A Phase I/IIa Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of AZD0022 as Monotherapy and in Combination With Anti-cancer Agents in Adult Participants With Tumours Harbouring a KRASG12D Mutation (ALAFOSS-01)

A Phase I/IIa, Open-label, Multi-centre Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of AZD0022 Monotherapy and in Combination With Anti-cancer Agents in Participants With Tumours Harbouring a KRASG12D Mutation (ALAFOSS-01)

This is a first-in-human, modular, Phase I/IIa, open-label, multi-centre study to assess the safety, tolerability, PK, and preliminary efficacy of AZD0022 monotherapy in combination with other anti-cancer agents in participants with tumours harbouring a KRASG12D mutation.

Study Overview

• Status: Terminated
• Conditions: Non-Small Cell Lung Cancer (NSCLC); Advanced Solid Tumours; Pancreatic Ductal Adenocarcinoma (PDAC); Colorectal Cancer (CRC)
• Intervention / Treatment: Drug: AZD0022; Drug: Cetuximab

Detailed Description

This first time in human, open-label, multi-centre study will administer AZD0022 orally to participants with tumours harbouring a KRASG12D mutation.

This study will have initially 2 modules.

• Module 1: AZD0022 monotherapy
• Module 2: AZD0022 in combination with other anti-cancer agents (Cetuximab)

Each Module has 3 parts. Dose Escalation (Part A), Dose Optimisation (Part B) and Potential Efficacy Expansion (Part C).

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Melbourne, Australia, 3000
    • Research Site
• Japan
  • Chūōku, Japan, 104-0045
    • Research Site
• South Korea
  • Seoul, South Korea, 03080
    • Research Site
• United States
  • California
    • Duarte, California, United States, 91010
      • Research Site
  • New York
    • New York, New York, United States, 10016
      • Research Site
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

For whole study:

1. Participant must be ≥ 18 years or the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the ICF.
2. Participants must have a histologically or cytologically confirmed metastatic or locally advanced tumour. Further details on tumour types are specified in Module-specific inclusion criteria.
3. Participants must have received and progressed on, are refractory or are intolerant to standard therapy for the specific tumour type, or as per Module-specific criteria. Participants with contraindications to, or who refuse SoC therapy may be considered, provided that it is documented and the participant has been informed about all available therapeutic options.
4. Documented KRASG12D mutation in tissue or liquid biopsy.
5. Provision of a FFPE tumour sample.
6. Participants must have at least one measurable target lesion per RECIST v1.1.
7. Adequate organ and marrow function as defined in study protocol.

Module 1 Key Inclusion Criteria

1. Type of tumours with a KRASG12D mutation:

   1. For NSCLC: Patients must have NSCLC that is not amenable to curative treatment and should have progressed on at least one prior line of SoC treatment for metastatic NSCLC (including but not limited to platinum-based chemotherapy, immunotherapy, targeted therapy or first line SoC combinations); prior experimental treatments are allowed.
   2. For CRC: Patients must have CRC that is not amenable to curative treatment and should have progressed on at least 2 prior lines of SoC treatment for metastatic CRC; prior experimental treatments are allowed.
   3. For PDAC: Patients must have PDAC that is not amenable to curative treatment and should have progressed at least one prior line of SoC treatment for metastatic PDAC (including but not limited to FOLFIRINOX, gemcitabine plus abraxane and gemcitabine monotherapy); prior experimental treatments are allowed.
   4. For patients enrolled in Part C (NSCLC and PDAC): at least one but no more than 2 lines of prior treatment in metastatic settings; prior experimental treatments are allowed.
2. Progression or recurrence of the disease within 6 months of completing neo/adjuvant treatment (ie, chemotherapy, immunotherapy, chemoradiotherapy, etc) will be considered as a first line of treatment.
3. For Part B food-effect cohort, participants must be able to eat a standard high-fat meal and must be able to fast for at least 10 hours.

Module 2 Inclusion Criteria

1. For Part A (M2A, dose escalation) participants must have pathologically documented locally advanced or metastatic CRC with a KRASG12D mutation.
2. For Part B (M2B, dose optimisation) participants must have pathologically documented locally advanced or metastatic, PDAC or CRC with a KRASG12D mutation.
3. For Part C (M2C, potential efficacy expansion) participants must have pathologically documented locally advanced or metastatic CRC with a KRASG12D mutation.

4(a) For CRC: Patients must have CRC that is not amenable to curative treatment and should have progressed on at least 2 prior lines of SoC treatment for metastatic CRC; prior treatment are allowed.

