Advanced Solid TumorPhase 1/2NCT05761223
A Phase I/II, Open-label Study to Investigate the Safety, Tolerability, PK, and Preliminary Efficacy of FB849
A Phase 1/2 study testing Phase Ia dose-escalation part of FB849 Monotherapy, Phase Ib dose-expansion of FB849 monotherapy and Phase IIb dose-escalation part of FB849 in Combination with Pembrolizumab in people with Advanced Solid Tumor, run by 1ST Biotherapeutics, Inc. at 5 sites in United States.
Trial summary
This is the first-in-human, multicenter, open-label Phase I/II study to investigate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of FB849 alone and in combination with pembrolizumab in subjects with advanced solid tumors for whom no standard therapy is available. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- Phase Ia dose-escalation part of FB849 Monotherapy, Phase Ib dose-expansion of FB849 monotherapy and Phase IIb dose-escalation part of FB849 in Combination with Pembrolizumab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 5 sitesUnited States
- Study dates
- 13 Dec 2023to Oct 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
- Subject should understand, sign, and date the written ICF prior to screening.
- Male or female aged 18 years or older.
- Subjects must have at least 1 measurable target lesion according to RECIST version 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Life expectancy ≥ 3 months in the opinion of the investigator.
- Adequate organ function and bone marrow function as indicated by the following screening assessments performed within 14 days prior to the first dose of study treatment
Who cannot join
- Known allergy or hypersensitivity to any component of the study treatment.
- Has a known additional malignancy that is progressing or has required active treatment.
- Has abnormal or inadequately controlled endocrine function.
- Inability to take oral medication or significant nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate absorption of oral medication.
- Previous anti-cancer therapy, including chemotherapy (chemotherapy with nitrosourea or mitomycin should be at least 6 weeks prior to initiation of study treatment), radiotherapy, molecular targeted therapy, or other investigational drugs received ≤ 4 weeks; endocrine therapy ≤ 2 weeks or ≤ 5-half-lives (whichever is shorter) prior to initiation of study treatment.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Wen Wee Ma
- Recruiting
Mary Crowley Cancer Research Center
Dallas, Texas, 40118
Douglas Orr
- Recruiting
Next Oncology Virginia
Fairfax, Virginia, 22031
Mohamad Adham Salkeni
- Recruiting
NEXT Oncology San Antonio
San Antonio, Texas, 78229
Ildefonso Rodriguez Rivera
- Recruiting
Summit Cancer Centers - Spokane Valley
Spokane, Washington, 99208
Arvind Chaudhry
About this study
Official title: A Phase I/II, Open-label Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of FB849 Administered in Subjects With Advanced Solid Tumors Alone and in Combination With Pembrolizumab
This is the first-in-human, multicenter, open-label Phase I/II study to investigate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of FB849 alone and in combination with pembrolizumab in subjects with advanced solid tumors for whom no standard therapy is available.
Read the detailed description
The study will be conducted in 3 parts: Phase I dose-escalation part with FB849 monotherapy and Phase II dose-escalation and dose-expansion parts of FB849 in combination with pembrolizumab.
The Phase Ia dose-escalation part will use an adaptive study design termed Bayesian optimal interval (BOIN) design to investigate the safety and tolerability of FB849, and determine the maximum tolerated dose (MTD) and preliminary recommended Phase II dose (RP2D) of FB849. A BOIN design is a hybrid of rule-based and model-based design, which has the flexibility of dose escalation and de-escalation and allows more subjects to be enrolled into the doses closest to the target toxicity rate.
Phase IIa enrollment will be initiated after Stage 1 of Phase Ib is completed. The selected RP2D from the prior Phase Ib part and a dose level ≥ 1 dose lower than the RP2D of FB849 will be selected by the SMC and will be evaluated in combination with a standard dose of pembrolizumab. Dose escalation will follow a BOIN design, but with at least 6 subjects at each FB849 dose level.
