What side effects are associated with this type of intervention?

The most common treatments for advanced solid tumors, particularly targeted therapies like RP-6306, often result in side effects such as fatigue, diarrhea, skin rash, and liver toxicity. When combined with other agents, these treatments can also cause hematologic toxicity (e.g., neutropenia, anemia), gastrointestinal issues (e.g., nausea, vomiting), and cardiovascular events. Managing these side effects is crucial to maintaining patient quality of life during treatment.

What prior FDA approvals exist?

The FDA has approved several targeted therapies for the treatment of advanced solid tumors. Notable examples include pembrolizumab (Keytruda), which targets PD-1 and is used for various cancers including melanoma and non-small cell lung cancer, and olaparib (Lynparza), a PARP inhibitor approved for ovarian and breast cancers with BRCA mutations. Additionally, nivolumab (Opdivo), another PD-1 inhibitor, is approved for melanoma, renal cell carcinoma, and non-small cell lung cancer. These therapies, like RP-6306, aim to target specific molecular pathways involved in tumor growth and progression.

What other types of research exist?

Promising alternatives to RP-6306 for advanced solid tumors include: 1) Pembrolizumab (Keytruda) combined with chemotherapy, which has shown efficacy in metastatic non-small-cell lung cancer. 2) Niraparib combined with nivolumab or ipilimumab, which has demonstrated potential in platinum-sensitive advanced pancreatic cancer. 3) Atezolizumab combined with bevacizumab, which has shown activity in metastatic renal cell carcinoma with variant histology. 4) Lutetium-177-PSMA-617, a radioligand therapy for metastatic castration-resistant prostate cancer. These therapies are supported by clinical trial data and are expected to be relevant treatment options in 2024.

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RP-6306 + RP-3500 for Cancer (MYTHIC Trial)

Phase 1

Recruiting

Research Sponsored by Repare Therapeutics

Eligibility Criteria Checklist

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

Must have

Lansky performance status ≥50% for patients ≤16 years of age, or ECOG score of 0, 1, or 2 for patients >16 years of age

Next generation sequencing (NGS) report obtained in a CLIA-certified or equivalent laboratory demonstrating eligible tumor biomarker

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

MYTHIC Trial Summary

This trial is testing a new cancer drug to see if it is safe and effective.

Who is the study for?

This trial is for people aged 12 and older with advanced solid tumors that are resistant or refractory. They must be able to take oral meds, have recovered from previous treatments, have a certain performance status score, weigh at least 40 kg if under 18, and not be pregnant. A report showing an eligible tumor biomarker is required.Check my eligibility

What is being tested?

The study tests the safety and effectiveness of RP-6306 alone or combined with RP-3500 in treating advanced solid tumors. It aims to find the highest dose patients can tolerate without severe side effects and to see how well these drugs work against the tumors.See study design

What are the potential side effects?

While specific side effects aren't listed here, common ones for cancer trials include nausea, fatigue, diarrhea, risk of infection due to low blood counts, liver issues, allergic reactions to medication components.

MYTHIC Trial Eligibility Criteria

Inclusion Criteria

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

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I am mostly active and can do most of my daily activities.

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My tumor has a specific marker found by advanced testing.

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I can swallow and keep down pills.

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I am under 18 and weigh at least 40 kg.

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My cancer is advanced, has spread, and doesn’t respond to treatment.

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I am under 18 and weigh at least 40 kg.

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My cancer is advanced, has spread, and is not responding to treatment.

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I am mostly active and can do most of my daily activities on my own.

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My tumor has a specific marker found by advanced genetic testing.

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I can provide tumor tissue or am willing to undergo a biopsy if it's safe.

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I can swallow and keep down pills.

MYTHIC Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Safety and Tolerability of RP-6306 either in monotherapy or in combination with RP-3500 or with Debio 0123 in patients with eligible advanced solid tumors

The effect of food on the PK of tablet formulation of RP-6306 when administered in fed conditions compared to administration under fasted conditions

The relative bioavailability of RP-6306 capsule formulation as compared to RP-6306 tablet formulation in the fasted state

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Secondary outcome measures

The plasma concentrations of RP-6306 and RP-3500 when dosed in combination

The plasma concentrations of RP-6306 monotherapy (capsule formulation) in the fasted and fed states

To assess preliminary anti-tumor activity achieved with RP-6306 monotherapy, RP-6306 in combination with RP-3500 or RP-6306 in combination with Debio 0123

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MYTHIC Trial Design

3Treatment groups

Experimental Treatment

Group I: Phase 1: RP-6306 in combination with RP-3500, Dose Escalation StudyExperimental Treatment2 Interventions

Patients receive RP-6306 with RP-3500 orally until disease progression, unacceptable toxicity, or investigator/patient decision. Dose escalation will proceed until a maximum tolerated dose is identified.

Group II: Phase 1: RP-6306 in combination with Debio 0123, Dose Escalation StudyExperimental Treatment2 Interventions

Patients receive RP-6306 with Debio 0123 orally until disease progression, unacceptable toxicity, or investigator/patient decision. Dose escalation will proceed until a maximum tolerated dose is identified.

Group III: Phase 1: RP-6306 Single-Agent, Dose Escalation and Food-effect StudyExperimental Treatment1 Intervention

Patients receive RP-6306 orally until disease progression, unacceptable toxicity, or investigator/patient decision. Dose escalation will proceed until a maximum tolerated dose is identified.

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

Targeted therapies for solid tumors, such as those being studied in the trial RP-6306, work by interfering with specific molecules and pathways that are crucial for cancer cell survival and growth. These therapies often target genetic mutations or proteins that are more prevalent in cancer cells, allowing for a more precise attack on the tumor while minimizing damage to normal cells. This precision can lead to fewer side effects and improved effectiveness compared to traditional chemotherapy. For solid tumor patients, this means more personalized treatment options that can potentially improve outcomes and quality of life.