INCA33890 for Metastatic Cancer

Recruiting at 37 trial locations

Overseen By Incyte Corporation Call Center (ex-US)

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Incyte Corporation

Must not be taking: Systemic steroids, Anticoagulants

Disqualifiers: Other malignancy, Cardiac disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

408 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called INCA33890 to see if it is safe and how well patients can tolerate it. The study focuses on people with advanced or metastatic solid tumors, which are cancers that have spread and are hard to treat. Researchers aim to find the highest dose that can be given without causing serious side effects.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on chronic systemic steroids or have recently changed anticoagulation therapies, you may not be eligible to participate.

What makes the drug INCA33890 unique for treating metastatic cancer?

INCA33890 is a novel treatment for metastatic cancer, but the provided research does not offer specific details about its unique features compared to existing treatments. It is important to consult clinical trial data or medical professionals for more information on its mechanism of action or benefits. ^{1 2 3 4 5}

Eligibility Criteria

Adults with certain advanced or metastatic solid tumors who've had disease progression after standard treatments, including immunotherapies if applicable. They must have a good performance status, measurable disease, and be willing to undergo tumor biopsies. Exclusions include significant medical conditions, more than four prior cancer treatments for advanced disease, active infections or hepatitis/HIV, recent anticoagulation therapy changes.

Inclusion Criteria

I am 18 years old or older.

My cancer is confirmed to be advanced or has spread to other parts.

My cancer progressed after treatment, including immunotherapy, unless I couldn't tolerate it.

Exclusion Criteria

I am taking more than 10 mg/day of prednisone or its equivalent.

I am taking steroids for an autoimmune disease.

I am not on long-term antibiotics or drugs for a chronic infection.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

INCA33890 is administered intravenously at a starting regimen, with subsequent dose regimens determined during study conduct

8-12 weeks

Dose Expansion

INCA33890 is administered at the recommended dose(s) for expansion in participants with advanced or metastatic ICI sensitive or ICI non-sensitive tumor types

8-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• INCA33890

Trial Overview The trial is testing the safety of a new drug called INCA33890 in patients with specific types of solid tumors. It aims to find the maximum tolerated dose and optimal dosing schedule by observing any dose-limiting toxicities that occur during treatment.

Participant Groups

Group I: Part 2b - Dose Expansion Combination Therapy - Group 4 Experimental Treatment 2 Interventions

INCA33890 will be administered in combination with cetuximab at the protocol-defined dose based on cohort assignment.

Group II: Part 2b - Dose Expansion Combination Therapy - Group 3 Experimental Treatment 3 Interventions

INCA33890 will be administered in combination with bevacizumab and FOLFOX at the protocol-defined dose based on cohort assignment.

Group III: Part 2b - Dose Expansion Combination Therapy - Group 2 Experimental Treatment 3 Interventions

INCA33890 will be administered in combination with bevacizumab and FOLFIRI at the protocol-defined dose based on cohort assignment.

Group IV: Part 2b - Dose Expansion Combination Therapy - Group 1 Experimental Treatment 2 Interventions

INCA33890 will be administered in combination with bevacizumab at the protocol-defined dose based on cohort assignment.

Group V: Part 2a - Dose Escalation Combination Therapy - Group 4 Experimental Treatment 2 Interventions

INCA33890 will be administered in combination with cetuximab at the protocol-defined dose based on cohort assignment.

Group VI: Part 2a - Dose Escalation Combination Therapy - Group 3 Experimental Treatment 3 Interventions

INCA33890 will be administered in combination with bevacizumab and FOLFOX at the protocol-defined dose based on cohort assignment.

Group VII: Part 2a - Dose Escalation Combination Therapy - Group 2 Experimental Treatment 3 Interventions

INCA33890 will be administered in combination with bevacizumab and FOLFIRI at the protocol-defined dose based on cohort assignment.

Group VIII: Part 2a - Dose Escalation Combination Therapy - Group 1 Experimental Treatment 2 Interventions

INCA33890 will be administered in combination with bevacizumab at the protocol-defined dose based on cohort assignment.

