Solid TumorsPhase 1NCT07558200
Phase Ia/Ib Study of FXB0871 Monotherapy in Locally Advanced/Metastatic Solid Tumors
A Phase 1 study testing Intervention1：FXB0871, Intervention2：FXB0871 and Intervention3：FXB0871 in people with Solid Tumors and Non-Small Cell Lung Cancer, run by Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. at 1 site in China.
Trial summary
This is a phase 1a/1b, open-label, multicenter, dose-escalation and dose-expansion study evaluating the safety, tolerability, antitumor activity, pharmacokinetics, and pharmacodynamics of FXB0871 monotherapy in adults with selected locally advanced or metastatic solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors, Non-Small Cell Lung Cancer, Hepatocellular Carcinoma
- What is being tested?
- Intervention1：FXB0871, Intervention2：FXB0871 and Intervention3：FXB0871
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2026to 18 Nov 2030
- Phase
- Phase 1
- 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
- Signed informed consent.
- Age ≥18 years.
- Histologically confirmed selected locally advanced or metastatic solid tumor with progression on, intolerance to, or no suitable standard therapy.
- ECOG performance status 0 or 1.
- At least one measurable lesion per RECIST v1.1.
- Pretreatment tumor tissue available (archival or fresh biopsy).
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- Life expectancy ≥12 weeks.
- Oxygen saturation ≥92% on room air.
- Left ventricular ejection fraction >50%.
- Adequate hematologic, coagulation, renal, hepatic, and cardiac function.
- Women of childbearing potential and sexually active men must use highly effective contraception.
- Tumor-specific eligibility applies, including prior anti-PD-(L)1 treatment failure for the selected cohorts.
Who cannot join
- Systemic anti-cancer therapy, major surgery, or radical radiotherapy within 4 weeks before first dose.
- Prior treatment with IL-2, IL-15, or IL-7.
- Active autoimmune disease requiring systemic treatment or immunodeficiency.
- Systemic corticosteroids (≥10 mg/day prednisone equivalent) or other immunosuppressive therapy within 28 days before first dose, with limited protocol-defined exceptions.
- Active or untreated central nervous system metastases, carcinomatous meningitis, or leptomeningeal disease.
- Uncontrolled infection or clinically significant unresolved toxicities from prior therapy.
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- Clinically significant cardiovascular/cerebrovascular disease, uncontrolled effusions/ascites, uncontrolled hypertension, or QTcF >470 ms.
- Active hepatitis B/C, syphilis, or HIV infection.
- Clinically significant interstitial lung disease or active noninfectious pneumonitis.
- Pregnancy or breastfeeding.
- Any other serious medical or psychiatric condition that, in the investigator's judgment, would make participation inappropriate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai East Hospital
Shanghai, Shanghai Municipality, 200000
Caicun Zhou, +86 13301825532, caicunzhoudr@163.com
Fei Zhou, +86 13801751704, story185@126.com
About this study
Official title: A Phase 1a/1b Open-Label, Multicenter, Dose Escalation, and Dose Expansion Trial to Evaluate the Safety, Anti-tumor Activity, Pharmacokinetic/Pharmacodynamic Characteristics of FXB0871 as Monotherapy in Participants With Selected Locally Advanced or Metastatic Solid Tumors
This is a phase 1a/1b, open-label, multicenter, dose-escalation and dose-expansion study evaluating the safety, tolerability, antitumor activity, pharmacokinetics, and pharmacodynamics of FXB0871 monotherapy in adults with selected locally advanced or metastatic solid tumors. In Part Ia, participants with selected solid tumors that have progressed after, are intolerant to, or are not suitable for standard therapy will receive FXB0871 in dose-escalation cohorts to determine the maximum tolerated dose and/or recommended phase 2 dose. In Part Ib, participants with PD-(L)1-resistant non-small cell lung cancer or hepatocellular carcinoma will receive FXB0871 in dose-expansion cohorts to further evaluate antitumor activity, safety, and dose optimization.
