Carcinoma, Non-Small-Cell LungPhase 1/2FWD1509NCT05068024
A Study of FWD1509 in Adults With Non-Small Cell Lung Cancer
A Phase 1/2 study testing FWD1509 MsOH in people with Carcinoma, Non-Small-Cell Lung, run by Forward Pharmaceuticals Co., Ltd. at 2 sites in United States.
Trial summary
The purpose of this study is to characterize the safety and tolerability of FWD1509 MsOH in advanced NSCLC patients and establish the maximum tolerable dose (MTD), recommended phase 2 dose (RP2D) in advanced NSCLC patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- FWD1509 MsOH
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Aug 2021to 30 Dec 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- A subject will be not eligible for inclusion in this study if any of the following criteria apply:
- Received anticancer therapy including cytotoxic chemotherapy, biological products and investigational agents, ≤ 21 days prior to first dose of FWD1509 MsOH; or received prior EGFR TKIs (e.g., gefitinib, erlotinib or osimertinib) ≤7 days prior to the first dose FWD1509 MsOH
- Have been diagnosed with another primary malignancy other than NSCLC except for patients with adequately treated non-melanoma skin cancer, cervical cancer in situ or definitively treated non-metastatic prostate cancer, or participants with another primary malignancy who are definitively relapse-free with at least 3 years elapsed since the diagnosis of the other primary malignancy
- Received radiotherapy ≤14 days prior to the first dose of FWD1509 MsOH or have not recovered from radiotherapy-related toxicities; palliative radiation administered outside the chest and brain, stereotactic radiosurgery (SRS), and stereotactic body radiotherapy are allowed up to 7 days prior to the first dose of FWD1509 MsOH
- Received strong CYP3A inhibitors and inducers within 2 weeks prior to the first dose of FWD1509 MsOH; they should be discontinued at least 2 weeks prior to the first dose of FWD1509 MsOH and avoided throughout the study duration (see Appendix 6)
- Received concomitant medications (e.g., statins) which are substrates of BCRP, p-glycoprotein or OATP1B1/1B3 (dose escalation part of phase 1 study)
Show all 23Show fewer
- Have undergone major surgery within 28 days prior to first dose of FWD1509 MsOH. Minor surgical procedures, such as catheter placement or minimally invasive biopsy, are allowed
- Brain Metastasis: Have known active brain metastases (have either previously untreated intracranial CNS metastases or previously treated intracranial CNS metastases with radiologically documented new or progressing CNS lesions), except for the following conditions
- Brain metastases are allowed if they have been treated with surgery and/or radiation and have been stable without requiring corticosteroids to control symptoms within 7 days before the first dose of FWD1509 MsOH and have no evidence of new or enlarging brain metastases
- Requiring corticosteroids to control symptoms within 7 days prior to the first dose of FWD1509 MsOH or during study period; patients previously treated for CNS metastases who are clinically stable, have no new lesions, and who do not need treatment with a corticosteroid within the 7 days before the first dose of FWD1509 MsOH and during study period are allowed to be enrolled
- Have current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging) or leptomeningeal disease (symptomatic or asymptomatic)
- Have significant, uncontrolled, or active cardiovascular disease
- QCc-related criteria:
- A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >480 milliseconds (ms) (CTCAE grade 1) using Fredericia's QT correction formula
- A history of additional risk factors for Torsades de Pointes (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome
- Have significant, uncontrolled, or active renal disease
- Have a known history of uncontrolled hypertension (per institution practice); participants with hypertension should be under treatment on study entry to control blood pressure
- Have any abnormal changes in the cornea or retina that may increase the risk of ocular toxicity during screening
- Have an ongoing or active infection, including but not limited to, the requirement for intravenous (IV) antibiotics, or a known history of human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV). Testing is not required in the absence of history
- Currently have or have a history of interstitial lung disease, radiation pneumonitis that required steroid treatment, or drug-related pneumonitis
- Female participants who are lactating and breastfeeding or have a positive urine or serum pregnancy test during the screening period
- Have gastrointestinal illness or disorder that could affect oral absorption of FWD1509 MsOH
- Have any condition or illness that, in the opinion of the investigator, might compromise participant safety or interfere with the evaluation of the safety of the drug
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Not yet recruiting
Gabrail Cancer Center
Canton, Ohio, 44718
Brittany Dessecker, 330-492-3345 ext. X213, bdessecker@gabrailcancercenter.com
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Terri Alexander, SN, 346-234-9744, TLAlexander@mdanderson.org
About this study
Official title: A Phase 1/2, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Tumor Activity of FWD1509 MsOH in Advanced Non-Small Cell Lung Cancer
The purpose of this study is to characterize the safety and tolerability of FWD1509 MsOH in advanced NSCLC patients and establish the maximum tolerable dose (MTD), recommended phase 2 dose (RP2D) in advanced NSCLC patients.
Read the detailed description
This study will be a first-in-human study evaluating the safety and tolerability of FWD1509 MsOH in subjects with advanced NSCLC, when FWD1509 MsOH is administered once daily as a single agent. FWD1509 MsOH is an oral TKI (Tyrosine Kinase Inhibitor) that blocks the function of tyrosine kinase. TKIs such as gefitinib, erlotinib or afatinib are recommended as the first-line therapy for EGFR mutated (exon 19 deletions or L858R point mutations in exon 21) NSCLC patients. However, the majority (>50%) of patients will develop acquired resistance after initially responding to gefitinib or erlotinib due to the occurrence of secondary mutations (mostly T709M) in EGFR. Osimertinib was subsequently developed to such secondary mutations, but for EGFRex20ins mutations, on which there is still no effective therapies focusing. FWD1509 MsOH is new generation EGFR-TKI targeting EGFR mutations such as exon 19 deletion, L858R substitution as well as T790M mutations. In particular, FWD1509 MsOH targets the EGFRex20ins mutation in NSCLC. In addition to activity against EGFR mutations, FWD1509 MsOH is also active against a variety of HER2 mutations.
The development of FWD1509 MsOH at this stage is mainly focused on treatment of NSCLC tumors with EGFRex20ins mutations, followed by further exploration against other targets.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- FWD1509 MsOH
- Keywords
- FWD1509 MsOH in advanced non-small cell lung cancer, Forward Pharma, Forward, FWD1509, NSCLC, MsOH, FWD-001, First-in-human, Non-small cell lung cancer, Advanced solid malignancies, Solid malignancies, Solid tumor, EGFR, EGFR ex20ins, EGFR mutation, TKI, HER2
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FWD1509 MsOHDrug
FWD1509 MsOH is administered orally once daily. The starting dose is 10 mg/day for dose-escalation phase, and the dose level to be investigated in the expansion study will depend on the emerging data. For dose-extension phase, the recommended Phase 2 dose will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Treatment of NSCLC patients with EGFR or HER2 genetic alterations | Experimental | Not described Receives: Drug: FWD1509 MsOH |
What is being measured
The primary outcome is the main question the study is designed to answer.
22-30 participants with treatment-related adverse events as assessed based on CTCAE v5.0.
Adverse events (AE), serious adverse events (SAE) and adverse events of special interest (AESI) will be assessed by Common Terminology Criteria for Adverse Events (CTCAE 5.0) grading system, changing from baseline and each treatment cycle (1 cycle=3 weeks). An Adverse Event (AE) is defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment.
Measured: 18 months
Secondary outcomes (14)
Cmax: Maximum Observed Plasma Concentration for FWD1509 MsOH
Measured: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for FWD1509 MsOH
Measured: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose
T1/2: Terminal Half-life for FWD1509 MsOH
Terminal plasma half-life is the time required to divide the plasma concentration by two after reaching pseudo-equilibrium, and not the time required to eliminate half the administered dose.
Measured: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose
AUC0-inf: Area Under the Plasma Concentration-time Curve From Time 0 to infinite time for FWD1509 MsOH
Measured: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for FWD1509 MsOH
Measured: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose
AUC0-24: Area Under the Plasma Concentration versus Time Curve From Time 0 to Time 24h for FWD1509
Measured: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose
AUCss: Area Under the Plasma Concentration versus Time Curve From Time 0 to the End of the Dosing Interval
Measured: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose
Apparent Plasma Clearance (CL/F), Apparent Volume of Distribution and Mean Residence Time (MRT)
Measured: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose
Extent of Accumulation on Multiple Dosing (Rac)
Measured: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose
ORR: Objective Response Rate
Confirmed ORR is defined as the proportion of participants who are confirmed to have achieved complete response (CR) or partial response (PR).
Measured: 18 months
DoR: Duration of Response
Duration of response is defined as the time interval from the time that the measurement criteria are first met for CR/PR (whichever is first recorded) until the first date that PD is objectively documented.
Measured: 18 months
DCR: Disease Control Rate
DCR is defined as the percentage of participants who have achieved CR, PR, or stable disease (SD) (in the case of SD, measurements must have met the SD criteria at least once after study entry at a minimum interval of 6 weeks) after the initiation of study drug.
Measured: 18 months
PFS: Progression Free Survival
PFS is defined as the time interval from the date of randomization until the first date at which the criteria for progressive disease (PD) according to RECIST version 1.1 are met or death, whichever occurs first.
Measured: 18 months
OS: Overall Survival
OS is defined as the interval from the date of randomization until death.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2021
- Study start23 Aug 2021
- Primary completion30 Oct 2022 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Forward Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- WuXi Clinical
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05068024
- Sponsor's protocol ID
- FWDCT-001
- Acronym
- FWD1509
- Status last verified
- Jul 2022
- First submitted
- 14 Sep 2021
- Last updated
- 26 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Tumor Activity of FWD1509 MsOH in Advanced Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT05068024
- Acronym / sponsor ID
- FWD1509 / FWDCT-001
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- FWD1509 MsOH in advanced non-small cell lung cancer, Forward Pharma, Forward, FWD1509, NSCLC, MsOH, FWD-001, First-in-human
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Forward Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- WuXi Clinical
- Study start
- 23 Aug 2021 (actual)
- Primary completion
- 30 Oct 2022 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 5 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to characterize the safety and tolerability of FWD1509 MsOH in advanced NSCLC patients and establish the maximum tolerable dose (MTD), recommended phase 2 dose (RP2D) in advanced NSCLC patients.
Detailed description
This study will be a first-in-human study evaluating the safety and tolerability of FWD1509 MsOH in subjects with advanced NSCLC, when FWD1509 MsOH is administered once daily as a single agent. FWD1509 MsOH is an oral TKI (Tyrosine Kinase Inhibitor) that blocks the function of tyrosine kinase. TKIs such as gefitinib, erlotinib or afatinib are recommended as the first-line therapy for EGFR mutated (exon 19 deletions or L858R point mutations in exon 21) NSCLC patients. However, the majority (>50%) of patients will develop acquired resistance after initially responding to gefitinib or erlotinib due to the occurrence of secondary mutations (mostly T709M) in EGFR. Osimertinib was subsequently developed to such secondary mutations, but for EGFRex20ins mutations, on which there is still no effective therapies focusing. FWD1509 MsOH is new generation EGFR-TKI targeting EGFR mutations such as exon 19 deletion, L858R substitution as well as T790M mutations. In particular, FWD1509 MsOH targets the EGFRex20ins mutation in NSCLC. In addition to activity against EGFR mutations, FWD1509 MsOH is also active against a variety of HER2 mutations.
