Phase 2
Completed N=52
A Study Exploring the Safety and Efficacy of INCAGN01949 in Combination With Immune Therapies in Advanced or Metastatic Malignancies
Advanced Malignancies
Source: ClinicalTrials.gov NCT03241173 ↗
Enrolled (actual)
52
Serious AEs
53.8%
Results posted
Sep 2022
Primary outcomePrimary: Phase 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) — 4; 4; 5; 5 Participants
Summary
The purpose of this study is to determine the safety, tolerability, and efficacy of INCAGN01949 when given in combination with immune therapies in participants with advanced or metastatic malignancies.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Phase 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) |
4; 4; 5; 5; 4; 5 | — |
| PRIMARY Phase 1: Number of Participants With a Grade 3 or Higher TEAE |
2; 1; 3; 3; 2; 2 | — |
| PRIMARY Phase 2: Objective Response Rate (ORR) |
— | — |
| SECONDARY Phase 1: ORR |
25.0; 25.0; 0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Phase 1: Duration of Response (DOR) |
97.0; NA; 86.0 | — |
| SECONDARY Phase 2: DOR |
— | — |
| SECONDARY Phase 1: Disease Control Rate (DCR) |
25.0; 25.0; 40.0; 0.0; 75.0; 0.0 | — |
| SECONDARY Phase 2: DCR |
— | — |
| SECONDARY Phase 1: Duration of Disease Control |
97.0; NA; 120.0; 58.0; 298.5; 100.0 | — |
| SECONDARY Phase 2: Duration of Disease Control |
— | — |
| SECONDARY Phase 1: Progression-free Survival (PFS) |
1.8; 1.8; 2.7; 1.8; 3.5; 1.6 | — |
| SECONDARY Phase 2: PFS |
— | — |
| SECONDARY Phase 2: Number of Participants With TEAEs |
— | — |
| SECONDARY Phase 2: Number of Participants With a Grade 3 or Higher TEAE |
— | — |
Eligibility Criteria
Inclusion Criteria
- Locally advanced or metastatic disease; locally advanced disease must not be amenable to resection with curative intent.
- Phase 1: Subjects with advanced or metastatic solid tumors.
- Phase 1: Subjects who have disease progression after treatment with available therapies.
- Phase 2: Subjects with advanced or metastatic gastric cancer, SCCHN, NSCLC, or RCC and are considered refractory to prior PD-1/L1 therapy.
- Presence of measurable disease based on RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
Exclusion Criteria
- Laboratory and medical history parameters not within the Protocol-defined range
- Receipt of anticancer medications or investigational drugs within protocol-defined intervals before the first administration of study drug.
- Has not recovered to ≤ Grade 1 from toxic effects of prior therapy.
- Active autoimmune disease.
- Known active central nervous system metastases and/or carcinomatous meningitis.
- Evidence of active, noninfectious pneumonitis or history of interstitial lung disease.
- Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation.
- Known history of human immunodeficiency virus (HIV); HIV 1/2 antibodies.
Data sourced from ClinicalTrials.gov (NCT03241173). 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.