Read the detailed description
This first-in-human study consists of a dose-escalation part (Part Ia) and a dose-expansion part (Part Ib). In Part Ia, adults with selected locally advanced or metastatic solid tumors will receive FXB0871 monotherapy by intravenous infusion every 2 weeks in sequential pre-determinde dose cohorts using a Bayesian optimal interval design. The planned dosing schedule is every 2 weeks, with a dose-limiting toxicity observation period of the first 2 treatment cycles. Additional intermediate dose levels, cohort expansion, and schedule optimization to every 3 or 4 weeks may be allowed according to protocol-defined safety, PK/PD, and preliminary antitumor activity data.
Part Ib will start after determination of the monotherapy recommended phase 2 dose (RP2D). Cohort A will enroll participants with PD-(L)1-resistant locally advanced or metastatic non-small cell lung cancer and randomize them 1:1 to receive FXB0871 at the RP2D or at a lower dose selected on the basis of Part Ia data. Cohort B will enroll participants with PD-(L)1-resistant locally advanced or metastatic hepatocellular carcinoma to receive FXB0871 at the RP2D. Participants may continue study treatment for up to 12 months or until unacceptable toxicity, disease progression, or another protocol-defined discontinuation criterion is met.
- Being tested
- Intervention1：FXB0871, Intervention2：FXB0871, Intervention3：FXB0871, Intervention4：FXB0871
- Keywords
- FXB0871, TEV-56278, PD-1, IL-2, Dose Escalation, Dose Expansion
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention1：FXB0871Biological
Also called TEV-56278
FXB0871 is administered by intravenous infusion at pre-determined dose level in Part Ia every 2 weeks. Treatment may continue for up to 12 months or until unacceptable toxicity, disease progression, or another protocol-defined discontinuation criterion is met.
Intervention2：FXB0871Biological
Also called TEV-56278
FXB0871 is administered by intravenous infusion at pre-determined dose level in Phase Ib every 2 weeks. Treatment may continue for up to 12 months or until unacceptable toxicity, disease progression, or another protocol-defined discontinuation criterion is met.
Intervention3：FXB0871Biological
Also called TEV-56278
FXB0871 is administered by intravenous infusion at pre-determined dose level in Phase Ib every 2 weeks. Treatment may continue for up to 12 months or until unacceptable toxicity, disease progression, or another protocol-defined discontinuation criterion is met.
Intervention4：FXB0871Biological
Also called TEV-56278
FXB0871 is administered by intravenous infusion at pre-determined dose level in Phase Ib every 2 weeks. Treatment may continue for up to 12 months or until unacceptable toxicity, disease progression, or another protocol-defined discontinuation criterion is met.
| Study group | Role | What they receive |
|---|---|---|
| Arm1：Part Ia Dose Escalation | Experimental | Participants with selected locally advanced or metastatic solid tumors will receive FXB0871 monotherapy by intravenous infusion every 2 weeks in sequential pre-determined dose-escalation cohorts or at intermediate dose levels every 2 weeks Receives: Biological: Intervention1：FXB0871 |
| Arm2：Part Ib Dose Expansion (NSCLC, RP2D) | Experimental | Participants with locally advanced or metastatic IO-resistant NSCLC will be randomized 1:1 to receive FXB0871 monotherapy at RP2D from Phase Ia by intravenous infusion every 2 weeks Receives: Biological: Intervention2：FXB0871 |
| Arm3：Part Ib Dose Expansion(NSCLC, <RP2D) | Experimental | Participants with locally advanced or metastatic IO-resistant NSCLC will be randomized 1:1 to receive FXB0871 monotherapy at a selected lower dose than RP2D from Phase Ia by intravenous infusion every 2 weeks Receives: Biological: Intervention3：FXB0871 |
| Arm4：Part Ib Dose Expansion(HCC, RP2D) | Experimental | Participants with locally advanced or metastatic IO-resistant HCC will receive FXB0871 monotherapy at RP2D from Phase Ia by intravenous infusion every 2 weeks Receives: Biological: Intervention4：FXB0871 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of dose-limiting toxicities (DLTs) in Phase Ia
Percentage of participants with protocol-defined DLTs during the DLT observation period in the dose-escalation phase
Measured: First 2 cycles after first dose (each cycle = 14 days; approximately 28 days).
