Adult Solid TumorPhase 1NCT05147272

Study of RP-6306 With Gemcitabine in Advanced Solid Tumors

A Phase 1 study testing RP-6306 (oral PKMYT1 inhibitor) in people with Adult Solid Tumor, run by Debiopharm International SA at 11 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

The primary purpose of this study is to assess the safety and tolerability of RP-6306 in combination gemcitabine, in patients with eligible advanced solid tumors, determine the maximum tolerated dose (MTD) of RP-6306 in combination with gemcitabine, identify a recommended phase 2 dose (RP2D) and preferred schedule… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Adult 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: 67 participants
Where: 11 sitesin 3 countries
Study dates: 16 Dec 2021to 28 Aug 2024
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 informed consent.
ECOG Performance status 0 or 1.
Locally advanced or metastatic resistant or refractory solid tumors.
Submission of available tumor tissue at screening or willingness to have a biopsy performed if safe and feasible.
Measurable disease as per RECIST v1.1.
Ability to swallow and retain oral medications.

Show all 10Show fewer

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.
Life expectancy ≥12 weeks after the start of the treatment

Who cannot join

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.
Known sensitivity to any of the ingredients of RP-6306 or gemcitabine.
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 and gemcitabine.

Show all 10Show fewer

Uncontrolled, symptomatic brain metastases.
Uncontrolled hypertension.
Moderate or severe hepatic impairment
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

11 sites in 3 countries.

Country

City, postcode or hospital

11 sites in 3 countries

United States9 sites

# 1023, START Midwest
Grand Rapids, Michigan, 49546
# 1017, Mayo Clinic
Jacksonville, Florida, 32224
# 1019, UCLA, Westwood Cancer Center
Los Angeles, California, 90095
# 1008, Columbia University
New York, New York, 10032
# 1004, Memorial Sloan Kettering Cancer Institute
New York, New York, 10065
# 1010, University of Pennsylvania
Philadelphia, Pennsylvania, 19104
# 1018, Mayo Clinic
Phoenix, Arizona, 85054
# 1016, Mayo Clinic
Rochester, Minnesota, 55902
# 1022, Moffitt Cancer Center
Tampa, Florida, 33612

Other trials in United States

Canada1 site

# 2001, Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2C1

Other trials in Canada

United Kingdom1 site

# 3003, Sarah Cannon Research Institute
London

Other trials in United Kingdom

About this study

Official title: Phase 1 Study of the PKMYT1 Inhibitor RP-6306 in Combination With Gemcitabine for the Treatment of Advanced Solid Tumors (MAGNETIC Study)

Read the detailed description

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

Evaluate the safety profile and MTD of RP-6306 with gemcitabine to establish the RP2D and schedule
Characterize the PK and pharmacodynamics of RP-6306 with gemcitabine
Assess preliminary anti-tumor activity associated with RP-6306 with gemcitabine

The Sponsor of the study has changed from 'Repare Therapeutics' to 'Debiopharm International SA' in the United States.

Conditions: Adult 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 Gemcitabine (IV)
RP-6306 in combination with gemcitabine

Study groups in NCT05147272
Study group	Role	What they receive
Phase 1 Dose Escalation	Experimental	Multiple dose levels of RP-6306 and gemcitabine Receives: Drug: RP-6306 (oral PKMYT1 inhibitor)

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Patients With of Treatment-related Adverse Event Data Per CTCAE v5.0 Criteria to Determine Safety and Tolerability of RP-6306 in Combination With Gemcitabine.
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
Number of Dose Limiting Toxicities, as Defined Per Protocol, That Occur During the First Cycle (21 Days) of Treatment at Each Dose Level
Evaluation of dose-limiting toxicities (DLTs) at or below a frequency of 25%
Measured: During 21 days from the initiation of the study treatment (C1D1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Dec 202128 Aug 2024

First posted7 Dec 2021
Study start16 Dec 2021
Primary completion28 Aug 2024
Study completion28 Aug 2024

