A Phase 1 interventional study of NVL-330 in Locally Advanced Solid Tumor and Metastatic Solid Tumor, sponsored by Nuvalent Inc.. Recruiting at 21 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Nuvalent Inc. · Phase 1, Interventional, and Treatment
Phase 1a/1b dose escalation and expansion study designed to evaluate the safety and tolerability of NVL-330, determine the recommended Phase 2 dose (RP2D), and evaluate the antitumor activity in participants with advanced or metastatic human epidermal growth factor receptor 2 (HER2) -altered non-small lung cancer (NSCLC).
Phase 1a dose escalation is designed to assess the safety and tolerability of NVL-330 and to select the candidate RP2D(s) and, if applicable, the MTD.
Phase 1b expansion is designed to further evaluate the overall safety and tolerability of the candidate RP2D(s) of NVL-330 and to determine the RP2D of NVL-330 in participants with advanced or metastatic HER2 mutant NSCLC.
The planned Phase 1a/1b first-in-human study is designed as a two-part clinical trial to investigate NVL-330 in pre-treated participants with advanced or metastatic HER2-altered NSCLC. The dose escalation phase of the trial is designed to enroll a set number of participants per cohort at protocol defined dose levels.
After the initial participants are treated at a given dose level and monitored for at least 28 days, available data will be reviewed, and initiation of the next dosing group will proceed with consideration given to the overall safety profile.
The expansion phase of the trial is designed to further evaluate safety and activity and to confirm the RP2D(s).
4,040 studies on the registry are indexed under Neoplasm Metastasis; 886 are open to participants now.
This study's planned enrollment of 200 is above the median of 50 across 3,268 interventional studies indexed under Neoplasm Metastasis.
Browse Neoplasm Metastasis studies →Nuvalent Inc. is the lead sponsor of 6 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Documented status as follows:
Identification of lesions as follows:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NVL-330 oral daily dosing
Drug: NVL-330
NVL-330 oral daily dosing
Drug: NVL-330
Oral Tablet of NVL-330
Recommended Phase 2 Dose (RP2D)
To determine up to 2 RP2D Candidates
Time frame: As determined by incidence of DLTs during the first 28 days of treatment (ie, Cycle 1)
Maximum Tolerated Dose (MTD)
If applicable, to determine the MTD
Time frame: As determined by incidence of DLTs during the first 28 days of treatment (ie, Cycle 1)
Incidence and severity of Treatment Emergent Adverse Events (TEAEs)
Number of participants with TEAEs as assessed by CTCAE, v5.0
Time frame: First dose of study drug through 30 days after the last dose of study drug
Effect of Food on Maximum Plasma Concentration (Cmax) of NVL-330
To determine the effect of food on maximum plasma concentration (Cmax) of NVL-330
Time frame: Pre-dose and up to 24 hours post-dose
Effect of Food on Area Under the Curve from Time 0 to 24 (AUC0-24) of NVL-330
To determine the effect of food on area under the curve from time 0 to 24 of NVL-330
Time frame: Pre-dose and up to 24 hours post-dose
Effect of Food on Area Under the Curve from Time 0 to Infinity (AUCinf) of NVL-330
To determine the effect of food on area under the curve from time 0 to infinity of NVL-330
Time frame: Pre-dose and up to 24 hours post-dose
Effect of Food on Time of Maximum Concentration (Tmax) of NVL-330
To determine the effect of food on time of maximum concentration of NVL-330
Time frame: Pre-dose and up to 24 hours post-dose
Maximum plasma concentration (Cmax) of NVL-330
To determine the maximum plasma concentration (Cmax) of NVL-330
Time frame: Pre-dose and up to 24 hours post-dose
Maximum plasma concentration (Cmax- dose normalized) of NVL-330
To determine the maximum plasma concentration (Cmax-dose normalized) of NVL-330
Time frame: Pre-dose and up to 24 hours post-dose