Group IX: Part 1b-Dose Expansion Monotherapy Experimental Treatment 1 Intervention

INCA33890 will be administered at the protocol-defined dose based on cohort assignment.

Group X: Part 1a - Dose Escalation Monotherapy Experimental Treatment 1 Intervention

INCA33890 will be administered at the protocol-defined dose based on cohort assignment.

Who Is Running the Clinical Trial?

Incyte Corporation

Lead Sponsor

Trials

408

Recruited

66,800+

Steven Stein

Incyte Corporation

Chief Medical Officer since 2015

MD from University of Witwatersrand

Hervé Hoppenot

Incyte Corporation

Chief Executive Officer since 2014

MBA from ESSEC Business School

Findings from Research

Current methods for evaluating new treatments in castration-resistant metastatic prostate cancer are limited, as traditional response criteria may not apply, especially in cases with bone-only disease.

While declines in prostate-specific antigen (PSA) levels can indicate some response to treatments like docetaxel, they are not validated for newer therapies, highlighting the need for better measures of clinical benefit and response in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical endpoints for drug development in prostate cancer. Ramiah, V., George, DJ., Armstrong, AJ.[2015]

Recent advancements in the diagnosis and treatment of prostate cancer have led to improved outcomes for localized disease, but many patients still experience relapse or are diagnosed with metastatic disease at the outset.

In the last five years, six new drugs have been approved for treating metastatic, castration-resistant prostate cancer, providing new options and raising important questions about the best management strategies for different disease stages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treatment strategies for advanced prostate cancer]. Küronya, Z., Bíró, K., Géczi, L., et al.[2021]

PCK3145 was found to be safe and well tolerated in 16 patients with metastatic hormone-refractory prostate cancer, with the most common side effects being pain and nausea, and only one serious adverse event (grade 4 cardiac arrhythmia) at the highest dose.

While no significant PSA responses were observed, PCK3145 showed potential efficacy by stabilizing disease in 10 patients and significantly reducing MMP-9 levels, suggesting it may help regulate metastatic tumor growth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability of PCK3145, a synthetic peptide derived from prostate secretory protein 94 (PSP94) in metastatic hormone-refractory prostate cancer. Hawkins, RE., Daigneault, L., Cowan, R., et al.[2022]

In a study of 98 patients with castration-resistant prostate cancer, the association between progression-free survival (PFS) and overall survival (OS) was found to be moderate, with correlations of 0.4 for radiographic PFS and 0.33 for PSA PFS, indicating that current PFS measures may not reliably predict OS.

The study suggests that improving the accuracy of radiographic PFS assessments, such as requiring confirmation of progression with a second scan, could enhance the correlation with overall survival, especially since factors like early therapy discontinuation can weaken this association.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The association between measures of progression and survival in castrate-metastatic prostate cancer. Scher, HI., Warren, M., Heller, G.[2007]

Metastatic malignant melanoma is a highly aggressive cancer with a very low survival rate, where current FDA-approved treatments like hydroxyurea, dacarbazine, and interleukin-2 have not significantly improved patient survival.

Innovative therapeutic strategies, including immune therapy, tyrosine kinase inhibitors, and angiogenesis inhibitors, are being explored to enhance treatment outcomes for patients with metastatic melanoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel therapeutics for the treatment of metastatic melanoma. Mansfield, AS., Markovic, SN.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

Clinical endpoints for drug development in prostate cancer. [2015]

2. Hungary pubmed.ncbi.nlm.nih.gov

[Treatment strategies for advanced prostate cancer]. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Safety and tolerability of PCK3145, a synthetic peptide derived from prostate secretory protein 94 (PSP94) in metastatic hormone-refractory prostate cancer. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

The association between measures of progression and survival in castrate-metastatic prostate cancer. [2007]

5. England pubmed.ncbi.nlm.nih.gov

Novel therapeutics for the treatment of metastatic melanoma. [2020]