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 Adult 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: 67 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05147272
Sponsor's protocol ID: RP-6306-02
Status last verified: Nov 2025
First submitted: 10 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
An Exploratory Study to Evaluate Immune Determinants of the Response to Adoptive Cell Therapy (ACT) in Solid and Hematologic Tumors
Solid Tumor, Adult, Solid Tumor, Childhood
Active, not recruitingPhase 1
Advanced or Recurrent Solid Tumors Treated With SHetA2
Solid Tumor, Adult
RecruitingObservational study
NCI Childhood Cancer Data Initiative (CCDI) Led Pediatric, Adolescent, and Young Adult Rare Cancer Registry for Very Rare Solid Tumors
Very Rare Tumors, Very Rare Cancers
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
RecruitingPhase 1
A Study With NKT3964 for Adults With Advanced/Metastatic Solid Tumors
Solid Tumor, Advanced Solid Tumor

All Adult Solid Tumor trials

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 Gemcitabine for the Treatment of Advanced Solid Tumors (MAGNETIC Study)
ClinicalTrials.gov ID: NCT05147272
Acronym / sponsor ID: RP-6306-02
Conditions: Adult Solid Tumor
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: Sponsor decided to terminate the study
Enrolment: 67 participants (actual)
Lead sponsor: Debiopharm International SAIndustry (pharma, biotech, devices)
Collaborators: Repare Therapeutics
Study start: 16 Dec 2021 (actual)
Primary completion: 28 Aug 2024 (actual)
Study completion: 28 Aug 2024 (actual)
First posted: 7 Dec 2021 (actual)
Results: Posted 16 Oct 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

Evaluate the safety profile and MTD of RP-6306 with gemcitabine to establish the RP2D and schedule
Characterize the PK and pharmacodynamics of RP-6306 with gemcitabine
Assess preliminary anti-tumor activity associated with RP-6306 with gemcitabine

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 Dose Escalation	Experimental	Drug: RP-6306 (oral PKMYT1 inhibitor)Multiple dose levels of RP-6306 and gemcitabine

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Male or female and ≥18 years-of-age at the time of informed consent.
ECOG Performance status 0 or 1.
Locally advanced or metastatic resistant or refractory solid tumors.
Submission of available tumor tissue at screening or willingness to have a biopsy performed if safe and feasible.
Measurable disease as per RECIST v1.1.

Key exclusion criteria (10 listed)

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.
Known sensitivity to any of the ingredients of RP-6306 or gemcitabine.
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: Gemcitabine (IV)RP-6306 in combination with gemcitabine	Drug	Phase 1 Dose Escalation

Primary outcome

Number of Patients With of Treatment-related Adverse Event Data Per CTCAE v5.0 Criteria to Determine Safety and Tolerability of RP-6306 in Combination With Gemcitabine.
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)
Number of Dose Limiting Toxicities, as Defined Per Protocol, That Occur During the First Cycle (21 Days) of Treatment at Each Dose Level
Time frame: During 21 days from the initiation of the study treatment (C1D1)
Evaluation of dose-limiting toxicities (DLTs) at or below a frequency of 25%

Results and safety

Results posted to the registry on 16 Oct 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Module 1a: 40 mg QD Lunresertib Continue + 800 mg/m2 Gemcitabine	1	0
Module 1a: 80 mg QD Lunresertib Continue + 800 mg/m2 Gemcitabine	7	2
Module 1a: 80 mg QD Lunresertib Continue + 600 mg/m2 Gemcitabine	4	0
Module 1a: 40 mg BID Lunresertib Continue + 800 mg/m2 Gemcitabine	4	0
Module 1a: 40 mg BID Lunresertib Continue + 600 mg/m2 Gemcitabine	10	5
Module 1a: 40 mg BID Lunresertib Continue + 400 mg/m2 Gemcitabine	8	3
Module 1b: 120 mg QD Lunresertib 3 Days on/4 Days Off + 800 mg/m2 Gemcitabine	5	0
Module 1b: 120 mg QD Lunresertib 3 Days on/4 Days Off + 600 mg/m2 Gemcitabine	5	2
Module 1b: 40 mg BID Lunresertib 3 Days on/4 Days Off + 800 mg/m2 Gemcitabine	4	0
Module 1b: 60 mg BID Lunresertib 3 Days on/4 Days Off + 600 mg/m2 Gemcitabine	4	3
Module 1b: 60 mg BID Lunresertib 3 Days on/4 Days Off + 400 mg/m2 Gemcitabine Day	6	2
Module 1b: 80 mg BID Lunresertib 3 Days on/4 Days Off + 800 mg/m2 Gemcitabine Day 1 and 8	4	0
Module 1b: 80 mg BID Lunresertib 3 Days on/4 Days Off + 600 mg/m2 Gemcitabine Day 1 and 8	3	1
Module 1b: 120 mg BID Lunresertib 3 Days on/4 Days Off + 800 mg/m2 Gemcitabine Day 1 and 8	2	0