In the Phase IIb part of the study, subjects with Type A cancer, Type B cancer, or Type C cancer will be enrolled in 3 cohorts to evaluate FB849 at the RP2D in combination with a standard dose of pembrolizumab to provide assessments of safety and anti-tumor activity of FB849. Both Phase II parts will also explore the impact of FB849 on pharmacodynamics and metabolites when in combination with pembrolizumab. Enrollment to Phase IIb will follow a Simon's two -stage design enrollment.
Subjects will be monitored for safety, tolerability, and preliminary efficacy throughout the study. Tumor response will be assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 approximately every 6 weeks (± 3 days) in the first 18 weeks, then every 9 weeks (± 7 days) thereafter until disease progression, using computed tomography or magnetic resonance imaging of the chest, abdomen/pelvis, and if clinically indicated additional assessments eg, craniocerebral imaging, bone scan. Treatment with FB849 will continue until the start of a new anti-cancer treatment, disease progression, subject refusal, unacceptable toxicity, death, lost to follow-up, etc, whichever occurs first. Subjects who discontinue treatment due to other reasons than disease progression will continue with tumor assessments as per protocol until disease progression, death, or starting a new anti-cancer treatment.
- Conditions
- Advanced Solid Tumor
- Being tested
- Phase Ia dose-escalation part of FB849 Monotherapy, Phase Ib dose-expansion of FB849 monotherapy, Phase IIb dose-escalation part of FB849 in Combination with Pembrolizumab, Phase IIb dose-expansion part of FB849 in Combination with Pembrolizumab (Type A cancer), Phase IIb dose-expansion part of FB849 in Combination with Pembrolizumab (Type B cancer)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phase Ia dose-escalation part of FB849 MonotherapyDrug
Also called FB849
At a given level dose once daily
Phase Ib dose-expansion of FB849 monotherapyDrug
Also called FB849
At recommended dose for expansion cohort once daily
Phase IIb dose-escalation part of FB849 in Combination with PembrolizumabDrug
Also called FB849, KEYTRUDA®
At recommended dose for expansion cohort once daily in combination with pembrolizumab
Phase IIb dose-expansion part of FB849 in Combination with Pembrolizumab (Type A cancer)Drug
Also called FB849, KEYTRUDA®
At recommended dose for expansion cohort once daily in combination with pembrolizumab
Phase IIb dose-expansion part of FB849 in Combination with Pembrolizumab (Type B cancer)Drug
Also called FB849, KEYTRUDA®
At recommended dose for expansion cohort once daily in combination with pembrolizumab
Phase IIb dose-expansion part of FB849 in Combination with Pembrolizumab (Type C cancer)Drug
Also called FB849, KEYTRUDA®
At recommended dose for expansion cohort once daily in combination with pembrolizumab
| Study group | Role | What they receive |
|---|---|---|
| Phase Ia dose-escalation part of FB849 Monotherapy | Experimental | Participations will receive FB849 orally once a day. Receives: Drug: Phase Ia dose-escalation part of FB849 Monotherapy |
| Phase Ib dose-expansion of FB849 monotherapy | Experimental | Participations will receive FB849 orally once a day. Receives: Drug: Phase Ib dose-expansion of FB849 monotherapy |
| Phase IIa dose-escalation part of FB849 in Combination with Pembrolizumab | Experimental | Participations will receive FB849 orally once a day in combination with pembrolizumab. Receives: Drug: Phase IIb dose-escalation part of FB849 in Combination with Pembrolizumab |
| Phase IIb dose-expansion part of FB849 in Combination with Pembrolizumab (Type A cancer) | Experimental | Participations will receive FB849 orally once a day in combination with pembrolizumab. Receives: Drug: Phase IIb dose-expansion part of FB849 in Combination with Pembrolizumab (Type A cancer) |
| Phase IIb dose-expansion part of FB849 in Combination with Pembrolizumab (Type B cancer) | Experimental | Participations will receive FB849 orally once a day in combination with pembrolizumab. Receives: Drug: Phase IIb dose-expansion part of FB849 in Combination with Pembrolizumab (Type B cancer) |
| Phase IIb dose-expansion part of FB849 in Combination with Pembrolizumab (Type C cancer) | Experimental | Participations will receive FB849 orally once a day in combination with pembrolizumab. Receives: Drug: Phase IIb dose-expansion part of FB849 in Combination with Pembrolizumab (Type C cancer) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety and tolerability of FB849 and to identify maximum tolerated dose (MTD)/ recommended Phase II dose (RP2D) and dosing schedule of FB849 in subjects with advanced solid tumors
The MTD is defined to be the highest safe dose with an estimated DLT rate less than 30.