(b) For PDAC: Patients must have PDAC that is not amenable to curative treatment and should have progressed at least one prior line of SoC treatment for metastatic PDAC (including but not limited to FOLFIRINOX, gemcitabine plus abraxane and gemcitabine monotherapy); prior experimental treatment are allowed.

(c) For patients enrolled in Part C (M2C), at least 2 but no more than 3 lines of prior treatment in metastatic setting; prior experimental treatment are allowed.

5. Progression or recurrence of the disease within 6 months of completing neo/adjuvant treatment (ie, chemotherapy, immunotherapy, and chemoradiotherapy) will be considered as a first line of treatment.

Exclusion Criteria:

For whole study:

1. Any significant laboratory finding or any severe and uncontrolled medical condition.
2. Any evidence of clinically significant current or prior ILD (eg, required IV steroids or high supplemental oxygen) or where a new suspected ILD cannot be ruled out by imaging at screening.
3. Spinal cord compression, leptomeningeal disease, or active brain metastases. Asymptomatic brain metastases are allowed
4. History of allogenic organ transplantation.

5. Participants with any of the following cardiac criteria:

   • Mean resting QTcF > 470 milliseconds on screening
   • Any factors that increase the risk of QT prolongation
   • Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (eg, complete left bundle branch block, second- or third-degree atrioventricular block), and clinically significant sinus node dysfunction not treated with pacemaker.
   • Bradycardia defined as a heart rate less than 60 beats per minute and/or hypotension defined as a blood pressure reading lower than 90 mm Hg for the top number (systolic) or 60 mm Hg for the bottom number (diastolic).
   • Baseline LVEF below the institutional lower limit of normal or < 50%, whichever is lower.
   • Symptomatic heart failure (as defined by New York Heart Association class ≥ 2).
   • Acute coronary syndrome/acute myocardial infarction, unstable angina pectoris, coronary intervention procedure with percutaneous coronary intervention, or coronary artery bypass grafting within 6 months before C1D1.
6. Prior exposure to any direct small molecule KRAS inhibitor.
7. Herbal preparations/medications are not allowed during treatment with study drug.
8. Any concomitant medications that are known strong inhibitors or inducers of CYP3A4/5, or sensitive CYP3A4/5 substrates or CYP3A4/5 substrates with a narrow therapeutic range. This also applies to moderate inhibitors and moderate inducers of CYP3A4/5 during Parts A and B of Modules 1 and 2.
9. Receipt of a cytotoxic or non-cytotoxic drug: 21 days or 5 half-lives, whichever is shorter, before the first dose of study intervention. Biological therapy including immune-oncology and monoclonal antibodies 28 days or 5 half-lives.
10. Less than or equal to 4 weeks for radiation therapy given with curative intent or ≤ 2 weeks for limited field radiation for palliation prior to the first dose of study treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Module 1 Part A. Dose Escalation; AZD0022 monotherapy	Drug: AZD0022; AZD0022 is an oral KRASG12D inhibitor that blocks KRASG12D function in patients with this type of mutation.
Experimental: Module 1 Part B. Dose Optimisation; AZD0022 monotherapy	Drug: AZD0022; AZD0022 is an oral KRASG12D inhibitor that blocks KRASG12D function in patients with this type of mutation.
Experimental: Module 1 Part C. Potential Efficacy Expansion; AZD0022 monotherapy	Drug: AZD0022; AZD0022 is an oral KRASG12D inhibitor that blocks KRASG12D function in patients with this type of mutation.
Experimental: Module 1 Part B. Food Effect Cohort; AZD0022 monotherapy	Drug: AZD0022; AZD0022 is an oral KRASG12D inhibitor that blocks KRASG12D function in patients with this type of mutation.
Experimental: Module 2 Part A. Dose Escalation; AZD0022 in combination with Cetuximab	Drug: AZD0022; AZD0022 is an oral KRASG12D inhibitor that blocks KRASG12D function in patients with this type of mutation.; Drug: Cetuximab; Cetuximab (Erbitux®) is a recombinant chimeric human/mouse Immunoglobulin G monoclonal antibody which binds to EGFR and competitively inhibits the binding of EGFR and other ligands
Experimental: Module 2 Part B. Dose Optimisation; AZD0022 in combination with Cetuximab	Drug: AZD0022; AZD0022 is an oral KRASG12D inhibitor that blocks KRASG12D function in patients with this type of mutation.; Drug: Cetuximab; Cetuximab (Erbitux®) is a recombinant chimeric human/mouse Immunoglobulin G monoclonal antibody which binds to EGFR and competitively inhibits the binding of EGFR and other ligands
Experimental: Module 2 Part C. Potential Efficacy Expansion; AZD0022 in combination with Cetuximab	Drug: AZD0022; AZD0022 is an oral KRASG12D inhibitor that blocks KRASG12D function in patients with this type of mutation.; Drug: Cetuximab; Cetuximab (Erbitux®) is a recombinant chimeric human/mouse Immunoglobulin G monoclonal antibody which binds to EGFR and competitively inhibits the binding of EGFR and other ligands