Primary outcome: Number of Patients With of Treatment-related Adverse Event Data Per CTCAE v5.0 Criteria to Determine Safety and Tolerability of RP-6306 in Combination With Gemcitabine.

Time frame: Start of treatment to 30 days post last dose. up to 1.5 years. Count of participants. Unit: Participants

Measure	Module 1a: 40 mg QD Lunresertib Continue + 800 mg/m2 Gemcitabine n = 1	Module 1a: 80 mg QD Lunresertib Continue + 800 mg/m2 Gemcitabine n = 7	Module 1a: 80 mg QD Lunresertib Continue + 600 mg/m2 Gemcitabine n = 4	Module 1a: 40 mg BID Lunresertib Continue + 800 mg/m2 Gemcitabine n = 4	Module 1a: 40 mg BID Lunresertib Continue + 600 mg/m2 Gemcitabine n = 10	Module 1a: 40 mg BID Lunresertib Continue + 400 mg/m2 Gemcitabine n = 8	Module 1b: 120 mg QD Lunresertib 3 Days on/4 Days Off + 800 mg/m2 Gemcitabine n = 5	Module 1b: 120 mg QD Lunresertib 3 Days on/4 Days Off + 600 mg/m2 Gemcitabine n = 5	Module 1b: 40 mg BID Lunresertib 3 Days on/4 Days Off + 800 mg/m2 Gemcitabine n = 4	Module 1b: 60 mg BID Lunresertib 3 Days on/4 Days Off + 600 mg/m2 Gemcitabine n = 4	Module 1b: 60 mg BID Lunresertib 3 Days on/4 Days Off + 400 mg/m2 Gemcitabine Day n = 6	Module 1b: 80 mg BID Lunresertib 3 Days on/4 Days Off + 800 mg/m2 Gemcitabine Day 1 and 8 n = 4	Module 1b: 80 mg BID Lunresertib 3 Days on/4 Days Off + 600 mg/m2 Gemcitabine Day 1 and 8 n = 3	Module 1b: 120 mg BID Lunresertib 3 Days on/4 Days Off + 800 mg/m2 Gemcitabine Day 1 and 8 n = 2
Value	0	3	3	4	8	7	5	5	1	3	4	1	3	2

Primary outcome: Number of Dose Limiting Toxicities, as Defined Per Protocol, That Occur During the First Cycle (21 Days) of Treatment at Each Dose Level

Time frame: During 21 days from the initiation of the study treatment (C1D1). Count of participants. Unit: Participants

Measure	Module 1a: 40 mg QD Lunresertib Continue + 800 mg/m2 Gemcitabine n = 1	Module 1a: 80 mg QD Lunresertib Continue + 800 mg/m2 Gemcitabine n = 6	Module 1a: 80 mg QD Lunresertib Continue + 600 mg/m2 Gemcitabine n = 3	Module 1a: 40 mg BID Lunresertib Continue + 800 mg/m2 Gemcitabine n = 3	Module 1a: 40 mg BID Lunresertib Continue + 600 mg/m2 Gemcitabine n = 10	Module 1a: 40 mg BID Lunresertib Continue + 400 mg/m2 Gemcitabine n = 7	Module 1b: 120 mg QD Lunresertib 3 Days on/4 Days Off + 800 mg/m2 Gemcitabine n = 3	Module 1b: 120 mg QD Lunresertib 3 Days on/4 Days Off + 600 mg/m2 Gemcitabine n = 4	Module 1b: 40 mg BID Lunresertib 3 Days on/4 Days Off + 800 mg/m2 Gemcitabine n = 4	Module 1b: 60 mg BID Lunresertib 3 Days on/4 Days Off + 600 mg/m2 Gemcitabine n = 3	Module 1b: 60 mg BID Lunresertib 3 Days on/4 Days Off + 400 mg/m2 Gemcitabine Day n = 4	Module 1b: 80 mg BID Lunresertib 3 Days on/4 Days Off + 800 mg/m2 Gemcitabine Day 1 and 8 n = 3	Module 1b: 80 mg BID Lunresertib 3 Days on/4 Days Off + 600 mg/m2 Gemcitabine Day 1 and 8 n = 3	Module 1b: 120 mg BID Lunresertib 3 Days on/4 Days Off + 800 mg/m2 Gemcitabine Day 1 and 8 n = 2
Value	0	2	2	2	4	4	2	3	0	1	2	1	3	2

