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A Phase 1/2 Study of the Selective Anaplastic Lymphoma Kinase (ALK) Inhibitor NVL-655 in Patients with Advanced NSCLC and Other Solid Tumors (ALKOVE-1)
EU CTIS ID: 2024-514266-39-00
What this study is testing
Phase 1 - To evaluate the overall safety and tolerability of NVL-655 Phase 1 - To determine the RP2D and, if applicable, the MTD of NVL-655 in patients with advanced ALK-positive solid tumors Phase 2 - To evaluate the efficacy of NVL-655 at the RP2D in patients with advanced ALK-positive NSCLC, including those with ALK resistance mutations, and other solid tumors
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥ 18 years
- Phase 2 Cohort 2f only: Age ≥ 12 years and weight > 40 kg.
- Disease criteria: Phase 1: Histologically or cytologically confirmed locally advanced or metastatic solid tumor with a documented ALK rearrangement or activating ALK mutation.
- Disease criteria: Cohorts 2a, 2b, 2c, 2d, and 2e: Histologically or cytologically confirmed locally advanced or metastatic ALK rearrangement or activating ALK mutation
- Disease criteria: Cohort 2f: Histologically or cytologically confirmed locally advanced or metastatic solid tumor (including NSCLC not eligible for Cohorts 2a-2e) with a documented ALK rearrangement or activating ALK mutation.
- Prior anticancer treatment: Phase 1: Must have evaluable disease (target or nontarget) according to RECIST 1.1
You likely can't join if
- Patient’s cancer has a known oncogenic driver alteration other than ALK
- Known allergy/hypersensitivity to excipients of NVL-655
- Major surgery within 4 weeks of first dose of study drug
- Ongoing or recent anticancer therapy
- Ongoing or recent radiation therapy
- Please refer to the protocol for further criteria
See the full eligibility criteria
- Age ≥ 18 years
- Phase 2 Cohort 2f only: Age ≥ 12 years and weight > 40 kg.
- Disease criteria: Phase 1: Histologically or cytologically confirmed locally advanced or metastatic solid tumor with a documented ALK rearrangement or activating ALK mutation.
- Disease criteria: Cohorts 2a, 2b, 2c, 2d, and 2e: Histologically or cytologically confirmed locally advanced or metastatic ALK rearrangement or activating ALK mutation
- Disease criteria: Cohort 2f: Histologically or cytologically confirmed locally advanced or metastatic solid tumor (including NSCLC not eligible for Cohorts 2a-2e) with a documented ALK rearrangement or activating ALK mutation.
- Prior anticancer treatment: Phase 1: Must have evaluable disease (target or nontarget) according to RECIST 1.1
- Prior anticancer treatment: Phase 2: Must have measurable disease, defined as ≥1 radiologically measurable target lesion according to RECIST 1.1
- Pre-treatment tumor tissue
- Please refer to the protocol for further criteria
- Patient’s cancer has a known oncogenic driver alteration other than ALK
- Known allergy/hypersensitivity to excipients of NVL-655
- Major surgery within 4 weeks of first dose of study drug
- Ongoing or recent anticancer therapy
- Ongoing or recent radiation therapy
- Please refer to the protocol for further criteria
The study team makes the final eligibility decision.
Where it's taking place
- Singapore
- United Kingdom
- Canada
- Taiwan
- Japan
- Australia
- Switzerland
- United States
- Korea, Republic of
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 0-17 years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Singapore; United Kingdom; Canada; Taiwan; Japan; Australia and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.