Measured: DLT Assessment at the end of Cycle 1(each cycle is 21 days.)
Secondary outcomes (2)
To determine the pharmacokinetic parameters such as Peak Plasma Concentration (Cmax) of FB849
The PK parameters should include, where appropriate, area under the concentration-time curve (AUC), maximum observed concentration (Cmax), time to maximum observed concentration (tmax), and apparent terminal elimination half-life (t1/2), apparent total body clearance (CL/F), apparent volume of distribution (Vz/F), Cmax at steady state (Css-max), minimum observed concentration at steady state (Css-min), AUC at steady state (AUCss), accumulation ratio (Rac), amount excretion (Ae), fraction excretion (Fe), renal clearance (CLR).
Measured: Blood: Predose, 1, 2, 4, 8, 12, 24 hours postdose at C1D1 and C1D21; predose and 4, 8, and 24 hours postdose at C1D8; predose at C1D15; and predose on C2D1, C4D1, and C6D1, Urine: predose and 0-4 hour, 4-8 hour, 8-12 hour, 12-24 hour post-dose
To assess preliminary anti-tumor activity of FB849
Tumor response will be assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 using computed tomography (CT) or magnetic resonance imaging (MRI) of the chest, abdomen/pelvis, and additional assessments (e.g., craniocerebral imaging, bone scan) based on clinical indications.
Measured: every 6 weeks (± 3 days) in the first 18 weeks, then every 12 weeks (± 7 days) thereafter until disease progression assessed up to approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2023
- Study start13 Dec 2023
- Primary completionJun 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies 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
- Non-randomised
- Intervention model
- Single group
- Model description
- The study will be conducted in 3 parts: Phase I dose-escalation part with FB849 monotherapy and Phase II dose-escalation and dose-expansion parts of FB849 in combination with pembrolizumab
- Masking
- None (open label)
- Enrolment
- 151 participants (estimated)
Sponsor and investigators
- Lead sponsor
- 1ST Biotherapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- 1STBIO Chief Development Officer, Study director, 1ST Biotherapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05761223
- Sponsor's protocol ID
- FB849_P101
- Other IDs
- KEYNOTE-F25, MK-3475-F25
- Status last verified
- Aug 2025
- First submitted
- 20 Feb 2023
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Open-label Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of FB849 Administered in Subjects With Advanced Solid Tumors Alone and in Combination With Pembrolizumab
- ClinicalTrials.gov ID
- NCT05761223
- Acronym / sponsor ID
- FB849_P101
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 151 participants (estimated)
- Lead sponsor
- 1ST Biotherapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 13 Dec 2023 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 9 Mar 2023 (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 the first-in-human, multicenter, open-label Phase I/II study to investigate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of FB849 alone and in combination with pembrolizumab in subjects with advanced solid tumors for whom no standard therapy is available.
Detailed description
The study will be conducted in 3 parts: Phase I dose-escalation part with FB849 monotherapy and Phase II dose-escalation and dose-expansion parts of FB849 in combination with pembrolizumab.
The Phase Ia dose-escalation part will use an adaptive study design termed Bayesian optimal interval (BOIN) design to investigate the safety and tolerability of FB849, and determine the maximum tolerated dose (MTD) and preliminary recommended Phase II dose (RP2D) of FB849. A BOIN design is a hybrid of rule-based and model-based design, which has the flexibility of dose escalation and de-escalation and allows more subjects to be enrolled into the doses closest to the target toxicity rate.
