Advanced Solid TumorPhase 1MINOTAURNCT05147350
Study of RP-6306 With FOLFIRI in Advanced Solid Tumors
A Phase 1 study testing RP-6306 (oral PKMYT1 inhibitor) in people with Advanced Solid Tumor, run by Debiopharm International SA at 9 sites in 4 countries.
Trial summary
The primary purpose of this study is to assess the safety and tolerability of RP-6306 with FOLFIRI in patients with eligible advanced solid tumors, determine the maximum tolerated dose (MTD), identify a recommended phase 2 dose (RP2D) and preferred schedule, and assess preliminary anti-tumor activity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- RP-6306 (oral PKMYT1 inhibitor)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 9 sitesin 4 countries
- Study dates
- 9 Aug 2022to 12 Feb 2025
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female and ≥18 years-of-age at the time of signature of the informed consent
- Confirmed advanced solid tumors resistant or refractory to standard treatment
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
- All patients must have locally advanced or metastatic CRC, GI, or esophageal cancer(s) and radiographic evidence of progressing disease.
- Measurable disease as per RECIST v1.1
- Submission of available tumor tissue or willingness to have a biopsy performed if safe and feasible
- Acceptable hematologic and organ function at screening
- Negative pregnancy test for women of childbearing potential at Screening and prior to first study drug.
Who cannot join
- 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.
- 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 study treatment dose.
Show all 12Show fewer
- Uncontrolled, symptomatic brain metastases.
- Uncontrolled high blood pressure
- Active, uncontrolled bacterial, fungal, or viral infection, including hepatitis B virus (HBV), hepatitis C virus (HCV), known human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS) related illness.
- Moderate or severe hepatic impairment
- Cardiac diseases currently or within the last 6 months as defined by New York Heart Association (NYHA) ≥Class 2
- Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol and/or follow-up procedures outlined in the protocol.
Trial locations and contacts
9 sites in 4 countries.
9 sites in 4 countries
United States5 sites
#1001, The University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030
#1019, UCLA, Westwood Cancer Center
Los Angeles, California, 90095
#1008, Columbia University
New York, New York, 10032
#1013, The University of Utah, Huntsman Cancer Center
Salt Lake City, Utah, 84112
#1022, Moffitt Cancer Center
Tampa, Florida, 33612
Spain2 sites
# 5002, South Texas Accelerated Research Therapeutics
Madrid
# 5003, Hospital Universitario HM Sanchinarro
Madrid
Canada1 site
# 2001, Princess Margaret Cancer Centre
Toronto, Ontario, ON M5G 2M9
United Kingdom1 site
# 3003, Sarah Cannon Research Institute
London, W1G 6AD
About this study
Official title: Phase 1 Study of the PKMYT1 Inhibitor RP-6306 in Combination With FOLFIRI for the Treatment of Advanced Solid Tumors
The primary purpose of this study is to assess the safety and tolerability of RP-6306 with FOLFIRI in patients with eligible advanced solid tumors, determine the maximum tolerated dose (MTD), identify a recommended phase 2 dose (RP2D) and preferred schedule, and assess preliminary anti-tumor activity.
Read the detailed description
To assess the safety and tolerability of RP-6306 in combination with FOLFIRI in patients with eligible, advanced solid tumors. Incidence and severity of treatment-emergent adverse events (TEAEs), laboratory assessments, vital signs, electrocardiograms (ECGs), and use of concomitant medications.
The Sponsor of the study has changed from 'Repare Therapeutics' to 'Debiopharm International SA' in the United States.
- Conditions
- Advanced Solid Tumor
- Being tested
- RP-6306 (oral PKMYT1 inhibitor)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RP-6306 (oral PKMYT1 inhibitor)Drug
Also called FOLFIRI
RP-6306 (Oral) in combination with FOLFIRI (IV)
| Study group | Role | What they receive |
|---|---|---|
| Phase 1: RP-6306 in combination with FOLFIRI Dose Escalation | Experimental | RP-6306 will be administered as oral capsules Multiple dose levels of RP-6306 (oral) and FOLFIRI (IV) Receives: Drug: RP-6306 (oral PKMYT1 inhibitor) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability of RP 6306 in Combination With FOLFIRI
Incidence of grade 3 and above Treatment Related Emergent Adverse Events (TRAEs)
Measured: Start of treatment to 30 days post last dose. up to 1.5 years
Recommended Phase 2 Dose (RP2D) and Schedule of RP-6306 in Combination With FOLFIRI
Evaluation of dose-limiting toxicities (DLTs) at or below a frequency of 25%.
