EP0057 in Combination With Olaparib in Relapsed Advanced Gastric Cancer and Small Cell Lung Cancer

Sponsor
Ellipses Pharma
Study ID
NCT05411679
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • EP0057 — DRUG
    EP0057 is an investigational nanoparticle-drug conjugate with a Camptothecin payload, that is administered intravenously
  • Olaparib tablets — DRUG
    Olaparib is a PARP inhibitor (poly \[adenosine diphosphate-ribose\] polymerase inhibitor) Other names: Lynparza

Study Details

The aim of EP0057 - 202 is to assess the safety and efficacy of EP0057 in combination with Olaparib (a PARP inhibitor) in two cancers where there is a high unmet need: extensive stage small cell lung cancer (SCLC) and ATM-negative gastric cancer (GC). EP0057-202 is a non-comparative, multi-arm, multi-centre, open label, Phase 2 study to determine the efficacy, safety, and tolerability of EP0057 in combination with olaparib (an approved PARP inhibitor) in defined patient populations with relapsed\* GC and SCLC. \*(see Eligibility Criteria for definition of "relapse" for each tumour type/population) The treatment cohorts will open sequentially at the Sponsor's discretion and patients may be enrolled into each cohort concurrently. EP0057 is an investigational nanoparticle-drug conjugate administered intravenously. The rationale for developing EP0057 is to enable selective entry of EP0057 into tumour tissue and as a result create preferential accumulation of EP0057, and therefore of the payload Camptothecin, to translate into maximum tumour cell killing.

Key Dates

Start date
Apr 30, 2023
Status verified
Jun 2023
Primary completion
Aug 31, 2024
Completion
Dec 31, 2024

Study Design

Enrollment
0 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
    patients with ataxia-telangiectasia mutated protein (ATM)-negative relapsed, advanced GC.
  • Experimental: Arm 2
    patients with relapsed extensive stage SCLC.

Primary Outcome Measure

Overall Response Rate (ORR) as measured using RECIST v1.1 [ Time Frame: Approximately 18 months ]

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