Solid TumorsPhase 1NCT06410131
Study in Patients With Advanced Solid Tumors to Evaluate the Safety of FTL008.16
A Phase 1 study testing FTL008.16 in people with Solid Tumors, run by Sound Biopharmaceuticals Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumors
- What is being tested?
- FTL008.16
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteChina
- Study dates
- 27 May 2025to Nov 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
- 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).
Show all 11Show fewer
- Eastern Cancer Collaboration (ECOG) Physical fitness score of 0 or 1.
- 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.
- If sexually active: men who are sexually active with females of child-bearing potential must agree to use highly effective methods of contraception during study participation and for at least 6 months after the last dose of study drug..
Who cannot join
- 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);
Show all 23Show fewer
- 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.
- Severe cardiovascular and cerebrovascular diseases, such as resting QTc interval ≥470ms (corrected QT interval, according to the Fridericia formula); Uncontrolled or poorly controlled hypertension (systolic more than 160mmHg or diastolic more than 100mmHg) 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) less than 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 (requiring steroid treatment with a prednisone equivalent dose of more than 10mg/ day) or symptomatic bronchospasm.
- 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.
- An active infection requiring intravenous anti-infective treatment, or severe unhealed wounds or ulcers, occurs within 14 days prior to the first dose.
- Positive human immunodeficiency virus (HIV) antibody test result, or active syphilis infection (i.e., positive treponema pallidum antibody and non-treponema pallidum antibody titer test result).
- Autoimmune liver disease and decompensated cirrhosis; People with active hepatitis B virus or hepatitis C virus.
- Systemic immunosuppressive therapy is required if received within 14 days before the first dose or during the trial. However, the following conditions were allowed: in the absence of active autoimmune disease, patients were allowed to use nasal spray, inhalation, or topical corticosteroid drugs, or other corticosteroid drugs with a prednisone equivalent dose ≤10 mg/ day.
- Receive live vaccination within 4 weeks prior to the initial study administration.
- Major surgical operations (including primary tumor operations, craniotomy, thoracotomy or laparotomy, etc., excluding vascular access establishment operations) were performed within 4 weeks prior to the first study of drug use.
- Those who have a history of psychotropic drug abuse and cannot quit or have a history of mental disorders.
- Pregnant or lactating women.
- There are other severe, acute, or chronic medical or psychiatric disorders or laboratory abnormalities, as determined by the investigator, that may increase the risks associated with participation in the study or that may interfere with the interpretation of the study findings.
- Patients who have participated in or are being treated in other clinical trials for any other drug within 28 days prior to the first dose and plan to receive other anticancer therapy or other investigational drug during the study period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Ning Li, MD
Ning Li, MD
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Solid Tumors
- Being tested
- FTL008.16
- Keywords
- Solid Tumors, Sound Biopharmaceuticals, FTL008.16
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FTL008.16Drug
IV infusion every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 Part 1 Dose Escalation | Experimental | Escalating doses of FTL008.16 depending on cohort at enrollment Receives: Drug: FTL008.16 |
| Arm 1 Part 2 Dose Expansion | Experimental | Two dose groups of FTL008.16 depending on data of Arm 1 Part 1 Receives: Drug: FTL008.16 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with dose-limiting toxicities (DLTs)
Number of participants with DLTs during the 28 days following the first administration of FTL008.16
Measured: First Cycle (28 days)
Secondary outcomes (3)
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: 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)
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)
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.
- First posted10 May 2024
- Study start27 May 2025
- Primary completionNov 2026 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sound Biopharmaceuticals Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ning Li, MD, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical SciencesShoubin Wen, MD, Study director, Sound Biopharmaceuticals Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06410131
- Sponsor's protocol ID
- FTL008.16-101
- Status last verified
- Jun 2025
- First submitted
- 30 Apr 2024
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06410131
- Acronym / sponsor ID
- FTL008.16-101
- Conditions
- Solid Tumors
- Keywords
- Solid Tumors, Sound Biopharmaceuticals, FTL008.16
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Sound Biopharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 May 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 10 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 Part 1 Dose Escalation | Experimental | Drug: FTL008.16Escalating doses of FTL008.16 depending on cohort at enrollment |
| Arm 1 Part 2 Dose Expansion | Experimental | Drug: FTL008.16Two dose groups of FTL008.16 depending on data of Arm 1 Part 1 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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).
Key exclusion criteria (23 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FTL008.16IV infusion every 2 weeks | Drug | Arm 1 Part 1 Dose Escalation, Arm 1 Part 2 Dose Expansion |
Primary outcome
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
3 secondary outcomes
To preliminarily evaluate the anti-tumor activity
Time frame: 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)
Time frame: 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)
Time frame: From first dose (Cycle 1 Day 1, each cycle is 28 days) until the last dose (up to 2 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Solid Tumors
Active, not recruiting
A Collaborative Intervention for Improving Cancer Pain Management in Cancer Survivors
Hematopoietic and Lymphoid System Neoplasm, Malignant Solid Neoplasm
RecruitingObservational study
NCI Childhood Cancer Data Initiative (CCDI) Led Pediatric, Adolescent, and Young Adult Rare Cancer Registry for Very Rare Solid Tumors
Very Rare Tumors, Very Rare Cancers
Active, not recruitingPhase 1
Research Study Utilizing Expanded Multi-antigen Specific Lymphocytes for the Treatment of Solid Tumors
Solid Tumors
RecruitingObservational study
Natural History and Biospecimen Acquisition for Children and Adults With Rare Solid Tumors
Malignant Solid Tumors, Other Neoplasms Solid Tumors
Enrolling by invitationObservational study
Collection of Tissue Specimens From Patients With Solid Tumors or Blood Disorders and Their HLA-Compatible Family Members
Neoplasms, Hematologic Neoplasms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ning Li, MD principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Shoubin Wen, MD study director
Sound Biopharmaceuticals Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FTL008.16 in people with Solid Tumors, run by Sound Biopharmaceuticals Ltd. at 1 site 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 11 inclusion and 23 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 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 (00862867648168, 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?
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 1 Jul 2025.