A Phase 1, First-in-Human, Open-Label, Dose Escalation and Dose Expansion Study of FTL008.16, a Recombinant Anti-CD137 and Anti-5T4 Bispecific Antibody, in Patients With Advanced or Metastatic Solid Tumors

Sound Biopharmaceuticals Ltd.1 site in 1 country68 target enrollmentMay 27, 2025

ConditionsSolid Tumors

InterventionsFTL008.16

DrugsFTL008.16

Overview

Phase: Phase 1
Intervention: FTL008.16
Conditions: Solid Tumors
Sponsor: Sound Biopharmaceuticals Ltd.
Enrollment: 68
Locations: 1
Primary Endpoint: Number of participants with dose-limiting toxicities (DLTs)
Status: Recruiting
Last Updated: 10 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is an open, multi-center, multi-cohort phase I clinical study designed to evaluate safety, tolerability, pharmacokinetics and initial efficacy of FTL008.16 in patients with advanced and metastatic solid tumors.

Detailed Description

This study is divided into two phases: Part 1(dose escalation of FTL008.16) and Part 2(dose extension of FTL008.16), which is intended to include about 40 to 68 subjects.

Registry

clinicaltrials.gov

Start Date

May 27, 2025

End Date

November 1, 2027

Last Updated

10 months ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Sound Biopharmaceuticals Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Voluntarily participate in the experiment and sign a written informed consent, with good compliance, and can follow the protocol visit plan and other research procedures.
•Age ≥18 years and ≤75 years at the time of signing the informed consent, both male and female.
•Expected survival ≥ 3 months.
•Histologically or cytologically confirmed advanced solid tumors; The enrollment should focus on subjects with multiple solid tumor types/histologies likely to express 5T4 antigen, including but not limited to non-small cell lung cancer (NSCLC), stomach cancer, esophageal cancer, colorectal cancer, pancreatic cancer, head cancer, cervical squamous cell carcinoma, renal cell carcinoma, urothelial carcinoma, prostate cancer, breast cancer, ovary cancer, cervical cancer, endometrial cancer or malignant pleural mesothelioma.
•Patients with advanced recurrence and metastasis of solid tumors with disease progression after standard treatment or intolerance to standard treatment or no standard treatment (definitions of standard treatment and recurrence refer to the latest CSCO guidelines or other authoritative diagnosis and treatment guidelines at home and abroad).
•According to RECIST 1.1 solid tumor efficacy evaluation criteria, the patient had at least one lesion that could be measured or evaluated on imaging (CT, MRT); Patients enrolled in the extended study should have at least one measurable lesion; (Note: Tumor lesions that have previously received local treatment (such as radiotherapy, ablation, vascular intervention, etc.) will not be considered measurable unless there is sufficient evidence to demonstrate clear imaging progression of the lesion after local treatment).
•Eastern Cancer Collaboration (ECOG) Physical fitness score of 0 or
•The patient must provide the required tumor tissue specimen (fresh tumor tissue or archived tumor tissue specimen).
•The results of laboratory examination during the screening period indicate that the subject has good organ function;
•If sexually active: females of childbearing potential must practice a medically effective methods of contraception during study participation and for at least 6 months after last dose of study drug.

Exclusion Criteria

•History of hypersensitivity or idiosyncrasy to the excipients of the study drug or to any monoclonal antibody.
•A history of malignancies other than the disease under study within the previous 5 years, with the exception of malignancies that have been cured after treatment and have no risk of recurrence (including but not limited to adequately treated thyroid cancer, cervical carcinoma in situ, basal or squamous cell skin cancer, or breast ductal carcinoma in situ treated with radical surgery).
•Systematic treatment with anti-tumor drugs (including chemotherapy, targeted therapy, antibody therapy, immunotherapy, endocrine therapy, etc.) was received within 4 weeks before the initial study.
•Patients who have previously received cell immunotherapy (CAR-T).
•Prior treatment with any anti-CD137/anti-5T4 antibody or drug (single agent or combination).
•Adverse reactions caused by previous treatment did not recover to CTCAE (version 5.0) grade 1 or below (Alopecia, neurotoxicity returned to grade 2 or below, adverse reactions that the investigators judged were not a safety risk could be included);
•Previously received allogeneic hematopoietic stem cell transplantation or solid organ transplantation;
•Active primary or metastatic tumors of the central nervous system (except in patients who have previously been treated and have discontinued treatment 4 weeks prior to the first study drug administration, symptomless patients who do not require long-term glucocorticoid therapy), seizures, spinal cord compression, meningeal metastases, or carcinomatous meningitis.
•Have or have suspected active autoimmune diseases, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, etc., but the following conditions can be included: Type 1 diabetes that can be controlled by alternative therapy alone, skin diseases that do not require systemic treatment (e.g. Psoriasis, vitiligo).
•Suffering from pleural effusion, ascites or pericardial effusion that cannot be controlled by clinical symptoms or treatment.

Arms & Interventions

Arm 1 Part 1 Dose Escalation

Escalating doses of FTL008.16 depending on cohort at enrollment

Intervention: FTL008.16

Arm 1 Part 2 Dose Expansion

Two dose groups of FTL008.16 depending on data of Arm 1 Part 1

Intervention: FTL008.16

Outcomes

Primary Outcomes

Number of participants with dose-limiting toxicities (DLTs)

Time Frame: First Cycle (28 days)

Number of participants with DLTs during the 28 days following the first administration of FTL008.16

Secondary Outcomes

To preliminarily evaluate the anti-tumor activity(Tumor efficacy was evaluated every 8 weeks for the first 56 weeks and every 12 weeks after 56 weeks following calendar days.)
Pharmacokinetic (PK) measure: Maximum observed serum concentration (Cmax)(From first dose (Cycle 1 Day 1, each cycle is 28 days) until the last dose (up to 2 years))
Pharmacokinetic (PK) measure: Area under the plasma concentration versus time curve (AUC)(From first dose (Cycle 1 Day 1, each cycle is 28 days) until the last dose (up to 2 years))