NeoplasmsPhase 1NCT06285097
A Study of PF-07820435 as a Single Agent and in Combination in Participants With Advanced Solid Tumors
A Phase 1 study testing PF-07820435 and Sasanlimab in people with Neoplasms and Non-small-cell Lung Cancer, run by Pfizer at 10 sites in 3 countries.
Trial summary
This study aims to evaluate the safety, and early signals of anti-tumor activity of PF-07820435 when administered alone (Part 1A) or in combination with sasanlimab (Part 1B; Part 2) in patients with selected advanced or metastatic solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms, Non-small-cell Lung Cancer, Melanoma
- What is being tested?
- PF-07820435 and Sasanlimab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 10 sitesin 3 countries
- Study dates
- 8 Feb 2024to 13 Feb 2025
- 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
- Histological or cytological diagnosis of advanced, unresectable, and/or metastatic or relapsed/refractory solid tumor
- Part 1A: Participants with solid tumors where anti-PD-(L)1 is an established treatment. Participants must have progressed on or following prior anti-PD-(L)1 therapy if approved, available, tolerable, and eligible
- Part 1B: Participants either meeting Part 1A criterion, or participants with "cold" solid tumors where anti-PD-(L)1 therapy is not an established treatment
- Part 2: Participants with NSCLC (Arm A) must have received platinum-based chemotherapy and anti-PD-(L)1 or have intolerability to or refusal of standard therapies. NSCLC participants with known activating mutation(s) must also have received prior approved and available targeted therapy(ies) for the associated mutation(s) or have intolerability or documented refusal of these therapies. Participants with UC (Arm B) must have received prior platinum-based chemotherapy, anti-PD-(L)1 therapy, or enfortumab vedotin, or have documented intolerability or refusal of the standard therapy(ies). Additional cohort indication(s) or dose regimens may be added and defined based on emerging data
- At least 1 measurable lesion based on RECIST 1.1 that has not been previously irradiated (Part 1 exceptions permitted after review and approval)
- Able to provide pre-treatment (and optional on-treatment) tumor tissue
Who cannot join
- Active or history of clinically significant gastrointestinal disease and other conditions that are unresolved or pose a risk to study treatment or procedures
- Active or history of pneumonitis/interstitial lung disease, pulmonary fibrosis requiring treatment with systemic steroid therapy
- Active or history of clinically significant autoimmune disease or other medical condition that required chronic systemic immunosuppressive therapy within recent 2 years
- History of severe immune-mediated adverse event or cytokine release syndrome that was considered related to prior immune modulatory therapy that required immunosuppressive therapy
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
United States6 sites
Corewell Health (reference non-engagement letter)
Grand Rapids, Michigan, 49503
START Midwest
Grand Rapids, Michigan, 49546
Sarah Cannon Research Institute - Pharmacy
Nashville, Tennessee, 37203
SCRI Oncology Partners
Nashville, Tennessee, 37203
Tristar Centennial Medical Center
Nashville, Tennessee, 37203
Florida Cancer Specialists Sarasota Drug Development Unit
Sarasota, Florida, 34232
Japan2 sites
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577
The Cancer Institute Hospital of JFCR
Koto, Tokyo, 135-8550
Puerto Rico2 sites
Hospital Oncologico Dr. Isaac Gonzalez-Martinez
Rio Piedras, 00935
Pan American Center for Oncology Trials, LLC
Rio Piedras, 00935
About this study
Official title: A PHASE 1 DOSE ESCALATION AND EXPANSION STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETIC, PHARMACODYNAMIC, AND ANTITUMOR ACTIVITY OF PF-07820435 AS MONOTHERAPY AND IN COMBINATION IN PARTICIPANTS WITH ADVANCED SOLID TUMORS
This study aims to evaluate the safety, and early signals of anti-tumor activity of PF-07820435 when administered alone (Part 1A) or in combination with sasanlimab (Part 1B; Part 2) in patients with selected advanced or metastatic solid tumors. Part 1 will be dose-finding and Part 2 of the study will further evaluate PF-07820435 at the recommended dose for combination expansion in patients with selected advanced solid tumors.
