NVL-520 for Solid Metastatic Tumor

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Chris O'Brien Lifehouse, Camperdown, AustraliaSolid Metastatic Tumor+1 MoreNVL-520 - Drug
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

This trial is a phase 1/2 study to test the safety and effectiveness of NVL-520 in patients with advanced solid tumors that have a specific gene mutation (ROS1-positive). The study will see how well patients tolerate the drug and if it has any effect on the tumor.

Eligible Conditions
  • Solid Metastatic Tumor
  • Locally Advanced Solid Tumors

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 17 Secondary · Reporting Duration: Within 28 days of last patient dosed during dose escalation.

Year 3
Clinical benefit rate (CBR)
Duration of response (DOR)
Objective response rate (ORR)
Progression-free survival (PFS)
Year 3
Objective Response Rate (ORR) (Phase 2)
Approximately 3 years
Overall survival (OS)
Time to response
Approximately 3 years.
Number of participants with treatment-emergent adverse events, as assessed by CTCAE, v5.0
Hour 24
Area under the curve at the end of the dosing interval (AUCtau) of NVL-520
Area under the curve from time 0 to 24 (AUC0-24) of NVL-520
Area under the curve from time 0 to infinity (AUCinf) of NVL-520
Average plasma concentration (Cavg) of NVL-520
Half-life (t1/2) of NVL-520
Maximum plasma concentration (Cmax) of NVL-520
Oral clearance (CL/F) of NVL-520
Plasma concentration at the end of the dosing interval (Ctau) of NVL-520
Time of maximum concentration (Tmax) of NVL-520
Volume of distribution (Vz/F) of NVL-520
Day 28
Recommended Phase 2 Dose (RP2D)
Day 28
Dose limiting toxicities (DLTs) (Phase 1)

Trial Safety

Safety Progress

1 of 3

Trial Design

6 Treatment Groups

Cohort 2c
1 of 6
Cohort 2b
1 of 6
Phase 1 dose escalation
1 of 6
Cohort 2e
1 of 6
Cohort 2a
1 of 6
Cohort 2d
1 of 6

Experimental Treatment

247 Total Participants · 6 Treatment Groups

Primary Treatment: NVL-520 · No Placebo Group · Phase 1 & 2

Cohort 2c
Drug
Experimental Group · 1 Intervention: NVL-520 · Intervention Types: Drug
Cohort 2b
Drug
Experimental Group · 1 Intervention: NVL-520 · Intervention Types: Drug
Phase 1 dose escalation
Drug
Experimental Group · 1 Intervention: NVL-520 · Intervention Types: Drug
Cohort 2e
Drug
Experimental Group · 1 Intervention: NVL-520 · Intervention Types: Drug
Cohort 2a
Drug
Experimental Group · 1 Intervention: NVL-520 · Intervention Types: Drug
Cohort 2d
Drug
Experimental Group · 1 Intervention: NVL-520 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: within 28 days of last patient dosed during dose escalation.

Who is running the clinical trial?

Nuvalent Inc.Lead Sponsor
1 Previous Clinical Trials
214 Total Patients Enrolled
1 Trials studying Solid Metastatic Tumor
214 Patients Enrolled for Solid Metastatic Tumor
Viola Zhu, MDStudy DirectorNuvalent Inc.
Viola Zhu, MD, PhDStudy DirectorNuvalent Inc.

Eligibility Criteria

Age Any Age · All Participants · 5 Total Inclusion Criteria

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Frequently Asked Questions

What are the key aims of this research trial?

"Nuvalent Inc., the clinical trial sponsor, has reported that their main objective for this study is to identify the Recommended Phase 2 Dose (RP2D) over a two-to-three year period. Secondary metrics include Clinical Benefit Rate (CBR), Number of participants affected by Treatment Emergent Adverse Events as per Common Terminology Criteria for Adverse Events Version 5.0, and average plasma concentration of NVL-520." - Anonymous Online Contributor

Unverified Answer

How many participants are actively engaging in this clinical investigation?

"To ensure the success of this trial, 247 participants meeting specified criteria must be recruited. Nuvalent Inc., the research sponsor, will administer the experiment from multiple locations such as NYU Langone Health in New York City and Georgetown University Medical Center in Washington D.C." - Anonymous Online Contributor

Unverified Answer

Are there any vacancies available to join the experiment?

"Affirmative, the information published on clinicaltrials.gov verifies that this medical trial is open for recruitment. First posted on April 1st 2022 and most recently updated October 6th 2022, 247 participants are being sought from twelve different healthcare facilities." - Anonymous Online Contributor

Unverified Answer

How many facilities are providing access to this research?

"NYU Langone Health in New York, Georgetown University Medical Center in Washington D.C., UCI Medical Centre in Orange California are just a few of the 12 other locations hosting this clinical trial." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.