Incidence and severity of adverse events (AEs), serious adverse events (SAEs), AEs leading to dose delay/interruption/reduction/treatment discontinuation in Phase Ia
Safety assessed by the incidence of treatment-emergent adverse events, serious adverse events, AEs leading to dose delay/interruption/reduction/treatment discontinuation in Phase Ia.
Measured: From first dose through 90 days after last dose or initiation of new anti-tumor therapy, whichever occurs first
Objective response rate (ORR) in Phase Ib
ORR defined as the proportion of participants with a best overall response of complete response (CR) or partial response (PR) per RECIST v1.1 in Phase Ib.
Measured: From first dose until disease progression, start of new anti-tumor therapy, withdrawal, death, or end of study (assessed every 8±1 weeks; approximately up to 24 months).
Secondary outcomes (22)
Objective response rate (ORR) in Phase Ia
Objective response rate (ORR), defined as the proportion of participants with a best overall response of complete response (CR) or partial response (PR), as assessed per RECIST v1.1 in Phase Ia.
Measured: From first dose until disease progression, start of new anti-tumor therapy, withdrawal, death, or end of study, whichever occurs first (tumor assessments every 8 ± 1 weeks; approximately up to 24 months).
Disease control rate (DCR) in Phase Ia
Disease control rate (DCR), defined as the proportion of participants with a best overall response of CR, PR, or stable disease (SD), as assessed per RECIST v1.1 in Phase Ia.
Measured: From first dose until disease progression, start of new anti-tumor therapy, withdrawal, death, or end of study, whichever occurs first (tumor assessments every 8 ± 1 weeks; approximately up to 24 months).
Duration of response (DOR) in Phase Ia
Duration of response (DOR), defined for participants with confirmed CR or PR as the time from first documented response to first documented disease progression or death from any cause, whichever occurs first, as assessed per RECIST v1.1 in Phase Ia.
Measured: From first documented CR or PR until first documented disease progression or death from any cause, whichever occurs first (approximately up to 24 months).
Progression-free survival (PFS) in Phase Ia
Progression-free survival (PFS), defined as the time from first dose to first documented disease progression or death from any cause, whichever occurs first, as assessed per RECIST v1.1 in Phase Ia.
Measured: From first dose until first documented disease progression or death from any cause, whichever occurs first (approximately up to 24 months).
Peak serum concentration (Cmax)
Maximum observed concentration
Measured: Predose up to Day 8
Time to maximum observed concentration (Tmax)
Time to maximum observed drug concentration
Measured: Predose up to Day 8
Area under the serum concentration-time curve (AUC0-last)
Area under the serum concentration-time curve from time 0 to last measurable drug concentration
Measured: Predose up to Day 8
Area under the serum concentration-time curve (AUC0-∞)
Area under the concentration-time curve from time zero (pre-dose) extrapolation to infinite time
Measured: Predose up to Day 8
Area under the serum concentration-time curve (AUCtau)
Area under the concentration-time curve over the dosing interval
Measured: Predose up to Day 8
Trough concentration (Ctrough)
Observed concentration at the end of a dosing interval, immediately before next administration
Measured: up to Day 8
Clearance (CL)
Systemic (total body) clearance following iv administration
Measured: Predose up to Day 8
Volume of distribution (Vz)
Volume of distribution following iv administration
Measured: Predose up to Day 8
Half-life (t1/2)
Terminal phase half-life
Measured: Predose up to Day 8
Average concentration (Cavg)
Average concentration over a dosing interval
Measured: Predose up to Day 8
Accumulation ratio (Rac)
Accumulation ratio
Measured: Predose up to Day 8
Incidence and severity of AEs/SAEs and AEs leading to dose modification or discontinuation in Phase Ib
Safety and tolerability in the dose-expansion phase.
Measured: From first dose through 90 days after last dose or initiation of new anti-tumor therapy, whichever occurs first.
ORR by modified RECIST (mRECIST) in the HCC cohort of Phase Ib
ORR in participants with hepatocellular carcinoma assessed by mRECIST.
Measured: From first dose until disease progression, start of new anti-tumor therapy, withdrawal, death, or end of study (assessed every 8±1 weeks; approximately up to 24 months).
