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

Sound Biopharmaceuticals Ltd.3 sites in 1 country44 target enrollmentJune 5, 2023

ConditionsSolid Tumor

InterventionsFTL001

DrugsFTL001

Overview

Phase: Phase 1
Intervention: FTL001
Conditions: Solid Tumor
Sponsor: Sound Biopharmaceuticals Ltd.
Enrollment: 44
Locations: 3
Primary Endpoint: Number of participants with dose-limiting toxicities (DLTs)
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Detailed Description

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.

Registry

clinicaltrials.gov

Start Date

June 5, 2023

End Date

March 2027

Last Updated

last year

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Sound Biopharmaceuticals Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients must give informed consent to this study prior to the study and sign a written informed consent form voluntarily;
•Age ≥18 and ≤75, both male and female;
•Expected survival time of more than 3 months;
•Histologically or cytologically confirmed advanced solid tumors;
•Patients with advanced recurrence, metastasis and refractory solid tumors whose disease progresses after standard treatment or who are intolerant to standard treatment or have no standard treatment (the definitions of standard treatment and refractory recurrence refer to authoritative diagnosis and treatment guidelines at home and abroad);
•At least 1 measurable lesion at baseline according to the definition of RECISTv1.1;
•ECOG performance score of 0 or 1;
•Adequate organ function;
•Fertile men or women with the possibility of becoming pregnant, using an effective contraceptive method during the trial, and continuing contraception for 6 months after the end of treatment;

Exclusion Criteria

•Have a history of malignancies other than the disease studied within the previous 5 years, except for 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);
•Prior anticancer therapy (chemotherapy, targeted agents, radiotherapy, and immunotherapy) within 28 days before first dose;
•Prior treatment with any anti-CD137 antibody or drug (single agent or combination);
•Adverse reactions caused by previous treatment that did not recover to CTCAE (version 5.0) grade 1 or below, hair loss, neurotoxicity to CTCAE (version 5.0) grade 2 or below, or other adverse reactions that researchers judged to have no 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 discontinued treatment 4 weeks before the first study drug administration, symptomless patients who do not require long-term glucocorticoid therapy), seizures, spinal cord compression, 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 clinical symptoms or symptomatic treatment of pleural fluid or ascites;
•Severe cardiovascular and cerebrovascular diseases, such as uncontrolled or poorly controlled high blood pressure or Pulmonary hypertension; Unstable angina pectoris or myocardial infarction, coronary artery bypass grafting or stenting within 6 months prior to study administration; Chronic heart failure with heart function ≥2 (NYHA rating); Degree II and above heart block; Left ventricular ejection fraction (LVEF) \< 50%; Study cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months prior to medication;
•History of pulmonary disease: interstitial pneumonia, obstructive pulmonary disease and symptomatic bronchospasm;

Arms & Interventions

Arm 1 Part 1 Dose Escalation

Escalating doses of FTL001 depending on cohort at enrollment

Intervention: FTL001

Arm 1 Part 2 Dose Expansion

Two dose groups of FTL001 depending on data of Arm 1 Part 1

Intervention: FTL001

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 FTL001

Secondary Outcomes

To preliminarily evaluate the anti-tumor activity(every 2 cycles (each cycle is 28 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))