A Study to Investigate FP002 in Subjects With Advanced Malignancies

NCT05982080 | Recruiting Phase 1

• 1 other identifier: FP002-CT1001-CN
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (5)

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

  During the first 4 week treatment cycle

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

  up to 24 months

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

  up to 24 months

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

  up to 24 months

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

  up to 24 months

Secondary Outcomes (23)

• Maximum plasma concentration (Cmax) of FP002

  up to 24 months

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

  up to 24 months

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

  up to 24 months

• Time to reach maximum plasma concentration (Tmax) of FP002

  up to 24 months

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

  up to 24 months

Study Arms (1)

FP002 Injection

EXPERIMENTAL

Dose escalation: FP002

Drug: FP002 Injection

Interventions

FP002 Injection DRUG

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.

FP002 Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Guangdong Fapon Biopharma Inc.: lead

Study Sites (3)

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361003, China

NOT YET RECRUITING

Shangdong Cancer Hospital & Institute

Jinan, Shangdong, China

RECRUITING

Linyi Cancer Hospital

Linyi, Shangdong, 276000, China

NOT YET RECRUITING

Study Officials

• Yuping Sun, MD

  Shangdong Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

• Linlin Wang, MD

  Shangdong Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arron Wang

CONTACT

+86 13926091581; clinitrial.register@fapon.com

Vincent Huo

CONTACT

+86 13825280524; clinitrial.register@fapon.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2023
• First Posted: August 8, 2023
• Study Start: August 2, 2023
• Primary Completion: April 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: August 25, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)