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NCT02903914 · OUTCOME

Recommended Phase 2 Dose (RP2D) of INCB001158

Arginase Inhibitor INCB001158 as a Single Agent and in Combination With Immune Checkpoint Therapy in Patients With Advanced/Metastatic Solid Tumors · Source last updated 2025-08-05

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
milligrams
Interval / dispersion
Not reported
Time frame
12 weeks

What was measured

The RP2D was determined by a traditional 3+3 dose-escalation design of single-agent INCB001158 in participants with advanced/metastatic solid tumors at doses of 50, 75, 100, or 150 mg.

Analysis population: Safety Population

Groups in this outcome

INCB001158 as Monotherapy at 50, 75, 100 and 150 mg BID

Monotherapy Part 1a: INCB001158 was administered orally in participants with advanced/metastatic solid tumors. Sequential dose escalation of single-agent INCB001158 took place in participants with advanced/metastatic solid tumors.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
INCB001158 as Monotherapy at 50, 75, 100 and 150 mg BID28

Reported measurements

Source class 1
Values in milligrams · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
INCB001158 as Monotherapy at 50, 75, 100 and 150 mg BID100Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        100
denoms
  1. counts
    1. group Id
      OG000
      value
      28
    units
    Participants
description
The RP2D was determined by a traditional 3+3 dose-escalation design of single-agent INCB001158 in participants with advanced/metastatic solid tumors at doses of 50, 75, 100, or 150 mg.
groups
  1. description
    Monotherapy Part 1a: INCB001158 was administered orally in participants with advanced/metastatic solid tumors. Sequential dose escalation of single-agent INCB001158 took place in participants with advanced/metastatic solid tumors.
    id
    OG000
    title
    INCB001158 as Monotherapy at 50, 75, 100 and 150 mg BID
param Type
NUMBER
population Description
Safety Population
reporting Status
POSTED
time Frame
12 weeks
title
Recommended Phase 2 Dose (RP2D) of INCB001158
type
SECONDARY
unit Of Measure
milligrams

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice