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Solid TumorPhase 1NCT06410092

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

A Phase 1 study testing FTL001 in people with Solid Tumor, run by Sound Biopharmaceuticals Ltd. at 3 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Solid Tumor
What is being tested?
FTL001
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
3 sitesChina
Study dates
5 Jun 2023to Mar 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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;

Who cannot join

  • 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;
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  • 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;
  • Active infection requiring intravenous anti-infective treatment, or unhealed wounds or ulcers occurring within 14 days prior to initial administration;
  • Test positive for human immunodeficiency virus (HIV) antibodies;
  • Hepatitis (non-alcoholic steatohepatitis, alcoholic or drug-related, autoimmune hepatitis) and cirrhosis with portal hypertension; Active hepatitis B or C:
  • Active tuberculosis (TB) is known to exist. Subjects suspected of active TB should be examined for chest X-rays, sputum, and clinical signs and symptoms.
  • Received systemic corticosteroids (prednisone > 10 mg/ day or equivalent) or other immunosuppressive drugs within 14 days prior to the initial study;
  • Receive live vaccination within 4 weeks prior to the initial study administration;
  • Major surgical procedures within 4 weeks prior to initial study medication (as defined by the investigator, open biopsy, severe trauma, etc.). Note: It is acceptable to replace an intravenous drip dropper. Had a major surgical procedure planned within 30 days of initial dosing (as determined by the investigator). Local procedures (such as placement of systemic ports, air-core needle biopsies, and prostate biopsies) are permitted, provided that the procedure is completed at least 24 hours before the first administration of the investigational therapeutic agent;
  • Pregnant or lactating women;
  • History of hypersensitivity or idiosyncrasy to the excipients of the study drug or to any monoclonal antibody;
  • Those who have previously received cellular immunotherapy (CAR-T).

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

CMO contact

0086-28-85250987

wenshb@soundbiopharma.com

China3 sites, 3 recruiting

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

    Yuankai Shi, MD

    Recruiting

  • West China Hospital

    Chengdu, Sichuan, 610041

    Li Zheng, MD

    Yongsheng Wang, MD

    Recruiting

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing Municipality, 400030

    Yongsheng Li, MD

    Recruiting

Other trials in China

About this study

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

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.

Read the 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.

Conditions
Solid Tumor
Being tested
FTL001
Keywords
Solid Tumor, FTL001, Sound Biopharmaceuticals

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FTL001Drug

    IV infusion every 2 weeks

Study groups in NCT06410092
Study groupRoleWhat they receive
Arm 1 Part 1 Dose EscalationExperimentalEscalating doses of FTL001 depending on cohort at enrollment
Receives: Drug: FTL001
Arm 1 Part 2 Dose ExpansionExperimentalTwo dose groups of FTL001 depending on data of Arm 1 Part 1
Receives: Drug: FTL001

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with dose-limiting toxicities (DLTs)

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

    Measured: First Cycle (28 days)

Secondary outcomes (3)

  1. To preliminarily evaluate the anti-tumor activity

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

    Measured: every 2 cycles (each cycle is 28 days)

  2. Pharmacokinetic (PK) measure: Maximum observed serum concentration (Cmax)

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

    Measured: From first dose (Cycle 1 Day 1, each cycle is 28 days) until the last dose (up to 2 years)

  3. Pharmacokinetic (PK) measure: Area under the plasma concentration versus time curve (AUC)

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

    Measured: From first dose (Cycle 1 Day 1, each cycle is 28 days) until the last dose (up to 2 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 May 2024
  2. Study start5 Jun 2023
  3. Primary completionJan 2026 (estimated)
  4. Study completionMar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
44 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06410092
Sponsor's protocol ID
FTL001-101
Status last verified
May 2024
First submitted
30 Apr 2024
Last updated
10 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing FTL001 in people with Solid Tumor, run by Sound Biopharmaceuticals Ltd. at 3 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact CMO (0086-28-85250987, wenshb@soundbiopharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with dose-limiting toxicities (DLTs) (time frame: First Cycle (28 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06410092.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2024.

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