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Advanced Solid TumorPhase 1NCT05982080

A Study to Investigate FP002 in Subjects With Advanced Malignancies

A Phase 1 study testing FP002 Injection in people with Advanced Solid Tumor, run by Guangdong Fapon Biopharma Inc. at 3 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumor
What is being tested?
FP002 Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
3 sitesChina
Study dates
2 Aug 2023to Jul 2026
Phase
Phase 1
Are there results?
None posted in the registry

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 informed consent form (ICF) and was able to comply with the protocol.
  • Male or female subjects ≥ 18 years of age on the day of ICF signing.
  • A life expectancy of > 3 months.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
  • Adequate organ and bone marrow function confirmed at screening and within 7 days before the first dose of study treatment.
  • Subjects with histologically or cytological confirmed malignancy diagnosis.
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  • 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.
  • Documented with at least 1 measurable lesion as assessed by RECIST 1.1.
  • Toxicity from prior anti-tumor treatment has resolved to ≤ Grade 1 as defined by NCI CTCAE v5.0.

Who cannot join

  • Subjects who have received other anti-CD47 or anti- SIRPα agents.
  • Prior organ or tissue allograft except for hematopoietic stem cell transplantation.
  • Treatment with investigational therapy within 4 weeks prior to initiation of study drug.
  • Severe infection requiring hospitalization or IV antibiotics, antivirals or antifungals within 14 days prior to enrollment.
  • 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.
  • Subjects who have experienced active autoimmune disease requiring systemic therapy within the past 2 years.
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  • 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.
  • Cardiovascular dysfunction or clinically significant cardiac disease.
  • Active infection with hepatitis C.
  • Receipt of a live vaccine within 30 days prior to the first dose of study treatment.
  • Known hypersensitivity to either the drug substances or inactive ingredient of FP002.
  • Known human immunodeficiency virus (HIV) positive.
  • 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.
  • Known inherited or acquired bleeding disorders.
  • Any other medical, family, social or mental conditions that the investigator considers unsuitable for participation in the study.
  • Daily requirement for corticosteroids (≥10 mg/kg) within 2 weeks prior to Day 1 of Cycle 1.
  • 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.
  • Presence of active brain metastases

Trial locations and contacts

3 sites in 1 country.

Arron Wang contact

+86 13926091581

clinitrial.register@fapon.com

Vincent Huo contact

+86 13825280524

clinitrial.register@fapon.com

China3 sites, 3 recruiting

  • Shangdong Cancer Hospital & Institute

    Jinan, Shangdong

    Yuping Sun, MD, +86-531-67627156, 13370582181@163.com

    Yuping Kong, MD

    Recruiting

  • Linyi Cancer Hospital

    Linyi, Shangdong, 276000

    Zhen Wang, LYSZLYYNSK@163.com

    Zhen Wang

    Not yet recruiting

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361003

    Wang Sheng, shengwang81@126.com

    Wang Sheng, M.M.

    Not yet recruiting

Other trials in China

About this study

Official title: A Phase 1 Study to Investigate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics Activity of FP002 in Subjects With Advanced Malignancies

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.

Being tested
FP002 Injection

What participants receive

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

  • FP002 InjectionDrug

    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.

Study groups in NCT05982080
Study groupRoleWhat they receive
FP002 InjectionExperimentalDose escalation: FP002
Receives: Drug: FP002 Injection

What is being measured

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

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

    Measured: During the first 4 week treatment cycle

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

    Measured: up to 24 months

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

    Measured: up to 24 months

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

    Measured: up to 24 months

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

    Measured: up to 24 months

Secondary outcomes (23)

  1. Maximum plasma concentration (Cmax) of FP002

    Measured: up to 24 months

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

    Measured: up to 24 months

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

    Measured: up to 24 months

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

    Measured: up to 24 months

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

    Measured: up to 24 months

  6. Apparent volume of distribution (Vd) of FP002

    Measured: up to 24 months

  7. Clearance rate (CLz)

    Measured: up to 24 months

  8. Terminal elimination rate constant (λz)

    Measured: up to 24 months

  9. Mean retention time (MRT)

    Measured: up to 24 months

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

    Measured: up to 24 months

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

    Measured: up to 24 months

  12. Average steady state concentration (Cav)

    Measured: up to 24 months

  13. Steady-state clearance rate (CLss)

    Measured: up to 24 months

  14. Steady-state volume of distribution (Vss)

    Measured: up to 24 months

  15. Accumulation index (Rac)

    Measured: up to 24 months

  16. Degree of fluctuation (DF)

    Measured: up to 24 months

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

    Measured: Up to 24 months

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

    Measured: Up to 24 months

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

    Measured: Up to 24 months

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

    Measured: Up to 24 months

  21. Anti-drug antibody

    Incidence, onset time and titer

    Measured: Up to 24 months

  22. Neutralizing antibody

    Incidence, onset time and titer

    Measured: Up to 24 months

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

    Measured: 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.

  1. First posted8 Aug 2023
  2. Study start2 Aug 2023
  3. Primary completionApr 2025 (estimated)
  4. Study completionJul 2026 (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
27 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05982080
Sponsor's protocol ID
FP002-CT1001-CN
Status last verified
Aug 2023
First submitted
7 Jul 2023
Last updated
25 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing FP002 Injection in people with Advanced Solid Tumor, run by Guangdong Fapon Biopharma Inc. at 3 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 9 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 25 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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?

Results are not available in the source record.

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?

Severity (as graded by CTCAE v5.0) of Dose Limiting Toxicity (DLT) (time frame: During the first 4 week treatment cycle). The study lists 5 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 NCT05982080.

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 25 Aug 2023.

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