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

FindCure Biosciences

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Advanced Malignant Solid Tumors

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT06499350

FC084-CA-102

Details and patient eligibility

About

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.

Full description

The study includes two phases. Phase Ib adopts a "3+3" dose escalation design to assess safety and tolerability of increasing dose levels of FC084CSA in combination of fixed dose of Tislelizumab. Phase IIa is the dose expansion phase to further observe the preliminary effectiveness of the recommended Phase 2 Dose of FC084CSA in combination of Tislelizumab.

Enrollment: 33 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Aged 18 to 75 years old male and female.
2. 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.
3. No known sensitizing mutations or other actionable oncogenes with approved therapies if available.
4. Prior PD-1/PD-L1 inhibitor combined with platinum-containing therapy failed;
5. According to RECIST 1.1, there is at least one measurable lesion.
6. ECOG performance status 0-1.
7. Major organs are functioning well.

Exclusion criteria

1. Not recovered from the adverse reactions caused by previous anti-tumor treatments (≥CTCAE grade 1).
2. Received anti-tumor therapy within 4 weeks before enrollment.
3. Participated in other clinical trials within 4 weeks before enrollment and used clinical investigational drugs during this period.
4. 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.
5. Patients with ascites (ascites), pleural effusion (pleural effusion) or pericardial effusion that cannot be controlled by drainage or other methods.
6. Central nervous system metastases with clinical symptoms.
7. With any situations that the researcher considers inappropriate to participate in this research.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

FC084CSA+Tislelizumab

Experimental group

Description:

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.

Treatment:

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

Drug: FC084CSA+Tislelizumab combination (dose escalation)