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A Study to Evaluate the Safety of INCA33890 in Participants With Advanced or Metastatic Solid Tumors

View on ClinicalTrials.gov ↗

At a glance

What the study gets you: Access to the study treatment being tested
Type of study: Interventional (receives a drug or procedure)
Time in hospital: In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention: INCA33890 (drug), bevacizumab (drug), FOLFIRI (drug), FOLFOX (drug)
How long the study runs: Study runs about 70 months (dates as stated)
About the drug or intervention: INCA33890 — drug: INCA33890 will be administered at protocol defined dose. · bevacizumab — drug: Bevacizumab will be administered at protocol defined dose. · FOLFIRI — drug: FOLFIRI will be administered at protocol defined dose. · FOLFOX — drug: FOLFOX will be administered at protocol defined dose. · Cetuximab — drug: Cetuximab will be administered at protocol defined dose. · ADG126 — drug: ADG126 will be administered at protocol defined dose.
Patient visit burden: Not specified by the sponsor

In plain English

This study looks at the safety of a treatment called INCA33890 in adults with advanced or metastatic solid tumours (cancer that has spread or cannot be removed). It is run by Incyte Corporation and has two parts: Part 1 for people whose cancer has got worse after, or who cannot take, other treatments including certain immunotherapies; Part 2 may include people with different treatment histories.

Who can take part

Adults aged 18 or over
Confirmed advanced or metastatic solid tumour (cancer that has spread or is advanced)
Part 1: cancer has got worse after other treatment, or you cannot tolerate, are not eligible for, or have refused available treatments, including certain immunotherapy drugs (anti-PD-(L)1 or anti-CTLA4) where relevant
Part 2: depending on the group, you may or may not have had treatment before for your cancer
Able to carry out light activity (performance status score of 0 or 1)
Willing to have tumour biopsies (small samples of the tumour taken) before and during treatment — these are required for some groups
Tumours that can be measured on scans

Who may not be able to

Another cancer that is growing or needs treatment, or a history of another cancer in the past 2 years
Side effects from earlier treatment that have not settled down
An active autoimmune disease needing treatment with steroid medicines that damp down the immune system
Untreated or worsening cancer spread to the brain or nervous system
Previous organ transplant, including a stem cell transplant from a donor
Serious or uncontrolled heart disease
Active hepatitis B, active hepatitis C, or HIV
Taking regular steroid tablets (more than 10 mg a day of prednisone or similar)
An ongoing infection needing antibiotic, antifungal, or antiviral treatment
Started or changed blood-thinning medicines in the last 3 months
Other serious uncontrolled health problems, for example inflamed blood vessels, aneurysms (bulges in blood vessels), past heart muscle inflammation (myocarditis), or a blocked bowel in the last 60 days

What taking part involves

• Not stated — ask the trial team about how INCA33890 is given and what treatment involves

Time commitment: Not stated — ask the trial team how long the study lasts and how many visits are involved; taking part includes tumour biopsies before and during treatment.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study: Testing a treatment
Ages: 18 Years and over
Who: All
Number of participants: 570
Started: 2023-07-24
Last checked: 2026-07

Plain English Summary

What is this study?

• Testing a new treatment for solid tumors
• Phase1 - 570 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

Who can take part?

• Ages 18 Years and over
• Diagnosed with solid tumors

Where?

• Cambridge - Cambridge University Hospitals Nhs Foundation Trust
• London - Guys and St Thomas Nhs Foundation Trust
• London - Imperial College Healthcare Nhs Trust - Hammersmith Hospital
• Manchester - The Christie Nhs Foundation Trust Uk
• +1 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Solid TumorsAdvanced Solid TumorsMetastatic Solid Tumors

How this trial compares with your answers

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

Age: 18 Years and over
Who can join: All genders

Biomarkers mentioned

HIV positive

What the study is looking for

✓≥18 years old
✓confirmed by testing a sample advanced or that has spread malignancies as defined in the protocol.
✓ECOG performance status score of 0 or 1.
✓Willingness to undergo pre- and on-treatment tumor biopsy (core or excisional). Biopsies are mandatory depending on...
✓Presence of cancer that can be measured on scans according to (standard scan measurements).

Who cannot take part

✗Any known additional cancer that is progressing or requires active treatment, or history of other cancer...
✗Not recovered to ≤ Grade 1 or baseline from residual toxicities of prior therapy.
✗Has active autoimmune disease requiring systemic immunosuppression with corticosteroids.
✗Brain or CNS metastases untreated or that have progressed.
✗History of organ transplant, including allogeneic stem cell transplantation.

See the full criteria

Inclusion Criteria: * ≥18 years old * Histologically or cytologically confirmed advanced or metastatic malignancies as defined in the protocol. * Part 1: Participants must have experienced disease progression after treatment with, be intolerant to, or be ineligible for, or refused available therapies, including anti-PD-(L)1 or anti-CTLA4 therapy if applicable, that are known to confer clinical benefit. Part 2: depending on cohort, participants may have received or not prior treatment for the malignancy under study. * ECOG performance status score of 0 or 1. * Willingness to undergo pre- and on-treatment tumor biopsy (core or excisional). Biopsies are mandatory depending on the cohorts. * Presence of measurable disease according to RECIST v1.1. Exclusion Criteria: * Any known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 2 years. * Not recovered to ≤ Grade 1 or baseline from residual toxicities of prior therapy. * Has active autoimmune disease requiring systemic immunosuppression with corticosteroids. * Brain or CNS metastases untreated or that have progressed. * History of organ transplant, including allogeneic stem cell transplantation. * History of clinically significant or uncontrolled cardiac disease. * Active HBV, active HCV, or HIV positive. * Is on chronic systemic steroids (\> 10 mg/day of prednisone or equivalent). * Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment * Participants that have been initiated on or had modifications in anticoagulation therapies within the last 3 months prior to first dose of treatment. * Significant concurrent, uncontrolled medical condition, eg: * Cardiovascular: Participants with known vasculitis, aneurisms, and other vascular malformations of clinical significance or history of myocarditis. * Gastrointestinal: Any bowel obstruction within 60 days prior to C1D1. * Participants with adequate laboratory values within the protocol defined ranges. Other protocol-defined Inclusion/Exclusion Criteria may apply.