- Conditions
- Neoplasms, Non-small-cell Lung Cancer, Melanoma, Squamous Cell Carcinoma of the Head and Neck, Renal Cell Carcinoma, Urothelial Carcinoma
- Being tested
- PF-07820435, Sasanlimab
- Keywords
- Sasanlimab, anti-Programmed death receptor-1 (PD-1), solid tumor, immunotherapy
- Medical subject headings
- Neoplasms, Carcinoma, Non-Small-Cell Lung, Melanoma, Squamous Cell Carcinoma of Head and Neck, Carcinoma, Renal Cell, Carcinoma, Transitional Cell, Colorectal Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-07820435Drug
immune agonist
SasanlimabBiological
A monoclonal antibody that blocks the interaction between PD-1 and PD-L1/L2
| Study group | Role | What they receive |
|---|---|---|
| Monotherapy dose escalation (Part 1A) | Experimental | Participants will receive PF-07820435 orally at the prescribed dose and frequency in 28-day cycles Receives: Drug: PF-07820435 |
| Combination dose escalation (Part 1B) | Experimental | Participants will receive PF-07820435 orally at the prescribed dose and frequency, in combination with sasanlimab (subcutaneous injection) at a fixed dose once every 4 weeks in 28-day cycles Receives: Drug: PF-07820435; Biological: Sasanlimab |
| Expansion (Part 2) - Tumor specific Arm A | Experimental | Participants will receive PF-07820435 orally at the prescribed dose and frequency in combination with sasanlimab SC once every 4 weeks in 28-day cycles Receives: Drug: PF-07820435; Biological: Sasanlimab |
| Expansion (Part 2) - Tumor specific Arm B | Experimental | Participants will receive PF-07820435 orally at the prescribed dose and frequency in combination with sasanlimab SC once every 4 weeks in 28-day cycles Receives: Drug: PF-07820435; Biological: Sasanlimab |
| Expansion (Part 2) - Arm C | Experimental | Participants will receive PF-07820435 orally at the prescribed dose and frequency in 28-day cycles Receives: Drug: PF-07820435 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with dose limiting toxicities (DLTs) in dose escalation (Part 1A and Part 1B)
DLT rate estimated based on data from DLT-evaluable participants during the DLT evaluation period
Measured: Baseline through 28 days after first dose
Number of patients with adverse events (AEs)
Characterized by type, frequency, severity (CTCAE v5; CRS by ASTCT), timing, seriousness, and relationship to study drug(s)
Measured: Baseline through up to 2 years
Number of patients with clinically significant lab abnormalities
Characterized by type, frequency, severity (CTCAE v5), and timing
Measured: Baseline through up to 2 years
Objective response rate (ORR) in Part 2 Expansion
Tumor response as assessed using RECIST 1.1
Measured: Baseline through 2 years or disease progression
Secondary outcomes (13)
Objective response rate (ORR) in dose escalation (Part 1A and Part 1B)
Tumor response as assessed by RECIST 1.1
Measured: Baseline through 2 years or disease progression
Duration of tumor response
Tumor response as assessed by RECIST 1.1
Measured: Baseline through 2 years or disease progression
Progression free survival (PFS)
Tumor response as assessed by RECIST 1.1
Measured: Baseline through 2 years or disease progression
Cmax (maximum concentration) of PF-07820435 and its active metabolite
Single and multiple dose PK parameters of PF-07820435 and its active metabolite
Measured: Serial timepoints following the first dose (Day 1), second dose (Day 8), and third dose (Day 15) of the first cycle (each cycle is 28 days); and Day 1 (dosing) of Cycle 2 and Day 1 (dosing) of Cycle 3.
Tmax (time to maximal plasma concentration) of PF-07820435 and its active metabolite
Single and multiple dose PK parameters of PF-07820435 and its active metabolite
Measured: Serial timepoints following the first dose (Day 1), second dose (Day 8), and third dose (Day 15) of the first cycle (each cycle is 28 days); and Day 1 (dosing) of Cycle 2 and Day 1 (dosing) of Cycle 3.
