Study to Assess Safety,Tolerability,Efficacy of PM01183 and Atezolizumab in Patients w/ Advanced Small Cell Lung Cancer.

Sponsor
Fundacion Oncosur
Study ID
NCT04253145
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

  • Carcinoma, Small Cell Lung

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • PM 01183 — DRUG
    Lyophilisate for solution for infusion
  • Atezolizumab — DRUG
    Concentrate for solution for infusion

Study Details

Prospective, open-label, uncontrolled and multicenter phase I-II study in SCLC patients with ECOG PS 0-1 who have failed one prior platinum-containing line but no more than one chemotherapy-containing line. The study will be divided into two parts: a dose-ranging phase I with escalating doses of PM01183 in combination with a fixed dose of atezolizumab, followed by a single-arm phase II part with expansion at the RD determined during the phase I.

Key Dates

Start date
Dec 13, 2019
Status verified
Nov 2023
Primary completion
May 31, 2025
Completion
May 31, 2025

Study Design

Enrollment
184 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: PM01183 w/ Atezolizumab
    Patients will receive atezolizumab at a fixed dose of 1200 mg intravenously (i.v.) as a 60-minute infusion (the second and subsequent infusions may be administered over 30 minutes) followed by PM01183 at a starting dose of 2.5 mg/m2 i.v. as a 1-hour infusion on Day 1 every three weeks (q3wk). Following analysis of cohorts, dose levels can be escalated from 2.5mg to 3.2, to a maximum dose of 3.5 mg of PM01183

Primary Outcome Measure

Determination of Maximum Tolerable Dose [ Time Frame: one cycle - 21 days ]

Central Contacts

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