FT536 Monotherapy and in Combination With Monoclonal Antibodies in Advanced Solid Tumors

Recruiting in Palo Alto (17 mi)

+4 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Fate Therapeutics

No Placebo Group

Breakthrough Therapy

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?This trial tests a new treatment using special immune cells and targeted protein therapy for patients with advanced solid tumors. The treatment aims to help the immune system attack cancer more effectively.

Eligibility Criteria

Inclusion Criteria

Cohorts B/B2/BB/BB2 and C/C2/CC/CC2: Subjects with NSCLC, HNSCC, gastroesophageal adenocarinoma, triple negative breast cancer, or urothelial carcinoma whose tumors express PD-L1 according to defined cutoff

Cohort D/D2/DD/DD2: Subjects with advanced solid tumor whose tumor(s) express HER2 defined as: ≥2+ by IHC, Average HER2 copy number ≥4 signals per cell by in situ hybridization or ≥4 copies as determined by next generation sequencing

Cohort F/F2/FF/FF2: NSCLC known to have at least one of the following: epidermal growth factor receptor (EGFR) driver mutation(s) and have progressed on or were intolerant to at least one prior line of EGFR Tyrosine Kinase Inhibitor (TKI) or were not candidates for or declined TKI; mesenchymal-epithelial transition (MET) exon 14 skipping mutation that has progressed on or intolerant of at least one prior line of MET TKI or were not candidates for or declined TKI; MET amplification defined as MET/CEP7 ratio ≥1.8 by Fluorescence in situ hybridization (FISH)

+6 more

Exclusion Criteria

Has Eastern Cooperative Oncology Group (ECOG) performance status ≥2

Has evidence of insufficient organ function

Has clinically significant cardiovascular disease including left-ventricular ejection fraction < 45%

+9 more

Participant Groups

6Treatment groups

Experimental Treatment

Group I: Cohort F/F2/FF/FF2: FT536 + AmivantamabExperimental Treatment5 Interventions

FT536 + amivantamab in participants with locally advanced or metastatic NSCLC.

Group II: Cohort E/E2/EE/EE2: FT536 + CetuximabExperimental Treatment5 Interventions

FT536 + cetuximab in participants with locally advanced or metastatic squamous NSCLC, CRC, or head and neck cancer.

Group III: Cohort D/D2/DD/DD2: FT536 + TrastuzumabExperimental Treatment5 Interventions

FT536 + trastuzumab in participants with locally advanced or metastatic documented human epidermal growth factor receptor 2 (HER2+) expressing tumors

Group IV: Cohort C/C2/CC/CC2: FT536 + Pembrolizumab, Nivolumab, or AtezolizumabExperimental Treatment7 Interventions

FT536 + pembrolizumab, nivolumab, or atezolizumab in participants with locally advanced or metastatic solid tumor indications with documented PD-L1 expression.

Group V: Cohort B/B2/BB/BB2: FT536 + AvelumabExperimental Treatment5 Interventions

FT536 + avelumab combination therapy in participants with locally advanced or metastatic solid tumor indications with documented PD-L1 expression.

Group VI: Cohort A/A2/AA/AA2: FT536 MonotherapyExperimental Treatment4 Interventions

FT536 monotherapy in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC), colorectal cancer (CRC), breast cancer (BC), ovarian cancer, or pancreatic cancer.

FT536 is already approved in United States for the following indications:

🇺🇸 Approved in United States as FT536 for:

None approved yet; currently in Phase 1 clinical trials for advanced solid tumors including ovarian cancer, fallopian tube cancer, and primary peritoneal cancer