Advanced Solid TumorsPhase 1/2NCT07131202
A Study of FL115 in Combination With a PD-1 Antibody in Advanced Solid Tumors
A Phase 1/2 study testing FL115+PD-1 in people with Advanced Solid Tumors, run by Suzhou Forlong Biotechnology Co., Ltd at 1 site in China.
Trial summary
This is an open-label, multicenter, Phase Ib/II clinical study designed to evaluate the safety, tolerability, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of FL115 in combination with the anti-PD-1 monoclonal antibody, in participants with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- FL115+PD-1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteChina
- Study dates
- 8 Jan 2026to 5 Dec 2028
- Phase
- Phase 1/2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects aged 18 years or older and up to 80 years old.
- Phase 1b：Patients with specific advanced solid tumors confirmed by histology or cytology who have failed all standard therapies, have no available standard treatment options, or are currently not suitable for standard treatment.
- Phase 2：Patients with advanced solid tumors of specific types, either previously treated with or naïve to standard therapies.
- With at least one measurable lesion (according to RECIST v1.1).
- ECOG score: 0 - 1.
- Expected survival period ≥ 12 weeks (judged by the investigator).
Show all 9Show fewer
- Sufficient organ function.
- Voluntary written informed consent and agree to comply with all protocol-specified procedures and follow-up evaluations.
- Fertile subjects (male and female) and their partners agree to use acceptable, investigator-approved contraception during the study-required period.
Who cannot join
- If any of the following criteria are met, the subjects will be excluded from the study:
- History of previous anti-tumor treatment:
- Previous use of IL-2 or IL-15 agonists, including but not limited to rhIL-15 (NCI), ALT-803 (ALTOR), NKTR-214 (Nektar).
- Subjects who received any anti-tumor investigational drugs, approved therapies, biologics, radiotherapy, or immunotherapy within 4 weeks before the first dose (except HRT(Hormoral Replacement Therapy), testosterone, oral contraceptives, ADT for prostate cancer, or endocrine therapy for breast cancer), endocrine therapy within 2 weeks, or palliative local radiotherapy within 14 days.
- Within 2 weeks before the first administration of the study drug, received traditional Chinese medicine for anti-tumor indications.
- Subjects who received oral fluoropyrimidines or small-molecule targeted therapies discontinued the treatment ≤2 weeks or 5 half-lives (whichever is longer) prior to the first dose of the study drug.
Show all 36Show fewer
- Subjects who received mitomycin C or nitrosourea treatment discontinued the medication ≤6 weeks prior to the first dose of the study drug.
- History of other previous treatments and toxicity recovery:
- Known or suspected allergies to FL115 and its excipients; known history of grade 3-4 allergic reactions to interleukin treatment or other fusion proteins.
- Known allergies to indomethacin, acetaminophen, diphenhydramine, ranitidine, cimetidine and/or famotidine.
- Received systemic immunosuppressants within 4 weeks before first dose, except for: ≤10 mg/day prednisone-equivalent, local/inhaled/nasal steroids, ≤7.5 mg/day for adrenal replacement, or one-time use for contrast allergy before imaging.
- Received treatment with granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), thrombopoietic agents (e.g., thrombopoietin [TPO], romiplostim, eltrombopag), or erythropoiesis-stimulating agents (e.g., erythropoietin [EPO]) within 14 days prior to screening.
- History of allogeneic organ or PBSC/bone marrow transplant.
- Received live viral vaccine within 4 weeks before first dose.
- Prior ≥Grade 3 or treatment-discontinuing irAEs, except for hypothyroidism, type 1 diabetes, or mild skin irAEs (excluding SJS, TEN, or severe dermatitis).
- All AEs from prior anti-tumor therapy have not resolved to baseline or ≤Grade 1 (per NCI CTCAE v5.0). Exceptions: hair loss (any grade) and ≤Grade 2 peripheral neuropathy are allowed; hypothyroidism that are well controlled with hormone replacement therapy or other conditions eligible per inclusion/exclusion criteria may be enrolled. Other ≤Grade 2 AEs may be allowed if deemed acceptable by the investigator and inclusion should be discussed with the sponsor's medical monitor.
