NCT03270176

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

Completed Phase 1 Last updated 1 June 2022

What this trial tests

Phase 1 trial testing Debio 1143 in Carcinoma, Non-Small-Cell Lung in 54 participants. Completed in 22 March 2022.

Timeline

10 October 2017

Primary endpoint
22 March 2022

22 March 2022

Quick facts

Lead sponsor	Debiopharm International SA
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	54
Start date	10 October 2017
Primary completion	22 March 2022
Estimated completion	22 March 2022
Sites	9 locations across Romania, Canada, Poland

Drugs / interventions tested

• Debio 1143 — full drug profile →
• Avelumab (avelumab) — full drug profile →

Conditions studied

• Carcinoma, Non-Small-Cell Lung — all drugs for Carcinoma, Non-Small-Cell Lung →
• Neoplasms — all drugs for Neoplasms →

Sponsor

Debiopharm International SA — full company profile →

Who can join

18 and older, any sex, with Carcinoma, Non-Small-Cell Lung or Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 participants with advanced solid malignancies.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. NF-κB in biology and targeted therapy: new insights and translational implications.
   Guo Q, Jin Y, Chen X, Ye X, et al · · 2024 · cited 1074× · PMID 38433280 · DOI 10.1038/s41392-024-01757-9
2. Successful Anti-PD-1 Cancer Immunotherapy Requires T Cell-Dendritic Cell Crosstalk Involving the Cytokines IFN-γ and IL-12.
   Garris CS, Arlauckas SP, Kohler RH, Trefny MP, et al · · 2018 · cited 806× · PMID 30552023 · DOI 10.1016/j.immuni.2018.09.024
3. Autophagy, ferroptosis, pyroptosis, and necroptosis in tumor immunotherapy.
   Gao W, Wang X, Zhou Y, Wang X, et al · · 2022 · cited 801× · PMID 35725836 · DOI 10.1038/s41392-022-01046-3
4. Mechanisms of Chemotherapy Resistance in Triple-Negative Breast Cancer-How We Can Rise to the Challenge.
   Nedeljković M, Damjanović A. · · 2019 · cited 576× · PMID 31443516 · DOI 10.3390/cells8090957
5. Emerging therapeutic agents for advanced non-small cell lung cancer.
   Chen R, Manochakian R, James L, Azzouqa AG, et al · · 2020 · cited 244× · PMID 32448366 · DOI 10.1186/s13045-020-00881-7
6. Ubiquitination and deubiquitination in cancer: from mechanisms to novel therapeutic approaches.
   Liu F, Chen J, Li K, Li H, et al · · 2024 · cited 195× · PMID 39048965 · DOI 10.1186/s12943-024-02046-3
7. Fueling the Fire: Inflammatory Forms of Cell Death and Implications for Cancer Immunotherapy.
   Rosenbaum SR, Wilski NA, Aplin AE. · · 2021 · cited 148× · PMID 33451983 · DOI 10.1158/2159-8290.cd-20-0805
8. Future Therapeutic Directions for Smac-Mimetics.
   Morrish E, Brumatti G, Silke J. · · 2020 · cited 108× · PMID 32053868 · DOI 10.3390/cells9020406