Advanced Malignant Solid TumorsPhase 1/2NCT06499350
A Study of FC084CSA in Combination of Tislelizumab in Patients With Advanced Malignant Solid Tumors
A Phase 1/2 study testing FC084CSA+Tislelizumab combination (dose escalation) and RP2D of FC084CSA+Tislelizumab combination (dose expansion) in people with Advanced Malignant Solid Tumors, run by FindCure Biosciences (ZhongShan) Co., Ltd. at 1 site in China.
Trial summary
The goal of this clinical trial is to learn the safety, tolerability, pharmacokinetic characteristics and efficacy of FC084CSA in combination with Tislelizumab in patients with advanced malignant solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Malignant Solid Tumors
- What is being tested?
- FC084CSA+Tislelizumab combination (dose escalation) and RP2D of FC084CSA+Tislelizumab combination (dose expansion)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteChina
- Study dates
- 13 Nov 2024to 30 Dec 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 75 years old male and female.
- Phase Ib: Patients with histologically or cytologically diagnosed solid tumors who have failed standard therapy; Phase IIa: Patients with histologically or cytologically confirmed stage IIIB/IIIC and stage IV NSCLC which surgery or radiotherapy cannot be performed.
- No known sensitizing mutations or other actionable oncogenes with approved therapies if available.
- Prior PD-1/PD-L1 inhibitor combined with platinum-containing therapy failed;
- According to RECIST 1.1, there is at least one measurable lesion.
- ECOG performance status 0-1.
- Major organs are functioning well.
Who cannot join
- Not recovered from the adverse reactions caused by previous anti-tumor treatments (≥CTCAE grade 1).
- Received anti-tumor therapy within 4 weeks before enrollment.
- Participated in other clinical trials within 4 weeks before enrollment and used clinical investigational drugs during this period.
- Have undergone surgery within 4 weeks before enrollment, and the investigator believes that the patient's state has not recovered to the point where the study can be started.
- Patients with ascites (ascites), pleural effusion (pleural effusion) or pericardial effusion that cannot be controlled by drainage or other methods.
- Central nervous system metastases with clinical symptoms.
- With any situations that the researcher considers inappropriate to participate in this research.
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, 1 recruiting
- Recruiting
Shanghai East Hospital
Shanghai, Shanghai Municipality, 200120
Caicun Zhou, 13301825532, caicunzhoudr@163.com
About this study
Official title: A Dose-Escalation and Dose-Expansion Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of AXL Inhibitor FC084CSA Tablets in Combination With Tislelizumab in the Treatment of Advanced Malignant Solid Tumors
The goal of this clinical trial is to learn the safety, tolerability, pharmacokinetic characteristics and efficacy of FC084CSA in combination with Tislelizumab in patients with advanced malignant solid tumors.
Read the detailed description
The study includes two phases. Phase Ib adopts a "3+3" dose escalation design to assess safety and tolerability of increasing dose levels of FC084CSA in combination of fixed dose of Tislelizumab. Phase IIa is the dose expansion phase to further observe the preliminary effectiveness of the recommended Phase 2 Dose of FC084CSA in combination of Tislelizumab.
- Conditions
- Advanced Malignant Solid Tumors
- Being tested
- FC084CSA+Tislelizumab combination (dose escalation), RP2D of FC084CSA+Tislelizumab combination (dose expansion)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FC084CSA+Tislelizumab combination (dose escalation)Drug
Also called FC084CSA+BGB-A317 combination (dose escalation)
Increasing dose levels of FC084CSA+fixed dose Tislelizumab combination therapy
RP2D of FC084CSA+Tislelizumab combination (dose expansion)Drug
Also called RP2D of FC084CSA+BGB-A317 combination (dose expansion)
RP2D of FC084CSA+fixed dose Tislelizumab combination therapy
| Study group | Role | What they receive |
|---|---|---|
| FC084CSA+Tislelizumab | Experimental | This is a single arm phase I trial in a 3 + 3 dose escalation and cohort expansion design evaluating the safety and tolerability of FC084CSA in combination with Tislelizumab. Increasing dose levels of FC084CSA with fixed dose of Tislelizumab. Dose escalation continues until dose-limiting toxicities (DLT) are observed in one-third of participants. If no DLT occurs, the next cohort will be enrolled at the next planned dose level. If 1 DLT occurs in a cohort, another 3 patients will be treated with the same dose level. Following the definition of the recommended Phase 2 Dose (RP2D) of FC084CSA in dose escalation phase, NSCLC dose expansion cohort is planned to perform a preliminary assessment of the anti-tumour efficacy and to further establish the safety profile of the RP2D of FC084CSA in combination with Tislelizumab. Receives: Drug: FC084CSA+Tislelizumab combination (dose escalation); Drug: RP2D of FC084CSA+Tislelizumab combination (dose expansion) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the Maximum Tolerated Dose (MTD)
The highest dose is defined at which no more than 1 of 3 evaluable participants has had a Dose Limiting Toxicity (DLT) according to NCI CTCAE V5.0 criteria and determination by Investigator and Data and Safety Monitoring Committee.