Measured: During 28 days (2 cycles) from the initiation of the study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2021
- Study start9 Aug 2022
- Primary completion12 Feb 2025
- Study completion12 Feb 2025
Why it stopped: Sponsor decided to terminate the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Dose Escalation and expansion
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Debiopharm International SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Repare Therapeutics
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05147350
- Sponsor's protocol ID
- RP-6306-03
- Acronym
- MINOTAUR
- Status last verified
- Nov 2025
- First submitted
- 3 Nov 2021
- Last updated
- 5 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of the PKMYT1 Inhibitor RP-6306 in Combination With FOLFIRI for the Treatment of Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05147350
- Acronym / sponsor ID
- MINOTAUR / RP-6306-03
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decided to terminate the study
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Debiopharm International SAIndustry (pharma, biotech, devices)
- Collaborators
- Repare Therapeutics
- Study start
- 9 Aug 2022 (actual)
- Primary completion
- 12 Feb 2025 (actual)
- Study completion
- 12 Feb 2025 (actual)
- First posted
- 7 Dec 2021 (actual)
- Results
- Posted 20 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to assess the safety and tolerability of RP-6306 with FOLFIRI in patients with eligible advanced solid tumors, determine the maximum tolerated dose (MTD), identify a recommended phase 2 dose (RP2D) and preferred schedule, and assess preliminary anti-tumor activity.
Detailed description
To assess the safety and tolerability of RP-6306 in combination with FOLFIRI in patients with eligible, advanced solid tumors. Incidence and severity of treatment-emergent adverse events (TEAEs), laboratory assessments, vital signs, electrocardiograms (ECGs), and use of concomitant medications.
The Sponsor of the study has changed from 'Repare Therapeutics' to 'Debiopharm International SA' in the United States.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Dose Escalation and expansion
| Arm | Type | Receives |
|---|---|---|
| Phase 1: RP-6306 in combination with FOLFIRI Dose Escalation | Experimental | Drug: RP-6306 (oral PKMYT1 inhibitor)RP-6306 will be administered as oral capsules Multiple dose levels of RP-6306 (oral) and FOLFIRI (IV) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female and ≥18 years-of-age at the time of signature of the informed consent
- Confirmed advanced solid tumors resistant or refractory to standard treatment
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
- All patients must have locally advanced or metastatic CRC, GI, or esophageal cancer(s) and radiographic evidence of progressing disease.
- Measurable disease as per RECIST v1.1
Key exclusion criteria (12 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RP-6306 (oral PKMYT1 inhibitor)Also: FOLFIRIRP-6306 (Oral) in combination with FOLFIRI (IV) | Drug | Phase 1: RP-6306 in combination with FOLFIRI Dose Escalation |
Primary outcome
Safety and Tolerability of RP 6306 in Combination With FOLFIRI
Time frame: Start of treatment to 30 days post last dose. up to 1.5 years
Incidence of grade 3 and above Treatment Related Emergent Adverse Events (TRAEs)
Recommended Phase 2 Dose (RP2D) and Schedule of RP-6306 in Combination With FOLFIRI
Time frame: During 28 days (2 cycles) from the initiation of the study treatment
Evaluation of dose-limiting toxicities (DLTs) at or below a frequency of 25%.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Advanced Solid Tumor
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RP-6306 (oral PKMYT1 inhibitor) in people with Advanced Solid Tumor, run by Debiopharm International SA at 9 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Spain, Canada, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability of RP 6306 in Combination With FOLFIRI (time frame: Start of treatment to 30 days post last dose. up to 1.5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.