TPX-0131 for Solid Metastatic Tumor

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Asan Medical Center, Seoul, Korea, Republic of
Solid Metastatic Tumor+6 More
TPX-0131 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a new drug called TPX-0131 is safe and effective in people with lung cancer.

See full description

Eligible Conditions

  • Solid Metastatic Tumor
  • ALK Gene Mutation
  • Solid Tumors, Advanced Solid Tumors
  • Non-Small Cell Lung Carcinoma (NSCLC)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Solid Metastatic Tumor

Study Objectives

This trial is evaluating whether TPX-0131 will improve 3 primary outcomes and 12 secondary outcomes in patients with Solid Metastatic Tumor. Measurement will happen over the course of Up to 120 hours post-dose.

Approximately 22 months
Define the Recommended Phase 2 Dose
Approximately 44 months
Adverse events (AEs)
CNS Progression-Free Survival (CNS-PFS)
Clinical benefit rate (CBR)
Define the objective response rate (ORR)
Duration of Response (DOR)
Intracranial tumor response
Overall survival (OS)
Patient-reported quality of life - Core Quality of Life Questionnaire
Patient-reported quality of life - Lung Cancer Quality of Life Questionnaire
Progression free survival (PFS)
Time to response (TTR)
Hour 120
AUC (area under plasma concentration time curve) of TPX-0131
Cmax (maximum plasma concentration) of TPX-0131
Day 28
Incidence of first cycle dose-limiting toxicities (DLTs) of TPX-0131

Trial Safety

Safety Progress

1 of 3

Other trials for Solid Metastatic Tumor

Trial Design

1 Treatment Group

TPX-0131
1 of 1
Experimental Treatment

This trial requires 210 total participants across 1 different treatment group

This trial involves a single treatment. TPX-0131 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

TPX-0131
Drug
The Phase 1 part of the study will determine the safety, tolerability, PK, MTD, and RP2D of TPX-0131. The Phase 2 part of the study will determine the safety, tolerability, PK and preliminary efficacy of TPX-0131 in specific cohorts.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: approximately 44 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly approximately 44 months for reporting.

Closest Location

Sarah Cannon Research Institute at Tennessee Oncology - Nashville, TN

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Solid Metastatic Tumor or one of the other 6 conditions listed above. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Age ≥ 18 (or as required by local regulation).
Histological or cytological confirmation of advanced/metastatic ALK+ NSCLC.
Pretreated with up to three prior lines of an ALK TKI treatment, including at least one prior line of a second or third-generation ALK TKI (alectinib, brigatinib, ensartinib, or lorlatinib) in Phase 1.
ECOG performance status ≤ 1.
Existence of measurable or evaluable disease (according to Response evaluation criteria in solid tumors [RECIST v1.1] criteria).
Subjects with asymptomatic CNS metastases and/or asymptomatic leptomeningeal carcinomatosis are eligible.
Adequate organ function.

Patient Q&A Section

What is cancer?

"Cancer is a disease caused by genetic mutations that change how cells grow and make new cells. Patients can have many different types or stages of cancer, which can be hard to distinguish from a single problem. Cancer is also a disease which is often diagnosed too late, making sure that the right treatment is started for the optimal outcome." - Anonymous Online Contributor

Unverified Answer

What are common treatments for cancer?

"Many treatments used (e.g., drug therapy, massage therapy, massage, psychological counseling, and massage therapy) are unsupported, and should not be used. It is important that patients are aware of the lack of evidence for the effectiveness of these treatments." - Anonymous Online Contributor

Unverified Answer

How serious can cancer be?

"The seriousness of the disease and the lack of early intervention can be assessed. The high incidence and the large number of children and young adults that have and are getting cancer is a concern that justifies the necessity of early diagnosis and treatment." - Anonymous Online Contributor

Unverified Answer

What are the signs of cancer?

"Signs of cancer occur in approximately 25% of children with cancer. This suggests that signs of cancer are more common in young children than older children or adults." - Anonymous Online Contributor

Unverified Answer

Can cancer be cured?

"Only 25% of survivors showed no signs of active disease. All patients with advanced [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer) are candidates for palliative treatment, as survival is often short, especially when cancer has spread." - Anonymous Online Contributor

Unverified Answer

What causes cancer?

"In the majority of cases, the cause of cancer remains unknown. The cancer can be triggered by genetics, lifestyle behaviours, environment or viruses. The combination of cancer occurrence can be modulated by a number of risk factors. While most cancer cases can be accurately correlated to specific factors, others remain less obvious. It is important for health professionals to identify these factors to prevent and better treat cancer.\n" - Anonymous Online Contributor

Unverified Answer

How many people get cancer a year in the United States?

"It is estimated that approximately 350,000 new cases of cancer of the skin will be diagnosed in the United States in 2006. Approximately 40,000 new bladder cancers will be diagnosed in 2006 in the United States. More than 20,000 people with colon cancer will die from the disease each year in the United States." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of cancer?

"The most frequent etiologies of carcinogenesis described in the literature are: 1. Viruses and associated mutagens; 2. Genetic predisposition to carcinoma, particularly inherited carcinoma; and 3. Other causes, namely radiation carcinoma, in addition to the three mentioned." - Anonymous Online Contributor

Unverified Answer

Is tpx-0131 typically used in combination with any other treatments?

"Tpx-0131 is typically combined with conventional drugs as part of chemotherapy to treat patients with locally advanced or stage IV rectal cancer after surgery. However, studies of therapies with tpx-0131 alone or in combination with standard drugs are rare." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for cancer?

"Many stakeholders in clinical cancer research have concerns about the benefit-risk profile of clinical trials. These concerns are particularly salient in the context of late-stage cancers. In this paper, participants discuss how these concerns should inform clinical trial design and conduct, as well as clinical trial participation and communication." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of tpx-0131?

"This Phase I clinical trial data on tpx-0131 for the treatment of solid tumors in patients with unresectable metastatic or locally advanced solid tumors was promising. The side effects experienced during this study were mostly mild and transient and were of mild to moderate severity. Further work to understand and improve the tolerability of this candidate drug is warranted." - 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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