Who is sponsoring NCT04957290?

NCT04957290 is sponsored by Noxopharm Limited.

What drugs are being tested in NCT04957290?

Interventions in NCT04957290: NOX66, NOX66, NOX66, NOX66, NOX66, EBRT.

Is NCT04957290 still recruiting?

NCT04957290 is currently terminated. Last updated 18 June 2024.

Are results published for NCT04957290?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-06-18 · How we verify

NCT04957290

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study of NOX66 and External Beam Radiotherapy in Patients With Metastatic Castration-resistant Prostate Cancer and Other Solid Tumors

Terminated Phase 1, PHASE2 Results posted Last updated 18 June 2024

What this trial tests

Phase 1, PHASE2 trial testing NOX66 in Metastatic Castration-resistant Prostate Cancer and Other Solid Tumors in 21 participants. Terminated before completion.

Timeline

25 October 2021

Primary endpoint
10 May 2023

7 June 2023

Quick facts

Lead sponsor	Noxopharm Limited
Phase	Phase 1, PHASE2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	21
Start date	25 October 2021
Primary completion	10 May 2023
Estimated completion	7 June 2023
Sites	2 locations across United States

Drugs / interventions tested

NOX66 — full drug profile →
NOX66 — full drug profile →
NOX66 — full drug profile →
NOX66 — full drug profile →
NOX66 — full drug profile →
EBRT

Conditions studied

Metastatic Castration-resistant Prostate Cancer and Other Solid Tumors — all drugs for Metastatic Castration-resistant Prostate Cancer and Other Solid Tumors →

Sponsor

Noxopharm Limited — full company profile →

Who can join

18 and older, any sex, with Metastatic Castration-resistant Prostate Cancer and Other Solid Tumors. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Part 1 (Dose Escalation): Number of Dose-limiting Toxicities (DLTs) Primary · Cycle 1 (Day 1 to Day 21)

Maximum tolerated dose (MTD) and RP2D of NOX66 in combination with low-dose EBRT in patients with any solid tumor. MTD is defined as the dose level at which no more than 1 patient out of 6 has a DLT at the end of Cycle 1. RP2D is the highest dose at which no more than 1 patient out of 6 has a DLT at the end of Cycle 1 and the dosage form, is acceptable to patients. A DLT is defined as an AE that occurs during Cycle 1 (Day 1 to Day 21) that is unrelated to the disease, intercurrent illness or concomitant medications and that, possibly- definitely related to NOX66 alone or in combination with E

Group	Value	95% CI
Part 1: Dose Cohort 1: NOX66 800 mg	0
Part 1: Dose Cohort 2: NOX66 1200 mg	0
Part 1: Dose Cohort 3: NOX66 1600 mg	0

Part 1: Incidence of Adverse Events (AEs) for NOX66 Secondary · From Screening (Days -28 to -2) until the Follow-up visit/End of Study (EOS) (through study completion, an average of 19 month)

Characterization of the safety and tolerability of NOX66.

With at least one Adverse Event

Group	Value	95% CI
Part 1: Dose Cohort 1: NOX66 800 mg	4
Part 1: Dose Cohort 2: NOX66 1200 mg	7
Part 1: Dose Cohort 3: NOX66 1600 mg	9

With at least one TEAE (Treatment Emergent Adverse Event)

Group	Value	95% CI
Part 1: Dose Cohort 1: NOX66 800 mg	4
Part 1: Dose Cohort 2: NOX66 1200 mg	7
Part 1: Dose Cohort 3: NOX66 1600 mg	9

Dose Limiting Toxicity

Group	Value	95% CI
Part 1: Dose Cohort 1: NOX66 800 mg	0
Part 1: Dose Cohort 2: NOX66 1200 mg	0
Part 1: Dose Cohort 3: NOX66 1600 mg	0

Fatal TEAE

Group	Value	95% CI
Part 1: Dose Cohort 1: NOX66 800 mg	0
Part 1: Dose Cohort 2: NOX66 1200 mg	1
Part 1: Dose Cohort 3: NOX66 1600 mg	0

AEs that were greater than Grade 2 severity

Group	Value	95% CI
Part 1: Dose Cohort 1: NOX66 800 mg	1
Part 1: Dose Cohort 2: NOX66 1200 mg	5
Part 1: Dose Cohort 3: NOX66 1600 mg	5

TEAE related to Study Treatment (NOX66)

Group	Value	95% CI
Part 1: Dose Cohort 1: NOX66 800 mg	4
Part 1: Dose Cohort 2: NOX66 1200 mg	4
Part 1: Dose Cohort 3: NOX66 1600 mg	6

Part 1: TEAEs by Relationship to EBRT Administration Secondary · From Screening (Days -28 to -2) until the Follow-up visit/EOS (through study completion, an average of 19 month)

Evaluation of the safety and tolerability of both doses of EBRT (8 Gy or 20/25 Gy).

