Solid Tumor Refractory to Conventional TreatmentPhase 1FXS887-I101NCT07345637
Phase I Study of FXS887 in the Treatment of Solid Tumors
A Phase 1 study testing FXS887 in people with Solid Tumor Refractory to Conventional Treatment, run by Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. at 1 site in China.
Trial summary
This is a single-arm, open-label, dose-escalation and dose-expansion Phase I clinical trial evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of FXS887 in patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor Refractory to Conventional Treatment
- What is being tested?
- FXS887
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteChina
- Study dates
- 5 Jan 2026to 31 Dec 2027
- 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
- Aged ≥ 18 years, male or female;
- Participants must fully understand the requirements of the study and voluntarily sign the written informed consent;
- Participants with histologically/cytologically confirmed advanced solid tumors who have received ≥ 1 line of systemic therapy prior to enrollment in the study and experienced failure of standard therapy (disease progression or intolerance);
- Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, participants must have at least one measurable target lesion;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1;
- Estimated life expectancy of ≥ 12 weeks;
- Participants must have adequate organ and bone marrow function.
- For female participants of childbearing age, the serum pregnancy test within 7 days prior to the first dose of the study drug must be negative; eligible participants of reproductive potential (both males and females) must agree to use reliable contraceptive methods (hormonal, barrier, abstinence, etc.) with their partners during the study period and for at least 6 months after the last dose of the study drug.
Who cannot join
- Within the washout period of prior anti-tumor medication treatment (4 weeks or 5 half-lives after the last dose, whichever is longer) prior to the first dose of FXS887;
- Have participated in another clinical study within 4 weeks prior to the first dose of FXS887;
- Have a history of hypersensitivity to any known components of FXS887 or its analogues;
- Have intolerance to ATR inhibitors or have received ATR inhibitors within 4 weeks or 5 half-lives (whichever is longer) prior to the first dose of FXS887;
- Need to take strong CYP3A inhibitors and/or inducers, as well as P-gp (P-glycoprotein) inhibitors and/or inducers within 14 days (or 5 half-lives, whichever is longer) prior to the first dose of FXS887 and during the study period;
- Need to take drugs known to prolong the QTc interval during the study period;
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- Have had other malignant tumors within 2 years prior to the first dose of FXS887, except for local tumors that have been cured and judged by the investigator to have a low risk of recurrence;
- Have received radiation therapy within 14 days prior to the first dose of FXS887;
- Have not recovered from adverse events caused by prior anti-cancer treatment (recovered to Grade 1 or baseline), except for alopecia, pigmentation of any grade, Grade ≤2 peripheral sensory neuropathy, and items explicitly specified in the inclusion criteria;
- Have refractory nausea and vomiting, chronic gastrointestinal diseases including but not limited to active diverticulitis and symptomatic peptic ulcers, inability to swallow oral medications, or a history of extensive small bowel resection or other conditions that significantly impair gastrointestinal absorption as judged by the investigator;
- Have undergone major surgery within 2 weeks prior to the first dose or have not recovered from surgical complications;
- Have primary central nervous system (CNS) tumors, meningeal metastasis, spinal cord compression, or brainstem metastasis; participants with known untreated brain metastases or symptomatic or unstable disease are excluded; participants who have completed treatment for brain metastases (radiation therapy or surgery) with stable metastases and no relevant symptoms (without medication control) within 4 weeks prior to the first dose may be enrolled;
- Have severe cardiovascular diseases;
- Have uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage and medical intervention;
- Have active infections requiring treatment (e.g., participants are receiving anti-infective treatment) within 14 days prior to the first dose of FXS887, including Hepatitis C virus (HCV), Human Immunodeficiency Virus (HIV), uncontrolled active Hepatitis B virus (HBV) infection, syphilis infection, known active tuberculosis, etc.
- Known infection with hepatitis B virus (HBV) or hepatitis C virus (HCV):
- participants with controlled HBV infection (serum HBV-DNA < 500 IU/mL or < 2,000 copies/mL) are allowed to enroll in this study.
- participants who are HCV antibody-positive with controlled infection [polymerase chain reaction (PCR) for serum HCV-RNA below the lower limit of detection] are allowed to enroll in this study.
- History of human immunodeficiency virus (HIV) infection;
- History of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis requiring steroid therapy, or clinically active ILD;
- Known substance abuse or psychiatric disorder that may interfere with compliance with study requirements;
- Participants are pregnant, breastfeeding, or planning to become pregnant during the study period;
- Investigator considers the participant has other factors that may affect study results or interfere with participation in the entire study, including past or existing medical conditions, treatment or laboratory abnormalities, or unwillingness to comply with study procedures, restrictions, and requirements-any condition deemed unsuitable for enrollment by the investigator.
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
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Che Li, 86 21 3819 6379, junqian@fudan.edu.cn
About this study
Official title: A Single-Arm, Open-Label, Dose-Escalation and Expansion Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of FXS887 in Patients With Advanced Solid Tumors
This is a single-arm, open-label, dose-escalation and dose-expansion Phase I clinical trial evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of FXS887 in patients with advanced solid tumors. FXS887 is a innovative ATR inhibitors of a class of small-molecule inhibitors targeting ATR kinase.
