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RecruitingNCT05982080Updated Aug 25, 2023

A Study to Investigate FP002 in Subjects With Advanced Malignancies

A Phase 1 interventional study of FP002 Injection in Advanced Solid Tumor, sponsored by Guangdong Fapon Biopharma Inc.. Recruiting at 3 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-25.

Sponsored by Guangdong Fapon Biopharma Inc. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Apr 2025, 1 year 6 months ago, but the record still lists the study as recruiting.
  • Started Aug 2023; still recruiting 3 years 2 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
27
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The goal of this phase 1 study is to assess the safety, and tolerability of FP002 to determine the dose recommended for dose expansion in subjects with advanced solid tumor.

Read the detailed description

This study is a phase 1 study of FP002 as monotherapy in patients with advanced solid tumor. The study will evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic profile, immunogenicity, and preliminary anti-tumor activity of FP002 in patients with advanced solid tumors.

02

Conditions studied

  • Advanced Solid Tumor

Browse trials for

03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 27 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

This is the only study on the registry with Guangdong Fapon Biopharma Inc. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Signed informed consent form (ICF) and was able to comply with the protocol.
  2. Male or female subjects ≥ 18 years of age on the day of ICF signing.
  3. A life expectancy of > 3 months.
  4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
  5. Adequate organ and bone marrow function confirmed at screening and within 7 days before the first dose of study treatment.
  6. Subjects with histologically or cytological confirmed malignancy diagnosis.
  7. Documented advanced solid tumors, defined as patients have no standard treatment or who have failed/are intolerant to standard treatment according to the investigator's judgment.
  8. Documented with at least 1 measurable lesion as assessed by RECIST 1.1.
  9. Toxicity from prior anti-tumor treatment has resolved to ≤ Grade 1 as defined by NCI CTCAE v5.0.

Exclusion criteria

Exclusion Criteria:

  1. Subjects who have received other anti-CD47 or anti- SIRPα agents.
  2. Prior organ or tissue allograft except for hematopoietic stem cell transplantation.
  3. Treatment with investigational therapy within 4 weeks prior to initiation of study drug.
  4. Severe infection requiring hospitalization or IV antibiotics, antivirals or antifungals within 14 days prior to enrollment.
  5. Subjects who have received chemotherapy within 4 weeks or 5 half-lives (whichever is shorter) before the first dose (within 6 weeks before the first dose of mitomycin or nitrosoureas) or received immunotherapy, radical radiotherapy or major surgery within 4 weeks or palliative radiotherapy within 2 weeks.
  6. Subjects who have experienced active autoimmune disease requiring systemic therapy within the past 2 years.
  7. A positive test result for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by a certified nucleic acid test within the last 30 days before the first dose of study treatment.
  8. Cardiovascular dysfunction or clinically significant cardiac disease.
  9. Active infection with hepatitis C.
  10. Receipt of a live vaccine within 30 days prior to the first dose of study treatment.
  11. Known hypersensitivity to either the drug substances or inactive ingredient of FP002.
  12. Known human immunodeficiency virus (HIV) positive.
  13. A history of other malignancies other than effectively treated basal cell carcinoma of skin, squamous cell carcinoma of skin, or effectively resected carcinoma in situ of the cervix.
  14. Known inherited or acquired bleeding disorders.
  15. Any other medical, family, social or mental conditions that the investigator considers unsuitable for participation in the study.
  16. Daily requirement for corticosteroids (≥10 mg/kg) within 2 weeks prior to Day 1 of Cycle 1.
  17. Women who are lactating or pregnant as confirmed by pregnancy test within 7 days before the first dose of study treatment. Unwilling to use adequate contraceptive methods during the study and for at least 7 months after the last dose of study treatment.
  18. Presence of active brain metastases
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
27 participants (estimated)

Study arms

  • Experimental
    FP002 Injection

    Dose escalation: FP002

    Drug: FP002 Injection

Interventions

  • DrugFP002 Injection

    Up to 6 FP002 dose levels (0.3, 1.0, 3.0, 10, 20, 30 mg/kg administered intravenously may be evaluated. Subjects will receive weekly infusions of FP002 until disease progression, unacceptable toxicity, consent withdrawal, physician decision, or start of subsequent anticancer therapy, whichever occurs first.

