FTL001

Yuankai Shi, MD

Yongsheng Li, MD

Li Zheng, MD

Yongsheng Wang, MD

Shoubin Wen, MD

This is an open, multi-center, Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics/pharmacokinetics and initial efficacy of FTL001 in patients with advanced and metastatic solid tumors.

The study is divided into two phases, Part 1 (FTL001 dose escalation) and Part 2 (FTL001 dose expansion), and is intended to include approximately 26-44 participants.

Study in Patients With Advanced Solid Malignancies to Evaluate the Safety of FTL001

A Phase 1, First-in-Human, Open-Label, Dose Escalation and Dose Expansion Study of FTL001 in Patients With Advanced or Metastatic Solid Tumors

Number of participants with DLTs during the 28 days following the first administration of FTL001

Computed tomography (CT) scans of tumors will be evaluated according to RECIST 1.1 and iRECIST (2017).

PK samples will be collected at predefined timepoints to determine Cmax.

PK samples will be collected at predefined timepoints to determine AUC.

Sound Biopharmaceuticals Ltd.

All Drugs and Chemicals

Antibodies

Antibodies, Bispecific

Immunoglobulins

Escalating doses of FTL008.16 depending on cohort at enrollment

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

FTL008.16

Ning Li, MD

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.

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.

Study in Patients With Advanced Solid Tumors to Evaluate the Safety of FTL008.16

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

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

Computed tomography (CT) scans of tumors will be evaluated according to RECIST 1.1 and iRECIST (2017)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study in Patients With Advanced Solid Malignancies to Evaluate the Safety of FTL001	NCT06410092	Solid Tumor	FTL001	18 Years - 75 Years	Sound Biopharmaceuticals Ltd.
Study in Patients With Advanced Solid Malignancies to Evaluate the Safety of FTL001	NCT06410092	Solid Tumor	FTL001	18 Years - 75 Years	Sound Biopharmaceuticals Ltd.
Study in Patients With Advanced Solid Tumors to Evaluate the Safety of FTL008.16	NCT06410131	Solid Tumors	FTL008.16	18 Years - 75 Years	Sound Biopharmaceuticals Ltd.

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