ClinicalTrials.gg
Not yet recruitingNCT07823322NEXERA-204Updated Sep 22, 2026

A Study to Evaluate INCA33890 in the Treatment of Circulating Tumor DNA-Positive Stage II/III Microsatellite Stable Colorectal Cancer After Curative Resection and Chemotherapy

A Phase 2 interventional study of INCA33890 in CRC (Colorectal Cancer), sponsored by Incyte Corporation. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-22.

Sponsored by Incyte Corporation · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 18 studies in Colorectal Neoplasms by Incyte Corporation — 3 open to participants now, 5 under way, 1 of them phase 3. Colorectal Neoplasms · Incyte Corporation.

Planned enrollment
13th of 18
40 · median 70
Started
2026
with 1 other
Phase 2
3 of 18
1 open now
Registered
18th of 18
by date

Among the 18 studies in Colorectal Neoplasms by Incyte Corporation, this one is the 13th largest by planned enrollment, is one of 2 that started in 2026, is one of 3 in phase 2, and was the 18th registered.

Colorectal Neoplasms

6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.

Browse Colorectal Neoplasms studies →

Open to participants now

3 of the 18 studies in Colorectal Neoplasms by Incyte Corporation are open now, in 12 countries. Recruiting first, the newest first:

By country, each count listing its studies:

All 3 open studies →

Who these studies take

Of the 1,185 Colorectal Neoplasms studies recruiting now, 769 (65%) set no upper age limit and 265 (22%) stop at 75 or younger; 48 take children under 18; 123 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 18 studies in Colorectal Neoplasms by Incyte Corporation, or all of them as a file.
02

Study summary

The purpose of this study is to evaluate INCA33890 in the treatment of circulating tumor DNA-positive stage II/III microsatellite stable colorectal cancer after curative resection and chemotherapy.

03

Conditions studied

  • CRC (Colorectal Cancer)

Keywords

  • Colorectal Cancer
  • Colon Cancer
  • INCA33890
  • Circulating tumor DNA (ctDNA)
  • Signatera
  • Minimal residual disease (MRD)
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Received curative-intent (R0) resection of confirmed Stage II or III colorectal adenocarcinoma.
  • Completed all and/or adjuvant chemotherapy, including at least 3 months of fluoropyrimidine-based chemotherapy.
  • Has minimal residual disease (MRD), defined as ctDNA positive by the Signatera™ assay (whole exome sequencing [WES] or whole genome sequencing [WGS]) in a blood sample collected between:

    • 2 weeks and 12 months after completion of adjuvant chemotherapy or
    • 4 weeks and 12 months after curative resection following total neoadjuvant therapy.

Note: If the participant received any therapy for MRD, ctDNA positivity must be confirmed in a blood sample collected at least 4 weeks after completion of that investigational therapy and within the applicable 12-month window described above.

  • Has no clinical or radiographic evidence of disease confirmed by chest, abdominal, and pelvic PET-CT scan and by brain imaging (MRI or CT scan with contrast) within 4 weeks prior to C1D1 study drug administration.
  • performance status of 0 or 1.
  • Adequate organ function determined by laboratory results.

Exclusion criteria

Exclusion Criteria:

  • History of (Stage IV) colorectal adenocarcinoma, including oligometastatic disease or metastatic recurrence, even if all metastatic sites and the primary tumor were completely resected and the patient is currently without evidence of disease.
  • MSI-H/dMMR per historical data in the medical record.
  • History of other within 2 years.
  • Treatment with an anti-PD-(L)1 or for any indication within the last 3 years.
  • Active disease that has required systemic treatment in the past 2 years.
  • Significant concurrent and/or uncontrolled medical condition.
  • History of organ transplant, including stem cell transplantation.

Other protocol-defined inclusion/exclusion criteria apply.

Terms in these criteria, in plain language(9)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

PD-1, PD-L1 and checkpoint inhibitors

PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.

PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    INCA33890

    INCA33890 will be administered at the protocol-defined dose.

    Drug: INCA33890

Interventions

  • INCA33890 will be administered at protocol defined dose.

06

What researchers measure

Primary outcomes

  1. Circulating tumor DNA (ctDNA) clearance

    Defined as ctDNA positive at baseline and change to ctDNA negative at 3 months.

    Time frame: 3 months

Secondary outcomes

  1. ctDNA clearance by visit

    Defined as ctDNA positive at baseline and change to ctDNA negative at corresponding visits.

    Time frame: Up to approximately 19 months

  2. Absolute change from baseline in ctDNA levels at each visit

    Time frame: Up to approximately 19 months

  3. Percent change from baseline in ctDNA levels at each visit

    Time frame: Up to approximately 19 months

  4. Disease-free survival (DFS)

    Defined as the time from the date of first dose of study drug to the date of recurrence, second primary CRC malignancy, or death from any cause, whichever occurs first.

    Time frame: Up to approximately 19 months

  5. Treatment Emergent Adverse Events (TEAEs)

    Adverse events reported for the first time or worsening of a pre-existing event, occurring after first dose of study drug and up to 90 days after last dose of INCA33890 or the start of new anticancer therapy, whichever comes first.

    Time frame: Up to approximately 19 months

  6. TEAEs leading to dose interruptions, dose delays or discontinuation of study treatment

    TEAEs leading to dose interruption, dose delay or study drug discontinuation.

    Time frame: Up to approximately 19 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes — Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

Supporting information: Study protocol, Statistical analysis plan

Time frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.

Access criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.

Data sharing details ↗ · www.incyte.com

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for May 2029, 30 months later.

Of 120 industry-sponsored phase 2 interventional studies under Colorectal Neoplasms, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 72. This study's planned 30 months is below that.

Counting every sponsor, half of 618 studies reached it within 49 months; a quarter within 31 and three quarters within 75.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 11, 2026
First posted
Sep 16, 2026
StartEst.
Oct 26, 2026
Primary completionEst.
May 14, 2029
CompletionEst.
May 14, 2029
Last update
Sep 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07823322
Lead sponsor
Incyte Corporation
Responsible party
Sponsor
First posted
Sep 16, 2026
Start date
Oct 26, 2026 (estimated)
Primary completion
May 14, 2029 (estimated)
Completion
May 14, 2029 (estimated)
Last update
Sep 22, 2026

Study contacts

Incyte Corporation Call Center (US)
Contact
medinfo@incyte.com
1.855.463.3463
Incyte Corporation Call Center (ex-US)
Contact
eumedinfo@incyte.com
+800 00027423
Incyte Medical Monitor
study director · Incyte Corporation

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Studies of the drug tested here: Anti-PD-1/Anti-TGFbRII Bispecific Antibody INCA33890

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