History of Changes for Study: NCT04855656

Study of RP-6306 in Advanced Solid Tumors

A study version is represented by a row in the table.
Select two study versions to compare. One each from columns A and B.
Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
Click "Compare" to do the comparison and show the differences.
Select a version's Submitted Date link to see a rendering of the study for that version.
The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
Hover over the "Recruitment Status" to see how the study's recruitment status changed.
Study edits or deletions are displayed in red.
Study additions are displayed in green.

Study Record Versions

Version	Submitted Date	Changes
1	April 19, 2021	None (earliest Version on record)
2	April 26, 2021	Contacts/Locations and Study Status
3	May 12, 2021	Recruitment Status, Study Status and Contacts/Locations
4	September 10, 2021	Contacts/Locations and Study Status
5	September 27, 2021	Study Status and Contacts/Locations
6	December 6, 2021	Study Status and Contacts/Locations
7	April 25, 2022	Study Status, Contacts/Locations, Outcome Measures, Arms and Interventions, Study Identification, Study Design and Study Description
8	May 4, 2023	Study Status, Contacts/Locations and Study Design
9	July 27, 2023	Contacts/Locations and Study Status
10	January 26, 2024	Study Status
11	April 10, 2024	Outcome Measures, Contacts/Locations, Arms and Interventions, Study Description, Study Status, Study Identification, Eligibility, Study Design and Sponsor/Collaborators

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	RP-6306-01
Brief Title:	Study of RP-6306 in Advanced Solid Tumors
Official Title:	Phase 1 Study of the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Clinical Activity of RP-6306 in Patients With Advanced Solid Tumors (MYTHIC Study)
Secondary IDs:

Study Status


Record Verification:	March 2021
Overall Status:	Not yet recruiting
Study Start:	April 2021
Primary Completion:	April 2023 [Anticipated]
Study Completion:	June 2023 [Anticipated]

First Submitted:	April 9, 2021
First Submitted that Met QC Criteria:	April 19, 2021
First Posted:	April 22, 2021 [Actual]

Last Update Submitted that Met QC Criteria:	April 19, 2021
Last Update Posted:	April 22, 2021 [Actual]

Sponsor/Collaborators


Sponsor:	Repare Therapeutics
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:	Yes
U.S. FDA-regulated Device:	No
Data Monitoring:	No

Study Description

Brief Summary:

The primary purpose of this study is to assess the safety and tolerability of RP-6306 in patients with eligible advanced solid tumors, determine the maximum tolerated dose (MTD) and assess preliminary anti-tumor activity.

Detailed Description:

Phase 1, multi-center, open-label, dose-escalation study to:

Evaluate the safety profile and MTD of RP-6306 when administered orally to establish the recommended Phase 2 dose and schedule
Characterize the PK and pharmacodynamics of RP-6306 monotherapy
Assess preliminary anti-tumor activity associated with RP-6306 monotherapy

Conditions


Conditions:	Advanced Solid Tumor
Keywords:

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 1
Interventional Study Model:	Single Group Assignment
Number of Arms:	1
Masking:	None (Open Label)
Allocation:	N/A
Enrollment:	60 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Experimental: Phase 1: RP-6306 Single-Agent, Dose Escalation and Food-effect Study 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.	Drug: RP-6306 Oral PKMYT1 Inhibitor

Outcome Measures


Primary Outcome Measures:
1.	Safety and Tolerability of RP-6306 in patients with advanced solid tumors as assessed by NCI CTCAE v5.0 [ Time Frame: Up to 90 days after last administration of study intervention ]
2.	To define the MTD of RP-6306 monotherapy, and determine a recommended Phase 2 dose (RP2D) and preferred schedule [ Time Frame: Up to 90 days after last administration of study intervention ]
Secondary Outcome Measures:
1.	To assess PK parameters of RP-6306 monotherapy in fasted and fed states [ Time Frame: through study completion, an average of 1 year ]
2.	To assess the relationship between pharmacodynamic biomarkers and PK of RP-6306 at different dose levels and/or schedules [ Time Frame: for the first 3 months on treatment ]
3.	To assess preliminary anti-tumor activity of RP-6306 monotherapy [ Time Frame: Through Study Completion, an average of 1 year ]

Eligibility


Minimum Age:	12 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	Inclusion Criteria: Male or female and ≥12 years-of-age at the time of informed consent. Lansky performance status ≥50% for patients ≤16 years of age, or ECOG score of 0, 1, or 2 for patients >16 years of age. Locally advanced or metastatic resistant or refractory solid tumors. Patients <18 years of age must weigh at least 40 kg. Submission of available tumor tissue at screening or willingness to have a biopsy performed if safe and feasible Next generation sequencing (NGS) report obtained in a CLIA-certified or equivalent laboratory demonstrating eligible tumor biomarker. Measurable disease as per RECIST v1.1. Ability to swallow and retain oral medications. Acceptable hematologic and organ function at screening. Negative pregnancy test (serum) for women of childbearing potential (WOCBP) at Screening. Resolution of all toxicities of prior therapy or surgical procedures. Any prior radiation must have been completed at least 7 days prior to the start of study drugs, and patients must have recovered from any acute adverse effects prior to the start of study treatment. Exclusion Criteria: Chemotherapy or small molecule antineoplastic agent given within 21 days or <5 half-lives, whichever is shorter, prior to first dose of study drug. History or current condition, therapy, or laboratory abnormality that might confound the study results or interfere with the patient's participation for the full duration of the study treatment. Patients who are pregnant or breastfeeding. Life-threatening illness, medical condition, active uncontrolled infection, or organ system dysfunction or other reasons which, in the investigator's opinion, could compromise the participating patient's safety. Major surgery within 4 weeks prior to first dose of RP-6306. Uncontrolled, symptomatic brain metastases. Uncontrolled hypertension. Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol and/or follow-up procedures outlined in the protocol.

Contacts/Locations


Central Contact Person:	Peter Manley, MD Telephone: 857-322-5553 Email: pmanley@reparerx.com
Locations:

IPDSharing


Plan to Share IPD:	No

References


Citations:
Links:
Available IPD/Information: