Unresectable or Metastatic Solid Tumors
Conditions
Keywords
Solid tumors, locally advanced unresectable tumor, metastatic solid tumors
Brief summary
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.
Interventions
DRUGRetifanlimab
Part 1: INCMGA00012 at the protocol-defined starting dose administered intravenously every 4 weeks, with dose escalation to determine the maximum tolerated dose. Part 2: INCMGA00012 at the recommended dose from Part 1.
DRUGEpacadostat
Part 1: Epacadostat at the protocol-defined starting dose administered orally twice daily, with dose escalation to determine the maximum tolerated dose. Part 2: Epacadostat at the recommended dose from Part 1.
DRUGINCB050465
Part 1: INCB050465 at the protocol-defined starting dose administered orally once daily, with dose escalation to determine the maximum tolerated dose. Part 2: INCB050465 at the recommended dose from Part 1.
Sponsors
Incyte Corporation
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of treatment-emergent adverse events | Up to approximately 30 months | Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tmax of INCMGA00012 when given in combination with immune therapies | Up to approximately 4 months | Defined as time to maximum concentration. Other pharmacokinetic measures (including Cmin and AUC0-t) will also be evaluated. |
| Cmax of epacadostat when given in combination with INCMGA00012 | Up to approximately 4 months | Defined as maximum observed plasma or serum concentration. Other pharmacokinetic measures (including Cmin and AUC0-t) will also be evaluated. |
| Tmax of epacadostat when given in combination with INCMGA00012 | Up to approximately 4 months | Defined as time to maximum concentration. Other pharmacokinetic measures (including Cmin and AUC0-t) will also be evaluated. |
| Cmax of INCB050645 when given in combination with INCMGA00012 | Up to approximately 4 months | Defined as maximum observed plasma or serum concentration. Other pharmacokinetic measures (including Cmin and AUC0-t) will also be evaluated. |
| Cmax of INCMGA00012 when given in combination with immune therapies | Up to approximately 4 months | Defined as maximum observed plasma or serum concentration. Other pharmacokinetic measures (including Cmin and AUC0-t) will also be evaluated. |
| Overall response rate | Up to approximately 30 months | 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. |
| Duration of response | Up to approximately 30 months | 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. |
| Progression-free survival | Up to approximately 30 months | 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. |
| Overall survival | Up to approximately 30 months | Defined as the time from randomization to death due to any cause. |
| Tmax of INCB050645 when given in combination with INCMGA00012 | Up to approximately 4 months | Defined as time to maximum concentration. Other pharmacokinetic measures (including Cmin and AUC0-t) will also be evaluated. |
Countries
United States
Outcome results
None listed