What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include chemotherapeutic agents like docetaxel, platinum-based drugs (cisplatin, carboplatin), and targeted therapies. Docetaxel can cause side effects such as fatigue, nausea, hair loss, and increased risk of infection due to low white blood cell counts. Platinum-based drugs often lead to nausea, vomiting, nephrotoxicity, ototoxicity, and neuropathy. Targeted therapies, such as those inhibiting BRAF, MEK, or HER2, can cause skin rashes, diarrhea, liver function abnormalities, and, in some cases, severe adverse events like intracranial hemorrhage or cardiac issues. The combination of these treatments can increase the likelihood and severity of these side effects.

What prior FDA approvals exist?

For Non-Small Cell Lung Cancer (NSCLC), the FDA has approved several targeted therapies based on specific genetic mutations. For instance, selpercatinib and pralsetinib are approved for RET fusion-positive NSCLC, and fam-trastuzumab deruxtecan is approved for HER2-mutant NSCLC. These treatments focus on specific molecular targets similar to the approach of the SMARCA2 degrader in the PRT3789 trial, which targets tumors with SMARCA4 mutations.

What other types of research exist?

Promising alternatives to PRT3789 for NSCLC patients include Furmonertinib, which has shown efficacy in EGFR mutation-positive NSCLC, and Dacomitinib, which has demonstrated clinical efficacy for patients with rare EGFR mutations. Additionally, ongoing research into the use of PARP inhibitors like Olaparib and Niraparib for patients with specific genetic alterations may provide new treatment options.

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SMARCA2 degrader

PRT3789 for Solid Tumors

Phase 1

Recruiting

Research Sponsored by Prelude Therapeutics

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 baseline through approximately 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called PRT3789, which breaks down a protein in cancer cells, alone and with another drug, docetaxel. Docetaxel is a potent antitumor agent used in treating various cancers. It targets patients with advanced cancers that have lost a specific gene. The drug works by destroying a protein that helps cancer cells grow, potentially stopping the cancer from spreading.

Who is the study for?

This trial is for adults with advanced or metastatic solid tumors that have a specific genetic change called SMARCA4 mutation. They should be in fairly good health (ECOG 0 or 1), have tried other treatments without success, and can provide a tumor sample. People with certain other cancers, heart issues, uncontrolled electrolyte disorders, or brain metastases cannot join.

What is being tested?

PRT3789 is being tested to see how safe it is and what dose works best for treating these tumors. It's an early-phase study where researchers will slowly increase the dose to find the highest amount patients can take without serious side effects.

What are the potential side effects?

Since PRT3789 is new and this trial aims to discover its safety profile, potential side effects are not fully known yet. However, participants may experience typical drug-related reactions like fatigue, nausea, allergic responses or more serious conditions depending on their individual reaction.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through approximately 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline through approximately 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through approximately 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

Dose limiting toxicity (DLT) of PRT3789 monotherapy and in combination with docetaxel

Maximum tolerated dose (MTD)/ Recommended phase 2 dose (RP2D) of PRT3789 monotherapy and in combination with docetaxel

Safety and tolerability of PRT3789 monotherapy and in combination with docetaxel: AEs, CTCAE Assessments

Secondary study objectives

Efficacy of PRT3789 monotherapy and in combination with docetaxel: Clinical benefit rate (CBR)

Efficacy of PRT3789 monotherapy and in combination with docetaxel: Duration of response (DOR)

Efficacy of PRT3789 monotherapy and in combination with docetaxel: Objective response rate (ORR)

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: PRT3789/Docetaxel CombinationExperimental Treatment2 Interventions

PRT3789 and Docetaxel will be administered by intravenous infusions

Group II: PRT3789 MonotherapyExperimental Treatment1 Intervention

PRT3789 will be administered by intravenous infusion

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Docetaxel

1995

Completed Phase 4

~6550

Do I qualify?Apply below to find out

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

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include chemotherapy, immune checkpoint inhibitors, and targeted therapies. Chemotherapy, such as docetaxel, works by killing rapidly dividing cancer cells. Immune checkpoint inhibitors, like nivolumab and pembrolizumab, enhance the immune system's ability to recognize and destroy cancer cells by blocking proteins that inhibit immune responses. Targeted therapies, including SMARCA2 degraders like PRT3789, focus on specific genetic mutations or proteins involved in cancer cell growth and survival. These treatments are crucial for NSCLC patients as they offer personalized and potentially more effective options, especially for those with specific genetic profiles or who have failed first-line treatments.

The efficacy of combining antiangiogenic agents with chemotherapy for patients with advanced non-small cell lung cancer who failed first-line chemotherapy: a systematic review and meta-analysis.