Disease control rate (DCR) in Phase Ib
Disease control rate (DCR), defined as the proportion of participants with a best overall response of CR, PR, or SD, as assessed per RECIST v1.1 in Phase Ib.
Measured: From first dose until disease progression, start of new anti-tumor therapy, withdrawal, death, or end of study, whichever occurs first (tumor assessments every 8 ± 1 weeks; approximately up to 24 months).
Time to response (TTR) in Phase Ib
Time to response (TTR), defined as the time from first dose to the first documented CR or PR, as assessed per RECIST v1.1 in Phase Ib.
Measured: From first dose to first documented CR or PR (tumor assessments every 8 ± 1 weeks; approximately up to 24 months).
Duration of response (DOR) in Phase Ib
Duration of response (DOR), defined for participants with confirmed CR or PR as the time from first documented response to first documented disease progression or death from any cause, whichever occurs first, as assessed per RECIST v1.1 in Phase Ib.
Measured: From first documented CR or PR until first documented disease progression or death from any cause, whichever occurs first (approximately up to 24 months).
Title:Progression-free survival (PFS) in Phase Ib
Progression-free survival (PFS), defined as the time from first dose to first documented disease progression or death from any cause, whichever occurs first, as assessed per RECIST v1.1 in Phase Ib.
Measured: From first dose until first documented disease progression or death from any cause, whichever occurs first (approximately up to 24 months).
Overall survival (OS) in Phase Ib
Overall survival measured from first dose to death from any cause.
Measured: From first dose until death from any cause (approximately up to 24 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start15 May 2026 (estimated)
- Primary completion23 Apr 2030 (estimated)
- Study completion18 Nov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- More trials run by Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.The 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07558200
- Sponsor's protocol ID
- FXB0871-I101
- Status last verified
- Apr 2026
- First submitted
- 7 Apr 2026
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1a/1b Open-Label, Multicenter, Dose Escalation, and Dose Expansion Trial to Evaluate the Safety, Anti-tumor Activity, Pharmacokinetic/Pharmacodynamic Characteristics of FXB0871 as Monotherapy in Participants With Selected Locally Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT07558200
- Acronym / sponsor ID
- FXB0871-I101
- Keywords
- FXB0871, TEV-56278, PD-1, IL-2, Dose Escalation, Dose Expansion
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 May 2026 (estimated)
- Primary completion
- 23 Apr 2030 (estimated)
- Study completion
- 18 Nov 2030 (estimated)
- First posted
- 30 Apr 2026 (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 1a/1b, open-label, multicenter, dose-escalation and dose-expansion study evaluating the safety, tolerability, antitumor activity, pharmacokinetics, and pharmacodynamics of FXB0871 monotherapy in adults with selected locally advanced or metastatic solid tumors. In Part Ia, participants with selected solid tumors that have progressed after, are intolerant to, or are not suitable for standard therapy will receive FXB0871 in dose-escalation cohorts to determine the maximum tolerated dose and/or recommended phase 2 dose. In Part Ib, participants with PD-(L)1-resistant non-small cell lung cancer or hepatocellular carcinoma will receive FXB0871 in dose-expansion cohorts to further evaluate antitumor activity, safety, and dose optimization.
Detailed description
This first-in-human study consists of a dose-escalation part (Part Ia) and a dose-expansion part (Part Ib). In Part Ia, adults with selected locally advanced or metastatic solid tumors will receive FXB0871 monotherapy by intravenous infusion every 2 weeks in sequential pre-determinde dose cohorts using a Bayesian optimal interval design. The planned dosing schedule is every 2 weeks, with a dose-limiting toxicity observation period of the first 2 treatment cycles. Additional intermediate dose levels, cohort expansion, and schedule optimization to every 3 or 4 weeks may be allowed according to protocol-defined safety, PK/PD, and preliminary antitumor activity data.