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of participants with Dose-Limiting Toxicity (DLT), Adverse events (AEs) and Serious Adverse Events (SAEs).	Determine if treatment with AZD0022 as a monotherapy and in combination with other anti-cancer agents is safe and tolerable through the assessment of DLTs, AEs, SAEs, and change from baseline in laboratory parameters, vital signs, and ECGs. Part A (Dose Escalation) and Part B (Dose Optimisation). DLTs only applicable for Part A.	From time of informed consent, through study completion to 30 days post last dose; an average of 2 years
Number of patients who discontinue AZD0022 due to toxicity	To investigate the safety and tolerability of AZD0022 as a monotherapy and in combination with other anti-cancer agents in participants with advanced tumours harbouring a KRASG12D mutation Part A (Dose Escalation) and Part B (Dose Optimisation)	From time of informed consent to 30 days post last dose
ORR (Objective Response Rate)	Evaluated according to RECIST v1.1 (Response Evaluation Criteria in Solid Tumours Version 1.1) Part C (Potential Efficacy Expansion) Percentage of participants with a confirmed Complete Response (CR) or Partial Response (PR)	Time from first dose of AZD002 through study completion; approximate duration of 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CR rate (Complete Response)	To assess the preliminary anti-tumour activity of AZD0022 as a monotherapy and in combination with other anti-cancer agents Radiological response evaluated according to RECIST v1.1 (Response Evaluation Criteria in Solid Tumours Version 1.1) Part A (Dose Escalation), Part B (Dose Optimisation) and Part C (Potential Efficacy Expansion) Percentage of participants with a confirmed Complete Response (CR)	From first dose (non-randomised study parts) or from randomisation (randomised) through study completion; approximate duration of 2 years
DoR (Duration of Response)	To assess the preliminary anti-tumour activity of AZD0022 as a monotherapy and in combination with other anti-cancer agents Radiological response evaluated according to RECIST v1.1 (Response Evaluation Criteria in Solid Tumours Version 1.1) Part A (Dose Escalation), Part B (Dose Optimisation) and Part C (Potential Efficacy Expansion). Time from the date of first documented evidence of CR or PR until date of first documented disease progression or death.	From the date of first response until date of disease progression (RECIST 1.1) or death in the absence of disease progression; approximate duration of 2 years.
DCR (Disease Control Rate)	To assess the preliminary anti-tumour activity of AZD0022 as a monotherapy and in combination with other anti-cancer agents Radiological response evaluated according to RECIST v1.1 (Response Evaluation Criteria in Solid Tumours Version 1.1) Part A (Dose Escalation), Part B (Dose Optimisation) and Part C (Potential Efficacy Expansion). Percentage of participants who have a confirmed CR, PR, or Stable Disease (SD) for at least 11 weeks after start of treatment.	From first dose (non-randomised study parts) or from randomisation (randomised) until progression. For each patient, this is expected to be at 12 weeks
DRR (Durable Response Rate)	To assess the preliminary anti-tumour activity of AZD0022 as a monotherapy and in combination with other anti-cancer agents Radiological response evaluated according to RECIST v1.1 (Response Evaluation Criteria in Solid Tumours Version 1.1) Part A (Dose Escalation), Part B (Dose Optimisation) and Part C (Potential Efficacy Expansion). Percentage of participants who have a confirmed response (CR/PR) with a duration of at least 3 months.	From first documented response up until progression, or the last evaluable assessment in the absence of progression; approximate duration of 2 years.
TTR (Time to Response)	To assess the preliminary anti-tumour activity of AZD0022 as a monotherapy and in combination with other anti-cancer agents Radiological response evaluated according to RECIST v1.1 (Response Evaluation Criteria in Solid Tumours Version 1.1) Part A (Dose Escalation), Part B (Dose Optimisation) and Part C (Potential Efficacy Expansion) Time from first dose/randomisation date until date of first documented evidence of CR or PR per RECIST v1.1	From first dose (non-randomised study parts) or from randomisation (randomised study parts) until the date of documented objective response; approximate duration of 2 years.