- Past medical history and surgical history:
- Malignant tumors of the blood system (such as acute lymphocytic leukemia, acute myeloid leukemia, myelodysplastic syndrome, chronic lymphocytic leukemia, chronic myeloid leukemia, non-Hodgkin's lymphoma, Hodgkin's lymphoma, and multiple myeloma).
- Subjects with active central nervous system (CNS) metastatic lesions or meningeal metastasis. Exception: Asymptomatic subjects with CNS metastatic tumors if the clinical condition is controlled.
- Subjects who had other malignant tumors within 2 years before screening. Subjects with curable local tumors (such as basal or squamous cell skin cancer, cervical or breast carcinoma in situ), can be included after clear cure.
- Have active autoimmune diseases or a history of autoimmune diseases requiring systemic steroids or immunosuppressants, such as rheumatoid arthritis, lupus, Wegener's granulomatosis, Sjogren's syndrome, IBD, multiple sclerosis, myasthenia gravis, myositis, autoimmune hepatitis, vasculitis, immune thrombocytopenia, autoimmune hemolytic anemia, or glomerulonephritis.
- Exception: subjects with well-controlled endocrine disorders treated with HRT (e.g., hypothyroidism, type 1 diabetes).
- Subjects had any of the following pulmonary toxic reactions/diseases in the past:
- Significantly clinically significant severe pulmonary-specific diseases, including but not limited to: pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease, history of idiopathic pulmonary fibrosis, organizing pneumonia (such as obliterative bronchiolitis), history of drug-induced pneumonia.
- Active interstitial lung disease (ILD) or interstitial pneumonia; history of requiring hormone or other immunosuppressant treatment for ILD or (non-infectious) pneumonia.
- Found by history or CT examination that there was active tuberculosis infection within 1 year before enrollment or more than 1 year ago with no regular treatment.
- Judged by the investigator to have uncontrollable pleural effusion, pericardial effusion, or peritoneal effusion.
- Have a significant clinical history of cardiovascular diseases.
- Underwent major surgery within 4 weeks prior to signing the informed consent form.
- Infectious Disease History:
- Severe infections within 4 weeks before first dose.
- Any history of confirmed active HBV, HCV, HIV, or active tuberculosis infection
- Other Conditions.
- Pregnant or breastfeeding women.
- Known, documented, or suspected substance abuse. Exceptions: Prescribed opioids for pain control or other investigator-approved, medically justified cases (pending sponsor medical lead agreement).
- Any other conditions deemed by the investigator to render the subject unsuitable for participation.
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
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510000
Li Zhang, zhangli@sysucc.org.cn
About this study
Official title: A Phase Ib/II, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, Preliminary Efficacy, Pharmacokinetics, and Pharmacodynamics of FL115 in Combination With a PD-1 Monoclonal Antibody in Patients With Advanced Solid Tumors
This is an open-label, multicenter, Phase Ib/II clinical study designed to evaluate the safety, tolerability, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of FL115 in combination with the anti-PD-1 monoclonal antibody, in participants with advanced solid tumors. All enrolled participants will receive FL115 and Sintilimab via intravenous (IV) infusion. Treatment will continue until disease progression (excluding pseudoprogression), unacceptable toxicity, or other protocol-specified criteria for study or treatment discontinuation, whichever occurs first.
The study consists of two parts: a dose-escalation phase (Phase Ib) and a cohort-expansion phase (Phase II). The Phase 2 part will explore the preliminary efficacy and safety of the combination therapy in patients with advanced solid tumors across different tumor types.
- Conditions
- Advanced Solid Tumors
- Being tested
- FL115+PD-1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FL115+PD-1Drug
Combined treatment
| Study group | Role | What they receive |
|---|---|---|
| Combined treatment | Experimental | Not described Receives: Drug: FL115+PD-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerance
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: From screening to 30 days after last dose
MTD/RDE
Maximal Tolerance Dose/Recommended dosage expand
Measured: through study completion, an average of 15 months
ORR
The researchers evaluated the objective response rate (ORR) as per RECIST v1.1.
