate, best overall response rate, duration of response, clinical benefit rate, progression-free survival at 6 months, and overall survival at 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and objective response rate, best overall response rate, duration of response, clinical benefit rate, progression-free survival at 6 months, and overall survival at 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of patients with of treatment-related adverse event data per CTCAE v5.0 criteria and frequency of dose limiting toxicities, to determine safety and tolerability of RP-6306 in combination with FOLFIRI.

To identify a maximum tolerated dose (MTD)

Secondary study objectives

Area under the plasma concentration versus time curve (AUC) from time 0 to 8 hours post dose

Best percent change in tumor size from baseline

Minimum blood plasma concentration (Cmin) will be observed directly from data

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Phase 1: RP-6306 in combination with FOLFIRI Dose EscalationExperimental Treatment1 Intervention

RP-6306 will be administered as oral capsules Multiple dose levels of RP-6306 (oral) and FOLFIRI (IV)

0 / 11Eligibility criteria met

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

The most common treatments for solid tumors often involve combination therapies like FOLFIRI, which includes folinic acid, fluorouracil, and irinotecan. Folinic acid boosts the efficacy of fluorouracil, which disrupts DNA synthesis, while irinotecan inhibits topoisomerase I, preventing DNA replication. These mechanisms target different aspects of cancer cell survival, making the treatment more effective. This is particularly important for solid tumor patients as it can help overcome drug resistance and improve overall treatment outcomes.

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