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Small Molecule Inhibitor
Dose Escalation of RMC-4630 Monotherapy in Relapsed/Refractory 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
No Placebo-Only Group
Summary
This trial is testing a drug called RMC-4630 on adults whose solid tumors have come back or didn't respond to previous treatments. The drug aims to slow or stop tumor growth by targeting a specific overactive pathway in cancer cells.
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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of participants with adverse events (AEs)
Number of participants with dose limiting toxicities (DLTs)
Secondary study objectives
Accumulation Ratio
Area Under the Curve (AUC)
Cmax
+4 moreSide effects data
From 2022 Phase 1 & 2 trial • 113 Patients • NCT03989115100%
diarrhoea
75%
decreased appetite
50%
dehydration
50%
dizziness
25%
thrombocytopenia
25%
oedema peripheral
25%
fatigue
25%
cough
25%
pleural effusion
25%
constipation
25%
vomiting
25%
dry mouth
25%
lymphocyte count decreased
25%
hypoalbuminaemia
25%
anaemia
25%
fall
25%
weight decreased
25%
hypophosphataemia
25%
dermatitis acneiform
25%
gait disturbance
25%
dyspnoea
25%
platelet count decreased
25%
hyponatraemia
100%
80%
60%
40%
20%
0%
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)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Find a Location
Who is running the clinical trial?
Revolution Medicines, Inc.Lead Sponsor
12 Previous Clinical Trials
3,221 Total Patients Enrolled
SanofiIndustry Sponsor
2,216 Previous Clinical Trials
4,047,499 Total Patients Enrolled