Clinical trial · Interventional
Study of RP-6306 With Gemcitabine in Advanced Solid Tumors
Phase 1 Study of the PKMYT1 Inhibitor RP-6306 in Combination With Gemcitabine for the Treatment of Advanced Solid Tumors (MAGNETIC Study)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor decided to terminate the study
Summary
Brief summary (as posted)
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, examine preliminary pharmacokinetics (PK) and assess anti-tumor activity.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Solid Tumor | Adult Solid Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RP-6306 (oral PKMYT1 inhibitor) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Phase 1 Dose Escalation
- description
- Multiple dose levels of RP-6306 and gemcitabine
- interventionNames
- Drug: RP-6306 (oral PKMYT1 inhibitor)
Primary outcomes (2)
- 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.
- timeFrame
- Start of treatment to 30 days post last dose. up to 1.5 years
- description
- Incidence of grade 3 and above Treatment Related Emergent Adverse Events (TRAEs)
- measure
- Number of Dose Limiting Toxicities, as Defined Per Protocol, That Occur During the First Cycle (21 Days) of Treatment at Each Dose Level
- timeFrame
- During 21 days from the initiation of the study treatment (C1D1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. * 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 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. * 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. * 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.
References
Publications (0)
Data not yet available