Read the detailed description
There will be two parts for this study:
Phase 1a is a dose-escalation, open-label study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of FXS887 in patients with advanced solid tumors. Approximately 14 subjects are expected to be enrolled.
Dose escalation will adopt a combination of "accelerated titration" and "3+3" design. The initial 2 dose cohorts will use the accelerated titration, while the 3+3 design will be implemented starting in other dose cohorts. If a Dose Limiting Toxicity (DLT) event or a study treatment-related adverse event of grade ≥2 occurs during the DLT observation period, the current dose cohort will switch to the 3+3 design. Eligible subjects will receive oral FXS887 once daily. The DLT observation period is within 28 days after the first dose (Cycle 1), followed by multiple-dose studies in Cycle 2 and subsequent cycles. Treatment will continue until the subject experiences disease progression, death, unacceptable toxicity, withdrawal of informed consent, or other reasons requiring discontinuation of study treatment (whichever occurs first).
Phase 1b is an open-label, dose-expansion study that plans to enroll eligible patients with advanced solid tumors. The sample size will be determined based on the results of the Phase 1a, to further evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of FXS887 at the recommended expansion dose(s).
- Being tested
- FXS887
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FXS887Drug
FXS887 is an innovative ATR inhibitor targeting ATR kinase.
| Study group | Role | What they receive |
|---|---|---|
| FXS887 | Experimental | This is a single-arm, open-label, dose-escalation and dose-expansion Phase I clinical trial evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of FXS887 in patients with advanced solid tumors. It mainly consists of two parts: the Phase Ia dose-escalation study and the Phase Ib dose-expansion study. Participants will receive FXS887 orally once-daily at determined dose levels on a 28-day cycle. Receives: Drug: FXS887 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with DLTs
DLTs will be assessed during the dose-escalation phase and are defined as toxicities that meet pre-defined DLT criteria and assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, intercurrent illness, or concomitant medications that occurs within the first cycle (28 days) of treatment.
Measured: Up to Day 28
Maximum tolerated dose (MTD) or Maximum administered dose(MAD)
The MTD is defined as the highest dose level at which the proportion of subjects who experience Dose-Limiting Toxicity (DLT) is less than 1/3 during the DLT observation period. If the MTD is not established after the completion of the dose-escalation, the highest safe dose level will be defined as the MAD.
Measured: Up to 12 Months
Incidence of Treatment-Emergent Adverse Events (TEAEs)[Safety and Tolerability]
Number and frequency of subjects with adverse events, including changes in vital signs, electrocardiograms (ECGs), physical examinations, and laboratory parameters, graded according to NCI CTCAE v5.0.
Measured: From first dose of study drug until 30 days after the last dose.
Phase 1a: recommended phase 2 dose (RP2D)
The RP2D (Recommended Phase 2 Dose) determined based on comprehensive consideration of safety, tolerability, PK (pharmacokinetics), PD (pharmacodynamics), and efficacy data.
Measured: Up to 12 Months
Secondary outcomes (6)
Peak Plasma Concentration (Cmax) of FXS887
Maximum observed plasma concentration of FXS887 following single and multiple doses.
Measured: From the day of first dose to 30 days after last dose of FXS887
Area under the plasma concentration-time curve (AUC)of FXS887
The area under the plasma concentration-time curve of FXS887 following single and multiple doses.
Measured: From the day of first dose to 30 days after last dose of FXS887
Time to reach maximum plasma concentration (Tmax) of FXS887
Time to reach maximum plasma concentration of FXS887 following single and multiple doses.
Measured: From the day of first dose to 30 days after last dose of FXS887
Elimination Half-Life (t1/2) of FXS887
Apparent terminal elimination half-life of FXS887 in plasma.
Measured: From the day of first dose to 30 days after last dose of FXS887
Objective response rate, ORR
Antitumor activity by evaluation of tumor response assessments based on RECIST 1.1
Measured: From first dose of study drug until the date of first documented disease progression or death from any cause, whichever occurs first, assessed up to 24 months.
Progression Free Survival
Antitumor activity by evaluation of tumor response assessments based on RECIST 1.1
Measured: From first dose of study drug until the date of first documented disease progression or death from any cause, whichever occurs first, assessed 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 posted16 Jan 2026
- Study start5 Jan 2026 (estimated)
- Primary completion28 Apr 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor Refractory to Conventional TreatmentStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07345637
- Sponsor's protocol ID
- FXS887-I101
- Acronym
- FXS887-I101
- Status last verified
- Jan 2026
- First submitted
- 23 Dec 2025
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Open-Label, Dose-Escalation and Expansion Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of FXS887 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07345637
- Acronym / sponsor ID
- FXS887-I101 / FXS887-I101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Jan 2026 (estimated)
- Primary completion
- 28 Apr 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 16 Jan 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 single-arm, open-label, dose-escalation and dose-expansion Phase I clinical trial evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of FXS887 in patients with advanced solid tumors. FXS887 is a innovative ATR inhibitors of a class of small-molecule inhibitors targeting ATR kinase.
