Advanced Solid Tumors
Conditions
Brief 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. 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.
Interventions
DRUGFL115+PD-1
Combined treatment
Sponsors
Suzhou Forlong Biotechnology Co., Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female subjects aged 18 years or older and up to 80 years old. 2. 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. 3. With at least one measurable lesion (according to RECIST v1.1). 4. ECOG score: 0 - 1. 5. Expected survival period ≥ 12 weeks (judged by the investigator). 6. Sufficient organ function. 7. Voluntary written informed consent and agree to comply with all protocol-specified procedures and follow-up evaluations. 8. Fertile subjects (male and female) and their partners agree to use acceptable, investigator-approved contraception during the study-required period.
Exclusion criteria
If any of the following criteria are met, the subjects will be excluded from the study: 1. History of previous anti-tumor treatment: 1. Previous use of IL-2 or IL-15 agonists, including but not limited to rhIL-15 (NCI), ALT-803 (ALTOR), NKTR-214 (Nektar). 2. 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. 3. Within 2 weeks before the first administration of the study drug, received traditional Chinese medicine for anti-tumor indications. 4. 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. 5. Subjects who received mitomycin C or nitrosourea treatment discontinued the medication ≤6 weeks prior to the first dose of the study drug. 2. History of other previous treatments and toxicity recovery: 1. Known or suspected allergies to FL115 and its excipients; known history of grade 3-4 allergic reactions to interleukin treatment or other fusion proteins. 2. Known allergies to indomethacin, acetaminophen, diphenhydramine, ranitidine, cimetidine and/or famotidine. 3. 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. 4. 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. 5. History of allogeneic organ or PBSC/bone marrow transplant. 6. Received live viral vaccine within 4 weeks before first dose. 7. Prior ≥Grade 3 or treatment-discontinuing irAEs, except for hypothyroidism, type 1 diabetes, or mild skin irAEs (excluding SJS, TEN, or severe dermatitis). 8. 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MTD/RDE | through study completion, an average of 15 months | Maximal Tolerance Dose/Recommended dosage expand |
| ORR | About 24 months | The researchers evaluated the objective response rate (ORR) as per RECIST v1.1. |
| Safety and Tolerance | From screening to 30 days after last dose | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 |
Countries
China
Contacts
Primary ContactXuxiajun Medical Director
Outcome results
None listed