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NCT01609556 · OUTCOME

Number of Participants With Gynecologic Cancer Intergroup (GCIG) CA-125 Criteria Clinical Responses

First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Mirvetuximab Soravtansine in Adults With Ovarian Cancer and Other Folate Receptor 1 (FOLR1)-Positive Solid Tumors · Source last updated 2021-02-17

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From first dose of study drug until CA-125 response (maximum exposure: 36 weeks for dose-escalation Schedule A, 101.3 weeks for dose-escalation Schedule B, 124 weeks for dose-expansion EOC, 33.3 weeks for dose-expansion EC)

What was measured

CA-125 response was defined as at least 50% reduction in CA-125 levels from baseline. The date of response corresponded to the date when the CA 125 level was first reduced by 50%.

Analysis population: CA-125 evaluable population included participants who had a baseline CA-125 value greater than or equal to (\>=) 2 \* upper limit of normal (ULN), received at least 1 dose of study drug, and had at least 1 post-dose CA-125 assessment.

Groups in this outcome

Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.15 mg/kg Q3W)

Participants received mirvetuximab soravtansine 0.15 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.

Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.5 mg/kg Q3W)

Participants received mirvetuximab soravtansine 0.5 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.

Dose Escalation: Schedule A (Mirvetuximab Soravtansine 1.0 mg/kg Q3W)

Participants received mirvetuximab soravtansine 1.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.

Dose Escalation: Schedule A (Mirvetuximab Soravtansine 2.0 mg/kg Q3W)

Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.

Dose Escalation: Schedule A (Mirvetuximab Soravtansine 3.3 mg/kg Q3W)

Participants received mirvetuximab soravtansine 3.3 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.

Dose Escalation: Schedule A (Mirvetuximab Soravtansine 5.0 mg/kg Q3W)

Participants received mirvetuximab soravtansine 5.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.

Dose Escalation: Schedule A (Mirvetuximab Soravtansine 6.0 mg/kg Q3W)

Participants received mirvetuximab soravtansine 6.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.

Dose Escalation: Schedule A (Mirvetuximab Soravtansine 7.0 mg/kg Q3W)

Participants received mirvetuximab soravtansine 7.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.

Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.1 mg/kg Weekly)

Participants received mirvetuximab soravtansine 1.1 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.

Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.8 mg/kg Weekly)

Participants received mirvetuximab soravtansine 1.8 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.

Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.0 mg/kg Weekly)

Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.

Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.5 mg/kg Weekly)

Participants received mirvetuximab soravtansine 2.5 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.

Dose Expansion: Cohort 1 (Mirvetuximab Soravtansine Q3W)

Participants with EOC, primary peritoneal cancer, or fallopian tube cancer resistant to platinum-based therapy received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.

Dose Expansion: Cohort 2 (Mirvetuximab Soravtansine Q3W)

Participants with FOLR1-positive uterine cancer (that was advanced or recurrent and had received at least 1 platinum-based regimen, and no more than 5 prior systemic treatment regimens for EC) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.

Dose Expansion: Cohort 3 (Mirvetuximab Soravtansine Q3W)

Participants with biopsy-accessible relapsed or refractory ovarian cancer, primary peritoneal cancer, or fallopian tube cancer received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.

Dose Expansion: Cohort 5 (Mirvetuximab Soravtansine Q3W)

Participants with EOC primary peritoneal cancer or fallopian tube cancer (that had relapsed following platinum-based therapy, excluding those participants with primary platinum refractory disease or low grade or clear cell ovarian cancer) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.

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

Analysis denominator · Participants

GroupSource count
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.15 mg/kg Q3W)1
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.5 mg/kg Q3W)0
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 1.0 mg/kg Q3W)0
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 2.0 mg/kg Q3W)1
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 3.3 mg/kg Q3W)3
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 5.0 mg/kg Q3W)10
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 6.0 mg/kg Q3W)2
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 7.0 mg/kg Q3W)3
Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.1 mg/kg Weekly)2
Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.8 mg/kg Weekly)2
Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.0 mg/kg Weekly)4
Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.5 mg/kg Weekly)5
Dose Expansion: Cohort 1 (Mirvetuximab Soravtansine Q3W)31
Dose Expansion: Cohort 2 (Mirvetuximab Soravtansine Q3W)12
Dose Expansion: Cohort 3 (Mirvetuximab Soravtansine Q3W)20
Dose Expansion: Cohort 5 (Mirvetuximab Soravtansine Q3W)26

