NCT02801097 (PAYLOAD) is a Phase 1 clinical trial of RRx-001 in Malignant Solid Tumor, sponsored by EpicentRx, Inc..

Who is sponsoring NCT02801097?

NCT02801097 is sponsored by EpicentRx, Inc..

What drugs are being tested in NCT02801097?

Interventions in NCT02801097: RRx-001, Irinotecan.

What condition does NCT02801097 study?

NCT02801097 studies Malignant Solid Tumor, Metastatic Cancer, Advanced Cancer.

Is NCT02801097 still recruiting?

NCT02801097 is currently terminated. Last updated 17 May 2022.

Last reviewed 2022-05-17 · How we verify

NCT02801097: PAYLOAD

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

RRx-001 in Combination With Irinotecan in Metastatic or Advanced Cancer (PAYLOAD)

Terminated Phase 1 Last updated 17 May 2022

What this trial tests

Phase 1 trial testing RRx-001 in Malignant Solid Tumor in 28 participants. Terminated before completion.

Timeline

30 August 2016

Primary endpoint
22 November 2018

9 December 2019

Quick facts

Lead sponsor	EpicentRx, Inc.
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	28
Start date	30 August 2016
Primary completion	22 November 2018
Estimated completion	9 December 2019
Sites	2 locations across United States

Drugs / interventions tested

RRx-001 — full drug profile →
Irinotecan (irinotecan) — full drug profile →

Conditions studied

Malignant Solid Tumor — all drugs for Malignant Solid Tumor →
Metastatic Cancer — all drugs for Metastatic Cancer →
Advanced Cancer — all drugs for Advanced Cancer →

Sponsor

EpicentRx, Inc. — full company profile →

Who can join

18 and older, any sex, with Malignant Solid Tumor or Metastatic Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a phase 1 open-label trial to evaluate the safety, pharmacodynamics and clinical activity of RRx-001 administered in combination with irinotecan. RRx-001 is associated with resensitization to irinotecan in tumors that are previously refractory. This effect has been attributed to the ability of RRx-001 to restore the expression of aberrantly silenced genes, thus re-establishing pathway functions. However, resensitization may have more than one mechanism, among them Pgp pump inhibition and vascular modulation, leading to improved penetration of standard chemotherapy.

Publications & conference data

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

Emerging phagocytosis checkpoints in cancer immunotherapy.
Liu Y, Liu Y, Wang Y, Yang Y, et al · · 2023 · cited 186× · PMID 36882399 · DOI 10.1038/s41392-023-01365-z
Deciphering the role of CD47 in cancer immunotherapy.
Liu Y, Liu Y, Weng L, Wang Y, et al · · 2024 · cited 41× · PMID 39167629 · DOI 10.1016/j.jare.2023.10.009
A Review of RRx-001: A Late-Stage Multi-Indication Inhibitor of NLRP3 Activation and Chronic Inflammation.
Jayabalan N, Oronsky B, Cabrales P, Reid T, et al · · 2023 · cited 30× · PMID 36920652 · DOI 10.1007/s40265-023-01838-z
Lactylation in cancer: metabolic mechanism and therapeutic strategies.
Sui Y, Shen Z, Wang Z, Feng J, et al · · 2025 · cited 11× · PMID 39979245 · DOI 10.1038/s41420-025-02349-4
Development of small molecule drugs targeting immune checkpoints.
Chen L, Zhao X, Liu X, Ouyang Y, et al · · 2024 · cited 10× · PMID 38727005 · DOI 10.20892/j.issn.2095-3941.2024.0034

Verify or expand the search:

Other trials of RRx-001

Trials testing the same drug.

NCT05966194 — RRx-001 for Reducing Oral Mucositis in Patients Receiving Chemotherapy and Radiation for Head and Neck Cancer · Phase 2 · recruiting
NCT04525014 — RRx-001 Given With Irinotecan and Temozolomide for Pediatric Patients With Recurrent or Progressive Malignant Solid and · Phase 1 · terminated
NCT03515538 — Safety and Efficacy of RRx-001 in the Attenuation of Oral Mucositis in Patients Receiving Chemoradiation for the Treatme · Phase 2 · completed
NCT02518958 — A Phase I, Open-Label, Multiple Ascending Dose Study of RRx-001 and Nivolumab · Phase 1 · completed
NCT02452970 — RRx-001 in Second Line Treatment of Advanced Cholangiocarcinoma Prior to Readministration of First-Line Therapy · Phase 2 · terminated

Other recruiting trials for Malignant Solid Tumor

Currently open trials in the same condition.

NCT06057038 — A Safety Trial of GEN1042 in Japanese Subjects With Malignant Solid Tumors · Phase 1 · active not recruiting
NCT05629689 — A Study to Evaluate GEH200520/GEH200521 (18F) Safety and Tolerability When Used for PET Scans in Patients With Solid Tum · Phase 1 · recruiting
NCT05103358 — Phase 2 Basket Trial of Nab-sirolimus in Patients With Malignant Solid Tumors With Pathogenic Alterations in TSC1/TSC2 G · Phase 2 · active not recruiting
NCT05141474 — Assessment of the Safety and Tolerability of ex Vivo Next-generation Neoantigen-selected Tumor-infiltrating Lymphocyte ( · EARLY_PHASE1 · recruiting
NCT04632108 — A 1/2 Phase Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ASKB589 in Patients · Phase 1, PHASE2 · active not recruiting

Other EpicentRx, Inc. trials

Trials by the same sponsor.

NCT05966194 — RRx-001 for Reducing Oral Mucositis in Patients Receiving Chemotherapy and Radiation for Head and Neck Cancer · Phase 2 · recruiting
NCT04525014 — RRx-001 Given With Irinotecan and Temozolomide for Pediatric Patients With Recurrent or Progressive Malignant Solid and · Phase 1 · terminated
NCT05566041 — A Phase 3, Controlled, Open-label, Global Randomized Study of RRx-001 With a Platinum Doublet or a Platinum Doublet in S · Phase 3 · active not recruiting
NCT04673942 — A Study of AdAPT-001 in Subjects With Sarcoma and Refractory Solid Tumors · Phase 2 · recruiting
NCT03699956 — RRx-001 Sequentially With a Platinum Doublet or a Platinum Doublet in Third-Line or Beyond in Patients With Small Cell L · Phase 3 · terminated

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 NCT02801097 (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 EpicentRx, Inc.
Last refreshed: 17 May 2022

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/NCT02801097.

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