NCT03291938

IACS-010759 in Advanced Cancers

Completed Phase 1 Last updated 24 November 2020

What this trial tests

Phase 1 trial testing Oxidative Phosphorylation Inhibitor IACS-010759 in Advanced Malignant Solid Neoplasm in 29 participants. Completed in 23 November 2020.

Timeline

13 November 2017

Primary endpoint
23 November 2020

23 November 2020

Quick facts

Lead sponsor	M.D. Anderson Cancer Center
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	29
Start date	13 November 2017
Primary completion	23 November 2020
Estimated completion	23 November 2020
Sites	1 location across United States

Drugs / interventions tested

• Oxidative Phosphorylation Inhibitor IACS-010759 — full drug profile →
• Pharmacodynamic Study
• Pharmacokinetic Study

Conditions studied

• Advanced Malignant Solid Neoplasm — all drugs for Advanced Malignant Solid Neoplasm →
• Anatomic Stage III Breast Cancer AJCC v8 — all drugs for Anatomic Stage III Breast Cancer AJCC v8 →
• Anatomic Stage IIIA Breast Cancer AJCC v8 — all drugs for Anatomic Stage IIIA Breast Cancer AJCC v8 →
• Anatomic Stage IIIB Breast Cancer AJCC v8 — all drugs for Anatomic Stage IIIB Breast Cancer AJCC v8 →

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

18 and older, any sex, with Advanced Malignant Solid Neoplasm or Anatomic Stage III Breast Cancer AJCC v8. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase I trial studies the side effects and best dose of oxidative phosphorylation inhibitor IACS-010759 (IACS-010759) in treating patients with lymphoma that has come back (relapsed) or does not respond to treatment (refractory) or solid tumors that have spread to other places in the body (advanced/metastatic) or cannot be removed by surgery (unresectable). IACS-010759 may stop the growth of cancer or tumor cells by blocking some of the enzymes needed for cell growth.

Publications & conference data

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

1. Complex I inhibitor of oxidative phosphorylation in advanced solid tumors and acute myeloid leukemia: phase I trials.
   Yap TA, Daver N, Mahendra M, Zhang J, et al · · 2023 · cited 306× · PMID 36658425 · DOI 10.1038/s41591-022-02103-8
2. Molecular Profiling Reveals Unique Immune and Metabolic Features of Melanoma Brain Metastases.
   Fischer GM, Jalali A, Kircher DA, Lee WC, et al · · 2019 · cited 274× · PMID 30787016 · DOI 10.1158/2159-8290.cd-18-1489
3. Altered metabolism in cancer: insights into energy pathways and therapeutic targets.
   Tufail M, Jiang CH, Li N. · · 2024 · cited 265× · PMID 39294640 · DOI 10.1186/s12943-024-02119-3
4. Resistance to neoadjuvant chemotherapy in triple-negative breast cancer mediated by a reversible drug-tolerant state.
   Echeverria GV, Ge Z, Seth S, Zhang X, et al · · 2019 · cited 246× · PMID 30996079 · DOI 10.1126/scitranslmed.aav0936
5. Mitochondrial adaptation in cancer drug resistance: prevalence, mechanisms, and management.
   Jin P, Jiang J, Zhou L, Huang Z, et al · · 2022 · cited 180× · PMID 35851420 · DOI 10.1186/s13045-022-01313-4
6. Context-Specific Determinants of the Immunosuppressive Tumor Microenvironment in Pancreatic Cancer.
   Falcomatà C, Bärthel S, Schneider G, Rad R, et al · · 2023 · cited 148× · PMID 36622087 · DOI 10.1158/2159-8290.cd-22-0876
7. Targeting Cancer Stem Cells in Triple-Negative Breast Cancer.
   Park SY, Park SY, Choi JH, Nam JS. · · 2019 · cited 135× · PMID 31324052 · DOI 10.3390/cancers11070965
8. Why All the Fuss about Oxidative Phosphorylation (OXPHOS)?
   Xu Y, Xue D, Bankhead A, Neamati N. · · 2020 · cited 127× · PMID 33103432 · DOI 10.1021/acs.jmedchem.0c01013