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Advanced Solid TumorsPhase 1NCT06990698

A Phase 1 Study to Investigate FP008 in Subjects With Advanced Solid Tumors

A Phase 1 study testing FP008 for injection in people with Advanced Solid Tumors, run by Zhuhai Fapon Biopharma Co., Ltd. at 6 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of the phase 1 study is to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics activity of FP008 in subjects with advanced solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumors
What is being tested?
FP008 for injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
6 sitesChina
Study dates
12 Jun 2025to Sep 2028
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 written ICF and be able to comply with the protocol.
  • Male and female subjects ≥18 years of age.
  • Life expectancy of >3 months.
  • Laboratory values for sufficient organ function at screening.
  • Toxicity from prior antitumor treatment has resolved to ≤Grade 1 as defined by NCI CTCAE v5.0.
  • Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to the start of FP008.
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  • Male or women of childbearing potential, if sexually active, must agree to use contraception considered adequate and appropriate by the investigator during the period of study drug administration and for at least 5 months after the last dose of FP008.
  • ECOG performance status of 0 to 1.
  • Histologically or cytologically confirmed malignancy diagnosis and at least one measurable documented advanced/unresectable or metastatic solid tumor as assessed by RECIST v1.1.
  • Documented progressive disease, refractory/resistance/intolerant to standard therapy (documented the reason(s) why they are intolerant to standard therapy by the investigator), or there is no standard therapy.

Who cannot join

  • Subjects who have received other IL-10 agents.
  • A history of other malignancies other than basal cell carcinoma of skin, squamous cell carcinoma of skin, non-muscle invasive bladder cancer, thyroid papillary carcinoma or carcinoma in situ of the cervix that have been cured for 2 years after effective treatment.
  • Received live vaccine within 30 days prior to the first dose of FP008.
  • Not completely recovered from the effects of major surgery or significant traumatic injury at least 14 days before the first dose of FP008.
  • Known hypersensitivity to either the drug substances or inactive ingredient of FP008.
  • Subjects with diagnosis of immunodeficiency, organ transplant requiring immunosuppressive therapy, or allogeneic bone marrow or hematopoietic stem cell transplant.
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  • Daily requirement for corticosteroids within 2 weeks prior to first dose of FP008.
  • Any other medical disorder, physical exam finding, laboratory finding, altered mental status, or psychiatric condition that the investigator considers unsuitable for participation in the study.
  • Cardiovascular dysfunction or clinically significant cardiac disease.

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Arron Wang contact

86-13926091581

clinitrial.register@fapon.com

6 sites in 1 country

China6 sites, 6 recruiting

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510280

    Manming Cao, MD., +86-20-62782355, caomanming@126.com

    Manming Cao, MD.

    Recruiting

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310000

    Hanguang Hu, MD., +86-571-86992927, huhanguang@zju.edu.cn

    Hanguang Hu, MD.

    Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

    Zhengbo Song, MD., +86-571-88122168, zjccgcp_phase1@126.com

    Zhengbo Song, MD.

    Recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330209

    Bin Fu, MD., +86-791-86319516, urodoc@126.com

    Bin Fu, MD.

    Recruiting

  • Shanxi Cancer Hospital

    Taiyuan, Shanxi, 030013

    Xin Wang, MD., +86-351-4651037, WXCAMS@126.com

    Xin Wang, MD.

    Recruiting

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430014

    Xinjun Liang, MD., +86-27-87670107, doctorlxj@163.com

    Xinjun Liang, MD.

    Recruiting

Other trials in China

About this study

Official title: A Phase 1 First-In-Human Study to Investigate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics Activity of FP008 in Subjects With Advanced Solid Tumors

The goal of the phase 1 study is to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics activity of FP008 in subjects with advanced solid tumors.

Read the detailed description

This is a first-in-human (FIH), multicenter, open-label, dose escalation and dose expansion Phase 1 study of FP008 injection in subjects with advanced solid tumors. This study will evaluate the safety, tolerability, PK, PD, immunogenicity, and preliminary antitumor activity of FP008.