Part Ib will start after determination of the monotherapy recommended phase 2 dose (RP2D). Cohort A will enroll participants with PD-(L)1-resistant locally advanced or metastatic non-small cell lung cancer and randomize them 1:1 to receive FXB0871 at the RP2D or at a lower dose selected on the basis of Part Ia data. Cohort B will enroll participants with PD-(L)1-resistant locally advanced or metastatic hepatocellular carcinoma to receive FXB0871 at the RP2D. Participants may continue study treatment for up to 12 months or until unacceptable toxicity, disease progression, or another protocol-defined discontinuation criterion is met.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm1：Part Ia Dose Escalation | Experimental | Biological: Intervention1：FXB0871Participants with selected locally advanced or metastatic solid tumors will receive FXB0871 monotherapy by intravenous infusion every 2 weeks in sequential pre-determined dose-escalation cohorts or at intermediate dose levels every 2 weeks |
| Arm2：Part Ib Dose Expansion (NSCLC, RP2D) | Experimental | Biological: Intervention2：FXB0871Participants with locally advanced or metastatic IO-resistant NSCLC will be randomized 1:1 to receive FXB0871 monotherapy at RP2D from Phase Ia by intravenous infusion every 2 weeks |
| Arm3：Part Ib Dose Expansion(NSCLC, <RP2D) | Experimental | Biological: Intervention3：FXB0871Participants with locally advanced or metastatic IO-resistant NSCLC will be randomized 1:1 to receive FXB0871 monotherapy at a selected lower dose than RP2D from Phase Ia by intravenous infusion every 2 weeks |
| Arm4：Part Ib Dose Expansion(HCC, RP2D) | Experimental | Biological: Intervention4：FXB0871Participants with locally advanced or metastatic IO-resistant HCC will receive FXB0871 monotherapy at RP2D from Phase Ia by intravenous infusion every 2 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Signed informed consent.
- Age ≥18 years.
- Histologically confirmed selected locally advanced or metastatic solid tumor with progression on, intolerance to, or no suitable standard therapy.
- ECOG performance status 0 or 1.
- At least one measurable lesion per RECIST v1.1.
Key exclusion criteria (11 listed)
- Systemic anti-cancer therapy, major surgery, or radical radiotherapy within 4 weeks before first dose.
- Prior treatment with IL-2, IL-15, or IL-7.
- Active autoimmune disease requiring systemic treatment or immunodeficiency.
- Systemic corticosteroids (≥10 mg/day prednisone equivalent) or other immunosuppressive therapy within 28 days before first dose, with limited protocol-defined exceptions.
- Active or untreated central nervous system metastases, carcinomatous meningitis, or leptomeningeal disease.
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 |
|---|---|---|
| Intervention1：FXB0871Also: TEV-56278FXB0871 is administered by intravenous infusion at pre-determined dose level in Part Ia every 2 weeks. Treatment may continue for up to 12 months or until unacceptable toxicity, disease progression, or another protocol-defined discontinuation criterion is met. | Biological | Arm1：Part Ia Dose Escalation |
| Intervention2：FXB0871Also: TEV-56278FXB0871 is administered by intravenous infusion at pre-determined dose level in Phase Ib every 2 weeks. Treatment may continue for up to 12 months or until unacceptable toxicity, disease progression, or another protocol-defined discontinuation criterion is met. | Biological | Arm2：Part Ib Dose Expansion (NSCLC, RP2D) |
| Intervention3：FXB0871Also: TEV-56278FXB0871 is administered by intravenous infusion at pre-determined dose level in Phase Ib every 2 weeks. Treatment may continue for up to 12 months or until unacceptable toxicity, disease progression, or another protocol-defined discontinuation criterion is met. | Biological | Arm3：Part Ib Dose Expansion(NSCLC, <RP2D) |
| Intervention4：FXB0871Also: TEV-56278FXB0871 is administered by intravenous infusion at pre-determined dose level in Phase Ib every 2 weeks. Treatment may continue for up to 12 months or until unacceptable toxicity, disease progression, or another protocol-defined discontinuation criterion is met. | Biological | Arm4：Part Ib Dose Expansion(HCC, RP2D) |
Primary outcome
Incidence and severity of dose-limiting toxicities (DLTs) in Phase Ia
Time frame: First 2 cycles after first dose (each cycle = 14 days; approximately 28 days).
