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

Sponsor

Incyte Corporation (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05836324

Collaborator

(none)

100

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Solid Tumors Advanced Solid Tumors Metastatic Solid Tumors	Drug: INCA33890	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jun 23, 2023

Anticipated Primary Completion Date :

May 23, 2026

Anticipated Study Completion Date :

May 23, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Part 1a - Dose Escalation INCA33890 will be administered at a protocol defined starting regimen intravenously. Subsequent dose regimens will be determined during study conduct.	Drug: INCA33890 INCA33890 will be administered at protocol defined dose.
Experimental: Part 1b-Dose Expansion INCA33890 will be administered at the recommended dose(s) for expansion (RDE[s]) in participants with advanced or metastatic ICI sensitive or ICI non sensitive tumor types	Drug: INCA33890 INCA33890 will be administered at protocol defined dose.

Arm

Intervention/Treatment

Experimental: Part 1a - Dose Escalation

INCA33890 will be administered at a protocol defined starting regimen intravenously. Subsequent dose regimens will be determined during study conduct.

Drug: INCA33890

INCA33890 will be administered at protocol defined dose.

Experimental: Part 1b-Dose Expansion

INCA33890 will be administered at the recommended dose(s) for expansion (RDE[s]) in participants with advanced or metastatic ICI sensitive or ICI non sensitive tumor types

Drug: INCA33890

INCA33890 will be administered at protocol defined dose.

Outcome Measures

Primary Outcome Measures

Number of participants with Dose Limiting Toxicities (DLTs) [Up to 28 days]
Number of participants with Treatment Emerging Adverse Events (TEAEs) [Up to 2 years]
Number of participants with TEAEs leading to dose modification or discontinuation [Up to 2 years]

Secondary Outcome Measures

Objective response Rate [2 years]
Disease Control Rate [2 years]
Duration of Response [2 years]
Pharmacokinetics Parameter : Cmax of INCA33890 [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]
Pharmacokinetics Parameter : Tmax of INCA33890 [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]
Pharmacokinetics Parameter : Cmin of INCA33890 [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]
Pharmacokinetics Parameter : AUC(0-t) of INCA33890 [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]
Pharmacokinetics Parameter : AUC 0-∞ of INCA33890 [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]
Pharmacokinetics Parameter : CL/F of INCA33890 [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]
Pharmacokinetics Parameter : Vz/F of INCA33890 [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]
Pharmacokinetics Parameter : t1/2 of INCA33890 [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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Incyte Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Incyte Corporation

ClinicalTrials.gov Identifier:

NCT05836324

Other Study ID Numbers:

INCA 33890-101

First Posted:

May 1, 2023

Last Update Posted:

May 1, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Incyte Corporation

Solid Tumors

INCA33890

Additional relevant MeSH terms:

Neoplasms

Study Results

No Results Posted as of May 1, 2023