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NCT02923349 · REGISTRY CONDITION SEARCH

A Phase 1/2, Open-Label, Dose-Escalation, Safety Study of INCAGN01949 in Subjects With Advanced or Metastatic Solid Tumors

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE1, PHASE2
Status at capture
COMPLETED
Registry last update
2025-08-24

The purpose of this study is to determine the safety and tolerability and assess preliminary efficacy of INCAGN01949 in subjects with advanced or metastatic solid tumors.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Maximum Observed Concentration (Cmax) of INCAGN01949 in Plasma

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outcome · POSTED

Area Under the Single-dose Concentration-time Curve (AUC0-t) of INCAGN01949

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outcome · POSTED

Objective Response Rate Per RECIST and Modified RECIST

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outcome · POSTED

Duration of Response Per RECIST and Modified RECIST

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outcome · POSTED

Progression-free Survival Per RECIST and Modified RECIST

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outcome · POSTED

Duration of Disease Control Per RECIST and Modified RECIST

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outcome · POSTED

Number of Participants With Treatment-related Adverse Events

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outcome · POSTED

Time to Maximum Concentration of INCAGN01949 in Plasma

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outcome · POSTED

Summary of Trough Concentrations(Cmin) of INCAGN01949

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * Locally advanced or metastatic disease; locally advanced disease must not be amenable to resection with curative intent. * Subjects who have disease progression after treatment with available therapies that are known to confer clinical benefit, or who are intolerant to treatment, or who refuse standard treatment. There is no limit to the number of prior treatment regimens. * Part 1: Subjects with advanced or metastatic solid tumors. * Part 2: Subjects with advanced or metastatic adenocarcinoma of the endometrium, ovarian cancer, renal cell carcinoma, melanoma, and non-small cell lung cancer. * Presence of measureable disease based on RECIST v1.1. * Eastern Cooperative Oncology Group performance status 0 or 1. Exclusion Criteria: * Laboratory and medical history parameters not within the protocol-defined range. * Receipt of anticancer medications or investigational drugs within the protocol-defined intervals before the first administration of study drug. * Has not recovered to ≤ Grade 1 from toxic effects of prior therapy (including prior immunotherapy) and/or complications from prior surgical intervention before starting therapy. * Receipt of a live vaccine within 30 days of planned start of study drug. * Active autoimmune disease that required systemic treatment in the past.
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. intervention Names
    1. Drug: INCAGN01949
    label
    INCAGN01949
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. INCAGN01949
    description
    Initial cohort dose of INCAGN01949 monotherapy at the protocol-defined starting dose, with subsequent cohort escalations based on protocol-specific criteria. The recommended dose will be taken forward into expansion cohorts.
    name
    INCAGN01949
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
87
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment
    measure
    Number of Participants With Treatment-related Adverse Events
    time Frame
    From screening through 60 days after end of treatment, up to 11 months
secondary Outcomes
  1. description
    To evaluate the Cmax of INCAGN01949 in subjects with advanced or metastatic solid tumors.
    measure
    Maximum Observed Concentration (Cmax) of INCAGN01949 in Plasma
    time Frame
    Pre-infusion for cycles 1,2,3,4,5,6 and 7, 10-minutes, 4 hrs, 24 hrs post-infusion, Day 8 for cycles 1 & 6
  2. description
    To evaluate the AUC0-t of INCAGN01949 in subjects with advanced or metastatic solid tumors
    measure
    Area Under the Single-dose Concentration-time Curve (AUC0-t) of INCAGN01949
    time Frame
    Pre-infusion for cycles 1,2,3,4,5,6 and 7, 10-minutes, 4 hrs, 24 hrs post-infusion, Day 8 for cycles 1 & 6
  3. description
    ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 and mRECIST v1.1. by investigator determination.
    measure
    Objective Response Rate Per RECIST and Modified RECIST
    time Frame
    Baseline and every 8 weeks,up to 11 months
  4. description
    ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 and mRECIST v1.1. by investigator determination.
    measure
    Duration of Response Per RECIST and Modified RECIST
    time Frame
    Baseline and every 8 weeks, up to 11 months
  5. description
    ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 and mRECIST v1.1. by investigator determination.
    measure
    Progression-free Survival Per RECIST and Modified RECIST
    time Frame
    Baseline and every 8 weeks, up to 11 months
  6. description
    ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 and mRECIST v1.1. by investigator determination.
    measure
    Duration of Disease Control Per RECIST and Modified RECIST
    time Frame
    Baseline and every 8 weeks, up to 11 months
  7. description
    To evaluate the Tmax of INCAGN01949 in subjects with advanced or metastatic solid tumors.
    measure
    Time to Maximum Concentration of INCAGN01949 in Plasma
    time Frame
    Pre-infusion for cycles 1,2,3,4,5,6 and 7, 10-minutes, 4 hrs, 24 hrs post-infusion, Day 8 for cycles 1 & 6
  8. description
    To evaluate the Cmin of INCAGN01949 in subjects with advanced or metastatic solid tumors. Cmin is the minimum observed concentration of INCAGN1949
    measure
    Summary of Trough Concentrations(Cmin) of INCAGN01949
    time Frame
    Pre-infusion for cycles 1,2,3,4,5,6 and 7, 10-minutes, 4 hrs, 24 hrs post-infusion, Day 8 for cycles 1 & 6
Full study description
brief Summary
The purpose of this study is to determine the safety and tolerability and assess preliminary efficacy of INCAGN01949 in subjects with advanced or metastatic solid tumors.
Source references
references
  1. citation
    Davis EJ, Martin-Liberal J, Kristeleit R, Cho DC, Blagden SP, Berthold D, Cardin DB, Vieito M, Miller RE, Hari Dass P, Orcurto A, Spencer K, Janik JE, Clark J, Condamine T, Pulini J, Chen X, Mehnert JM. First-in-human phase I/II, open-label study of the anti-OX40 agonist INCAGN01949 in patients with advanced solid tumors. J Immunother Cancer. 2022 Oct;10(10):e004235. doi: 10.1136/jitc-2021-004235.
    pmid
    36316061
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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      source file
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    Preserved source evidence · Not medical advice