Phase IIa enrollment will be initiated after Stage 1 of Phase Ib is completed. The selected RP2D from the prior Phase Ib part and a dose level ≥ 1 dose lower than the RP2D of FB849 will be selected by the SMC and will be evaluated in combination with a standard dose of pembrolizumab. Dose escalation will follow a BOIN design, but with at least 6 subjects at each FB849 dose level.
In the Phase IIb part of the study, subjects with Type A cancer, Type B cancer, or Type C cancer will be enrolled in 3 cohorts to evaluate FB849 at the RP2D in combination with a standard dose of pembrolizumab to provide assessments of safety and anti-tumor activity of FB849. Both Phase II parts will also explore the impact of FB849 on pharmacodynamics and metabolites when in combination with pembrolizumab. Enrollment to Phase IIb will follow a Simon's two -stage design enrollment.
Subjects will be monitored for safety, tolerability, and preliminary efficacy throughout the study. Tumor response will be assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 approximately every 6 weeks (± 3 days) in the first 18 weeks, then every 9 weeks (± 7 days) thereafter until disease progression, using computed tomography or magnetic resonance imaging of the chest, abdomen/pelvis, and if clinically indicated additional assessments eg, craniocerebral imaging, bone scan. Treatment with FB849 will continue until the start of a new anti-cancer treatment, disease progression, subject refusal, unacceptable toxicity, death, lost to follow-up, etc, whichever occurs first. Subjects who discontinue treatment due to other reasons than disease progression will continue with tumor assessments as per protocol until disease progression, death, or starting a new anti-cancer treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- The study will be conducted in 3 parts: Phase I dose-escalation part with FB849 monotherapy and Phase II dose-escalation and dose-expansion parts of FB849 in combination with pembrolizumab
| Arm | Type | Receives |
|---|---|---|
| Phase Ia dose-escalation part of FB849 Monotherapy | Experimental | Drug: Phase Ia dose-escalation part of FB849 MonotherapyParticipations will receive FB849 orally once a day. |
| Phase Ib dose-expansion of FB849 monotherapy | Experimental | Drug: Phase Ib dose-expansion of FB849 monotherapyParticipations will receive FB849 orally once a day. |
| Phase IIa dose-escalation part of FB849 in Combination with Pembrolizumab | Experimental | Drug: Phase IIb dose-escalation part of FB849 in Combination with PembrolizumabParticipations will receive FB849 orally once a day in combination with pembrolizumab. |
| Phase IIb dose-expansion part of FB849 in Combination with Pembrolizumab (Type A cancer) | Experimental | Drug: Phase IIb dose-expansion part of FB849 in Combination with Pembrolizumab (Type A cancer)Participations will receive FB849 orally once a day in combination with pembrolizumab. |
| Phase IIb dose-expansion part of FB849 in Combination with Pembrolizumab (Type B cancer) | Experimental | Drug: Phase IIb dose-expansion part of FB849 in Combination with Pembrolizumab (Type B cancer)Participations will receive FB849 orally once a day in combination with pembrolizumab. |
| Phase IIb dose-expansion part of FB849 in Combination with Pembrolizumab (Type C cancer) | Experimental | Drug: Phase IIb dose-expansion part of FB849 in Combination with Pembrolizumab (Type C cancer)Participations will receive FB849 orally once a day in combination with pembrolizumab. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject should understand, sign, and date the written ICF prior to screening.
- Male or female aged 18 years or older.
- Subjects must have at least 1 measurable target lesion according to RECIST version 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Life expectancy ≥ 3 months in the opinion of the investigator.
Key exclusion criteria (5 listed)
- Known allergy or hypersensitivity to any component of the study treatment.
- Has a known additional malignancy that is progressing or has required active treatment.
- Has abnormal or inadequately controlled endocrine function.
