A Phase I of FXS0260 in Advanced Solid Tumor
NCT07933666, Phase 1, Not yet recruiting, Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | A Phase I of FXS0260 in Advanced Solid Tumor | ClinicalTrials.gov |
| NCT number | NCT07933666 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 1 | ClinicalTrials.gov |
| Enrollment | 20 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. | ClinicalTrials.gov |
| Conditions | Solid Tumor Refractory to Conventional Treatment | ClinicalTrials.gov |
| Interventions | FXS0260 | ClinicalTrials.gov |
| First posted | 2026-11-12 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Incidence of DLTs | From the first dose through Day 24 (Phase Ia only) | DLTs will be assessed during the DLT observation period in Phase Ia. DLT-evaluable participants are defined as those who experience a DLT during the DLT observation period or receive at least 70% of the planned doses and complete the safety assessments. | ClinicalTrials.gov |
| Primary | Determination of MTD or MAD | Up to 12 Months | The MTD will be inferre based on DLT data and all safety data observed at all dose levels. The MTD is defined as the highest dose level at which no more than 30% of participants experience a DLT during the DLT observation period in the dose-escalation phase.If the MTD is not reached, the highest safe dose level will be defined as the MAD. | ClinicalTrials.gov |
| Primary | Incidence, Severity, and Relationship to Study Drug of Adverse Events (AEs) | From the first dose of FXS0260 through 28 days after the last dose. | The incidence, severity, and relationship to FXS0260 of adverse events will be assessed. The severity of adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 6.0. | ClinicalTrials.gov |
| Primary | Determination of RP2D | Through completion of the dose-escalation and dose-expansion assessments | The RP2D of FXS0260 will be determined based on an integrated assessment of safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and efficacy data. | ClinicalTrials.gov |
| Secondary | Peak Plasma Concentration (Cmax) of FXS0260 | From prodose on Day1 to 7 days after last dose of FXS0260 | Pharmacokinetic parameter | ClinicalTrials.gov |
| Secondary | The area under the plasma concentration-time curve from time 0 to the last measurable ocncentration (AUC0-t)of FXS0260 | From prodose on Day1 to 7 days after last dose of FXS0260 | Pharmacokinetic parameter | ClinicalTrials.gov |
| Secondary | Time to reach maximum plasma concentration (Tmax) of FXS0260 | From prodose on Day1 to 7 days after last dose of FXS0260 | Pharmacokinetic parameter | ClinicalTrials.gov |
| Secondary | Elimination Half-life (T1/2) of FXS0260 | From prodose on Day1 to 7 days after last dose of FXS0260 | Pharmacokinetic parameter | ClinicalTrials.gov |
| Secondary | Apparent Clearance (CL/F) of FXS0260 | From prodose on Day1 to 7 days after last dose of FXS0260 | Pharmacokinetic parameter | ClinicalTrials.gov |
| Secondary | Apparent volume of distribution (Vz/F) of FXS0260 | From prodose on Day1 to 7 days after last dose of FXS0260 | Pharmacokinetic parameter | ClinicalTrials.gov |
| Secondary | Average concentration at steady state(Cavg,ss) of FXS0260 | From prodose on Day1 to 7 days after last dose of FXS0260 | Pharmacokinetic parameter | ClinicalTrials.gov |
| Secondary | Minimum observed concentration at steady state(Cmin,ss) of FXS0260 | From prodose on Day1 to 7 days after last dose of FXS0260 | Pharmacokinetic parameter | ClinicalTrials.gov |
| Secondary | Maximum observed concentration at steady state(Cmax,ss)of FXS0260 | From prodose on Day1 to 7 days after last dose of FXS0260 | Pharmacokinetic parameter | ClinicalTrials.gov |
| Secondary | Elimination rate constant (λz) of FXS0260 | From prodose on Day1 to 7 days after last dose of FXS0260 | Pharmacokinetic parameter | ClinicalTrials.gov |
| Secondary | Apparent volume of distribution at steady state(Vss/F) of FXS0260 | From prodose on Day1 to 7 days after last dose of FXS0260 | Pharmacokinetic parameter | ClinicalTrials.gov |
| Secondary | Area under the plasma concentration time curve from time 0 to infinity(AUC0-∞)of FXS0260 | From prodose on Day1 to 7 days after last dose of FXS0260 | Pharmacokinetic parameter | ClinicalTrials.gov |
| Secondary | Area under the plasma concentration-time curve over the dosing interval at steady state (AUCtau,ss) of FXS0260 | From prodose on Day1 to 7 days after last dose of FXS0260 | Pharmacokinetic parameter | ClinicalTrials.gov |
| Secondary | Accumulation ratio(AR) based on Cmax of FXS0260 | From prodose on Day1 to 7 days after last dose of FXS0260 | Pharmacokinetic parameter | ClinicalTrials.gov |
| Secondary | Accumulation ratio(AR) based on AUCtau, ss of FXS0260 | From prodose on Day1 to 7 days after last dose of FXS0260 | Pharmacokinetic parameter | ClinicalTrials.gov |
| Secondary | Objective response rate, ORR | From first dose of study drug until disease progression as defined by RECIST v1.1 , initiation of new anticancer therapy, death, withdrawal of informed consent, loss to follow-up, or the end of the study, whichever occurs first, assessed up to 24 months. | Antitumor activity by evaluation of tumor response assessments based on RECIST 1.1 | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)