What side effects are associated with this type of intervention?

Common treatments for solid tumors, including mTOR inhibitors like RMC-5552, often cause side effects such as stomatitis, rash, fatigue, infections, hyperglycemia, hyperlipidemia, and pneumonitis. Other chemotherapeutic agents like cisplatin, paclitaxel, and gemcitabine can lead to nausea, vomiting, neutropenia, neuropathy, and fatigue. The severity and frequency of these side effects can vary based on the specific drug and patient condition.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of solid tumors that target pathways similar to mTORC1 inhibitors. Notable examples include everolimus and temsirolimus, both of which are mTOR inhibitors used in various cancers such as renal cell carcinoma and breast cancer. Additionally, kinase inhibitors like cabozantinib and regorafenib, which target multiple pathways including those involved in tumor growth and angiogenesis, have also been approved for treating solid tumors. These drugs highlight the ongoing efforts to target specific molecular pathways in cancer treatment.

What other types of research exist?

Promising alternatives to RMC-5552 for solid tumors include MLN0128, another mTOR inhibitor, which has shown significant activity in preclinical models. Additionally, immune checkpoint inhibitors such as pembrolizumab and nivolumab, either alone or in combination with other agents, have demonstrated efficacy in various solid tumors. Cabozantinib, a tyrosine kinase inhibitor, is also a viable option, particularly for medullary thyroid cancer and renal cell carcinoma.

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RMC-5552 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

Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

Participants in the Dose-Expansion Component must have molecular aberrations in the mTOR pathway

Must not have

Subjects with stomatitis or mucositis of any grade

Active, clinically significant interstitial lung disease or pneumonitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug, RMC-5552, on adults whose solid tumors have come back or didn't respond to other treatments. The goal is to see if the drug can safely stop or slow down tumor growth, particularly in tumors with specific genetic changes.

Who is the study for?

Adults with advanced solid tumors that have not responded to standard treatments, or who can't tolerate them, are eligible. They must be over 18 years old, in fairly good health (ECOG status of 0-1), and have normal blood counts as well as liver and kidney function. Those with specific genetic changes in the mTOR pathway may also join.

What is being tested?

The trial is testing different doses of a new cancer drug called RMC-5552 on its own to see how safe it is and how the body responds to it. The goal is to find the best dose for future studies by gradually increasing the amount given to participants.

What are the potential side effects?

Possible side effects include reactions at the infusion site, changes in blood sugar levels, mouth sores or inflammation (stomatitis/mucositis), fatigue, digestive issues like nausea or diarrhea, and potential impacts on heart or lung health.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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My cancer has specific changes in the mTOR pathway.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have sores in my mouth or throat.

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I have a serious lung condition that is not under control.

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I do not have uncontrolled diabetes or abnormal fasting glucose levels.

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My cancer originated in the brain or spinal cord.

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I have a serious heart condition.

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I have or might have cancer spread to my brain, spinal cord, or its coverings.

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

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 more

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-5552Experimental Treatment1 Intervention

RMC-5552 for IV administration

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for solid tumors include targeted therapies, chemotherapy, and immunotherapy. Targeted therapies, such as mTORC1 inhibitors like RMC-5552, work by inhibiting specific molecules involved in tumor growth and survival pathways, such as the PI3K/AKT/mTOR pathway. This inhibition can lead to reduced tumor cell proliferation and increased apoptosis. Chemotherapy uses cytotoxic drugs to kill rapidly dividing cells, while immunotherapy boosts the body's immune system to recognize and destroy cancer cells. These treatments are crucial for solid tumor patients as they offer multiple mechanisms to control tumor growth, improve survival rates, and potentially enhance the effectiveness of other therapies.

Probing metabolic alterations in breast cancer in response to molecular inhibitors with Raman spectroscopy and validated with mass spectrometry.Deciphering the molecular mechanism of tetrandrine in inhibiting hepatocellular carcinoma and increasing sorafenib sensitivity by combining network pharmacology and experimental evaluation.Epithelial to mesenchymal transition in the liver field: the double face of Everolimus in vitro.