NCT06521554 A Study of NVL-330 in Patients With Advanced or Metastatic HER2-altered NSCLC (HEROEX-1)
| NCT ID | NCT06521554 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Nuvalent Inc. |
| Condition | Locally Advanced Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-07-18 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 200 participants in total. It began in 2024-07-18 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 18 years 2. Histologically or cytologically confirmed locally advanced or metastatic NSCLC 3. Documented HER2 status as follows: 1. Phase 1a: Documented oncogenic HER2 mutation such as HER2 exon20 insertion mutations or single nucleotide variants or HER2 amplification. 2. Phase 1b: Documented oncogenic HER2 mutation. 4. Identification of lesions as follows: 1. Phase 1a: Must have evaluable disease (target or nontarget) according to RECIST 1.1. 2. Phase 1b: Must have measurable disease, defined as ≥ 1 radiologically measurable target lesion according to RECIST 1.1. 5. Adequate organ function and bone marrow reserve Exclusion Criteria: 1. Participant's cancer has known oncogenic driver alteration other than HER2 2. Known allergy/hypersensitivity to excipients of NVL-330 3. Major surgery within 4 weeks of the first dose of study drug 4. Ongoing or recent anticancer therapy 5. Actively receiving systemic treatment or direct medical intervention on another therapeutic clinical study
Contact & Investigator
Steve Margossian, MD PhD
STUDY DIRECTOR
Nuvalent Inc.
Frequently Asked Questions
Who can join the NCT06521554 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Locally Advanced Solid Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06521554 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06521554 currently recruiting?
Yes, NCT06521554 is actively recruiting participants. Contact the research team at clinicaltrials@nuvalent.com for enrollment information.
Where is the NCT06521554 trial being conducted?
This trial is being conducted at Irvine, United States, Sacramento, United States, Stanford, United States, Denver, United States and 11 additional locations.
Who is sponsoring the NCT06521554 clinical trial?
NCT06521554 is sponsored by Nuvalent Inc.. The principal investigator is Steve Margossian, MD PhD at Nuvalent Inc.. The trial plans to enroll 200 participants.