Measured: Approximately 8 months
Determine the Recommended Phase 2 Dose (RP2D)
The RP2D is based upon the review of all available data including safety, pharmacokinetic, preliminary anti-tumor activity, and MTD.
Measured: Approximately 8 months
Determine dose-limiting toxicity (DLT)
Determine the DLT of FC084CSA
Measured: 21 days after first dose
Objective response rate (ORR)
To explore the clinical effectiveness. Tumor response based on RECIST 1.1
Measured: Approximately 12 months
Secondary outcomes (7)
Disease control rate (DCR)
DCR as assessed using RECIST 1.1
Measured: Approximately 12 months
Progression free survival (PFS)
PFS as assessed using RECIST 1.1
Measured: Approximately 12 months
Overal suvival (OS)
It is defined as the time from date of first dose to the date of death (due to any cause). Subjects who are alive will be censored at the last known alive dates.
Measured: Approximately 18 months
Pharmacokinetic (PK) Cmax
To investigate the pharmacokinetic (PK) profile of FC084CSA
Measured: Approximately 12 months
Pharmacokinetic (PK) Tmax
To investigate the pharmacokinetic (PK) profile of FC084CSA
Measured: Approximately 12 months
Pharmacokinetic (PK) AUC 0-t
To investigate the pharmacokinetic (PK) profile of FC084CSA
Measured: Approximately 12 months
Pharmacokinetic (PK) AUC 0-∞
To investigate the pharmacokinetic (PK) profile of FC084CSA
Measured: Approximately 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start13 Nov 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant Solid TumorsStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- FC084CSA in combination with Tislelizumab
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FindCure Biosciences (ZhongShan) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Caicun Zhou, Principal investigator, Shanghai East Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06499350
- Sponsor's protocol ID
- FC084-CA-102
- Status last verified
- Sep 2026
- First submitted
- 8 Jul 2024
- Last updated
- 4 Sep 2026
- Results posted
- 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 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-Escalation and Dose-Expansion Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of AXL Inhibitor FC084CSA Tablets in Combination With Tislelizumab in the Treatment of Advanced Malignant Solid Tumors
- ClinicalTrials.gov ID
- NCT06499350
- Acronym / sponsor ID
- FC084-CA-102
- Conditions
- Advanced Malignant Solid Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- FindCure Biosciences (ZhongShan) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Nov 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 12 Jul 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.
The goal of this clinical trial is to learn the safety, tolerability, pharmacokinetic characteristics and efficacy of FC084CSA in combination with Tislelizumab in patients with advanced malignant solid tumors.
Detailed description
The study includes two phases. Phase Ib adopts a "3+3" dose escalation design to assess safety and tolerability of increasing dose levels of FC084CSA in combination of fixed dose of Tislelizumab. Phase IIa is the dose expansion phase to further observe the preliminary effectiveness of the recommended Phase 2 Dose of FC084CSA in combination of Tislelizumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- FC084CSA in combination with Tislelizumab
| Arm | Type | Receives |
|---|---|---|
| FC084CSA+Tislelizumab | Experimental | Drug: FC084CSA+Tislelizumab combination (dose escalation), Drug: RP2D of FC084CSA+Tislelizumab combination (dose expansion)This is a single arm phase I trial in a 3 + 3 dose escalation and cohort expansion design evaluating the safety and tolerability of FC084CSA in combination with Tislelizumab. Increasing dose levels of FC084CSA with fixed dose of Tislelizumab. Dose escalation continues until dose-limiting toxicities (DLT) are observed in one-third of participants. If no DLT occurs, the next cohort will be enrolled at the next planned dose level. If 1 DLT occurs in a cohort, another 3 patients will be treated with the same dose level. Following the definition of the recommended Phase 2 Dose (RP2D) of FC084CSA in dose escalation phase, NSCLC dose expansion cohort is planned to perform a preliminary assessment of the anti-tumour efficacy and to further establish the safety profile of the RP2D of FC084CSA in combination with Tislelizumab. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged 18 to 75 years old male and female.
