INCB001158 for Mesothelioma

Phase-Based Estimates
1
Effectiveness
1
Safety
START, San Antonio, TX
Mesothelioma+10 More
INCB001158 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Mesothelioma

Study Summary

This study is evaluating whether INCB001158 is safe and has activity in people with advanced/metastatic solid tumors.

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Eligible Conditions

  • Mesothelioma
  • Carcinoma, Renal Cell
  • Renal Cell Adenocarcinoma
  • Colorectal Carcinoma (CRC)
  • Malignant Neoplasm of Stomach
  • Lung Cancers
  • Bladder Cancer, Cancer
  • Tumors, Solid
  • Head and Neck Cancer
  • Metastatic Cancers
  • UC (Urothelial Cancer)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether INCB001158 will improve 2 primary outcomes and 14 secondary outcomes in patients with Mesothelioma. Measurement will happen over the course of 12 Weeks.

12 Weeks
AUC0-12 Plasma Pharmacokinetic (PK) Profile of INCB001158
AUCt Plasma Pharmacokinetic (PK) Profile of INCB001158
CL/F Plasma Pharmacokinetic (PK) Profile of INCB001158
Plasma pharmacokinetic (PK) profile of INCB001158 alone and in combination with Pembrolizumab
RP2D of INCB001158 with Pembrolizumab
Recommended Phase 2 Dose (RP2D) of INCB001158
Recommended Phase 2 Dose (RP2D) of INCB001158 in Combination With Pembrolizumab
Tmax Plasma Pharmacokinetic (PK) Profile of INCB001158
Day 1
Pharmacokinetics: Cmax of INCB001158
Month 6
Safety and Tolerability of INCB001158 as a single agent and in combination with Pembrolizumab: Incidence of Adverse Events
Month 24
Anti-tumor Activity of INCB001158 as Monotherapy and in Combination with Pembrolizumab for patients with advanced/metastatic solid tumors
Best Overall Response (BOR) Anti-tumor Activity of INCB001158 as Monotherapy and in Combination With Pembrolizumab for Patients With Advanced/Metastatic Solid Tumors
Duration of Response (DOR) Anti-tumor Activity of INCB001158 as Monotherapy and in Combination With Pembrolizumab for Patients With Advanced/Metastatic Solid Tumors
Overall Response Rate (ORR) Anti-tumor Activity of INCB001158 as Monotherapy and in Combination With Pembrolizumab for Patients With Advanced/Metastatic Solid Tumors
Progression-free Survival (PFS) Anti-tumor Activity of INCB001158 as Monotherapy and in Combination With Pembrolizumab for Patients With Advanced/Metastatic Solid Tumors
Up to 6 months
Determination of the Safety and Tolerability of INCB001158 as a Single Agent and in Combination With Pembrolizumab: Incidence of Adverse Events

Trial Safety

Trial Design

8 Treatment Groups

No Control Group
INCB00158 was administered in combination with pembroluzimab at 75mg twice daily

This trial requires 260 total participants across 8 different treatment groups

This trial involves 8 different treatments. INCB001158 is the primary treatment being studied. Participants will be divided into 8 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

INCB00158 was administered in combination with pembroluzimab at 75mg twice dailyCombination Part 1b: INCB001158 and Pembrolizumab administered in patients with advanced/metastatic NSCLC, Melanoma, Urothelial Cell Cancer, MSI CRC, MSS CRC, Gastric or Gastroesophageal Junction (GEJ) Cancer, SCCHN and Mesothelioma. Multiple dose levels will be explored to determine the recommended phase 2 dose (RP2D).
INCB00158 was administered as monotherapy at 75mg twice daily
Drug
Monotherapy Part 2a: INCB001158 administered orally at the RP2D in patients with advanced/metastatic NSCLC (EGFR and Anaplastic Lymphoma Kinase (ALK) negative) previously treated with Standard of Care (SOC).
INCB00158 was administered in combination with pembroluzimab at 50mg twice daily
Drug
Monotherapy Part 2d: INCB001158 administered orally at the RP2D in patients with any tumor types in Parts 2a, 2b, or 2c.
INCB00158 was administered in combination with pembroluzimab at 100mg twice dailyPart 3a: INCB001158 and Pembrolizumab the combination RP2D in patients with advanced/metastatic NSCLC (EGFR and ALK negative) with disease progression on anti-PD-1 therapy or prolonged stable disease on Pembrolizumab in the immediate prior line of therapy.
INCB001158 50 mg BID in combination with pembrolizumabPart C: evaluated a reduced dose of INCB001158 50 mg BID in combination with pembrolizumab with patients with moderately impaired renal function.
INCB00158 was administered as monotherapy at 150mg twice daily
Drug
Monotherapy Part 2c: INCB001158 administered orally at the RP2D in patients with Bladder Cancer, Gastric or Gastroesophageal Junction (GEJ) Cancer, Renal Cell Cancer (RCC), Squamous Cell Carcinoma of the Head and Neck (SCCHN), Urothelial Cell Cancer (UCC), or Melanoma, previously treated with SOC.
INCB00158 was administered as monotherapy at 100mg twice daily
Drug
Monotherapy Part 2b: INCB001158 administered orally at the RP2D in patients with advanced/metastatic CRC previously treated with SOC.
INCB00158 was administered as monotherapy at 50mg twice daily
Drug
Monotherapy Part 1a: INCB001158 administered orally in patients with advanced/metastatic solid tumors. Escalating doses will be explored to determine the recommended phase 2 dose (RP2D).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CB-1158
Not yet FDA approved
Pembrolizumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: until disease progression/study discontinuation up to 24 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly until disease progression/study discontinuation up to 24 months for reporting.