PFS (Progression Free Survival)	To assess the preliminary anti-tumour activity of AZD0022 as a monotherapy and in combination with other anti-cancer agents Radiological response evaluated according to RECIST v1.1 (Response Evaluation Criteria in Solid Tumours Version 1.1) Part A (Dose Escalation), Part B (Dose Optimisation) and Part C (Potential Efficacy Expansion). Time from first dose/randomisation date until date of first documented disease progression or death.	'From first dose (non-randomised study parts) or from randomisation (randomised study parts) to progressive disease or death in the absence of disease progression; approximate duration of 2 years
Change in tumour size	To assess the preliminary anti-tumour activity of AZD0022 as a monotherapy and in combination with other anti-cancer agents Radiological response evaluated according to RECIST v1.1 (Response Evaluation Criteria in Solid Tumours Version 1.1) Part A (Dose Escalation), Part B (Dose Optimisation) and Part C (Potential Efficacy Expansion) Percentage change in tumor size from baseline per RECIST v1.1	From the first dose of study intervention (non-randomised study parts) or from randomisation (randomised), at predefined intervals throughout the administration of AZD0022; approximate duration of 2 years.
OS (Overall Survival)	To assess the preliminary anti-tumour activity of AZD0022 as a monotherapy and in combination with other anti-cancer agents Part A (Dose Escalation), Part B (Dose Optimisation) and Part C (Potential Efficacy Expansion). Time from first dose/randomisation date until death due to any case.	From first dose of study intervention (non-randomised study parts) or from randomisation (randomised study parts) to death; approximate duration of 2 years.
Complete Molecular Response (cMR).	To assess the molecular response rate via ctDNA on treatment with AZD0022 as a monotherapy and in combination with other anti-cancer agents Part A (Dose Escalation), Part B (Dose Optimisation) and Part C (Potential Efficacy Expansion).	From the first dose of study intervention (non-randomised study parts) or from randomisation (randomised study parts), at predefined intervals throughout the administration of AZD0022; approximate duration of 2 years.
Pharmacokinetics of AZD0022: Maximum plasma concentration of the study drug (Cmax)	Maximum observed plasma concentration of the study drug Part A (Dose Escalation) and Part B (Dose Optimisation)	From the first dose of study intervention (non-randomised study parts) or from randomisation (randomised study parts), at predefined intervals throughout the administration of AZD0022; approximate duration of 2 years.
Pharmacokinetics of AZD0022: Time to maximum plasma concentration of the study drug (T-max)	Time to maximum observed plasma concentration of the study drug Part A (Dose Escalation) and Part B (Dose Optimisation)	From the first dose of study intervention (non-randomised study parts) or from randomisation (randomised study parts), at predefined intervals throughout the administration of AZD0022; approximate duration of 2 years.
Pharmacokinetics of AZD0022: AuClast (Area Under the Plasma Contentration-Time Curve to the Last Measurable Plasma Concentration)	A pharmacokinetic measurement of the volume of plasma from which the study drug is completely removed per unit time. Part A (Dose Escalation) and Part B (Dose Optimisation)	From the first dose of study intervention (non-randomised study parts) or from randomisation (randomised study parts), at predefined intervals throughout the administration of AZD0022 until Cycle 3 Day 1.
Pharmacokinetics of AZD0022: Terminal elimination half-life (t 1/2)	Terminal elimination half life. Part A (Dose Escalation) and Part B (Dose Optimisation)	From the first dose of study intervention (non-randomised study parts) or from randomisation (randomised study parts), at predefined intervals throughout the administration of AZD0022 until Cycle 3 Day 1.
Incidence of participants with Adverse events (AEs) and Serious Adverse Events (SAEs).	Determine if treatment with AZD0022 as a monotherapy and in combination with other anticancer agents is safe and tolerable through the assessment of AEs, SAEs, and change from baseline in laboratory parameters, vital signs, and ECGs. Part C (Potential Efficacy Expansion).	From time of informed consent, through study completion to 30 days post last dose; an average of 2 years
Number of patients who discontinue AZD0022 due to toxicity	To further assess the safety and tolerability of AZD0022 as a monotherapy and in combination with other anti-cancer agents Part C (Potential Efficacy Expansion).	From time of informed consent, through study completion to 30 days post last dose; an average of 2 years
