TNO155 for Gastrointestinal Stromal Tumors

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Novartis Investigative Site, Chuo ku, Japan
Gastrointestinal Stromal Tumors+8 More
TNO155 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

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

See full description

Eligible Conditions

  • Gastrointestinal Stromal Tumors
  • Esophageal SCC
  • Squamous Cell Carcinoma Head and Neck Cancer (HNSCC)
  • Colorectal Carcinoma (CRC)
  • Non-small Cell Lung Carcinoma

Treatment Effectiveness

Study Objectives

This trial is evaluating whether TNO155 will improve 3 primary outcomes and 13 secondary outcomes in patients with Gastrointestinal Stromal Tumors. Measurement will happen over the course of 1 year.

1 year
DLT incidence
3 years
AE and SAE incidence
Dose interruptions, reductions and dose intensity, by treatment
Efficacy measurements per RECIST v1.1: DCR
Efficacy measurements per RECIST v1.1: DOR
Efficacy measurements per RECIST v1.1: ORR
Efficacy measurements per RECIST v1.1: PFS
Efficacy measurements per iRECIST: DCR
Efficacy measurements per iRECIST: DOR
Efficacy measurements per iRECIST: ORR
Efficacy measurements per iRECIST: PFS
Overall Survival
Pharmacokinetics (PK): AUClast
Pharmacokinetics (PK): AUCtau
Pharmacokinetics (PK): Cmax
Pharmacokinetics (PK): Tmax

Trial Safety

Trial Design

2 Treatment Groups

TNO155 in combination with ribociclib
1 of 2
TNO155 in combination with spartalizumab
1 of 2
Experimental Treatment

This trial requires 185 total participants across 2 different treatment groups

This trial involves 2 different treatments. TNO155 is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

TNO155 in combination with ribociclibTNO155 in combination with ribociclib
TNO155 in combination with spartalizumabTNO155 in combination with spartalizumab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Spartalizumab
Not yet FDA approved
Ribociclib
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 3 years for reporting.

Closest Location

Massachusetts General Hospital - Boston, MA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Signed informed consent must be obtained prior to participation in the study.
Age ≥ 18 years. For Japan only: written consent is necessary both from the patient and his/her legal representative if he/she is under the age of 20 years.
ECOG (Eastern Cooperative Oncology Group) performance status ≤ 1.
a. For TNO155 plus spartalizumab combination: i. Advanced EGFR WT, ALK WT NSCLC, after progression on or intolerance to platinum-containing combination chemotherapy and after progression on anti-PD-1 or anti-PD-L1 therapy.
ii. Advanced HNSCC or esophageal SCC, after progression on or intolerance to platinum-containing combination chemotherapy.
iii. Advanced CRC, after progression on or intolerance to all standard-of-care (SOC) therapy per local guidelines.
b. For TNO155 plus ribociclib combination: i. Advanced NSCLC, after progression on or intolerance to platinum-containing combination chemotherapy and anti-PD-1 or anti-PD-L1 therapy.
ii. Advanced HNSCC or esophageal SCC after progression on or intolerance to, platinum-containing combination chemotherapy and anti-PD-1 or anti-PD-L1 therapy, where such therapy is available and considered standard of care.
iii. Advanced CRC or GIST, after progression on or intolerance to all SOC therapy per local guidelines.
a. For TNO155 plus spartalizumab combination: i. Advanced EGFR WT, ALK WT, KRAS G12C NSCLC after progression on or intolerance to platinum-containing combination chemotherapy and after progression on anti-PD-1 or anti-PD-L1 therapy.

Patient Q&A Section

What is carcinoma, non-small-cell lung?

"Carcinoma, NSCLC, describes lung tumors consisting of mostly or predominantly malignant cells. Small cell carcinoma of the lung is a sub-type of NSCLC that is rarely recognized by clinicians because of its fast growth pattern and rapid spread." - Anonymous Online Contributor

Unverified Answer

What are the signs of carcinoma, non-small-cell lung?

"A history of smoking and COPD are risk factors for lung cancer, which could have been prevented by early detection. More research on occupational lung disease is indicated." - Anonymous Online Contributor

Unverified Answer

Can carcinoma, non-small-cell lung be cured?