Closest Location

START - San Antonio, TX

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:
*Additional cohort specific criteria may apply
Must be age 18 or older
Ability to provide written informed consent in accordance with federal, local, and institutional guidelines
Histological or cytological diagnosis of metastatic cancer or locally advanced cancer that is not amenable to local therapy
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
Life Expectancy of at least 3 months
Adequate hepatic, renal (moderately impaired renal function in cohort 1c only), cardiac, and hematologic function
Measurable disease by RECISTv1.1 criteria
Resolution of treatment-related toxicities
Willingness to avoid pregnancy or fathering children

Patient Q&A Section

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

What are common treatments for mesothelioma?

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Mesothelioma is often treated using surgery, chemotherapy, and radiation and then sometimes with surgery and radiation therapy. These therapies can generally improve survival. The role of surgery remains contentious. Treatment remains controversial because surgery and chemotherapy are often used in a neoadjuvant context, with surgery to help patients with cancer survive the initial therapies and then to shrink their disease, but no randomized trials to date suggest that surgery should be used as an adjuvant treatment after neoadjuvant therapy.

Unverified Answer

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

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About 25,000 people in the United States are diagnosed with mesothelioma a year. Rates appear to be increasing over time, especially among smokers. Smoking may not be the only cause of this cancer.

Unverified Answer

Can mesothelioma be cured?

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There is no cure for malignant mesothelioma, and the optimal treatment for this deadly disease is still under investigation. However, the treatment of peritoneal mesothelioma can achieve significant remission in up to 15% of cases.

Unverified Answer

What is mesothelioma?

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An increase in the use of surgery has significantly reduced the mortality rates of primary and metastatic mesothelioma, but it has not changed their survival rates. Mesothelioma remains a lethal disease for which no cure exists.

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What causes mesothelioma?

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Mesothelioma is thought to be caused by chronic exposures; the causes are unknown. Some chemicals may trigger a latent condition at work or other environmental exposures are known to increase the risk.

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What are the signs of mesothelioma?

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Several signs are suggestive of malignancy and should be reported to the surgeon on follow-up. Other signs may be normal and require no further investigation.

Unverified Answer

Who should consider clinical trials for mesothelioma?

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In symptomatic pleural malignant mesothelioma, clinical trials are not worthwhile. In the absence of a clinical trial, optimal management should be discussed in consultation with a subspecialist. Although a recent European Union guideline for mesothelioma recommend a standard of care for all patients, clinical trials could improve patient safety. The most important areas for future clinical trials are adjuvant therapies and therapies targeting the mesothelin signaling pathway.

Unverified Answer

What is the average age someone gets mesothelioma?

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The average age of a patient diagnosed with malignant pleural mesothelioma in the United States is 58 years old. In 2003, there were an estimated 6,600 new cases, and another 8,800 had pleural mesothelioma, but most people are diagnosed when they have the advanced disease. Patients with the early or earlier disease are typically much younger than patients who have advanced disease, and they are more likely to receive curative therapy and have a better prognosis

Unverified Answer

Is incb001158 typically used in combination with any other treatments?

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Recent findings confirms the use of INCB001158 combined with chemotherapy for metastatic mesothelioma. We could not show any significant impact of INCB001158 on QOL or the number of metastatic lesions. We found no significant improvement in PFS or OS compared to chemotherapy alone. We therefore can not recommend INCB001158 as a first-line treatment for metastatic mesothelioma.

Unverified Answer

What is incb001158?

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The most recent data from the National Cancer Institute(NCI) reports an overall incidence rate in all persons aged 60 or more in the US is 5.27 per 100,000; Mesothelioma incidence rate decreased more rapidly after age 90. Mesothelioma incidence rate has not declined after the age 80. The incidence rate from 2000-2009 was 5.36 per 100,000 of all persons in the U.S, and the Mesothelioma incidence rate decreased significantly after age 80 and before age 90. Mesothelioma incidence rate has not changed substantially since 1950s except after age 90.

Unverified Answer

Has incb001158 proven to be more effective than a placebo?

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The only drug licensed in Canada for malignant mesothelioma to date is INCB001158 - one of the first drugs that targets the protein PDGFR and has shown significant anti-tumour effects in preclinical studies. Findings from a recent study show that INCB001158 is superior to placebo in inducing clinical benefit in a phase 2 clinical study. To our knowledge, this is the first study to show a significant difference in response rates of two treatments in patients with mesothelioma using an objective (radiological and clinical) criterion.

Unverified Answer

How quickly does mesothelioma spread?

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The most common pattern of progression is pleural infiltration spreading into the peritoneum, mediastinum, and in some cases, the subdiaphragmatic cavity and/or distant lymph nodes. The incidence of involvement of distant lymph nodes was low, 6.0% in this series. Most of the mesothelioma cases involved pleura or peritoneum and were noninvasive. The stage at diagnosis is significant in determining the pattern of progression. Only 10% to 15% of patients who present at stage IIB or III at diagnosis go on to develop metastasis in the lung. Therefore, these factors should affect treatment strategies and expectations in determining survival.

Unverified Answer
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