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NCT Number: NCT05836324

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Cancer Hospital Chinese Academy of Medical Sciences, Beijing, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Dose Limiting Toxicities (DLTs)

    Time frame: Up to 28 days

  2. Treatment Emerging Adverse Events (TEAEs)

    Time frame: Up to 2 years

  3. TEAEs leading to dose modification or discontinuation

    Time frame: Up to 2 years

Secondary outcomes

  1. Objective response Rate

    Time frame: 2 years

  2. Disease Control Rate

    Time frame: 2 years

  3. Duration of Response

    Time frame: 2 years

  4. Pharmacokinetics Parameter : Cmax of INCA33890

    Time frame: Pre dose - Day 1 of Cycle 1(C1D1)- 28 (each cycle is 28 days), Day 15 of Cycle 1-3; 10min and 4hrs Post dose(PD) - C1D1,C1D4, 24hrs PD C1D2, any time PD Day 4, 8, 22, of Cycle 1, and any time during 30 day Follow Up

  5. Pharmacokinetics Parameter : Tmax of INCA33890

    Time frame: Pre dose - Day 1 of Cycle 1(C1D1)- 28 (each cycle is 28 days), Day 15 of Cycle 1-3; 10min and 4hrs Post dose(PD) - C1D1,C1D4, 24hrs PD C1D2, any time PD Day 4, 8, 22, of Cycle 1, and any time during 30 day Follow Up

  6. Pharmacokinetics Parameter : Cmin of INCA33890

    Time frame: Pre dose - Day 1 of Cycle 1(C1D1)- 28 (each cycle is 28 days), Day 15 of Cycle 1-3; 10min and 4hrs Post dose(PD) - C1D1,C1D4, 24hrs PD C1D2, any time PD Day 4, 8, 22, of Cycle 1, and any time during 30 day Follow Up

  7. Pharmacokinetics Parameter : AUC(0-t) of INCA33890

    Time frame: Pre dose - Day 1 of Cycle 1(C1D1)- 28 (each cycle is 28 days), Day 15 of Cycle 1-3; 10min and 4hrs Post dose(PD) - C1D1,C1D4, 24hrs PD C1D2, any time PD Day 4, 8, 22, of Cycle 1, and any time during 30 day Follow Up

  8. Pharmacokinetics Parameter : AUC 0-∞ of INCA33890

    Time frame: Pre dose - Day 1 of Cycle 1(C1D1)- 28 (each cycle is 28 days), Day 15 of Cycle 1-3; 10min and 4hrs Post dose(PD) - C1D1,C1D4, 24hrs PD C1D2, any time PD Day 4, 8, 22, of Cycle 1, and any time during 30 day Follow Up

  9. Pharmacokinetics Parameter : CL of INCA33890

    Time frame: Pre dose - Day 1 of Cycle 1(C1D1)- 28 (each cycle is 28 days), Day 15 of Cycle 1-3; 10min and 4hrs Post dose(PD) - C1D1,C1D4, 24hrs PD C1D2, any time PD Day 4, 8, 22, of Cycle 1, and any time during 30 day Follow Up

  10. Pharmacokinetics Parameter : Vz of INCA33890

    Time frame: Pre dose - Day 1 of Cycle 1(C1D1)- 28 (each cycle is 28 days), Day 15 of Cycle 1-3; 10min and 4hrs Post dose(PD) - C1D1,C1D4, 24hrs PD C1D2, any time PD Day 4, 8, 22, of Cycle 1, and any time during 30 day Follow Up

  11. Pharmacokinetics Parameter : t1/2 of INCA33890

    Time frame: Pre dose - Day 1 of Cycle 1(C1D1)- 28 (each cycle is 28 days), Day 15 of Cycle 1-3; 10min and 4hrs Post dose(PD) - C1D1,C1D4, 24hrs PD C1D2, any time PD Day 4, 8, 22, of Cycle 1, and any time during 30 day Follow Up

Study contacts

Contact information is provided by the study sponsor or research team.

Incyte Corporation Call Center (US)

CONTACT

[email protected]

1.855.463.3463

Incyte Corporation Call Center (ex-US)

CONTACT

[email protected]

+800 00027423

Sponsors and collaborators

Lead sponsor

Incyte Corporation

Industry

Registry information

Official study title

A Phase 1, Open-Label, Multicenter Study of INCA33890 in Participants With Advanced or Metastatic Solid Tumors

Important dates

Study start
2023
Primary completion
2029
Study completion
2029
First posted
May 1, 2023
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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