AUClast (area under the curve from time 0 to the last measurable timepoint) of PF-07820435 and its active metabolite
Single and multiple dose PK parameters of PF-07820435 and its active metabolite
Measured: Serial timepoints following the first dose (Day 1), second dose (Day 8), and third dose (Day 15) of the first cycle (each cycle is 28 days); and Day 1 (dosing) of Cycle 2 and Day 1 (dosing) of Cycle 3.
Cmin (minimum concentration) of PF-07820435 and its active metabolite after multiple dosing only
Multiple dose PK parameters of PF-07820435 and its active metabolite
Measured: Serial timepoints following the first dose (Day 1), second dose (Day 8), and third dose (Day 15) of the first cycle (each cycle is 28 days); and Day 1 (dosing) of Cycle 2 and Day 1 (dosing) of Cycle 3.
Change from baseline of immune markers within biopsied tumor tissue
Change in CD8 immune marker will be analyzed
Measured: Baseline through about 6 weeks after first dose
Pre-dose trough concentrations of sasanlimab (Part 1B and Part 2)
Single and multiple dose PK parameters of sasanlimab
Measured: Day 1 (pre-dose) of each cycle (28 days) for the first 3 cycles, then Day 1 on every 3rd cycle until 2 years or disease progression
Incidence and titers of ADA and NAb against sasanlimab (Part 1B and Part 2)
Immunogenicity assessment
Measured: Day 1 (pre-dose) of each cycle (28 days) for the first 3 cycles, then Day 1 on every 3rd cycle until 2 years or disease progression
Cmax of PF-07820435 and its active metabolite under fasted and fed conditions (Part 2 subset) subset of participants in Part 2
The analysis applies to Part 2 Food Effect Subset only
Measured: On Day 1 (first dose) and Day 15 (third dose): Pre-dose, 0.5 hour (h), 1h, 2h, 4h, 6h, and 24h post dose.
Tmax of PF-07820435 and its active metabolite under fasted and fed conditions (Part 2 subset) subset of participants in Part 2
The analysis applies to Part 2 Food Effect Subset only
Measured: On Day 1 (first dose) and Day 15 (third dose): Pre-dose, 0.5 hour (h), 1h, 2h, 4h, 6h, and 24h post dose.
AUC of PF-07820435 and its active metabolite under fasted and fed conditions (Part 2 subset) subset of participants in Part 2
The analysis applies to Part 2 Food Effect Subset only
Measured: On Day 1 (first dose) and Day 15 (third dose): Pre-dose, 0.5 hour (h), 1h, 2h, 4h, 6h, and 24h post dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start8 Feb 2024
- Primary completion3 Jan 2025
- Study completion13 Feb 2025
Why it stopped: The trial was terminated for strategic business reasons; the decision was not based on any safety and/or efficacy concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06285097
- Sponsor's protocol ID
- C5391001
- Other IDs
- NCT06285097
- Status last verified
- Sep 2025
- First submitted
- 23 Jan 2024
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 1 DOSE ESCALATION AND EXPANSION STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETIC, PHARMACODYNAMIC, AND ANTITUMOR ACTIVITY OF PF-07820435 AS MONOTHERAPY AND IN COMBINATION IN PARTICIPANTS WITH ADVANCED SOLID TUMORS
- ClinicalTrials.gov ID
- NCT06285097
- Acronym / sponsor ID
- C5391001
- Conditions
- Neoplasms, Non-small-cell Lung Cancer, Melanoma, Squamous Cell Carcinoma of the Head and Neck, Renal Cell Carcinoma, Urothelial Carcinoma
- Keywords
- Sasanlimab, anti-Programmed death receptor-1 (PD-1), solid tumor, immunotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The trial was terminated for strategic business reasons; the decision was not based on any safety and/or efficacy concerns.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 8 Feb 2024 (actual)
- Primary completion
- 3 Jan 2025 (actual)
- Study completion
- 13 Feb 2025 (actual)
- First posted
- 29 Feb 2024 (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 study aims to evaluate the safety, and early signals of anti-tumor activity of PF-07820435 when administered alone (Part 1A) or in combination with sasanlimab (Part 1B; Part 2) in patients with selected advanced or metastatic solid tumors. Part 1 will be dose-finding and Part 2 of the study will further evaluate PF-07820435 at the recommended dose for combination expansion in patients with selected advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Monotherapy dose escalation (Part 1A) | Experimental | Drug: PF-07820435Participants will receive PF-07820435 orally at the prescribed dose and frequency in 28-day cycles |
| Combination dose escalation (Part 1B) | Experimental | Drug: PF-07820435, Biological: SasanlimabParticipants will receive PF-07820435 orally at the prescribed dose and frequency, in combination with sasanlimab (subcutaneous injection) at a fixed dose once every 4 weeks in 28-day cycles |