"Lung cancer has been cured mostly by systemic anticancer therapy. However, in a small percentage of cases, the cancer may relapse. Therefore, alternative treatments to chemotherapy have been used to attempt cancer cure. In patients with advanced non-small-cell lung cancer, a combination of chemoradiation and chemotherapy is the currently recommended treatment. Although there are several clinical trials focusing on chemo-radiation or chemoradiation, few studies have documented that treatment result more effective. Considering that the treatment of patients with advanced NSCLC is often not curative, alternative therapeutic strategies are necessary. In the field of oncology, cancer cure or cure of cancer is a goal of many research efforts." - Anonymous Online Contributor

Unverified Answer

How many people get carcinoma, non-small-cell lung a year in the United States?

"About 140,000 people become newly diagnosed with carcinoma of the lung each year. Tobacco smoking is still a major cause of death from lung cancer." - Anonymous Online Contributor

Unverified Answer

What causes carcinoma, non-small-cell lung?

"The majority of lung cancer cases are due to squamous carcinoma of other organs. If a primary site is missed, then the majority of patients still have squamous cell carcinoma. Other factors influencing risk are age, family history, and a number of genetic conditions. Smoking causes the majority of squamous cell carcinomas, but the role of genetics and the environment could not be excluded. Histological subtype shows great heterogeneity with respect to risk factors and prognosis." - Anonymous Online Contributor

Unverified Answer

What are common treatments for carcinoma, non-small-cell lung?

"Treatment of small-cell [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer) with chemotherapy alone increases life expectancy from less than three months to 12 months, but with chemotherapy, the cancer is unlikely to come back. Chemotherapy also gives a small survival advantage when used in combination with surgery. If chemotherapy is given by itself, the cancer is likely to be cured. For non-small-cell lung cancer, chemotherapy improves the overall survival rate, but does this only by a small percentage point relative to surgery. Radiotherapy increases the overall survival rate for non-small-cell lung cancer by only a small percentage point. For both small- and non-small-cell lung cancer, surgery should always be used in combination with chemotherapy or radiotherapy." - Anonymous Online Contributor

Unverified Answer

Does carcinoma, non-small-cell lung run in families?

"Carcinoma, non-small-cell lung runs in families. The disease is associated with an increased prevalence of smoking and other exposures, including the use of certain psychoactive drugs, suggesting that genetic susceptibility has a contribution." - Anonymous Online Contributor

Unverified Answer

Does tno155 improve quality of life for those with carcinoma, non-small-cell lung?

"Overall survival in NSCLC for patients who received tno155 was comparable to those receiving the standard of care. The overall survival benefit of tno155 in this study was not consistent with current recommendations for NSCLC. The efficacy of tno155 may be related to the low percentage of patients who smoked. This pilot study showed significant improvements in QoL, which are important for treating cancer and are important for NSCLC as well. In this population, tno155 led to improved symptoms and increased physical function (e.g., walking distance). tno155 also helped to improve patients QoL compared to the standard of care." - Anonymous Online Contributor

Unverified Answer

Has tno155 proven to be more effective than a placebo?

"Overall, results of the current study demonstrated that tno155 had no measurable effects on overall survival. However, when used according to the guidelines, tno155 may have been more potent than conventional cyclophosphamide treatment, even in the presence of advanced or recurrent CLL." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for carcinoma, non-small-cell lung?

"If the patient is willing to comply with the proposed trial and the clinician is confident that the therapy will be efficacious, then patients should be offered the option of clinical trial treatment." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in tno155 for therapeutic use?

"We have demonstrated the potential for this drug to be a useful chemotherapeutic agent against NSCLC. Our preclinical and clinical studies, if successful, would be [conducted in Phase I and II trials. However, tno155 can be administered as a chemotactic agent with the potential to act as a potent immunostimulant by targeting its natural receptor, GRP-56 (a member of the C1q sub-family of immunoglobulins)." - Anonymous Online Contributor

Unverified Answer

How does tno155 work?

"Allogeneic CD44s-knockout tumor cell lines are sensitive to Tno155 treatment irrespective of their tumor phenotype, suggesting that the combination of this gene with conventional immune checkpoint agents may have potent antitumor, antitumor immune checkpoint activity at nontargeted sites." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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