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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

+3 more

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

+3 more

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

Find a Location

Who is running the clinical trial?

Debiopharm International SAIndustry Sponsor

50 Previous Clinical Trials

6,817 Total Patients Enrolled

Repare TherapeuticsLead Sponsor

8 Previous Clinical Trials

880 Total Patients Enrolled

Media Library

RP-3500 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT04855656 — Phase 1

Solid Tumors Research Study Groups: Phase 1: RP-6306 in combination with Debio 0123, Dose Escalation Study, Phase 1: RP-6306 Single-Agent, Dose Escalation and Food-effect Study, Phase 1: RP-6306 in combination with RP-3500, Dose Escalation Study

Solid Tumors Clinical Trial 2023: RP-3500 Highlights & Side Effects. Trial Name: NCT04855656 — Phase 1

RP-3500 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04855656 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does RP-6306 pose any danger to humans?

"The safety rating for RP-6306 was assigned a 1 as it is currently in the first phase of trials, wherein there are limited data sets that demonstrate efficacy and safety."

Answered by AI

Are various healthcare facilities conducting this research project in the city?

"This study is being conducted at Participating Site # 1007 in Providence, Rhode island; Participating Site # 1001 in Houston, Texas; and Participating Site # 1012 in New Haven, Connecticut alongside 11 other medical sites."

Answered by AI

Are there any openings available for participants in this research program?

"Affirmative. The information on clinicaltrials.gov verifies that this investigation, which debuted April 30th 2021, is still making progress in its recruitment process and seeks 120 participants from 11 distinct sites."

Answered by AI

What is the overall size of this clinical investigation's participant pool?

"Affirmative, the information published on clinicaltrials.gov confirms that this trial is actively recruiting volunteers. The study was initially posted in April 2021 and most recently updated a year later. A total of 120 participants must be recruited from 11 medical centres across the US to complete the project."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of RP-6306 Alone or in Combination With RP-3500 or Debio 0123 in Patients With Advanced Solid Tumors

2021. "Study of RP-6306 Alone or in Combination With RP-3500 or Debio 0123 in Patients With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04855656.