A Study of FL115 in Combination With a PD-1 Antibody in Advanced Solid Tumors

NCT07131202 | Recruiting Phase 1

• 1 other identifier: FL115-201
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (3)

• Safety and Tolerance

  Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

  From screening to 30 days after last dose

• MTD/RDE

  Maximal Tolerance Dose/Recommended dosage expand

  through study completion, an average of 15 months

• ORR

  The researchers evaluated the objective response rate (ORR) as per RECIST v1.1.

  About 24 months

Study Arms (1)

Combined treatment

EXPERIMENTAL

Drug: FL115+PD-1

Interventions

FL115+PD-1 DRUG

Combined treatment

Combined treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Suzhou Forlong Biotechnology Co., Ltd: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510000, China

RECRUITING

Central Study Contacts

Xuxiajun Medical Director

CONTACT

+86-18101882657; xiajunxu@forlongbiotech.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: August 20, 2025
• Study Start: January 8, 2026
• Primary Completion (Estimated): December 5, 2026
• Study Completion (Estimated): December 5, 2028
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)