Group	Value	95% CI
Part 1: Dose Cohort 1: NOX66 800 mg	1
Part 1: Dose Cohort 2: NOX66 1200 mg	2
Part 1: Dose Cohort 3: NOX66 1600 mg	3
Part 1: Dose Cohort 1: NOX66 800 mg	0
Part 1: Dose Cohort 2: NOX66 1200 mg	2
Part 1: Dose Cohort 3: NOX66 1600 mg	2
Part 1: Dose Cohort 1: NOX66 800 mg	3
Part 1: Dose Cohort 2: NOX66 1200 mg	3
Part 1: Dose Cohort 3: NOX66 1600 mg	5

Adverse events — posted to ClinicalTrials.gov

Time frame: All AEs and SAEs will be collected from the signing of the ICF until 30 days after the last dose of study drug at the time points specified in the Schedule of assessments with an average of 7 months for each participant.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Part 1: Dose Cohort 1: NOX66 800 mg

Serious: 1/4 (25%)

Deaths: 0/4

Part 1: Dose Cohort 2: NOX66 1200 mg

Serious: 3/7 (43%)

Deaths: 2/7

Part 1: Dose Cohort 3: NOX66 1600 mg

Serious: 5/10 (50%)

Deaths: 1/10

Serious adverse events (13 terms)

Reaction	System	Part 1: Dose Cohort 1: NOX…	Part 1: Dose Cohort 2: NOX…	Part 1: Dose Cohort 3: NOX…
Angina pectoris	Cardiac disorders	—	—	—
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	—	—	—
Anemia	Blood and lymphatic system disorders	—	—	—
Encephalopathy	Nervous system disorders	—	—	—
pleural effusion	Respiratory, thoracic and mediastinal disorders	—	—	—
diarrhea	Gastrointestinal disorders	—	—	—
Sinus tachycardia	Cardiac disorders	—	—	—
Respiratory distress	Respiratory, thoracic and mediastinal disorders	—	—	—
General physical health deterioration	General disorders	—	—	—
Non-cardiac chest pain	General disorders	—	—	—
Failure to thrive	Metabolism and nutrition disorders	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—
Confusional state	Psychiatric disorders	—	—	—

Other adverse events (13 terms — click to expand)

Reaction	System	Part 1: Dose Cohort 1: NOX…	Part 1: Dose Cohort 2: NOX…	Part 1: Dose Cohort 3: NOX…
Nausea	Gastrointestinal disorders	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—
Dizziness	Nervous system disorders	—	—	—
Fatigue	General disorders	—	—	—
Lymphopenia	Blood and lymphatic system disorders	—	—	—
Insomnia	Psychiatric disorders	—	—	—
Proteinuria	Renal and urinary disorders	—	—	—
Anorectal discomfort	Gastrointestinal disorders	—	—	—
Proctitis	Gastrointestinal disorders	—	—	—
Headache	Nervous system disorders	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—

Most-reported serious reactions: Angina pectoris, Acute respiratory failure, Anemia, Encephalopathy, pleural effusion, diarrhea, Sinus tachycardia, Respiratory distress.

Data from ClinicalTrials.gov NCT04957290 adverse events section.

Sponsor's own description

This is a Phase 1b/Phase 2a, open-label, multicenter study to determine the safety, tolerability, recommended Phase 2 dose (RP2D), efficacy, pharmacokinetics (PK) and pharmacodynamic (PD) properties of idronoxil when rectally administered as a suppository (NOX66) to patients with any solid tumor (Part 1) and patients with metastatic castration-resistant prostate cancer (mCRPC), breast cancer (BC) and non-small-cell lung cancer (NSCLC) (Part 2) who are eligible for low-dose external beam radiotherapy (EBRT) for at least one symptomatic or minimally symptomatic lesion (for the prevention of symptoms).

Publications & conference data

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

Macrophages Are a Double-Edged Sword: Molecular Crosstalk between Tumor-Associated Macrophages and Cancer Stem Cells.
Luo S, Yang G, Ye P, Cao N, et al · · 2022 · cited 38× · PMID 35740975 · DOI 10.3390/biom12060850
The STING in Non-Alcoholic Fatty Liver Diseases: Potential Therapeutic Targets in Inflammation-Carcinogenesis Pathway.
Lv J, Xing C, Chen Y, Bian H, et al · · 2022 · cited 9× · PMID 36297353 · DOI 10.3390/ph15101241
Conjugated Nanoparticles for Solid Tumor Theranostics: Unraveling the Interplay of Known and Unknown Factors.
Chavda VP, Balar PC, Nalla LV, Bezbaruah R, et al · · 2023 · cited 8× · PMID 37867666 · DOI 10.1021/acsomega.3c05069

Verify or expand the search:

Other trials of NOX66

Trials testing the same drug.

NCT05100628 — A Study of NOX66 Plus Doxorubicin in Anthracycline-naïve, Adult Patients With Soft Tissue Sarcoma · Phase 1 · terminated
NCT04555213 — A Dose Escalation and Dose Expansion Study of NOX66 in the Treatment of COVID-19 · Phase 1 · completed
NCT03307629 — Safety and Tolerability of NOX66 in Combination With Palliative Radiotherapy in Patients With Late-Stage Prostate Cancer · Phase 1 · completed
NCT02941523 — Safety, PK and Efficacy of NOX66 as a Monotherapy and Combined With Carboplatin in Refractory Solid Tumours · Phase 1, PHASE2 · completed

Other Noxopharm Limited trials

Trials by the same sponsor.

NCT05100628 — A Study of NOX66 Plus Doxorubicin in Anthracycline-naïve, Adult Patients With Soft Tissue Sarcoma · Phase 1 · terminated
NCT04555213 — A Dose Escalation and Dose Expansion Study of NOX66 in the Treatment of COVID-19 · Phase 1 · completed
NCT03780465 — A Study of Safety and Tolerability of NOX66 in Healthy Volunteers · Phase 1 · withdrawn
NCT03307629 — Safety and Tolerability of NOX66 in Combination With Palliative Radiotherapy in Patients With Late-Stage Prostate Cancer · Phase 1 · completed
NCT02941523 — Safety, PK and Efficacy of NOX66 as a Monotherapy and Combined With Carboplatin in Refractory Solid Tumours · Phase 1, PHASE2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04957290 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Noxopharm Limited
Last refreshed: 18 June 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04957290.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing