NCT04000529

Phase Ib Study of TNO155 in Combination With Spartalizumab or Ribociclib in Selected Malignancies

Terminated Phase 1 Last updated 30 September 2025

What this trial tests

Phase 1 trial testing TNO155 in Non-small Cell Lung Carcinoma in 122 participants. Terminated before completion.

Timeline

30 July 2019

Primary endpoint
15 January 2024

15 January 2024

Quick facts

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	122
Start date	30 July 2019
Primary completion	15 January 2024
Estimated completion	15 January 2024
Sites	10 locations across Hong Kong, Japan, Belgium, Germany, Australia, China, Singapore, United States

Drugs / interventions tested

• TNO155 — full drug profile →
• Spartalizumab — full drug profile →
• Ribociclib (ribociclib) — full drug profile →

Conditions studied

• Non-small Cell Lung Carcinoma — all drugs for Non-small Cell Lung Carcinoma →
• Head and Neck Squamous Cell Carcinoma — all drugs for Head and Neck Squamous Cell Carcinoma →
• Esophageal SCC — all drugs for Esophageal SCC →
• Gastrointestinal Stromal Tumors — all drugs for Gastrointestinal Stromal Tumors →

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

18 and older, any sex, with Non-small Cell Lung Carcinoma or Head and Neck Squamous Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study was a Phase Ib, multi-center, open-label study of TNO155 in combination with spartalizumab or ribociclib with a dose escalation part followed by a dose expansion part in adult subjects with advanced solid tumors.

These two treatment arms enrolled subjects in parallel to characterize the safety, tolerability, PK, PD and preliminary antitumor activity.

The study treatment was administered until the subject experienced unacceptable toxicity, progressive disease, and/or had treatment discontinued at the discretion of the Investigator or the subject, or due to withdrawal of consent.

Publications & conference data

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

1. Combination strategies with PD-1/PD-L1 blockade: current advances and future directions.
   Yi M, Zheng X, Niu M, Zhu S, et al · · 2022 · cited 1018× · PMID 35062949 · DOI 10.1186/s12943-021-01489-2
2. RAS-targeted therapies: is the undruggable drugged?
   Moore AR, Rosenberg SC, McCormick F, Malek S. · · 2020 · cited 832× · PMID 32528145 · DOI 10.1038/s41573-020-0068-6
3. The current state of the art and future trends in RAS-targeted cancer therapies.
   Punekar SR, Velcheti V, Neel BG, Wong KK. · · 2022 · cited 382× · PMID 36028717 · DOI 10.1038/s41571-022-00671-9
4. CDK4 and CDK6 kinases: From basic science to cancer therapy.
   Fassl A, Geng Y, Sicinski P. · · 2022 · cited 351× · PMID 35025636 · DOI 10.1126/science.abc1495
5. Improvement of the anticancer efficacy of PD-1/PD-L1 blockade via combination therapy and PD-L1 regulation.
   Wu M, Huang Q, Xie Y, Wu X, et al · · 2022 · cited 336× · PMID 35279217 · DOI 10.1186/s13045-022-01242-2
6. Expanding the Reach of Precision Oncology by Drugging All KRAS Mutants.
   Hofmann MH, Gerlach D, Misale S, Petronczki M, et al · · 2022 · cited 247× · PMID 35046095 · DOI 10.1158/2159-8290.cd-21-1331
7. 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
8. Targeting <i>KRAS</i> Mutant Non-Small-Cell Lung Cancer: Past, Present and Future.
   Uras IZ, Moll HP, Casanova E. · · 2020 · cited 109× · PMID 32560574 · DOI 10.3390/ijms21124325