A Study of FC084CSA in Combination of Tislelizumab in Patients With Advanced Malignant Solid Tumors

NCT06499350 | Recruiting Phase 1

• 1 other identifier: FC084-CA-102
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn the safety, tolerability, pharmacokinetic characteristics and efficacy of FC084CSA in combination with Tislelizumab in patients with advanced malignant solid tumors.

Conditions

Advanced Malignant Solid Tumors

Outcome Measures

Primary Outcomes (4)

• Determine the Maximum Tolerated Dose (MTD)

  The highest dose is defined at which no more than 1 of 3 evaluable participants has had a Dose Limiting Toxicity (DLT) according to NCI CTCAE V5.0 criteria and determination by Investigator and Data and Safety Monitoring Committee.

  Approximately 8 months

• Determine the Recommended Phase 2 Dose (RP2D)

  The RP2D is based upon the review of all available data including safety, pharmacokinetic, preliminary anti-tumor activity, and MTD.

  Approximately 8 months

• Determine dose-limiting toxicity (DLT)

  Determine the DLT of FC084CSA

  21 days after first dose

• Objective response rate (ORR)

  To explore the clinical effectiveness. Tumor response based on RECIST 1.1

  Approximately 12 months

Secondary Outcomes (7)

• Disease control rate (DCR)

  Approximately 12 months

• Progression free survival (PFS)

  Approximately 12 months

• Overal suvival (OS)

  Approximately 18 months

• Pharmacokinetic (PK) Cmax

  Approximately 12 months

• Pharmacokinetic (PK) Tmax

  Approximately 12 months

Study Arms (1)

FC084CSA+Tislelizumab

EXPERIMENTAL

This is a single arm phase I trial in a 3 + 3 dose escalation and cohort expansion design evaluating the safety and tolerability of FC084CSA in combination with Tislelizumab. Increasing dose levels of FC084CSA with fixed dose of Tislelizumab. Dose escalation continues until dose-limiting toxicities (DLT) are observed in one-third of participants. If no DLT occurs, the next cohort will be enrolled at the next planned dose level. If 1 DLT occurs in a cohort, another 3 patients will be treated with the same dose level. Following the definition of the recommended Phase 2 Dose (RP2D) of FC084CSA in dose escalation phase, NSCLC dose expansion cohort is planned to perform a preliminary assessment of the anti-tumour efficacy and to further establish the safety profile of the RP2D of FC084CSA in combination with Tislelizumab.

Drug: FC084CSA+Tislelizumab combination (dose escalation); Drug: RP2D of FC084CSA+Tislelizumab combination (dose expansion)

Interventions

FC084CSA+Tislelizumab combination (dose escalation) DRUG

Increasing dose levels of FC084CSA+fixed dose Tislelizumab combination therapy

Also known as: FC084CSA+BGB-A317 combination (dose escalation)

FC084CSA+Tislelizumab

RP2D of FC084CSA+Tislelizumab combination (dose expansion) DRUG

RP2D of FC084CSA+fixed dose Tislelizumab combination therapy

Also known as: RP2D of FC084CSA+BGB-A317 combination (dose expansion)

FC084CSA+Tislelizumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 to 75 years old male and female.
• Phase Ib: Patients with histologically or cytologically diagnosed solid tumors who have failed standard therapy; Phase IIa: Patients with histologically or cytologically confirmed stage IIIB/IIIC and stage IV NSCLC which surgery or radiotherapy cannot be performed.
• No known sensitizing mutations or other actionable oncogenes with approved therapies if available.
• Prior PD-1/PD-L1 inhibitor combined with platinum-containing therapy failed;
• According to RECIST 1.1, there is at least one measurable lesion.
• ECOG performance status 0-1.
• Major organs are functioning well.

You may not qualify if:

• Not recovered from the adverse reactions caused by previous anti-tumor treatments (≥CTCAE grade 1).
• Received anti-tumor therapy within 4 weeks before enrollment.
• Participated in other clinical trials within 4 weeks before enrollment and used clinical investigational drugs during this period.
• Have undergone surgery within 4 weeks before enrollment, and the investigator believes that the patient's state has not recovered to the point where the study can be started.
• Patients with ascites (ascites), pleural effusion (pleural effusion) or pericardial effusion that cannot be controlled by drainage or other methods.
• Central nervous system metastases with clinical symptoms.
• With any situations that the researcher considers inappropriate to participate in this research.

Sponsors & Collaborators

• FindCure Biosciences (ZhongShan) Co., Ltd.: lead

Study Sites (1)

Shanghai East Hospital

Shanghai, Shanghai Municipality, 200120, China

RECRUITING

Study Officials

• Caicun Zhou

  Shanghai East Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tingjin Wang

CONTACT

18664044814; wangtingjin@find-cure.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

Model Details: FC084CSA in combination with Tislelizumab

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 12, 2024
• Study Start: November 13, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 10, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)