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.15 mg/kg Q3W)0Not reportedNot reportedNot reportedNot reported
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.5 mg/kg Q3W)0Not reportedNot reportedNot reportedNot reported
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 1.0 mg/kg Q3W)0Not reportedNot reportedNot reportedNot reported
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 2.0 mg/kg Q3W)0Not reportedNot reportedNot reportedNot reported
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 3.3 mg/kg Q3W)0Not reportedNot reportedNot reportedNot reported
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 5.0 mg/kg Q3W)3Not reportedNot reportedNot reportedNot reported
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 6.0 mg/kg Q3W)1Not reportedNot reportedNot reportedNot reported
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 7.0 mg/kg Q3W)1Not reportedNot reportedNot reportedNot reported
Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.1 mg/kg Weekly)1Not reportedNot reportedNot reportedNot reported
Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.8 mg/kg Weekly)2Not reportedNot reportedNot reportedNot reported
Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.0 mg/kg Weekly)2Not reportedNot reportedNot reportedNot reported
Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.5 mg/kg Weekly)3Not reportedNot reportedNot reportedNot reported
Dose Expansion: Cohort 1 (Mirvetuximab Soravtansine Q3W)23Not reportedNot reportedNot reportedNot reported
Dose Expansion: Cohort 2 (Mirvetuximab Soravtansine Q3W)4Not reportedNot reportedNot reportedNot reported
Dose Expansion: Cohort 3 (Mirvetuximab Soravtansine Q3W)11Not reportedNot reportedNot reportedNot reported
Dose Expansion: Cohort 5 (Mirvetuximab Soravtansine Q3W)17Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        3
      7. group Id
        OG006
        value
        1
      8. group Id
        OG007
        value
        1
      9. group Id
        OG008
        value
        1
      10. group Id
        OG009
        value
        2
      11. group Id
        OG010
        value
        2
      12. group Id
        OG011
        value
        3
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      0
    3. group Id
      OG002
      value
      0
    4. group Id
      OG003
      value
      1
    5. group Id
      OG004
      value
      3
    6. group Id
      OG005
      value
      10
    7. group Id
      OG006
      value
      2
    8. group Id
      OG007
      value
      3
    9. group Id
      OG008
      value
      2
    10. group Id
      OG009
      value
      2
    11. group Id
      OG010
      value
      4
    12. group Id
      OG011
      value
      5
    units
    Participants
description
CA-125 response was defined as at least 50% reduction in CA-125 levels from baseline. The date of response corresponded to the date when the CA 125 level was first reduced by 50%.
groups
  1. description
    Participants received mirvetuximab soravtansine 0.15 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
    id
    OG000
    title
    Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.15 mg/kg Q3W)
  2. description
    Participants received mirvetuximab soravtansine 0.5 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
    id
    OG001
    title
    Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.5 mg/kg Q3W)
  3. description
    Participants received mirvetuximab soravtansine 1.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
    id
    OG002
    title
    Dose Escalation: Schedule A (Mirvetuximab Soravtansine 1.0 mg/kg Q3W)
  4. description
    Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
    id
    OG003
    title
    Dose Escalation: Schedule A (Mirvetuximab Soravtansine 2.0 mg/kg Q3W)
  5. description
    Participants received mirvetuximab soravtansine 3.3 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
    id
    OG004
    title
    Dose Escalation: Schedule A (Mirvetuximab Soravtansine 3.3 mg/kg Q3W)
  6. description
    Participants received mirvetuximab soravtansine 5.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
    id
    OG005
    title
    Dose Escalation: Schedule A (Mirvetuximab Soravtansine 5.0 mg/kg Q3W)
  7. description
    Participants received mirvetuximab soravtansine 6.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
    id
    OG006
    title
    Dose Escalation: Schedule A (Mirvetuximab Soravtansine 6.0 mg/kg Q3W)
  8. description
    Participants received mirvetuximab soravtansine 7.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
    id
    OG007
    title
    Dose Escalation: Schedule A (Mirvetuximab Soravtansine 7.0 mg/kg Q3W)
  9. description
    Participants received mirvetuximab soravtansine 1.1 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
    id
    OG008
    title
    Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.1 mg/kg Weekly)
  10. description
    Participants received mirvetuximab soravtansine 1.8 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
    id
    OG009
    title
    Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.8 mg/kg Weekly)
  11. description
    Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
    id
    OG010
    title
    Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.0 mg/kg Weekly)
  12. description
    Participants received mirvetuximab soravtansine 2.5 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
    id
    OG011
    title
    Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.5 mg/kg Weekly)
param Type
COUNT_OF_PARTICIPANTS
population Description
CA-125 evaluable population included participants who had a baseline CA-125 value greater than or equal to (\>=) 2 \* upper limit of normal (ULN), received at least 1 dose of study drug, and had at least 1 post-dose CA-125 assessment.
reporting Status
POSTED
time Frame
From first dose of study drug until CA-125 response (maximum exposure: 36 weeks for dose-escalation Schedule A, 101.3 weeks for dose-escalation Schedule B, 124 weeks for dose-expansion EOC, 33.3 weeks for dose-expansion EC)
title
Number of Participants With Gynecologic Cancer Intergroup (GCIG) CA-125 Criteria Clinical Responses
type
SECONDARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice