Solid Tumor, AdultPhase 1NCT05069935
FT538 in Combination With Monoclonal Antibodies in Advanced Solid Tumors
A Phase 1 study testing FT538, Cyclophosphamide and Fludarabine in people with Solid Tumor, Adult, run by Fate Therapeutics at 4 sites in United States.
Trial summary
This is a Phase 1 dose-finding study of FT538 in combination with monoclonal antibodies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Adult
- What is being tested?
- FT538, Cyclophosphamide and Fludarabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 4 sitesUnited States
- Study dates
- 15 Oct 2021to 11 Aug 2023
- Phase
- Phase 1
- 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
- Subjects with locally advanced or metastatic disease who have progressed after at least one line of therapy and diagnosis of one of the following by treatment cohort:
- Cohort A: The following solid tumor malignancies where anti-PD-1/PD-L1 antibodies are approved: cutaneous melanoma, non-small cell/small cell lung cancer, renal cell carcinoma, head and neck squamous cell cancer, microsatellite instability-high/ mismatch repair deficient cancer, gastric cancer, esophageal cancer, cervical cancer, merkel cell carcinoma, endometrial carcinoma, tumor mutation burden-high ≥ 10 mutations/megabase], cutaneous squamous cell carcinoma, triple-negative breast cancer.
- Cohort B: HER2+ breast cancer that has relapsed or progressed on trastuzumab and progressed on either pertuzumab or HER2-targeting antibody drug conjugate; HER2+ gastric cancer that has relapsed or progressed on trastuzumab-containing therapy; OR any other HER2+ solid tumor having progressed on at least one line of standard-of-care therapy. For any tumor type in this cohort, HER2 status must be documented by a U.S. Food and Administration (FDA) approved test to be ≥2+ IHC or Average HER2 copy number ≥4 signals per cell by in situ hybridization.
- Cohort C: CRC having progressed following prior cetuximab treatment or has KRAS/NRAS mutation; HNSCC having progressed following prior cetuximab.
- Capable of giving signed informed consent
- Aged ~ 18 years old
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- Willingness to comply with study procedures and duration
- Measurable disease per RECIST v1.1
- For subjects with >1 measurable lesion by RECIST v1.1 that can be safely accessed, willingness to undergo tumor biopsy
- Contraceptive use for women and men as defined in the protocol
Who cannot join
- Pregnant or breast-feeding women
- ECOG performance status greater than or equal to 2
- Evidence of insufficient organ function
- Clinically significant cardiovascular disease including left-ventricular ejection fraction < 45%
- Receipt of therapy within 2 weeks prior to Day 1 or five half-lives, whichever is shorter or any investigational therapy within 28 days prior to Day 1
- Known active central nervous system (CNS) involvement by malignancy that hasn'thas not remained stable for at least 3 months following effective treatment for CNS disease
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- Non-malignant CNS disease such as stroke, epilepsy, CNS vasculitis or neurodegenerative disease or receipt of medications for these conditions
- Currently receiving or likely to require immunosuppressive therapy Active bacterial, fungal, or viral infections including hep B, Hep C or HIV Live vaccine within 6 weeks prior to start of lympho-conditioning
- Known allergy to albumin (human) or DMSO
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Hackensack University Medical Center
Hackensack, New Jersey, 07601
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Sarah Cannon
Nashville, Tennessee, 37203
NEXT Oncology
San Antonio, Texas, 78229
About this study
Official title: A Phase I, Open-Label, Multicenter Study of FT538 in Combination With Monoclonal Antibodies in Subjects With Advanced Solid Tumors
This is a Phase 1 dose-finding study of FT538 in combination with monoclonal antibodies.
Read the detailed description
This is a Phase 1 dose-finding study of FT538 given in combination with a monoclonal antibody following lymphodepletion in subjects with advanced solid tumors. The study will consist of a dose-escalation stage and an expansion stage where participants will be enrolled into indication-specific cohorts.
- Conditions
- Solid Tumor, Adult
- Being tested
- FT538, Cyclophosphamide, Fludarabine, Monoclonal antibody - Dose Escalation, Monoclonal antibody - Dose Expansion
- Keywords
- anti-PD-1 / PD-L1 antibodies approved, HER2+, Metastatic CRC, Head and Neck Squamous Cell Carcinoma, NK Cells, Urothelial Cancer, Renal Cell Carcinoma, merkel cell carcinoma, non-small cell lung cancer, NSCLC, triple negative breast cancer, immune checkpoint inhibitor, melanoma, renal cell carcinoma, lung cancer,, triple-negative breast cancer,, head and neck squamous cell carcinoma,, urothelial carcinoma (UC),, Merkel cell carcinoma, squamous, hepatocellular carcinoma, gastric cancer, esophageal cancer, endometrial cancer,
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Carcinoma, Renal Cell, Carcinoma, Merkel Cell, Carcinoma, Non-Small-Cell Lung, Triple Negative Breast Neoplasms, Melanoma, Lung Neoplasms, Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FT538Drug
Also called NK Cell Therapy
FT538 is an allogeneic natural killer (NK)-cell immunotherapy
CyclophosphamideDrug
Also called Cy
Lympho-conditioning agent
FludarabineDrug
Also called Flu
Lympho-conditioning agent
Monoclonal antibody - Dose EscalationCombination product
Also called mAb
either avelumab, trastuzumab or cetuximab
Monoclonal antibody - Dose ExpansionCombination product
Also called mAb
either avelumab, atezolizumab, nivolumab, pembrolizumab, trastuzumab or cetuximab
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation | Experimental | * Cohort A: FT538 plus avelumab in subjects with advanced solid tumors malignancies where anti-PD-1/PD-L1 antibodies are approved
* Cohort B: FT538 plus trastuzumab in subjects with advanced documented HER2+ tumors
* Cohort C: FT538 plus cetuximab in subjects with advanced colorectal cancer (CRC) or head and neck squamous cell carcinoma (HNSCC) Receives: Drug: FT538; Drug: Cyclophosphamide; Drug: Fludarabine; Combination Product: Monoclonal antibody - Dose Escalation |
| Dose Expansion | Experimental | * Cohort A, Arm 1: FT538 plus avelumab in subjects with advanced solid tumors malignancies where anti-PD-1/PD-L1 antibodies are approved (except urothelial carcinoma (UC))
* Cohort A, Arm 2: FT538 plus an anti-PD-1 antibody (nivolumab or pembrolizumab) in subjects with solid tumor malignancies where anti-PD-1/PD-L1 antibodies are approved (except UC)
* Cohort B, Arm 1: FT538 plus trastuzumab in subjects with HER2+ tumors
* Cohort C, Arm 1: FT538 plus cetuximab in subjects with advanced CRC or HNSCC
Subjects with UC may be enrolled in the randomized expansion cohorts as follows:
* Cohort A, Arm R1: FT538 plus avelumab
* Cohort A, Arm R2: FT538 plus atezolizumab Receives: Drug: FT538; Drug: Cyclophosphamide; Drug: Fludarabine; Combination Product: Monoclonal antibody - Dose Expansion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Define the Recommended Phase 2 Dose (RP2D)
To define the RP2D of FT538 in combination with the following mAbs in subjects with advanced solid tumors: avelumab, trastuzumab, cetuximab, atezolizumab, nivolumab, and pembrolizumab
Measured: Up to ~1.5 years
Incidence and Severity of Adverse Events (AEs)0
To evaluate the safety and tolerability of FT538 in combination with the following mAbs in subjects with advanced solid tumors: avelumab, trastuzumab, cetuximab, atezolizumab, nivolumab, and pembrolizumab
Measured: Up to ~5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2021
- Study start15 Oct 2021
- Primary completion11 Aug 2023
- Study completion11 Aug 2023
Why it stopped: This study was terminated by the Sponsor.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, AdultStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fate Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fate Trial Disclosure, Study director, Fate Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05069935
- Sponsor's protocol ID
- FT538-102
- Status last verified
- Sep 2023
- First submitted
- 10 Sep 2021
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label, Multicenter Study of FT538 in Combination With Monoclonal Antibodies in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05069935
- Acronym / sponsor ID
- FT538-102
- Conditions
- Solid Tumor, Adult
- Keywords
- anti-PD-1 / PD-L1 antibodies approved, HER2+, Metastatic CRC, Head and Neck Squamous Cell Carcinoma, NK Cells, Urothelial Cancer, Renal Cell Carcinoma, merkel cell carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was terminated by the Sponsor.
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Fate TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 11 Aug 2023 (actual)
- Study completion
- 11 Aug 2023 (actual)
- First posted
- 6 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.
This is a Phase 1 dose-finding study of FT538 in combination with monoclonal antibodies.