Plasma concentration at the end of the dosing interval (Ctau) of NVL-330
To determine the plasma concentration at the end of the dosing interval (Ctau) of NVL-330
Time frame: Pre-dose and up to 24 hours post-dose
Plasma concentration 24 hours post-dose (C24) of NVL-330
To determine the plasma concentration 24 hours post-dose (C24) of NVL-330
Time frame: Pre-dose and up to 24 hours post-dose
Average plasma concentration (Cavg) of NVL-330
To determine the average plasma concentration (Cavg) of NVL-330
Time frame: Pre-dose and up to 24 hours post-dose
Time of maximum concentration (Tmax) of NVL-330
To determine the time of maximum concentration (Tmax) of NVL-330
Time frame: Pre-dose and up to 24 hours post-dose
Area Under the Curve at the End of the Dosing Interval (AUCtau) of NVL-330
To determine the area under the curve at the end of the dosing interval (AUCtau) of NVL-330
Time frame: Pre-dose and up to 24 hours post-dose
Area Under the Curve at the End of the Dosing Interval (AUCtau - dose normalized) of NVL-330
To determine the area under the curve at the end of the dosing interval (AUCtau - dose normalized) of NVL-330
Time frame: Pre-dose and up to 24 hours post-dose
Area Under the Curve From Time 0 to 24 (AUC0-24) of NVL-330
To determine the area under the curve from time 0 to 24 (AUC0-24) of NVL-330
Time frame: Pre-dose and up to 24 hours post-dose
Area Under the Curve From Time 0 to 24 (AUC0-24 - dose normalized) of NVL-330
To determine the area under the curve from time 0 to 24 (AUC0-24 - dose normalized) of NVL-330
Time frame: Pre-dose and up to 24 hours post-dose
Area Under the Curve From Time 0 to Infinity (AUCinf) of NVL-330
To determine the area under the curve from time 0 to infinity (AUCinf) of NVL-330
Time frame: Pre-dose and up to 24 hours post-dose
Area Under the Curve From Time 0 to Infinity (AUCinf - dose normalized) of NVL-330
To determine the area under the curve from time 0 to infinity (AUCinf - dose normalized) of NVL-330
Time frame: Pre-dose and up to 24 hours post-dose
Oral clearance (CL/F) of NVL-330
To determine the oral clearance (CL/F) of NVL-330
Time frame: Pre-dose and up to 24 hours post-dose
Volume of Distribution (Vz/F) of NVL-330
To determine the volume of distribution (Vz/F) of NVL-330
Time frame: Pre-dose and up to 24 hours post-dose
Accumulation Ratio of NVL-330
To determine the ratio of accumulation of NVL-330
Time frame: Pre-dose and up to 24 hours post-dose
Half-life (t1/2) of NVL-330
To determine the half-life (t1/2) of NVL-330
Time frame: Pre-dose and up to 24 hours post-dose
Objective Response Rate (ORR)
Objective Response Rate (ORR) as determined by RECIST 1.1 criteria
Time frame: 2 -3 years after first participant dosed
Duration of Response (DOR)
Time from first investigator-assessed response to radiographic disease progression or death
Time frame: 2 to 3 years after first participant dosed
Intracranial Objective Response Rate (IC-ORR)
The proportion of participants with a confirmed intracranial response (IC-CR or IC-PR)
Time frame: 2 to 3 years after first participant dosed
Intracranial Duration of Response (IC-DOR)
The time from first investigator-assessed intracranial response to radiographic intracranial disease progression or death
Time frame: 2 to 3 years after first participant dosed
Time to Response (TTR)
The time from first dose to first confirmed radiographic response
Time frame: Approximately 3 years
Not enrolling at this site — choose another above.
Started Jul 2024 (actual). Primary completion is estimated for Jan 2027, 30 months after the start.
Of 286 industry-sponsored phase 1 interventional studies under Neoplasm Metastasis, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 75. This study's planned 30 months is below that.
Counting every sponsor, half of 496 studies reached it within 54 months; a quarter within 33 and three quarters within 83.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Nuvalent Inc.