| Expansion (Part 2) - Tumor specific Arm A | Experimental | Drug: PF-07820435, Biological: SasanlimabParticipants will receive PF-07820435 orally at the prescribed dose and frequency in combination with sasanlimab SC once every 4 weeks in 28-day cycles |
| Expansion (Part 2) - Tumor specific Arm B | Experimental | Drug: PF-07820435, Biological: SasanlimabParticipants will receive PF-07820435 orally at the prescribed dose and frequency in combination with sasanlimab SC once every 4 weeks in 28-day cycles |
| Expansion (Part 2) - Arm C | Experimental | Drug: PF-07820435Participants will receive PF-07820435 orally at the prescribed dose and frequency in 28-day cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histological or cytological diagnosis of advanced, unresectable, and/or metastatic or relapsed/refractory solid tumor
- Part 1A: Participants with solid tumors where anti-PD-(L)1 is an established treatment. Participants must have progressed on or following prior anti-PD-(L)1 therapy if approved, available, tolerable, and eligible
- Part 1B: Participants either meeting Part 1A criterion, or participants with "cold" solid tumors where anti-PD-(L)1 therapy is not an established treatment
- Part 2: Participants with NSCLC (Arm A) must have received platinum-based chemotherapy and anti-PD-(L)1 or have intolerability to or refusal of standard therapies. NSCLC participants with known activating mutation(s) must also have received prior approved and available targeted therapy(ies) for the associated mutation(s) or have intolerability or documented refusal of these therapies. Participants with UC (Arm B) must have received prior platinum-based chemotherapy, anti-PD-(L)1 therapy, or enfortumab vedotin, or have documented intolerability or refusal of the standard therapy(ies). Additional cohort indication(s) or dose regimens may be added and defined based on emerging data
- At least 1 measurable lesion based on RECIST 1.1 that has not been previously irradiated (Part 1 exceptions permitted after review and approval)
Key exclusion criteria (4 listed)
- Active or history of clinically significant gastrointestinal disease and other conditions that are unresolved or pose a risk to study treatment or procedures
- Active or history of pneumonitis/interstitial lung disease, pulmonary fibrosis requiring treatment with systemic steroid therapy
- Active or history of clinically significant autoimmune disease or other medical condition that required chronic systemic immunosuppressive therapy within recent 2 years
- History of severe immune-mediated adverse event or cytokine release syndrome that was considered related to prior immune modulatory therapy that required immunosuppressive therapy
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 |
|---|---|---|
| PF-07820435immune agonist | Drug | Combination dose escalation (Part 1B), Expansion (Part 2) - Arm C, Expansion (Part 2) - Tumor specific Arm A, Expansion (Part 2) - Tumor specific Arm B, Monotherapy dose escalation (Part 1A) |
| SasanlimabA monoclonal antibody that blocks the interaction between PD-1 and PD-L1/L2 | Biological | Combination dose escalation (Part 1B), Expansion (Part 2) - Tumor specific Arm A, Expansion (Part 2) - Tumor specific Arm B |
Primary outcome
Number of patients with dose limiting toxicities (DLTs) in dose escalation (Part 1A and Part 1B)
Time frame: Baseline through 28 days after first dose
DLT rate estimated based on data from DLT-evaluable participants during the DLT evaluation period
Number of patients with adverse events (AEs)
Time frame: Baseline through up to 2 years
Characterized by type, frequency, severity (CTCAE v5; CRS by ASTCT), timing, seriousness, and relationship to study drug(s)
Number of patients with clinically significant lab abnormalities
Time frame: Baseline through up to 2 years
Characterized by type, frequency, severity (CTCAE v5), and timing
Objective response rate (ORR) in Part 2 Expansion
Time frame: Baseline through 2 years or disease progression
Tumor response as assessed using RECIST 1.1
13 secondary outcomes
Objective response rate (ORR) in dose escalation (Part 1A and Part 1B)
Time frame: Baseline through 2 years or disease progression
Duration of tumor response
Time frame: Baseline through 2 years or disease progression
Progression free survival (PFS)
Time frame: Baseline through 2 years or disease progression
Cmax (maximum concentration) of PF-07820435 and its active metabolite
Time frame: Serial timepoints following the first dose (Day 1), second dose (Day 8), and third dose (Day 15) of the first cycle (each cycle is 28 days); and Day 1 (dosing) of Cycle 2 and Day 1 (dosing) of Cycle 3.
