NCT01760525 (CCGM097X2101) is a Phase 1 clinical trial of CGM097 in Solid Tumor With p53 Wild Type Status, sponsored by Novartis Pharmaceuticals.

Who is sponsoring NCT01760525?

NCT01760525 is sponsored by Novartis Pharmaceuticals.

What drugs are being tested in NCT01760525?

Interventions in NCT01760525: CGM097.

What condition does NCT01760525 study?

NCT01760525 studies Solid Tumor With p53 Wild Type Status.

Is NCT01760525 still recruiting?

NCT01760525 is currently completed. Last updated 15 June 2021.

Last reviewed 2021-06-15 · How we verify

NCT01760525: CCGM097X2101

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

A Phase I Dose Escalation Study of CGM097 in Adult Patients With Selected Advanced Solid Tumors

Completed Phase 1 Last updated 15 June 2021

What this trial tests

Phase 1 trial testing CGM097 in Solid Tumor With p53 Wild Type Status in 51 participants. Completed in 24 July 2020.

Timeline

20 March 2013

Primary endpoint
24 July 2020

24 July 2020

Quick facts

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	51
Start date	20 March 2013
Primary completion	24 July 2020
Estimated completion	24 July 2020
Sites	5 locations across France, Germany, Switzerland, Singapore, United States

Drugs / interventions tested

CGM097 — full drug profile →

Conditions studied

Solid Tumor With p53 Wild Type Status — all drugs for Solid Tumor With p53 Wild Type Status →

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

18 and older, any sex, with Solid Tumor With p53 Wild Type Status. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a first in human phase I study of single agent CGM097 in patients with advanced solid tumors who have progressed despite standard therapy or for whom no standard therapy exists. The tumor must be characterized by p53wt status. The study consists of a dose escalation part where patients will receive escalating doses of CGM097, and a dose expansion part in which patients are given CGM097 at the maximum tolerated dose (MTD) or Recommended Phase 2 Dose (RP2D). Each dose escalation step will be decided based on the recommendation from an adaptive Bayesian logistic regression model (BLRM).

Publications & conference data

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

Targeting p53 pathways: mechanisms, structures, and advances in therapy.
Wang H, Guo M, Wei H, Chen Y. · · 2023 · cited 580× · PMID 36859359 · DOI 10.1038/s41392-023-01347-1
Recent advances in the development of protein-protein interactions modulators: mechanisms and clinical trials.
Lu H, Zhou Q, He J, Jiang Z, et al · · 2020 · cited 570× · PMID 32968059 · DOI 10.1038/s41392-020-00315-3
Tumor biomarkers for diagnosis, prognosis and targeted therapy.
Zhou Y, Tao L, Qiu J, Xu J, et al · · 2024 · cited 379× · PMID 38763973 · DOI 10.1038/s41392-024-01823-2
Targeting mutant p53 for cancer therapy: direct and indirect strategies.
Hu J, Cao J, Topatana W, Juengpanich S, et al · · 2021 · cited 379× · PMID 34583722 · DOI 10.1186/s13045-021-01169-0
Recent advances in targeting the "undruggable" proteins: from drug discovery to clinical trials.
Xie X, Yu T, Li X, Zhang N, et al · · 2023 · cited 246× · PMID 37669923 · DOI 10.1038/s41392-023-01589-z
The Roles of MDM2 and MDMX in Cancer.
Karni-Schmidt O, Lokshin M, Prives C. · · 2016 · cited 246× · PMID 27022975 · DOI 10.1146/annurev-pathol-012414-040349
Clinical Overview of MDM2/X-Targeted Therapies.
Burgess A, Chia KM, Haupt S, Thomas D, et al · · 2016 · cited 242× · PMID 26858935 · DOI 10.3389/fonc.2016.00007
The Role of p53 Signaling in Colorectal Cancer.
Liebl MC, Hofmann TG. · · 2021 · cited 231× · PMID 33924934 · DOI 10.3390/cancers13092125

Verify or expand the search:

Other Novartis Pharmaceuticals trials

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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 NCT01760525 (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 Novartis Pharmaceuticals
Last refreshed: 15 June 2021

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/NCT01760525.

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