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

Incyte

Status and phase: Enrolling; Phase 1

Conditions: Advanced Solid Tumors; Metastatic Solid Tumors; Solid Tumors

Treatments: Drug: INCA33890; Drug: bevacizumab; Drug: Cetuximab; Drug: FOLFOX; Drug: FOLFIRI

Study type: Interventional

Funder types: Industry

Identifiers

NCT05836324

2022-502456-31-00 (Registry Identifier)

INCA 33890-101

Details and patient eligibility

About

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.

Enrollment: 408 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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408 participants in 10 patient groups

Part 1a - Dose Escalation Monotherapy

Experimental group

Description:

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

Treatment:

Drug: INCA33890

Part 1b-Dose Expansion Monotherapy

Experimental group

Description:

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

Treatment:

Drug: INCA33890

Part 2a - Dose Escalation Combination Therapy - Group 1

Experimental group

Description:

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

Treatment:

Drug: bevacizumab

Drug: INCA33890

Part 2a - Dose Escalation Combination Therapy - Group 2

Experimental group

Description:

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

Treatment:

Drug: FOLFIRI

Drug: bevacizumab

Drug: INCA33890

Part 2a - Dose Escalation Combination Therapy - Group 3

Experimental group

Description:

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

Treatment:

Drug: FOLFOX

Drug: bevacizumab

Drug: INCA33890

Part 2a - Dose Escalation Combination Therapy - Group 4

Experimental group

Description:

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

Treatment:

Drug: Cetuximab

Drug: INCA33890

Part 2b - Dose Expansion Combination Therapy - Group 1

Experimental group

Description:

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

Treatment:

Drug: bevacizumab

Drug: INCA33890

Part 2b - Dose Expansion Combination Therapy - Group 2

Experimental group

Description:

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

Treatment:

Drug: FOLFIRI

Drug: bevacizumab

Drug: INCA33890

Part 2b - Dose Expansion Combination Therapy - Group 3

Experimental group

Description:

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

Treatment:

Drug: FOLFOX

Drug: bevacizumab

Drug: INCA33890

Part 2b - Dose Expansion Combination Therapy - Group 4

Experimental group

Description:

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

Treatment:

Drug: Cetuximab

Drug: INCA33890