INCA33890 for Metastatic Cancer

Recruiting at 45 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called INCA33890 for individuals with advanced or metastatic cancer, where the cancer has spread to different parts of the body. The main goal is to determine the safety of INCA33890 and identify the optimal dose, either alone or in combination with other cancer drugs like bevacizumab, cetuximab, FOLFOX, or FOLFIRI. This trial may suit those with solid tumors unresponsive to standard treatments or who cannot undergo them. Participants should be able to undergo tumor biopsies and have measurable disease for tracking. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering the opportunity to be among the first to receive this new treatment.

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.

Is there any evidence suggesting that INCA33890 is likely to be safe for humans?

Research has shown that INCA33890 is being tested for treating advanced or spreading solid tumors. This treatment remains in early research stages, so limited safety information is available. Early results suggest that INCA33890, when used alone, has a manageable safety profile. Some patients have experienced tumor shrinkage or stabilization. However, specific side effects of INCA33890 alone are not detailed.

When combined with bevacizumab (a drug that inhibits blood vessel growth in tumors), the safety of INCA33890 is still under study. Bevacizumab can cause serious side effects like bleeding and stomach issues, but careful monitoring usually manages these.

The safety of INCA33890 is also being evaluated when used with chemotherapy treatments like FOLFOX and FOLFIRI (both chemotherapy combinations). These combinations can cause side effects from both the drugs and chemotherapy, often including tiredness, nausea, and a higher risk of infection.

Lastly, when used with cetuximab (another cancer treatment), INCA33890 has shown a manageable safety profile in early studies. Common side effects of cetuximab include skin reactions and low magnesium levels in the blood.

Overall, while INCA33890 appears promising, more information from ongoing studies is needed to fully understand its safety in humans. Clinical trial participants are closely monitored to manage any side effects that might occur. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about INCA33890 because it represents a novel approach for treating metastatic cancer. Unlike current standard treatments, which often include chemotherapy and targeted therapies like bevacizumab, FOLFOX, and FOLFIRI, INCA33890 offers a new mechanism of action. It is designed to be used both as a monotherapy and in combination with other established treatments, potentially enhancing their effectiveness. This flexibility could lead to more personalized treatment plans, offering hope for better outcomes in a condition that is notoriously difficult to treat.

What evidence suggests that this trial's treatments could be effective for metastatic cancer?

Research has shown that INCA33890 achieved a promising success rate of 15.2% in previous studies, with some patients experiencing a significant reduction in tumor size. In this trial, participants will receive INCA33890 in different treatment arms. One arm combines INCA33890 with bevacizumab, a current cancer drug, expected to enhance effectiveness since bevacizumab has been shown to extend patient survival and slow cancer growth. Other arms will explore INCA33890 with chemotherapy treatments like FOLFOX or FOLFIRI, known to improve outcomes in advanced cancer, potentially increasing its effectiveness. Another arm will combine INCA33890 with cetuximab, another cancer treatment, which is promising due to cetuximab's proven benefits in treating certain cancers. These combinations aim to fight cancer more effectively by attacking it in different ways. ^{1 4 5 6 7}

Are You a Good Fit for This Trial?

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

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

I am fully active or can carry out light work.

I am willing to have tumor biopsies before and during treatment.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

Citations

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Incyte Announces Phase 1 Results for its TGFβR2×PD-1 ...

Within this cohort, 16 patients treated with INCA33890 responded (14 confirmed), with 15.2% achieving an objective response rate (ORR) and a ...

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INCA33890 for Metastatic Cancer

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 ...

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Incyte Announces Phase 1 Results for its TGFβR2×PD ...

Initial data (cut-off July 25, 2025) showed promising clinical efficacy with INCA33890 treatment. This trial is ongoing, and the data will ...

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Atezolizumab plus paclitaxel and bevacizumab as first-line ...

The objective response rate was 63.0% (95% CI: 52.8–72.4) and median overall survival was 27.4 months (95% CI: 23.4–37.4). No treatment-related deaths or new ...

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A Study to Evaluate the Safety of INCA33890 in Participants ...

To evaluate the safety, tolerability, and DLTs and determine the MTD and/or RDE(s) of INCA33890 in participants with select advanced or metastatic solid tumors.

7.

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incytemi.com/document/Poster/ESMO%202025%20-%20INCA33890%20TGF%CE%B2R2xPD-1%20in%20Solid%20Tumors%20(oral%20presentation).pdf

A Phase 1 Study of INCA33890, a TGFβR2×PD- ...

• Evaluation of INCA33890 in combination with SoC treatments in patients with CRC is ongoing. ADA, anti-drug antibody; CRC, colorectal cancer; ICI, immune ...