Unresectable or Metastatic Solid Tumors Clinical Trial
Official title:
A Phase 1b Study of INCMGA00012 in Combination With Other Therapies in Patients With Advanced Solid Tumors
| Verified date | February 2023 |
| Source | Incyte Corporation |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to determine the safety, preliminary evidence of clinical activity, and recommended Phase 2 dose (RP2D) of INCMGA00012 in combination with other agents that may improve the therapeutic efficacy of anti-PD-1 monotherapy.
| Status | Completed |
| Enrollment | 83 |
| Est. completion date | November 21, 2022 |
| Est. primary completion date | November 21, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Histologically proven, locally advanced unresectable or metastatic solid tumors for whom no approved therapy with demonstrated clinical benefit is available or participants who are intolerant to or have declined standard therapy - Measurable or nonmeasurable tumor lesions per RECIST v 1.1. - Willing to provide fresh or archival tumor tissue for correlative studies. - Eastern Cooperative Oncology Group performance status 0 to 1. - Willingness to avoid pregnancy or fathering children based on protocol-defined criteria. Exclusion Criteria: - Receipt of anticancer therapy within 21 days of the first administration of study treatment, with the exception of localized radiotherapy. - Toxicity of prior therapy that has not recovered to = Grade 1 or baseline (with the exception of alopecia and anemia not requiring transfusional support). - Laboratory values outside the protocol-defined range at screening. - Active autoimmune disease requiring systemic immunosuppression in excess of physiologic maintenance doses of corticosteroids. - Known hypersensitivity to any of the study drugs, excipients, or another monoclonal antibody which cannot be controlled with standard measures (eg, antihistamines and corticosteroids). - Evidence of interstitial lung disease or active, noninfectious pneumonitis. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Roswell Park Cancer Institute | Buffalo | New York |
| United States | University of Chicago Medical Center | Chicago | Illinois |
| United States | University of Florida - Shands Cancer Center | Gainesville | Florida |
| United States | The Angeles Clinic and Research Institute | Los Angeles | California |
| United States | Rutgers Cancer Institute of Nj | New Brunswick | New Jersey |
| United States | Yale New Haven Hospital | New Haven | Connecticut |
| United States | Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania |
| United States | Upmc Cancercenter | Pittsburgh | Pennsylvania |
| United States | South Texas Accelerated Research Therapeutics | San Antonio | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| Incyte Corporation |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of treatment-emergent adverse events | Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug. | Up to approximately 30 months | |
| Secondary | Cmax of INCMGA00012 when given in combination with immune therapies | Defined as maximum observed plasma or serum concentration. Other pharmacokinetic measures (including Cmin and AUC0-t) will also be evaluated. | Up to approximately 4 months | |
| Secondary | Tmax of INCMGA00012 when given in combination with immune therapies | Defined as time to maximum concentration. Other pharmacokinetic measures (including Cmin and AUC0-t) will also be evaluated. | Up to approximately 4 months | |
| Secondary | Cmax of epacadostat when given in combination with INCMGA00012 | Defined as maximum observed plasma or serum concentration. Other pharmacokinetic measures (including Cmin and AUC0-t) will also be evaluated. | Up to approximately 4 months | |
| Secondary | Tmax of epacadostat when given in combination with INCMGA00012 | Defined as time to maximum concentration. Other pharmacokinetic measures (including Cmin and AUC0-t) will also be evaluated. | Up to approximately 4 months | |
| Secondary | Cmax of INCB050645 when given in combination with INCMGA00012 | Defined as maximum observed plasma or serum concentration. Other pharmacokinetic measures (including Cmin and AUC0-t) will also be evaluated. | Up to approximately 4 months | |
| Secondary | Tmax of INCB050645 when given in combination with INCMGA00012 | Defined as time to maximum concentration. Other pharmacokinetic measures (including Cmin and AUC0-t) will also be evaluated. | Up to approximately 4 months | |
| Secondary | Overall response rate | Defined as the percentage of participants having complete response (CR) or partial response (PR) as determined by investigator assessment of radiographic disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and modified RECIST v1.1 for immune-based therapeutics. | Up to approximately 30 months | |
| Secondary | Duration of response | Defined as the time from the earliest date of CR or PR until the earliest date at which progression criteria are met or date of death due to any cause, whichever occurs first. | Up to approximately 30 months | |
| Secondary | Progression-free survival | Defined as the time from the start of therapy until the earliest date at which progression criteria are met or date of death due to any cause, whichever occurs first. | Up to approximately 30 months | |
| Secondary | Overall survival | Defined as the time from randomization to death due to any cause. | Up to approximately 30 months |