Percentage of participants with protocol-defined DLTs during the DLT observation period in the dose-escalation phase
Incidence and severity of adverse events (AEs), serious adverse events (SAEs), AEs leading to dose delay/interruption/reduction/treatment discontinuation in Phase Ia
Time frame: From first dose through 90 days after last dose or initiation of new anti-tumor therapy, whichever occurs first
Safety assessed by the incidence of treatment-emergent adverse events, serious adverse events, AEs leading to dose delay/interruption/reduction/treatment discontinuation in Phase Ia.
Objective response rate (ORR) in Phase Ib
Time frame: From first dose until disease progression, start of new anti-tumor therapy, withdrawal, death, or end of study (assessed every 8±1 weeks; approximately up to 24 months).
ORR defined as the proportion of participants with a best overall response of complete response (CR) or partial response (PR) per RECIST v1.1 in Phase Ib.
22 secondary outcomes
Objective response rate (ORR) in Phase Ia
Time frame: From first dose until disease progression, start of new anti-tumor therapy, withdrawal, death, or end of study, whichever occurs first (tumor assessments every 8 ± 1 weeks; approximately up to 24 months).
Disease control rate (DCR) in Phase Ia
Time frame: From first dose until disease progression, start of new anti-tumor therapy, withdrawal, death, or end of study, whichever occurs first (tumor assessments every 8 ± 1 weeks; approximately up to 24 months).
Duration of response (DOR) in Phase Ia
Time frame: From first documented CR or PR until first documented disease progression or death from any cause, whichever occurs first (approximately up to 24 months).
Progression-free survival (PFS) in Phase Ia
Time frame: From first dose until first documented disease progression or death from any cause, whichever occurs first (approximately up to 24 months).
Peak serum concentration (Cmax)
Time frame: Predose up to Day 8
Time to maximum observed concentration (Tmax)
Time frame: Predose up to Day 8
Area under the serum concentration-time curve (AUC0-last)
Time frame: Predose up to Day 8
Area under the serum concentration-time curve (AUC0-∞)
Time frame: Predose up to Day 8
Area under the serum concentration-time curve (AUCtau)
Time frame: Predose up to Day 8
Trough concentration (Ctrough)
Time frame: up to Day 8
Clearance (CL)
Time frame: Predose up to Day 8
Volume of distribution (Vz)
Time frame: Predose up to Day 8
Half-life (t1/2)
Time frame: Predose up to Day 8
Average concentration (Cavg)
Time frame: Predose up to Day 8
Accumulation ratio (Rac)
Time frame: Predose up to Day 8
Incidence and severity of AEs/SAEs and AEs leading to dose modification or discontinuation in Phase Ib
Time frame: From first dose through 90 days after last dose or initiation of new anti-tumor therapy, whichever occurs first.
ORR by modified RECIST (mRECIST) in the HCC cohort of Phase Ib
Time frame: From first dose until disease progression, start of new anti-tumor therapy, withdrawal, death, or end of study (assessed every 8±1 weeks; approximately up to 24 months).
Disease control rate (DCR) in Phase Ib
Time frame: From first dose until disease progression, start of new anti-tumor therapy, withdrawal, death, or end of study, whichever occurs first (tumor assessments every 8 ± 1 weeks; approximately up to 24 months).
Time to response (TTR) in Phase Ib
Time frame: From first dose to first documented CR or PR (tumor assessments every 8 ± 1 weeks; approximately up to 24 months).
Duration of response (DOR) in Phase Ib
Time frame: From first documented CR or PR until first documented disease progression or death from any cause, whichever occurs first (approximately up to 24 months).
Title:Progression-free survival (PFS) in Phase Ib
Time frame: From first dose until first documented disease progression or death from any cause, whichever occurs first (approximately up to 24 months).
Overall survival (OS) in Phase Ib
Time frame: From first dose until death from any cause (approximately up to 24 months).
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 30 Apr 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Intervention1：FXB0871, Intervention2：FXB0871 and Intervention3：FXB0871 in people with Solid Tumors and Non-Small Cell Lung Cancer, run by Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. at 1 site in China.
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 12 inclusion and 11 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: opening soon, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
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 Caicun Zhou (+86 13301825532, caicunzhoudr@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of dose-limiting toxicities (DLTs) in Phase Ia (time frame: First 2 cycles after first dose (each cycle = 14 days; approximately 28 days).). The study lists 3 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 30 Apr 2026.