- Phase Ib: Patients with histologically or cytologically diagnosed solid tumors who have failed standard therapy; Phase IIa: Patients with histologically or cytologically confirmed stage IIIB/IIIC and stage IV NSCLC which surgery or radiotherapy cannot be performed.
- No known sensitizing mutations or other actionable oncogenes with approved therapies if available.
- Prior PD-1/PD-L1 inhibitor combined with platinum-containing therapy failed;
- According to RECIST 1.1, there is at least one measurable lesion.
Key exclusion criteria (7 listed)
- Not recovered from the adverse reactions caused by previous anti-tumor treatments (≥CTCAE grade 1).
- Received anti-tumor therapy within 4 weeks before enrollment.
- Participated in other clinical trials within 4 weeks before enrollment and used clinical investigational drugs during this period.
- Have undergone surgery within 4 weeks before enrollment, and the investigator believes that the patient's state has not recovered to the point where the study can be started.
- Patients with ascites (ascites), pleural effusion (pleural effusion) or pericardial effusion that cannot be controlled by drainage or other methods.
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 |
|---|---|---|
| FC084CSA+Tislelizumab combination (dose escalation)Also: FC084CSA+BGB-A317 combination (dose escalation)Increasing dose levels of FC084CSA+fixed dose Tislelizumab combination therapy | Drug | FC084CSA+Tislelizumab |
| RP2D of FC084CSA+Tislelizumab combination (dose expansion)Also: RP2D of FC084CSA+BGB-A317 combination (dose expansion)RP2D of FC084CSA+fixed dose Tislelizumab combination therapy | Drug | FC084CSA+Tislelizumab |
Primary outcome
Determine the Maximum Tolerated Dose (MTD)
Time frame: Approximately 8 months
The highest dose is defined at which no more than 1 of 3 evaluable participants has had a Dose Limiting Toxicity (DLT) according to NCI CTCAE V5.0 criteria and determination by Investigator and Data and Safety Monitoring Committee.
Determine the Recommended Phase 2 Dose (RP2D)
Time frame: Approximately 8 months
The RP2D is based upon the review of all available data including safety, pharmacokinetic, preliminary anti-tumor activity, and MTD.
Determine dose-limiting toxicity (DLT)
Time frame: 21 days after first dose
Determine the DLT of FC084CSA
Objective response rate (ORR)
Time frame: Approximately 12 months
To explore the clinical effectiveness. Tumor response based on RECIST 1.1
7 secondary outcomes
Disease control rate (DCR)
Time frame: Approximately 12 months
Progression free survival (PFS)
Time frame: Approximately 12 months
Overal suvival (OS)
Time frame: Approximately 18 months
Pharmacokinetic (PK) Cmax
Time frame: Approximately 12 months
Pharmacokinetic (PK) Tmax
Time frame: Approximately 12 months
Pharmacokinetic (PK) AUC 0-t
Time frame: Approximately 12 months
Pharmacokinetic (PK) AUC 0-∞
Time frame: Approximately 12 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 4 Sep 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.
Caicun Zhou principal investigator
Shanghai East Hospital
1 site 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 FC084CSA+Tislelizumab combination (dose escalation) and RP2D of FC084CSA+Tislelizumab combination (dose expansion) in people with Advanced Malignant Solid Tumors, run by FindCure Biosciences (ZhongShan) 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 7 inclusion and 7 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 4 Sep 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 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 Tingjin Wang (18664044814, wangtingjin@find-cure.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the Maximum Tolerated Dose (MTD) (time frame: Approximately 8 months). 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 4 Sep 2026.