- Inability to take oral medication or significant nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate absorption of oral medication.
- Previous anti-cancer therapy, including chemotherapy (chemotherapy with nitrosourea or mitomycin should be at least 6 weeks prior to initiation of study treatment), radiotherapy, molecular targeted therapy, or other investigational drugs received ≤ 4 weeks; endocrine therapy ≤ 2 weeks or ≤ 5-half-lives (whichever is shorter) prior to initiation of study treatment.
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 |
|---|---|---|
| Phase Ia dose-escalation part of FB849 MonotherapyAlso: FB849At a given level dose once daily | Drug | Phase Ia dose-escalation part of FB849 Monotherapy |
| Phase Ib dose-expansion of FB849 monotherapyAlso: FB849At recommended dose for expansion cohort once daily | Drug | Phase Ib dose-expansion of FB849 monotherapy |
| Phase IIb dose-escalation part of FB849 in Combination with PembrolizumabAlso: FB849, KEYTRUDA®At recommended dose for expansion cohort once daily in combination with pembrolizumab | Drug | Phase IIa dose-escalation part of FB849 in Combination with Pembrolizumab |
| Phase IIb dose-expansion part of FB849 in Combination with Pembrolizumab (Type A cancer)Also: FB849, KEYTRUDA®At recommended dose for expansion cohort once daily in combination with pembrolizumab | Drug | Phase IIb dose-expansion part of FB849 in Combination with Pembrolizumab (Type A cancer) |
| Phase IIb dose-expansion part of FB849 in Combination with Pembrolizumab (Type B cancer)Also: FB849, KEYTRUDA®At recommended dose for expansion cohort once daily in combination with pembrolizumab | Drug | Phase IIb dose-expansion part of FB849 in Combination with Pembrolizumab (Type B cancer) |
| Phase IIb dose-expansion part of FB849 in Combination with Pembrolizumab (Type C cancer)Also: FB849, KEYTRUDA®At recommended dose for expansion cohort once daily in combination with pembrolizumab | Drug | Phase IIb dose-expansion part of FB849 in Combination with Pembrolizumab (Type C cancer) |
Primary outcome
To assess the safety and tolerability of FB849 and to identify maximum tolerated dose (MTD)/ recommended Phase II dose (RP2D) and dosing schedule of FB849 in subjects with advanced solid tumors
Time frame: DLT Assessment at the end of Cycle 1(each cycle is 21 days.)
The MTD is defined to be the highest safe dose with an estimated DLT rate less than 30.
2 secondary outcomes
To determine the pharmacokinetic parameters such as Peak Plasma Concentration (Cmax) of FB849
Time frame: Blood: Predose, 1, 2, 4, 8, 12, 24 hours postdose at C1D1 and C1D21; predose and 4, 8, and 24 hours postdose at C1D8; predose at C1D15; and predose on C2D1, C4D1, and C6D1, Urine: predose and 0-4 hour, 4-8 hour, 8-12 hour, 12-24 hour post-dose
To assess preliminary anti-tumor activity of FB849
Time frame: every 6 weeks (± 3 days) in the first 18 weeks, then every 12 weeks (± 7 days) thereafter until disease progression assessed up to approximately 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
- 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.
1STBIO Chief Development Officer study director
1ST Biotherapeutics
5 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 Phase Ia dose-escalation part of FB849 Monotherapy, Phase Ib dose-expansion of FB849 monotherapy and Phase IIb dose-escalation part of FB849 in Combination with Pembrolizumab in people with Advanced Solid Tumor, run by 1ST Biotherapeutics, Inc. at 5 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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact 1STBIO Information center (+82-31-895-4677, info@1stbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the safety and tolerability of FB849 and to identify maximum tolerated dose (MTD)/ recommended Phase II dose (RP2D) and dosing schedule of FB849 in subjects with advanced solid tumors (time frame: DLT Assessment at the end of Cycle 1(each cycle is 21 days.)). 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 Aug 2025.