Detailed description
This is a Phase 1 dose-finding study of FT538 given in combination with a monoclonal antibody following lymphodepletion in subjects with advanced solid tumors. The study will consist of a dose-escalation stage and an expansion stage where participants will be enrolled into indication-specific cohorts.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation | Experimental | Drug: FT538, Drug: Cyclophosphamide, Drug: Fludarabine, Combination Product: Monoclonal antibody - Dose Escalation* Cohort A: FT538 plus avelumab in subjects with advanced solid tumors malignancies where anti-PD-1/PD-L1 antibodies are approved * Cohort B: FT538 plus trastuzumab in subjects with advanced documented HER2+ tumors * Cohort C: FT538 plus cetuximab in subjects with advanced colorectal cancer (CRC) or head and neck squamous cell carcinoma (HNSCC) |
| Dose Expansion | Experimental | Drug: FT538, Drug: Cyclophosphamide, Drug: Fludarabine, Combination Product: Monoclonal antibody - Dose Expansion* Cohort A, Arm 1: FT538 plus avelumab in subjects with advanced solid tumors malignancies where anti-PD-1/PD-L1 antibodies are approved (except urothelial carcinoma (UC)) * Cohort A, Arm 2: FT538 plus an anti-PD-1 antibody (nivolumab or pembrolizumab) in subjects with solid tumor malignancies where anti-PD-1/PD-L1 antibodies are approved (except UC) * Cohort B, Arm 1: FT538 plus trastuzumab in subjects with HER2+ tumors * Cohort C, Arm 1: FT538 plus cetuximab in subjects with advanced CRC or HNSCC Subjects with UC may be enrolled in the randomized expansion cohorts as follows: * Cohort A, Arm R1: FT538 plus avelumab * Cohort A, Arm R2: FT538 plus atezolizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subjects with locally advanced or metastatic disease who have progressed after at least one line of therapy and diagnosis of one of the following by treatment cohort:
- Cohort A: The following solid tumor malignancies where anti-PD-1/PD-L1 antibodies are approved: cutaneous melanoma, non-small cell/small cell lung cancer, renal cell carcinoma, head and neck squamous cell cancer, microsatellite instability-high/ mismatch repair deficient cancer, gastric cancer, esophageal cancer, cervical cancer, merkel cell carcinoma, endometrial carcinoma, tumor mutation burden-high ≥ 10 mutations/megabase], cutaneous squamous cell carcinoma, triple-negative breast cancer.
- Cohort B: HER2+ breast cancer that has relapsed or progressed on trastuzumab and progressed on either pertuzumab or HER2-targeting antibody drug conjugate; HER2+ gastric cancer that has relapsed or progressed on trastuzumab-containing therapy; OR any other HER2+ solid tumor having progressed on at least one line of standard-of-care therapy. For any tumor type in this cohort, HER2 status must be documented by a U.S. Food and Administration (FDA) approved test to be ≥2+ IHC or Average HER2 copy number ≥4 signals per cell by in situ hybridization.
- Cohort C: CRC having progressed following prior cetuximab treatment or has KRAS/NRAS mutation; HNSCC having progressed following prior cetuximab.
- Capable of giving signed informed consent
Key exclusion criteria (9 listed)
- Pregnant or breast-feeding women
- ECOG performance status greater than or equal to 2
- Evidence of insufficient organ function
- Clinically significant cardiovascular disease including left-ventricular ejection fraction < 45%
- Receipt of therapy within 2 weeks prior to Day 1 or five half-lives, whichever is shorter or any investigational therapy within 28 days prior to Day 1
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 |
|---|---|---|
| FT538Also: NK Cell TherapyFT538 is an allogeneic natural killer (NK)-cell immunotherapy | Drug | Dose Escalation, Dose Expansion |
| CyclophosphamideAlso: CyLympho-conditioning agent | Drug | Dose Escalation, Dose Expansion |
| FludarabineAlso: FluLympho-conditioning agent | Drug | Dose Escalation, Dose Expansion |
| Monoclonal antibody - Dose EscalationAlso: mAbeither avelumab, trastuzumab or cetuximab | Combination product | Dose Escalation |
| Monoclonal antibody - Dose ExpansionAlso: mAbeither avelumab, atezolizumab, nivolumab, pembrolizumab, trastuzumab or cetuximab | Combination product | Dose Expansion |
Primary outcome
Define the Recommended Phase 2 Dose (RP2D)
Time frame: Up to ~1.5 years
To define the RP2D of FT538 in combination with the following mAbs in subjects with advanced solid tumors: avelumab, trastuzumab, cetuximab, atezolizumab, nivolumab, and pembrolizumab
Incidence and Severity of Adverse Events (AEs)0
Time frame: Up to ~5 years
To evaluate the safety and tolerability of FT538 in combination with the following mAbs in subjects with advanced solid tumors: avelumab, trastuzumab, cetuximab, atezolizumab, nivolumab, and pembrolizumab
Results and safety
The study was stopped early (reason given: This study was terminated by the Sponsor.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Individual participant dataSharing planned: No
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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.
Fate Trial Disclosure study director
Fate Therapeutics
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FT538, Cyclophosphamide and Fludarabine in people with Solid Tumor, Adult, run by Fate Therapeutics at 4 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 10 inclusion and 9 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: stopped early, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: This study was terminated by the Sponsor.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Define the Recommended Phase 2 Dose (RP2D) (time frame: Up to ~1.5 years). The study lists 2 primary outcomes in all. 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 21 Sep 2023.