Participant flow

A Phase 1 Study of Pegilodecakin (LY3500518) in Participants With Advanced Solid Tumors · Source last updated 2026-07-09

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

groups

1. description

   Participants received 0.08 or 0.1 mg of Pegilodecakin once daily (QD) administered subcutaneously (SC). Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.

   id

   FG000

   title

   Part A: Pegilodecakin 0.08/0.1 mg

2. description

   Participants received 0.2 or 0.25 mg of Pegilodecakin QD administered SC. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.

   id

   FG001

   title

   Part A: Pegilodecakin 0.2/0.25 mg

3. description

   Participants received 0.4 or 0.5 mg of Pegilodecakin QD administered SC. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.

   id

   FG002

   title

   Part A: Pegilodecakin 0.4/0.5 mg

4. description

   Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.

   id

   FG003

   title

   Part A: Pegilodecakin 0.8/1 mg

5. description

   Participants received 1.6 or 2 mg of Pegilodecakin QD administered SC Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.

   id

   FG004

   title

   Part A: Pegilodecakin 1.6/2 mg

6. description

   Participants received 3.2 or 4 mg of Pegilodecakin QD administered SC. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.

   id

   FG005

   title

   Part A: Pegilodecakin 3.2/4 mg

7. description

   Participants received 0.2 or 0.25 mg of Pegilodecakin QD administered SC along with Platinum/Taxane combination on Day 1 of each 21-day cycle for a maximum of 5 or 6 cycles. Participants received: Paclitaxel 200 or 175 mg/m² intravenously (IV) over 3 hours, or docetaxel 75 or 65 mg/m² IV over 1 hour, followed by carboplatin (AUC 6/5/4; max 6 × 150 mg) IV over 30 minutes or cisplatin 75 mg/m² IV over 6-8 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.

   id

   FG006

   title

   Part B: Pegilodecakin 0.2/0.25 mg + Platinum/Taxane

8. description

   Participants received 0.4 or 0.5 mg of Pegilodecakin QD administered SC along with Platinum/Taxane combination on Day 1 of each 21-day cycle for a maximum of 5 or 6 cycles. Participants received: Paclitaxel 200 or 175 mg/m² intravenously (IV) over 3 hours, or docetaxel 75 or 65 mg/m² IV over 1 hour, followed by carboplatin (AUC 6/5/4; max 6 × 150 mg) IV over 30 minutes or cisplatin 75 mg/m² IV over 6-8 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.

   id

   FG007

   title

   Part B: Pegilodecakin 0.4/0.5 mg + Platinum/Taxane

9. description

   Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC along with Platinum/Taxane combination on Day 1 of each 21-day cycle for a maximum of 5 or 6 cycles. Participants received: Paclitaxel 200 or 175 mg/m² intravenously (IV) over 3 hours, or docetaxel 75 or 65 mg/m² IV over 1 hour, followed by carboplatin (AUC 6/5/4; max 6 × 150 mg) IV over 30 minutes or cisplatin 75 mg/m² IV over 6-8 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.

   id

   FG008

   title

   Part B: Pegilodecakin 0.8/1 mg + Platinum/Taxane

10. description

    Participants received 0.2 or 0.25 mg of Pegilodecakin QD administered SC and FOLFOX treatment on Day 1 of each 14-day cycle for a maximum of 12 cycles. Participants received: oxaliplatin 85 mg/m2 IV over 2 hours, and leucovorin 200 mg/m2 IV over 2 hours, followed by 5-Fluorouracil (FU) 400 mg/m2 IV bolus over 2-4 minutes, 5-FU 600 mg/m2/day IV over 22 hours, and leucovorin 200 mg/m2 over 2 hours on Day 2 followed by 5-FU 400 mg/m2 IV bolus over 2-4 minutes, and 5-FU 600 mg/m2/day IV over 22 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.

    id

    FG009

    title

    Part C: Pegilodecakin 0.2/0.25 mg + FOLFOX

11. description

    Participants received 0.4 or 0.5 mg of Pegilodecakin QD administered SC and FOLFOX treatment on Day 1 of each 14-day cycle for a maximum of 12 cycles. Participants received: oxaliplatin 85 mg/m2 IV over 2 hours, and leucovorin 200 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus over 2-4 minutes, 5-FU 600 mg/m2/day IV over 22 hours, and leucovorin 200 mg/m2 over 2 hours on Day 2 followed by 5-FU 400 mg/m2 IV bolus over 2-4 minutes, and 5-FU 600 mg/m2/day IV over 22 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.

    id

    FG010

    title

    Part C: Pegilodecakin 0.4/0.5 mg + FOLFOX

12. description

    Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC and FOLFOX treatment on Day 1 of each 14-day cycle for a maximum of 12 cycles. Participants received: oxaliplatin 85 mg/m2 IV over 2 hours, and leucovorin 200 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus over 2-4 minutes, 5-FU 600 mg/m2/day IV over 22 hours, and leucovorin 200 mg/m2 over 2 hours on Day 2 followed by 5-FU 400 mg/m2 IV bolus over 2-4 minutes, and 5-FU 600 mg/m2/day IV over 22 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.

    id

    FG011

    title

    Part C: Pegilodecakin 0.8/1 mg + FOLFOX

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periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         5