Tmax (time to maximal plasma concentration) of PF-07820435 and its active metabolite
Time frame: Serial timepoints following the first dose (Day 1), second dose (Day 8), and third dose (Day 15) of the first cycle (each cycle is 28 days); and Day 1 (dosing) of Cycle 2 and Day 1 (dosing) of Cycle 3.
AUClast (area under the curve from time 0 to the last measurable timepoint) of PF-07820435 and its active metabolite
Time frame: Serial timepoints following the first dose (Day 1), second dose (Day 8), and third dose (Day 15) of the first cycle (each cycle is 28 days); and Day 1 (dosing) of Cycle 2 and Day 1 (dosing) of Cycle 3.
Cmin (minimum concentration) of PF-07820435 and its active metabolite after multiple dosing only
Time frame: Serial timepoints following the first dose (Day 1), second dose (Day 8), and third dose (Day 15) of the first cycle (each cycle is 28 days); and Day 1 (dosing) of Cycle 2 and Day 1 (dosing) of Cycle 3.
Change from baseline of immune markers within biopsied tumor tissue
Time frame: Baseline through about 6 weeks after first dose
Pre-dose trough concentrations of sasanlimab (Part 1B and Part 2)
Time frame: Day 1 (pre-dose) of each cycle (28 days) for the first 3 cycles, then Day 1 on every 3rd cycle until 2 years or disease progression
Incidence and titers of ADA and NAb against sasanlimab (Part 1B and Part 2)
Time frame: Day 1 (pre-dose) of each cycle (28 days) for the first 3 cycles, then Day 1 on every 3rd cycle until 2 years or disease progression
Cmax of PF-07820435 and its active metabolite under fasted and fed conditions (Part 2 subset) subset of participants in Part 2
Time frame: On Day 1 (first dose) and Day 15 (third dose): Pre-dose, 0.5 hour (h), 1h, 2h, 4h, 6h, and 24h post dose.
Tmax of PF-07820435 and its active metabolite under fasted and fed conditions (Part 2 subset) subset of participants in Part 2
Time frame: On Day 1 (first dose) and Day 15 (third dose): Pre-dose, 0.5 hour (h), 1h, 2h, 4h, 6h, and 24h post dose.
AUC of PF-07820435 and its active metabolite under fasted and fed conditions (Part 2 subset) subset of participants in Part 2
Time frame: On Day 1 (first dose) and Day 15 (third dose): Pre-dose, 0.5 hour (h), 1h, 2h, 4h, 6h, and 24h post dose.
Results and safety
The study was stopped early (reason given: The trial was terminated for strategic business reasons; the decision was not based on any safety and/or efficacy concerns.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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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.
Pfizer CT.gov Call Center study director
Pfizer
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PF-07820435 and Sasanlimab in people with Neoplasms and Non-small-cell Lung Cancer, run by Pfizer at 10 sites in 3 countries.
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 6 inclusion and 4 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 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Japan, Puerto Rico. 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: The trial was terminated for strategic business reasons; the decision was not based on any safety and/or efficacy concerns.). 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?
Number of patients with dose limiting toxicities (DLTs) in dose escalation (Part 1A and Part 1B) (time frame: Baseline through 28 days after first dose). The study lists 4 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 17 Sep 2025.