TDT (Time to Discontinuation of Treatment)	To estimate the anti-tumour activity of AZD0022 as a monotherapy and in combination with other anti-cancer agents. Part C (Potential Efficacy Expansion) Time from first dose/randomisation date until discontinuation of treatment or death due to any case.	From first dose until discontinuation of treatment for any reason; approximate duration of 2 years.
TFST (Time to First Subsequent Anti-Cancer)	To estimate the anti-tumour activity of AZD0022 as a monotherapy and in combination with other anti-cancer agents. Part C (Potential Efficacy Expansion). Time from first dose/randomisation date until start of first subsequent anti-cancer therapy after discontinuation of study treatment, or death due to any cause.	From date of first dose until start date of the first subsequent anti-cancer therapy after discontinuation of study treatment, or death; approximate duration of 2 years.
Change in phospho-ERK	To assess KRAS pathway inhibition on treatment with AZD0022 as monotherapy Module 1 Part A (Dose Escalation), Module 1 Part B (Dose Optimisation) and Module 1 Part C (Potential Efficacy Expansion)* Module 2 Part A (Dose Escalation), Module 2 Part B (Dose Optimisation) and Module 2 Part C (Potential efficacy expansion)* *Potential Efficacy Expansion at Sponsor discretion based on emerging data.	From baseline, at predefined intervals throughout the administration of AZD0022; approximate duration of 2 years.
Geometric mean and 90% CI for the ratio of fed:fasted in AUClast and Cmax for food-effect cohort.	To characterise the effect of food on AZD0022 as monotherapy Module 1 Food-effect only	From first dose, at predefined intervals throughout the administration of AZD0022; approximate duration of 2 years.
PFS (Progression Free Survival) by BICR	To assess anti-tumour activity of AZD0022 as monotherapy and in combination with other anti-cancer agents Radiological response evaluated according to RECIST v1.1 (Response Evaluation Criteria in Solid Tumours Version 1.1) Module 1 Part B (Dose Optimisation) and Module 1 Part C (Potential Efficacy Expansion) Module 2 Part B (Dose Optimisation) and Part C (Potential Efficacy Expansion)	From first dose (non-randomised study parts) or from randomisation (randomised study parts) to progressive disease or death in the absence of disease progression; approximate duration of 2 years
ORR (Objective Response Rate) by BICR	To assess anti-tumour activity of AZD0022 as monotherapy and in combination with other anti-cancer agents Radiological response evaluated according to RECIST v1.1 (Response Evaluation Criteria in Solid Tumours Version 1.1) Module 1 Part B (Dose Optimisation) and Module 1 Part C (Potential Efficacy Expansion) Module 2 Part B (Dose Optimisation) and Part C (Potential Efficacy Expansion)	From first dose (non-randomised study parts) or from randomisation (randomised) through study completion; approximate duration of 2 years
DoR (Duration of Rate) by BICR	To assess anti-tumour activity of AZD0022 as monotherapy and in combination with other anti-cancer agents Radiological response evaluated according to RECIST v1.1 (Response Evaluation Criteria in Solid Tumours Version 1.1) Module 1 Part B (Dose Optimisation) and Module 1 Part C (Potential Efficacy Expansion) Module 2 Part B (Dose Optimisation) and Part C (Potential Efficacy Expansion)	From the date of first response until date of disease progression (RECIST 1.1) or death in the absence of disease progression; approximate duration of 2 years.
ORR (Objective Response Rate) by Investigator	To assess anti-tumour activity of AZD0022 as monotherapy and in combination with other anti-cancer agents Radiological response evaluated according to RECIST v1.1 (Response Evaluation Criteria in Solid Tumours Version 1.1) Module 1 Part A (Dose Escalation) and Module 1 Part B (Dose Optimisation) Module 2 Part A (Dose Escalation) and Module 2 Part B (Dose Optimisation)	From first dose (non-randomised study parts) or from randomisation (randomised) through study completion; approximate duration of 2 years

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2024
• Primary Completion (Actual): October 20, 2025
• Study Completion (Actual): January 29, 2026

Study Registration Dates

• First Submitted: August 19, 2024
• First Submitted That Met QC Criteria: September 13, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Respiratory Tract Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Colonic Diseases; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Colorectal Neoplasms; Carcinoma, Non-Small-Cell Lung; Amino Acids, Peptides, and Proteins; Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Cetuximab
• Other Study ID Numbers: D7080C00001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
• IPD Sharing Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No