Adverse events

Time frame: Start of treatment to 30 days post last dose up to 1.5 years. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Module 1a: 40 mg QD Lunresertib Continue + 800 mg/m2 Gemcitabine	1 of 1 (100%)	1 of 1 (100%)	1 of 1
Module 1a: 80 mg QD Lunresertib Continue + 800 mg/m2 Gemcitabine	3 of 7 (42.9%)	7 of 7 (100%)	5 of 7
Module 1a: 80 mg QD Lunresertib Continue + 600 mg/m2 Gemcitabine	2 of 4 (50%)	4 of 4 (100%)	3 of 4
Module 1a: 40 mg BID Lunresertib Continue + 800 mg/m2 Gemcitabine	1 of 4 (25%)	4 of 4 (100%)	4 of 4
Module 1a: 40 mg BID Lunresertib Continue + 600 mg/m2 Gemcitabine	5 of 10 (50%)	10 of 10 (100%)	2 of 10
Module 1a: 40 mg BID Lunresertib Continue + 400 mg/m2 Gemcitabine	3 of 8 (37.5%)	8 of 8 (100%)	3 of 8
Module 1b: 120 mg QD Lunresertib 3 Days on/4 Days Off + 800 mg/m2 Gemcitabine	1 of 5 (20%)	5 of 5 (100%)	4 of 5
Module 1b: 120 mg QD Lunresertib 3 Days on/4 Days Off + 600 mg/m2 Gemcitabine	1 of 5 (20%)	5 of 5 (100%)	1 of 5
Module 1b: 40 mg BID Lunresertib 3 Days on/4 Days Off + 800 mg/m2 Gemcitabine	2 of 4 (50%)	4 of 4 (100%)	3 of 4
Module 1b: 60 mg BID Lunresertib 3 Days on/4 Days Off + 600 mg/m2 Gemcitabine	2 of 4 (50%)	4 of 4 (100%)	1 of 4
Module 1b: 60 mg BID Lunresertib 3 Days on/4 Days Off + 400 mg/m2 Gemcitabine Day	2 of 6 (33.3%)	6 of 6 (100%)	2 of 6
Module 1b: 80 mg BID Lunresertib 3 Days on/4 Days Off + 800 mg/m2 Gemcitabine Day 1 and 8	2 of 4 (50%)	4 of 4 (100%)	2 of 4
Module 1b: 80 mg BID Lunresertib 3 Days on/4 Days Off + 600 mg/m2 Gemcitabine Day 1 and 8	1 of 3 (33.3%)	3 of 3 (100%)	1 of 3
Module 1b: 120 mg BID Lunresertib 3 Days on/4 Days Off + 800 mg/m2 Gemcitabine Day 1 and 8	1 of 2 (50%)	2 of 2 (100%)	1 of 2

Limitations and caveats (from the sponsor): Module 1a and 1b was conducted. However, Module 1c and 1d were not conducted, and the study was terminated early by the sponsor/company

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

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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.

11 sites in 3 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 Adult Solid Tumor, run by Debiopharm International SA at 11 sites in 3 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 10 inclusion and 10 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 11 sites in United States, 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 16 Oct 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?

Number of Patients With of Treatment-related Adverse Event Data Per CTCAE v5.0 Criteria to Determine Safety and Tolerability of RP-6306 in Combination With Gemcitabine. (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?

On the ClinicalTrials.gov record for NCT05147272.

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.