Phase 2
Completed N=54
A Phase 1/2 Study of INCB001158 in Combination With Chemotherapy in Subjects With Solid Tumors
Source: ClinicalTrials.gov NCT03314935 ↗Enrolled (actual)
54
Serious AEs
55.7%
Results posted
Dec 2023
Primary outcomePrimary: Phases 1 and 2: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) — 8; 6; 13; 7 Participants
Summary
The purpose of this open-label nonrandomized Phase 1/2 study is to evaluate INCB001158 in combination with chemotherapy in participants with advanced/metastatic solid tumors.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Phases 1 and 2: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) |
8; 6; 13; 7; 4; 46 | — |
| PRIMARY Phase 1: Number of Participants With Any Dose-limiting Toxicity (DLT) |
0; 0; 0; 1; 0; 0 | — |
| PRIMARY Recommended Phase 2 Dose (RP2D) of INCB001158 When Given in Combination With Each Chemotherapy Regimen |
100 | — |
| PRIMARY Phase 2: Objective Response Rate (ORR) |
0.0; 24.2; 22.2; 9.1; 30.0; 16.7 | — |
| SECONDARY Phase 1: ORR |
12.5; 0.0; 0.0; 0.0; 25.0; 0.0 | — |
| SECONDARY Phases 1 and 2: Duration of Response |
5.8 | — |
| SECONDARY Phases 1 and 2: Disease Control Rate |
62.5; 83.3; 16.7; 57.1; 75.0; 100.0 | — |
| SECONDARY Phases 1 and 2: Progression-free Survival |
3.7; 6.6; 1.7; 3.9; 5.3; 6.4 | — |
| SECONDARY Cmin of INCB001158 in Participants Treated With INCB001158 in Combination With Chemotherapy on Cycle 2 Day 1 Following Repeated Dose Administration |
747; 407; 268; 542; 1020; 633 | — |
| SECONDARY Cmax of INCB001158 in Participants Treated With INCB001158 in Combination With Chemotherapy Following the First Dose on Cycle 1 Day 1 and on Cycle 2 Day 1 Following Repeated Dose Administration |
1290; 1350; 2160; 1100; 1760; 1640 | — |
| SECONDARY Tmax of INCB001158 in Participants Treated With INCB001158 in Combination With Chemotherapy Following the First Dose on Cycle 1 Day 1 and on Cycle 2 Day 1 Following Repeated Dose Administration |
4.13; 4.07; 4.08; 5.05; 4.09; 3.97 | — |
| SECONDARY AUC0-t of INCB001158 in Participants Treated With INCB001158 in Combination With Chemotherapy Following the First Dose on Cycle 1 Day 1 and on Cycle 2 Day 1 Following Repeated Dose Administration |
6910; 7240; 10600; 4680; 9290; 8840 | — |
| SECONDARY Tlast of INCB001158 in Participants Treated With INCB001158 in Combination With Chemotherapy Following the First Dose on Cycle 1 Day 1 and on Cycle 2 Day 1 Following Repeated Dose Administration |
7.53; 7.73; 7.53; 7.50; 7.53; 7.65 | — |
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically confirmed diagnosis of selected advanced or metastatic solid tumors.
- Presence of measurable disease per RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Baseline archival tumor specimen available or willingness to undergo a pretreatment tumor biopsy to obtain the specimen.
- Resolution of treatment-related toxicities.
- Adequate hepatic, renal, cardiac, and hematologic function.
- Additional cohort-specific criteria may apply.
Exclusion Criteria
- Subjects who participated in any other study in which receipt of an investigational study drug or device occurred within 28 days or 5 half-lives (whichever is longer) prior to first dose.
- Has received a prior monoclonal antibody within 4 weeks or 5 half-lives (whichever is shorter) before administration of study drug.
- Has had prior chemotherapy or targeted small molecule therapy within 2 weeks before administration of study treatment.
- Has received prior approved radiotherapy within 14 days of study therapy.
- Has had known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 2 years of study entry.
- Has an active autoimmune disease that has required systemic treatment in past 2 years.
- Has an active infection requiring systemic therapy.
- Has known active CNS metastases and/or carcinomatous meningitis.
- Women who are pregnant or breastfeeding.
Data sourced from ClinicalTrials.gov (NCT03314935). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.