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Small Molecule Inhibitor

RMC-4630 for Solid Tumors

Phase 1

Waitlist Available

Research Sponsored by Revolution Medicines, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

Study Summary

This trial is testing a new drug, RMC-4630, to see if it is safe and effective in treating adults with relapsed or refractory solid tumors.

Eligible Conditions

Solid Tumors

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants with adverse events (AEs)

Number of participants with dose limiting toxicities (DLTs)

Secondary outcome measures

Accumulation Ratio

Area Under the Curve (AUC)

Cmax

+4 more

Side effects data

From 2022 Phase 1 & 2 trial • 113 Patients • NCT03989115

100%

diarrhoea

75%

decreased appetite

50%

dehydration

50%

dizziness

25%

constipation

25%

vomiting

25%

weight decreased

25%

thrombocytopenia

25%

fall

25%

hypoalbuminaemia

25%

dry mouth

25%

dermatitis acneiform

25%

oedema peripheral

25%

anaemia

25%

pleural effusion

25%

fatigue

25%

cough

25%

lymphocyte count decreased

25%

hypophosphataemia

25%

gait disturbance

25%

dyspnoea

25%

platelet count decreased

25%

hyponatraemia

100%

80%

60%

40%

20%

Study treatment Arm

Intermittent RMC-4630 140mg (D1D2) + Osimertinib 80mg (QD)

Intermittent RMC-4630 80mg (D1D4) + Cobimetinib 40mg QD (21/7)

Intermittent RMC-4630 140mg (D1D4) + Cobimetinib 20mg QD (21/7)

Intermittent RMC-4630 80mg (D1D4) + Cobimetinib 20mg QD (21/7)

Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 20mg QD (21/7)

Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 40mg (D1D2)

Intermittent RMC-4630 140mg (D1D2) + Cobimetinib 60mg D1D2

Intermittent RMC-4630 100mg (D1D2) + Osimertinib 80mg (QD)

Trial Design

1Treatment groups

Experimental Treatment

Group I: RMC-4630Experimental Treatment1 Intervention

RMC-4630 for oral administration

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

RMC-4630

2019

Completed Phase 2

~120

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Revolution Medicines, Inc.Lead Sponsor

10 Previous Clinical Trials

1,929 Total Patients Enrolled

SanofiIndustry Sponsor

2,161 Previous Clinical Trials

3,511,906 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this exploration currently taking on new participants?

"The data hosted on clinicaltrials.gov states that recruitment for this trial is not ongoing, with the study first posted on September 28th 2018 and last updated August 31st 2022. Nevertheless, there are over 2 thousand five hundred other trials actively seeking patients at present."

Answered by AI

What risks are associated with the usage of RMC-4630?

"Limited data exists that supports the safety and efficacy of RMC-4630, so a rating of 1 was assigned to it."

Answered by AI

How pervasive is the conduct of this scientific investigation in city?

"Currently, 12 separate clinical sites are actively recruiting individuals to participate. Prominent locations include Austin, Sarasota and Sacramento as well as nine additional sites. It is preferable to choose a location nearby in order to avoid extensive travelling for those that enroll."

Answered by AI

What is the aim of this medical study?

"Sanofi, the clinical trial sponsor, has reported the primary outcome of this 28 day study is Number of participants with adverse events (AEs). Secondary endpoints include Duration of Response (DOR), Accumulation Ratio and Overall Response Rate (ORR) which are all assessed using RECIST v1.1 standards."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Dose Escalation of RMC-4630 Monotherapy in Relapsed/Refractory Solid Tumors

2018. "Dose Escalation of RMC-4630 Monotherapy in Relapsed/Refractory Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03634982.