Status:
COMPLETED
A Dose-Finding Study of the Second Mitochondrial Activator of Caspases (SMAC) Mimetic Debio 1143 When Given in Combination With Avelumab to Participants With Advanced Solid Malignancies and to Participants With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) After Platinum-Based Therapy
Lead Sponsor:
Debiopharm International SA
Conditions:
Carcinoma, Non-Small-Cell Lung
Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The study is primarily designed to assess the safety and tolerability of escalating oral doses of Debio 1143 and preliminary anti-tumour activity when combined with the standard dose of avelumab in pa...
Eligibility Criteria
Inclusion
- Part A • With advanced solid malignancies who are not eligible for standard therapy or for whom standard therapy has failed
- Part B
- • With histologically or cytologically confirmed NSCLC of stage IIIB or IV (per 7th International Association for the Study of Lung Cancer classification) that has progressed after one line of platinum containing doublet chemotherapy
- Part A and B
- Willingness and feasibility to provide a tumor biopsy sample both at screening and during treatment (If archived tumor material not older than 1 year is available, then the screening biopsy will not be performed).
- Participants with prior radiation therapy must have measurable disease in non-irradiated sites or documented evidence of progression within the radiation field.
- With known central nervous system (CNS) must have completed primary brain therapy (such as whole brain radiotherapy, stereotactic radiosurgery, or complete surgical resection) and must have remained clinically stable, asymptomatic, and without steroid treatment for at least 21 days.
Exclusion
- Not recovered (i.e. toxicity grade \>1) from prior investigational drug and/or anti-cancer therapy (chemo- or palliative radiotherapy).
- Symptomatic and/or progressive brain metastasis or carcinomatous meningitis.
- Immunosuppressive agents (such as steroids) for any reason should be tapered off before initiation of study treatment (except low-dose prednisone at a total dose of up to 10 mg/day).
- Part B only
- Tumor activating epidermal growth factor receptor (EGFR) mutation(s) or anaplastic lymphoma kinase (ALK)/ROS1 translocation/rearrangement (testing required in non-squamous participants if status is unknown).
- More than one prior line of chemotherapy and one line of anti-PD1/PDL1 therapy.
Key Trial Info
Start Date :
October 10 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 22 2022
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT03270176
Start Date
October 10 2017
End Date
March 22 2022
Last Update
June 1 2022
Active Locations (9)
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1
Cross Cancer Center Dept Medicine
Edmonton, Alberta, Canada, T6G 1Z2
2
British Columbia Cancer Agency
Vancouver, British Columbia, Canada, V5Z 4E6
3
Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
4
The Ottawa Hospital Cancer Centre (TOHCC)
Ottawa, Ontario, Canada, K1H 8L6