Measured: About 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start8 Jan 2026 (estimated)
- Primary completion5 Dec 2026 (estimated)
- Study completion5 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Forlong Biotechnology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07131202
- Sponsor's protocol ID
- FL115-201
- Status last verified
- Jan 2026
- First submitted
- 21 Jul 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: As the research has not yet begun, we will revise the plan based on the actual situation of the research after we obtain some data.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, Preliminary Efficacy, Pharmacokinetics, and Pharmacodynamics of FL115 in Combination With a PD-1 Monoclonal Antibody in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07131202
- Acronym / sponsor ID
- FL115-201
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Suzhou Forlong Biotechnology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 8 Jan 2026 (estimated)
- Primary completion
- 5 Dec 2026 (estimated)
- Study completion
- 5 Dec 2028 (estimated)
- First posted
- 20 Aug 2025 (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-label, multicenter, Phase Ib/II clinical study designed to evaluate the safety, tolerability, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of FL115 in combination with the anti-PD-1 monoclonal antibody, in participants with advanced solid tumors. All enrolled participants will receive FL115 and Sintilimab via intravenous (IV) infusion. Treatment will continue until disease progression (excluding pseudoprogression), unacceptable toxicity, or other protocol-specified criteria for study or treatment discontinuation, whichever occurs first.
The study consists of two parts: a dose-escalation phase (Phase Ib) and a cohort-expansion phase (Phase II). The Phase 2 part will explore the preliminary efficacy and safety of the combination therapy in patients with advanced solid tumors across different tumor types.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combined treatment | Experimental | Drug: FL115+PD-1 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female subjects aged 18 years or older and up to 80 years old.
- Phase 1b：Patients with specific advanced solid tumors confirmed by histology or cytology who have failed all standard therapies, have no available standard treatment options, or are currently not suitable for standard treatment.
- Phase 2：Patients with advanced solid tumors of specific types, either previously treated with or naïve to standard therapies.
- With at least one measurable lesion (according to RECIST v1.1).
- ECOG score: 0 - 1.
Key exclusion criteria (36 listed)
- History of previous anti-tumor treatment:
- History of other previous treatments and toxicity recovery:
- Past medical history and surgical history:
- Exception: subjects with well-controlled endocrine disorders treated with HRT (e.g., hypothyroidism, type 1 diabetes).
- Significantly clinically significant severe pulmonary-specific diseases, including but not limited to: pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease, history of idiopathic pulmonary fibrosis, organizing pneumonia (such as obliterative bronchiolitis), history of drug-induced pneumonia.
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 |
|---|---|---|
| FL115+PD-1Combined treatment | Drug | Combined treatment |
Primary outcome
Safety and Tolerance
Time frame: From screening to 30 days after last dose
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
MTD/RDE
Time frame: through study completion, an average of 15 months
Maximal Tolerance Dose/Recommended dosage expand
ORR
Time frame: About 24 months
The researchers evaluated the objective response rate (ORR) as per RECIST v1.1.
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 8 Jan 2026.
- Individual participant dataSharing planned: No. As the research has not yet begun, we will revise the plan based on the actual situation of the research after we obtain some data.
Related trials for Advanced Solid Tumors
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 1/2
Study of RAS(ON) Inhibitors in Combination With Ivonescimab in Patients With Solid Tumors
Advanced Solid Tumors, Metastatic Solid Tumors
Active, not recruitingPhase 1
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7566802 as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors
Locally Advanced Solid Tumors, Recurrent Solid Tumors
RecruitingPhase 1
A Study of Sofe-M in Participants With Selected Advanced Solid Tumors
Ovarian Neoplasms, Endometrial Neoplasms
RecruitingPhase 2
Study of Induction PD-1 Blockade in Subjects With Locally Advanced Mismatch Repair Deficient Solid Tumors
Rectal Adenocarcinoma, Clinical Stage: Stage II (T3-4, N-)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing FL115+PD-1 in people with Advanced Solid Tumors, run by Suzhou Forlong Biotechnology Co., 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 9 inclusion and 36 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 8 Jan 2026. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Xuxiajun Medical Director (+86-18101882657, xiajunxu@forlongbiotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerance (time frame: From screening to 30 days after last dose). The study lists 3 primary outcomes in all. 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 8 Jan 2026; AzTrials last refreshed its copy on 4 Nov 2026.