The study consists two parts: Part 1 (dose escalation phase) will evaluate the safety, tolerability, PK, PD, immunogenicity, and preliminary antitumor activity of FP008 treatment, and to estimate the DRDE(s) of FP008. Part 2 (Dose expansion phase) will evaluate the safety, tolerability, PK, PD, immunogenicity, and efficacy at the different DRDE(s)/schedule(s) of FP008 in subjects with selected advanced solid tumors.

Being tested
FP008 for injection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FP008 for injectionDrug

    FP008 should be administered intravenous weekly. Six FP008 dose levels are planned to evaluated.

Study groups in NCT06990698
Study groupRoleWhat they receive
FP008 for injectionExperimentalNot described
Receives: Drug: FP008 for injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose-limiting toxicities (DLTs)

    Measured: Up to 2 years

  2. Severity (as graded by NCI CTCAE v5.0) of TEAEs leading to discontinuation of study treatment

    Measured: Up to 2 years

  3. Severity (as graded by NCI CTCAE v5.0) of TRAEs leading to discontinuation of study treatment

    Measured: Up to 2 years

  4. Severity (as graded by NCI CTCAE v5.0) of SAEs leading to discontinuation of study treatment

    Measured: Up to 2 years

  5. Severity (as graded by NCI CTCAE v5.0) of irAEs leading to discontinuation of study treatment

    Measured: Up to 2 years

  6. Severity (as graded by NCI CTCAE v5.0) of AESIs leading to discontinuation of study treatment

    Measured: Up to 2 years

  7. Severity (as graded by NCI CTCAE v5.0) of AEs leading to discontinuation of study treatment

    Measured: Up to 2 years

Secondary outcomes (21)

  1. Maximum plasma concentration (Cmax) of FP008

    Measured: Up to 2 years

  2. Time to reach maximum plasma concentration (Tmax) of FP008

    Measured: Up to 2 years

  3. Area under the curve from time zero to the last measurable time point (AUC0-tlast) of FP008

    Measured: Up to 2 years

  4. Area under the curve extrapolated to infinity (AUC0-inf)of FP008

    Measured: Up to 2 years

  5. Apparent volume of distribution (V) of FP008

    Measured: Up to 2 years

  6. Clearance rate (CL)

    Measured: Up to 2 years

  7. Maximum plasma concentration during the dosing interval at steady state (Cmax,ss)

    Measured: Up to 2 years

  8. Minimum plasma concentration during the dosing interval at steady state (Cmin,ss)

    Measured: Up to 2 years

  9. Terminal elimination half-life (t1/2) of FP008

    Measured: Up to 2 years

  10. Incidence of ADA against FP008

    Measured: Up to 2 years

  11. Overall response rate (ORR) assessed using RECIST v1.1 and iRECIST

    Measured: Up to 2 years

  12. Duration of response (DoR) assessed using RECIST v1.1 and iRECIST

    Measured: Up to 2 years

  13. Disease control rate (DCR) assessed using RECIST v1.1 and iRECIST

    Measured: Up to 2 years

  14. Progression free survival (PFS) assessed using RECIST v1.1 and iRECIST

    Measured: Up to 2 years

  15. Time to response (TTR) assessed using RECIST v1.1 and iRECIST

    Measured: Up to 2 years

  16. Overall survival assessed using RECIST v1.1 and iRECIST

    Measured: Up to 2 years

  17. Onset time of ADA against FP008.

    Measured: Up to 2 years

  18. Titer of ADA against FP008.

    Measured: Up to 2 years

  19. Incidence of Nab against FP008.

    Measured: Up to 2 years

  20. Onset time of Nab against FP008.

    Measured: Up to 2 years

  21. Titer of Nab against FP008.

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2025
  2. Study start12 Jun 2025
  3. Primary completionMay 2028 (estimated)
  4. Study completionSep 2028 (estimated)

Resources

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
108 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06990698
Sponsor's protocol ID
FP008-CT1001
Status last verified
Sep 2026
First submitted
18 May 2025
Last updated
30 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing FP008 for injection in people with Advanced Solid Tumors, run by Zhuhai Fapon Biopharma Co., Ltd. at 6 sites 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 10 inclusion and 9 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 30 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 6 sites 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 Arron Wang (86-13926091581, clinitrial.register@fapon.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting toxicities (DLTs) (time frame: Up to 2 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06990698.

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 Sep 2026.

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