A Study to Investigate FP002 in Subjects With Advanced Malignancies

Advanced Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05982080
• Other study ID #: FP002-CT1001-CN
• Status: Recruiting
• Phase: Phase 1
• Start date: August 2, 2023
• Est. completion date: July 2026

Study information

• Verified date: August 2023
• Source: Guangdong Fapon Biopharma Inc.
• Contact: Arron Wang
• Phone: +86 13926091581
• Email: clinitrial.register[@]fapon.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 27
• Est. completion date: July 2026
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

1. Subjects who have received other anti-CD47 or anti- SIRPa 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

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

Intervention

Drug:
• FP002 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.

Locations

Country	Name	City	State
China	Shangdong Cancer Hospital & Institute	Jinan	Shangdong
China	Linyi Cancer Hospital	Linyi	Shangdong
China	The First Affiliated Hospital of Xiamen University	Xiamen	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Fapon Biopharma Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity (as graded by CTCAE v5.0) of Dose Limiting Toxicity (DLT)		During the first 4 week treatment cycle
Primary	Severity (as graded by CTCAE v5.0) of treatment-emergent AEs (TEAEs)		up to 24 months
Primary	Severity (as graded by CTCAE v5.0) of serious adverse events (SAEs)		up to 24 months
Primary	Severity (as graded by CTCAE v5.0) of adverse events of special interest (AESIs)		up to 24 months
Primary	Severity (as graded by CTCAE v5.0) of adverse events assessed		up to 24 months
Secondary	Maximum plasma concentration (Cmax) of FP002		up to 24 months
Secondary	Area under the curve from time zero to the last measurable time point (AUC0-t) of FP002		up to 24 months
Secondary	Area under the curve extrapolated to infinity (AUC0-inf)of FP002		up to 24 months
Secondary	Time to reach maximum plasma concentration (Tmax) of FP002		up to 24 months
Secondary	Terminal elimination half-life (t1/2) of FP002		up to 24 months
Secondary	Apparent volume of distribution (Vd) of FP002		up to 24 months
Secondary	Clearance rate (CLz)		up to 24 months
Secondary	Terminal elimination rate constant (?z)		up to 24 months
Secondary	Mean retention time (MRT)		up to 24 months
Secondary	Maximum plasma concentration during the dosing interval at steady state (Cmax,ss)		up to 24 months
Secondary	Minimum plasma concentration during the dosing interval at steady state (Cmin,ss)		up to 24 months
Secondary	Average steady state concentration (Cav)		up to 24 months
Secondary	Steady-state clearance rate (CLss)		up to 24 months
Secondary	Steady-state volume of distribution (Vss)		up to 24 months
Secondary	Accumulation index (Rac)		up to 24 months
Secondary	Degree of fluctuation (DF)		up to 24 months
Secondary	Duration of response (DoR) based on RECIST V1.1		Up to 24 months
Secondary	Disease control rate (DCR) based on RECIST V1.1		Up to 24 months
Secondary	Overall response rate (ORR) based on RECIST V1.1		Up to 24 months
Secondary	Progression free survival (PFS) based on RECIST V1.1		Up to 24 months
Secondary	Anti-drug antibody	Incidence, onset time and titer	Up to 24 months
Secondary	Neutralizing antibody	Incidence, onset time and titer	Up to 24 months
Secondary	Receptor of occupancy in RBC/CD3+ T cell		Up to 24 months