The development of FWD1509 MsOH at this stage is mainly focused on treatment of NSCLC tumors with EGFRex20ins mutations, followed by further exploration against other targets.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment of NSCLC patients with EGFR or HER2 genetic alterations | Experimental | Drug: FWD1509 MsOH |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (23 listed)
- A subject will be not eligible for inclusion in this study if any of the following criteria apply:
- Received anticancer therapy including cytotoxic chemotherapy, biological products and investigational agents, ≤ 21 days prior to first dose of FWD1509 MsOH; or received prior EGFR TKIs (e.g., gefitinib, erlotinib or osimertinib) ≤7 days prior to the first dose FWD1509 MsOH
- Have been diagnosed with another primary malignancy other than NSCLC except for patients with adequately treated non-melanoma skin cancer, cervical cancer in situ or definitively treated non-metastatic prostate cancer, or participants with another primary malignancy who are definitively relapse-free with at least 3 years elapsed since the diagnosis of the other primary malignancy
- Received radiotherapy ≤14 days prior to the first dose of FWD1509 MsOH or have not recovered from radiotherapy-related toxicities; palliative radiation administered outside the chest and brain, stereotactic radiosurgery (SRS), and stereotactic body radiotherapy are allowed up to 7 days prior to the first dose of FWD1509 MsOH
- Received strong CYP3A inhibitors and inducers within 2 weeks prior to the first dose of FWD1509 MsOH; they should be discontinued at least 2 weeks prior to the first dose of FWD1509 MsOH and avoided throughout the study duration (see Appendix 6)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FWD1509 MsOHFWD1509 MsOH is administered orally once daily. The starting dose is 10 mg/day for dose-escalation phase, and the dose level to be investigated in the expansion study will depend on the emerging data. For dose-extension phase, the recommended Phase 2 dose will be administered. | Drug | Treatment of NSCLC patients with EGFR or HER2 genetic alterations |
Primary outcome
22-30 participants with treatment-related adverse events as assessed based on CTCAE v5.0.
Time frame: 18 months
Adverse events (AE), serious adverse events (SAE) and adverse events of special interest (AESI) will be assessed by Common Terminology Criteria for Adverse Events (CTCAE 5.0) grading system, changing from baseline and each treatment cycle (1 cycle=3 weeks). An Adverse Event (AE) is defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment.
14 secondary outcomes
Cmax: Maximum Observed Plasma Concentration for FWD1509 MsOH
Time frame: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for FWD1509 MsOH
Time frame: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose
T1/2: Terminal Half-life for FWD1509 MsOH
Time frame: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose
AUC0-inf: Area Under the Plasma Concentration-time Curve From Time 0 to infinite time for FWD1509 MsOH
Time frame: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for FWD1509 MsOH
Time frame: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose
AUC0-24: Area Under the Plasma Concentration versus Time Curve From Time 0 to Time 24h for FWD1509
Time frame: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose
AUCss: Area Under the Plasma Concentration versus Time Curve From Time 0 to the End of the Dosing Interval
Time frame: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose
Apparent Plasma Clearance (CL/F), Apparent Volume of Distribution and Mean Residence Time (MRT)
Time frame: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose
Extent of Accumulation on Multiple Dosing (Rac)
Time frame: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose
ORR: Objective Response Rate
Time frame: 18 months
DoR: Duration of Response
Time frame: 18 months
DCR: Disease Control Rate
Time frame: 18 months
PFS: Progression Free Survival
Time frame: 18 months
OS: Overall Survival
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
Related trials for Carcinoma, Non-Small-Cell Lung
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing FWD1509 MsOH in people with Carcinoma, Non-Small-Cell Lung, run by Forward Pharmaceuticals Co., Ltd. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jo-Han Wang, Project Manager (+1-647-649-2850, jo-han.wang@wuxiapptec.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
22-30 participants with treatment-related adverse events as assessed based on CTCAE v5.0. (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2022.