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

• Status: Not yet recruiting
• Trial end date: 2026-05-23
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Incyte Corporation

Criteria

Inclusion Criteria:

• ≥18 years old

• Histologically or cytologically confirmed advanced or metastatic malignancies

• Participants must have experienced disease progression after treatment with available therapies, including anti-PD-(L)1 or anti-CTLA4 therapy if applicable, that are known to confer clinical benefit, or who are intolerant to, or ineligible for standard treatment. Prior anti-PD-(L)1 therapy should not have been discontinued because of intolerance.

• ECOG performance status score of 0 or 1.

• Willingness to undergo pre- and on-treatment tumor biopsy (core or excisional)

• Presence of measurable disease according to RECIST v1.1

• Part 1a only: Participants who have been previously treated with PD-1 inhibitor must undergo a washout period of 5 months or 5 times the half-life of the last PD-1, whichever is shorter, before the first dose of study drug.

• Bladder cancer (BC):

• Mixed histology with predominant urothelial carcinoma component is allowed.

• Pure small cell carcinoma, pure adenocarcinoma, and pure squamous cell carcinoma are excluded.

• Cervical squamous cell carcinoma and endocervical adenocarcinoma (CESC)

• Esophageal cancer (ESCA)

• Gastric adenocarcinoma (GC)

• Gastroesophageal adenocarcinoma (GEJ)

• Cutaneous malignant melanoma (Mel)

• Malignant pleural mesothelioma (MPM)

• Non-small cell lung cancer (NSCLC):

• Either squamous or nonsquamous histology is allowed. For mixed histology, there must be a predominant histology.

• Mixed small cell and non-small cell lung cancer histology is excluded.

• Tumors should not exhibit mutations in EGFR, ALK, ROS1, or BRAF.

• Ovarian Cancer (OC):

• Epithelial ovarian, fallopian tube, primary peritoneal carcinoma, or carcinosarcoma

• Sertoli-Leydig or germ cell cancers are excluded.

• Renal cell carcinoma (RCC)

• Head and neck squamous cell carcinoma (SCCHN):

• histologically or cytologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx not amenable to local therapy with curative intent (surgery or radiation with or without chemotherapy)

• Carcinoma of the nasopharynx, salivary gland, or nonsquamous histologies are excluded.

• Triple-negative breast cancer (TNBC):

• HER2-negative, ER-negative, and PgR-negative

• Pancreatic adenocarcinoma (PAAD)

• Colorectal cancer (CRC)

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.

• Received more than 4 prior anticancer regimen(s) for advanced or metastatic disease.

• History of clinically significant or uncontrolled cardiac disease

• Active HBV (or at risk of activation), 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

• Participants with adequate laboratory values within the protocol defined ranges.