      6. group Id

         FG005

         num Subjects

         0

      7. group Id

         FG006

         num Subjects

         0

      8. group Id

         FG007

         num Subjects

         0

      9. group Id

         FG008

         num Subjects

         0

      10. group Id

          FG009

          num Subjects

          0

      11. group Id

          FG010

          num Subjects

          1

      12. group Id

          FG011

          num Subjects

          0

      Show more (12 of 23)

      type

      Patient withdrew consent

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         5

      6. group Id

         FG005

         num Subjects

         0

      7. group Id

         FG006

         num Subjects

         0

      8. group Id

         FG007

         num Subjects

         0

      9. group Id

         FG008

         num Subjects

         2

      10. group Id

          FG009

          num Subjects

          0

      11. group Id

          FG010

          num Subjects

          1

      12. group Id

          FG011

          num Subjects

          0

      Show more (12 of 23)

      type

      Sponsor's decision

   3. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         0

      7. group Id

         FG006

         num Subjects

         0

      8. group Id

         FG007

         num Subjects

         0

      9. group Id

         FG008

         num Subjects

         0

      10. group Id

          FG009

          num Subjects

          0

      11. group Id

          FG010

          num Subjects

          0

      12. group Id

          FG011

          num Subjects

          0

      Show more (12 of 23)

      type

      Physician Decision

   4. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         0

      7. group Id

         FG006

         num Subjects

         0

      8. group Id

         FG007

         num Subjects

         0

      9. group Id

         FG008

         num Subjects

         0

      10. group Id

          FG009

          num Subjects

          0

      11. group Id

          FG010

          num Subjects

          0

      12. group Id

          FG011

          num Subjects

          0

      Show more (12 of 23)

      type

      Withdrawal by Subject

   5. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         1

      6. group Id

         FG005

         num Subjects

         0

      7. group Id

         FG006

         num Subjects

         0

      8. group Id

         FG007

         num Subjects

         0

      9. group Id

         FG008

         num Subjects

         2

      10. group Id

          FG009

          num Subjects

          0

      11. group Id

          FG010

          num Subjects

          0

      12. group Id

          FG011

          num Subjects

          0

      Show more (12 of 23)

      type

      Lost to Follow-up

   6. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         6

      3. group Id

         FG002

         num Subjects

         6

      4. group Id

         FG003

         num Subjects

         6

      5. group Id

         FG004

         num Subjects

         105

      6. group Id

         FG005

         num Subjects

         5

      7. group Id

         FG006

         num Subjects

         4

      8. group Id

         FG007

         num Subjects

         3

      9. group Id

         FG008

         num Subjects

         14

      10. group Id

          FG009

          num Subjects

          4

      11. group Id

          FG010

          num Subjects

          27

      12. group Id

          FG011

          num Subjects

          6

      Show more (12 of 23)

      type

      Death

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         6

      3. group Id

         FG002

         num Subjects

         6

      4. group Id

         FG003

         num Subjects

         6

      5. group Id

         FG004

         num Subjects

         117

      6. group Id

         FG005

         num Subjects

         5

      7. group Id

         FG006

         num Subjects

         4

      8. group Id

         FG007

         num Subjects

         3

      9. group Id

         FG008

         num Subjects

         18

      10. group Id

          FG009

          num Subjects

          4

      11. group Id

          FG010

          num Subjects

          29

      12. group Id

          FG011

          num Subjects

          6

      Show more (12 of 23)

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         6

      3. group Id

         FG002

         num Subjects

         6

      4. group Id

         FG003

         num Subjects

         6

      5. group Id

         FG004

         num Subjects

         117

      6. group Id

         FG005

         num Subjects

         5

      7. group Id

         FG006

         num Subjects

         4

      8. group Id

         FG007

         num Subjects

         3

      9. group Id

         FG008

         num Subjects

         18

      10. group Id

          FG009

          num Subjects

          4

      11. group Id

          FG010

          num Subjects

          29

      12. group Id

          FG011

          num Subjects

          6

      Show more (12 of 23)

      type

      Participants Who Received at Least One Dose of the Study Intervention.

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         1

      6. group Id

         FG005

         num Subjects

         0

      7. group Id

         FG006

         num Subjects

         0

      8. group Id

         FG007

         num Subjects

         0

      9. group Id

         FG008

         num Subjects

         0

      10. group Id

          FG009

          num Subjects

          0

      11. group Id

          FG010

          num Subjects

          0

      12. group Id

          FG011

          num Subjects

          0

      Show more (12 of 23)

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         6

      3. group Id

         FG002

         num Subjects

         6

      4. group Id

         FG003

         num Subjects

         6

      5. group Id

         FG004

         num Subjects

         116

      6. group Id

         FG005

         num Subjects

         5

      7. group Id

         FG006

         num Subjects

         4

      8. group Id

         FG007

         num Subjects

         3

      9. group Id

         FG008

         num Subjects

         18

      10. group Id

          FG009

          num Subjects

          4

      11. group Id

          FG010

          num Subjects

          29

      12. group Id

          FG011

          num Subjects

          6

      Show more (12 of 23)

      type

      NOT COMPLETED

   title

   Overall Study

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

Preserved source evidence · Not medical advice