Study of RP-6306 With Gemcitabine in Advanced Solid Tumors

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-16

Study Completion Date

2024-08-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study of RO6927005 Either As Monotherapy (Part A) or in Combination With Gemcitabine and Nab-Paclitaxel (Part B) to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Clinical Activity in Patients With Mesothelin-positive Metastatic and/or Locally Advanced Malignant Solid Tumors

NCT02317419

Cancer

TERMINATED PHASE1

PF-00477736 Is Being Studied In Advanced Solid Tumors In Combination With Chemotherapy With Gemcitabine

NCT00437203

Neoplasms

TERMINATED PHASE1

Multicenter, Open-label, Clinical and Pharmacokinetic Study of PM060184 in Combination With Gemcitabine in Selected Patients With Advanced Solid Tumors

NCT02533674

Solid Tumors

COMPLETED PHASE1

SKIP - A Double-blind Placebo-controlled Randomized Multicenter Trial of Skin Toxicity Treatment

NCT01418742

Colorectal Carcinoma

TERMINATED PHASE2

Study of Pemetrexed+Platinum Chemotherapy With or Without Cosibelimab in First Line Metastatic Non-squamous NSCLC

NCT04786964

Metastatic Non-squamous Non Small Cell Lung Cancer

TERMINATED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Adult Solid Tumor

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SEQUENTIAL

Dose Escalation and Expansion

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Phase 1 Dose Escalation

Multiple dose levels of RP-6306 and gemcitabine

Group Type EXPERIMENTAL

RP-6306 (oral PKMYT1 inhibitor)

Intervention Type DRUG

RP-6306 in combination with gemcitabine

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

RP-6306 (oral PKMYT1 inhibitor)

RP-6306 in combination with gemcitabine

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Gemcitabine (IV)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No