NCT04890613

Phase Ib Expansion Study of CX-5461 in Patients With Solid Tumours and BRCA2 and/or PALB2 Mutation

Recruiting now Phase 1 Last updated 4 June 2026

What this trial tests

Phase 1 trial testing CX-5461 in Advanced Solid Tumor in 52 participants. Currently enrolling.

Timeline

8 September 2021

Primary endpoint
1 March 2027

1 March 2027

Quick facts

Lead sponsor	Senhwa Biosciences, Inc.
Phase	Phase 1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	52
Start date	8 September 2021
Primary completion	1 March 2027
Estimated completion	1 March 2027
Sites	8 locations across United States, Canada

Drugs / interventions tested

• CX-5461 — full drug profile →

Conditions studied

• Advanced Solid Tumor — all drugs for Advanced Solid Tumor →

Sponsor

Senhwa Biosciences, Inc. — full company profile →

Who can join

18 and older, any sex, with Advanced Solid Tumor. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Determination of Recommended Phase 2 Dose (RP2D)
  Time frame: Safety cohort review will be conducted every 4 weeks from the date of first patient's enrollment to review safety data, until all patients have been enrolled and evaluated for toxicity.
  To identify the number of patients who discontinue study drug due to toxicity for each of the two dosing regimens independently.

Sponsor's own description

This is an open-label, multi-center, phase 1b study designed to determine a tolerable dose of CX-5461 administered by IV infusion on Day 1 and Day 8 of a 28-day cycle in patients with selected solid tumours and associated mutations for future Phase II trials. The safety and tolerability of CX-5461, preliminary evidence of antitumor effect and the effect of CX-5461 on the Health-Related Quality of Life (HRQoL) will also be evaluated. The study will also evaluate the predictive value of mutational signatures and explore the significance of dynamic changes in ctDNA levels and plasma DNA methylome profiling in this study's exploratory cohort.

Publications & conference data

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

1. Ribosome biogenesis in disease: new players and therapeutic targets.
   Jiao L, Liu Y, Yu XY, Pan X, et al · · 2023 · cited 216× · PMID 36617563 · DOI 10.1038/s41392-022-01285-4
2. TERT accelerates BRAF mutant-induced thyroid cancer dedifferentiation and progression by regulating ribosome biogenesis.
   Yu P, Qu N, Zhu R, Hu J, et al · · 2023 · cited 59× · PMID 37647391 · DOI 10.1126/sciadv.adg7125
3. The chemotherapeutic drug CX-5461 is a potent mutagen in cultured human cells.
   Koh GCC, Boushaki S, Zhao SJ, Pregnall AM, et al · · 2024 · cited 44× · PMID 38036782 · DOI 10.1038/s41588-023-01602-9
4. The impact of ribosome biogenesis in cancer: from proliferation to metastasis.
   Hwang SP, Denicourt C. · · 2024 · cited 43× · PMID 38633862 · DOI 10.1093/narcan/zcae017
5. Detection of alternative DNA structures and its implications for human disease.
   Matos-Rodrigues G, Hisey JA, Nussenzweig A, Mirkin SM. · · 2023 · cited 43× · PMID 37863029 · DOI 10.1016/j.molcel.2023.08.018
6. G-Quadruplexes in c-MYC Promoter as Targets for Cancer Therapy.
   Bahls B, Aljnadi IM, Emídio R, Mendes E, et al · · 2023 · cited 32× · PMID 36979947 · DOI 10.3390/biomedicines11030969
7. Ligands stimulating antitumour immunity as the next G-quadruplex challenge.
   Miglietta G, Marinello J, Russo M, Capranico G. · · 2022 · cited 29× · PMID 36114513 · DOI 10.1186/s12943-022-01649-y
8. Germline Aberrations in Pancreatic Cancer: Implications for Clinical Care.
   Casolino R, Corbo V, Beer P, Hwang CI, et al · · 2022 · cited 22× · PMID 35805011 · DOI 10.3390/cancers14133239