Detailed description
There will be two parts for this study:
Phase 1a is a dose-escalation, open-label study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of FXS887 in patients with advanced solid tumors. Approximately 14 subjects are expected to be enrolled.
Dose escalation will adopt a combination of "accelerated titration" and "3+3" design. The initial 2 dose cohorts will use the accelerated titration, while the 3+3 design will be implemented starting in other dose cohorts. If a Dose Limiting Toxicity (DLT) event or a study treatment-related adverse event of grade ≥2 occurs during the DLT observation period, the current dose cohort will switch to the 3+3 design. Eligible subjects will receive oral FXS887 once daily. The DLT observation period is within 28 days after the first dose (Cycle 1), followed by multiple-dose studies in Cycle 2 and subsequent cycles. Treatment will continue until the subject experiences disease progression, death, unacceptable toxicity, withdrawal of informed consent, or other reasons requiring discontinuation of study treatment (whichever occurs first).
Phase 1b is an open-label, dose-expansion study that plans to enroll eligible patients with advanced solid tumors. The sample size will be determined based on the results of the Phase 1a, to further evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of FXS887 at the recommended expansion dose(s).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FXS887 | Experimental | Drug: FXS887This is a single-arm, open-label, dose-escalation and dose-expansion Phase I clinical trial evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of FXS887 in patients with advanced solid tumors. It mainly consists of two parts: the Phase Ia dose-escalation study and the Phase Ib dose-expansion study. Participants will receive FXS887 orally once-daily at determined dose levels on a 28-day cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged ≥ 18 years, male or female;
- Participants must fully understand the requirements of the study and voluntarily sign the written informed consent;
- Participants with histologically/cytologically confirmed advanced solid tumors who have received ≥ 1 line of systemic therapy prior to enrollment in the study and experienced failure of standard therapy (disease progression or intolerance);
- Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, participants must have at least one measurable target lesion;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1;
Key exclusion criteria (23 listed)
- Within the washout period of prior anti-tumor medication treatment (4 weeks or 5 half-lives after the last dose, whichever is longer) prior to the first dose of FXS887;
- Have participated in another clinical study within 4 weeks prior to the first dose of FXS887;
- Have a history of hypersensitivity to any known components of FXS887 or its analogues;
- Have intolerance to ATR inhibitors or have received ATR inhibitors within 4 weeks or 5 half-lives (whichever is longer) prior to the first dose of FXS887;
- Need to take strong CYP3A inhibitors and/or inducers, as well as P-gp (P-glycoprotein) inhibitors and/or inducers within 14 days (or 5 half-lives, whichever is longer) prior to the first dose of FXS887 and during the study period;
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 |
|---|---|---|
| FXS887FXS887 is an innovative ATR inhibitor targeting ATR kinase. | Drug | FXS887 |
Primary outcome
Number of participants with DLTs
Time frame: Up to Day 28
DLTs will be assessed during the dose-escalation phase and are defined as toxicities that meet pre-defined DLT criteria and assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, intercurrent illness, or concomitant medications that occurs within the first cycle (28 days) of treatment.
Maximum tolerated dose (MTD) or Maximum administered dose(MAD)
Time frame: Up to 12 Months
The MTD is defined as the highest dose level at which the proportion of subjects who experience Dose-Limiting Toxicity (DLT) is less than 1/3 during the DLT observation period. If the MTD is not established after the completion of the dose-escalation, the highest safe dose level will be defined as the MAD.
Incidence of Treatment-Emergent Adverse Events (TEAEs)[Safety and Tolerability]
Time frame: From first dose of study drug until 30 days after the last dose.
Number and frequency of subjects with adverse events, including changes in vital signs, electrocardiograms (ECGs), physical examinations, and laboratory parameters, graded according to NCI CTCAE v5.0.
Phase 1a: recommended phase 2 dose (RP2D)
Time frame: Up to 12 Months
The RP2D (Recommended Phase 2 Dose) determined based on comprehensive consideration of safety, tolerability, PK (pharmacokinetics), PD (pharmacodynamics), and efficacy data.
6 secondary outcomes
Peak Plasma Concentration (Cmax) of FXS887
Time frame: From the day of first dose to 30 days after last dose of FXS887
Area under the plasma concentration-time curve (AUC)of FXS887
Time frame: From the day of first dose to 30 days after last dose of FXS887
Time to reach maximum plasma concentration (Tmax) of FXS887
Time frame: From the day of first dose to 30 days after last dose of FXS887
Elimination Half-Life (t1/2) of FXS887
Time frame: From the day of first dose to 30 days after last dose of FXS887
Objective response rate, ORR
Time frame: From first dose of study drug until the date of first documented disease progression or death from any cause, whichever occurs first, assessed up to 24 months.
Progression Free Survival
Time frame: From first dose of study drug until the date of first documented disease progression or death from any cause, whichever occurs first, assessed 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 16 Jan 2026.
- 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.
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 FXS887 in people with Solid Tumor Refractory to Conventional Treatment, 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 8 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jan 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 Xiaohua Wu (+86 21 6417 5590 ext. 81000, wu.xh@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with DLTs (time frame: Up to Day 28). 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 16 Jan 2026.