NVL-655 for Metastatic or Locally Advanced Solid Tumors

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Mass General Hospital, Boston, MA
Metastatic or Locally Advanced Solid Tumors+3 More
NVL-655 - Drug
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

Phase 1/2, dose escalation and expansion study designed to evaluate the safety and tolerability of NVL-655, determine the recommended phase 2 dose (RP2D), and evaluate the antitumor activity in patients with advanced ALK- positive (ALK+) NSCLC and other solid tumors. Phase 1 will determine the RP2D and, if applicable, the MTD of NVL-655 in patients with advanced ALK+ solid tumors. Phase 2 will determine the objective response rate (ORR) as assessed by Blinded Independent Central Review (BICR) of NVL-655 at the RP2D. Secondary objectives will include the duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS), and clinical benefit rate (CBR) of NVL-655 in patients with advanced ALK-positive NSCLC and other solid tumors.

Eligible Conditions

  • Metastatic or Locally Advanced Solid Tumors
  • Locally Advanced Solid Tumors
  • Solid Metastatic Tumor

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Metastatic or Locally Advanced Solid Tumors

Study Objectives

3 Primary · 17 Secondary · Reporting Duration: 2-3 years after first patient dosed

Year 3
Clinical benefit rate (CBR)
Duration of response (DOR)
Objective response rate (ORR) (Phase 1)
Progression-free survival (PFS)
Year 3
Objective Response Rate (ORR) (Phase 2)
Approximately 3 years
Number of participants with treatment-emergent adverse events, as assessed by CTCAE, V5.0
Overall survival (OS)
Time to response
Hour 24
Area under the curve at the end of the dosing interval (AUCtau) of NVL-655
Area under the curve from time 0 to 24 (AUC0-24) of NVL-655
Area under the curve from time 0 to infinity (AUCinf) of NVL-655
Average plasma concentration (Cavg) of NVL-655
Half-life (t1/2) of NVL-655
Maximum plasma concentration, (Cmax) of NVL-655
Oral clearance (CL/F) of NVL-655
Plasma concentration at the end of the dosing interval (Ctau) of NVL-655
Time of maximum concentration (Tmax) of NVL-655
Volume of distribution (Vz/F) of NVL-655
Day 21
Recommended Phase 2 Dose (RP2D)
Day 21
Dose limiting toxicities (DLTs) (Phase 1)

Trial Safety

Safety Progress

1 of 3

Other trials for Metastatic or Locally Advanced Solid Tumors

Trial Design

5 Treatment Groups

Phase 1 dose escalation
1 of 5
Cohort 2a
1 of 5
Cohort 2c
1 of 5
Cohort 2b
1 of 5
Cohort 2d
1 of 5
Experimental Treatment

214 Total Participants · 5 Treatment Groups

Primary Treatment: NVL-655 · No Placebo Group · Phase 1 & 2

Phase 1 dose escalation
Drug
Experimental Group · 1 Intervention: NVL-655 · Intervention Types: Drug
Cohort 2a
Drug
Experimental Group · 1 Intervention: NVL-655 · Intervention Types: Drug
Cohort 2c
Drug
Experimental Group · 1 Intervention: NVL-655 · Intervention Types: Drug
Cohort 2b
Drug
Experimental Group · 1 Intervention: NVL-655 · Intervention Types: Drug
Cohort 2d
Drug
Experimental Group · 1 Intervention: NVL-655 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2-3 years after first patient dosed
Closest Location: Mass General Hospital · Boston, MA
Photo of Boston 1Photo of Boston 2Photo of Boston 3
2007First Recorded Clinical Trial
1 TrialsResearching Metastatic or Locally Advanced Solid Tumors
30 CompletedClinical Trials

Who is running the clinical trial?

Nuvalent Inc.Lead Sponsor
1 Previous Clinical Trials
247 Total Patients Enrolled
Viola Zhu, MD, PHDStudy DirectorNuvalent Inc.

Eligibility Criteria

Age Any Age · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a solid tumor with a documented ALK rearrangement or activating ALK mutation.
You have histologically or cytologically confirmed locally advanced or metastatic NSCLC with a documented ALK rearrangement.
You have a solid tumor with a documented ALK rearrangement or activating ALK mutation.
You have evaluable disease (target or nontarget) according to RECIST 1.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.