06

What researchers measure

Primary outcomes

  1. Severity (as graded by CTCAE v5.0) of Dose Limiting Toxicity (DLT)

    Time frame: During the first 4 week treatment cycle

  2. Severity (as graded by CTCAE v5.0) of treatment-emergent AEs (TEAEs)

    Time frame: up to 24 months

  3. Severity (as graded by CTCAE v5.0) of serious adverse events (SAEs)

    Time frame: up to 24 months

  4. Severity (as graded by CTCAE v5.0) of adverse events of special interest (AESIs)

    Time frame: up to 24 months

  5. Severity (as graded by CTCAE v5.0) of adverse events assessed

    Time frame: up to 24 months

Secondary outcomes

  1. Maximum plasma concentration (Cmax) of FP002

    Time frame: up to 24 months

  2. Area under the curve from time zero to the last measurable time point (AUC0-t) of FP002

    Time frame: up to 24 months

  3. Area under the curve extrapolated to infinity (AUC0-inf)of FP002

    Time frame: up to 24 months

  4. Time to reach maximum plasma concentration (Tmax) of FP002

    Time frame: up to 24 months

  5. Terminal elimination half-life (t1/2) of FP002

    Time frame: up to 24 months

  6. Apparent volume of distribution (Vd) of FP002

    Time frame: up to 24 months

  7. Clearance rate (CLz)

    Time frame: up to 24 months

  8. Terminal elimination rate constant (λz)

    Time frame: up to 24 months

  9. Mean retention time (MRT)

    Time frame: up to 24 months

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

    Time frame: up to 24 months

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

    Time frame: up to 24 months

  12. Average steady state concentration (Cav)

    Time frame: up to 24 months

  13. Steady-state clearance rate (CLss)

    Time frame: up to 24 months

  14. Steady-state volume of distribution (Vss)

    Time frame: up to 24 months

  15. Accumulation index (Rac)

    Time frame: up to 24 months

  16. Degree of fluctuation (DF)

    Time frame: up to 24 months

  17. Duration of response (DoR) based on RECIST V1.1

    Time frame: Up to 24 months

  18. Disease control rate (DCR) based on RECIST V1.1

    Time frame: Up to 24 months

  19. Overall response rate (ORR) based on RECIST V1.1

    Time frame: Up to 24 months

  20. Progression free survival (PFS) based on RECIST V1.1

    Time frame: Up to 24 months

  21. Anti-drug antibody

    Incidence, onset time and titer

    Time frame: Up to 24 months

  22. Neutralizing antibody

    Incidence, onset time and titer

    Time frame: Up to 24 months

  23. Receptor of occupancy in RBC/CD3+ T cell

    Time frame: Up to 24 months

07

Study locations

1 of 3 sites recruiting
  • The First Affiliated Hospital of Xiamen University
    Xiamen, Fujian 361003, China
    Not yet recruiting
  • Shangdong Cancer Hospital & Institute
    Jinan, Shangdong, China
    • Yuping Sun, MD · Contact · 13370582181@163.com · +86-531-67627156
    • Yuping Kong, MD · Principal investigator
    • Linlin Wang, MD · Principal investigator
    Recruiting
  • Linyi Cancer Hospital
    Linyi, Shangdong 276000, China
    Not yet recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 25, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05982080
Lead sponsor
Guangdong Fapon Biopharma Inc.
Responsible party
Sponsor
First posted
Aug 8, 2023
Start date
Aug 2, 2023
Primary completion
Apr 2025 (estimated)
Completion
Jul 2026 (estimated)
Last update
Aug 25, 2023

Study contacts

Arron Wang
Contact
clinitrial.register@fapon.com
+86 13926091581
Vincent Huo
Contact
clinitrial.register@fapon.com
+86 13825280524
Yuping Sun, MD
principal investigator · Shangdong Cancer Hospital & Institute
Linlin Wang, MD
principal investigator · Shangdong Cancer Hospital & Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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