Skip to content
← Full study record

NCT04579757 · OUTCOME

Dose Escalation and Dose Expansion Phases: Number of Patients With Antidrug Antibodies (ADA) to Tislelizumab

Surufatinib in Combination With Tislelizumab in Subjects With Advanced Solid Tumors · Source last updated 2025-05-08

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 the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 9 months for dose escalation phase and approximately 33 months for dose expansion phase

What was measured

Blood samples were collected at the specified timepoints to detect ADAs to tislelizumab. Treatment-boosted ADA was defined as ADA positive at baseline that was boosted to a 4-fold or higher-level following treatment administration. Treatment-induced ADA was defined as ADA negative at baseline and ADA positive post-baseline.

Analysis population: The ADA analysis set included all patients who received at least 1 dose of tislelizumab and had a baseline and at least 1 post-baseline ADA result.

Groups in this outcome

Dose Escalation Phase: Surufatinib 250 mg + Tislelizumab

Patients with advanced or metastatic solid tumors of any kind who had progressed on or were intolerant of standard therapies received surufatinib 250 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.

Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab

Patients with advanced or metastatic solid tumors of any kind who had progressed on or were intolerant of standard therapies received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.

Dose Expansion Phase: Cohort A: CRC

Patients with microsatellite stable, locally advanced or metastatic CRC that was previously treated with at least 3 prior lines of therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.

Dose Expansion Phase: Cohort B1: Thoracic NETs

Patients with thoracic NET who had progressive, locally advanced or metastatic, low-to-intermediate grade (Grade 1 or Grade 2), well-differentiated NETs that progressed on at least 1 line of standard therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.

Dose Expansion Phase: Cohort B2: GEP NETs

Patients with GEP NET who had progressive, locally advanced or metastatic, low-to-intermediate grade (Grade 1 or Grade 2), well-differentiated NETs that progressed on at least 1 line of standard therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.

Dose Expansion Phase: Cohort C: SCLC

Patients with locally advanced or metastatic SCLC that was previously progressed on first-line chemotherapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.

Dose Expansion Phase: Cohort D: GC

Patients with microsatellite stable, PD-L1 ≥5%, locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction (GC) and were previously treated with at least 2 lines of standard therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.

Dose Expansion Phase: Cohort E2: UPS

Patients with UPS who progressed on, or had discontinued due to intolerable toxicity to, at least 1 line of standard therapy or were unsuitable for standard frontline cytotoxic chemotherapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.

Dose Expansion Phase: Cohort F: ATC

Patients with locally advanced or metastatic ATC and who had a BRAFV600E mutation were previously treated with 1 line of systemic therapy (not including radiation therapy) with a BRAF-targeted therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.

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 Phase: Surufatinib 250 mg + Tislelizumab6
Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab5
Dose Expansion Phase: Cohort A: CRC14
Dose Expansion Phase: Cohort B1: Thoracic NETs8
Dose Expansion Phase: Cohort B2: GEP NETs16
Dose Expansion Phase: Cohort C: SCLC13
Dose Expansion Phase: Cohort D: GC2
Dose Expansion Phase: Cohort E2: UPS9
Dose Expansion Phase: Cohort F: ATC2

Reported measurements

Treatment-Boosted ADA
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Escalation Phase: Surufatinib 250 mg + Tislelizumab0Not reportedNot reportedNot reportedNot reported
Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab0Not reportedNot reportedNot reportedNot reported
Dose Expansion Phase: Cohort A: CRC2Not reportedNot reportedNot reportedNot reported
Dose Expansion Phase: Cohort B1: Thoracic NETs0Not reportedNot reportedNot reportedNot reported
Dose Expansion Phase: Cohort B2: GEP NETs0Not reportedNot reportedNot reportedNot reported
Dose Expansion Phase: Cohort C: SCLC0Not reportedNot reportedNot reportedNot reported
Dose Expansion Phase: Cohort D: GC0Not reportedNot reportedNot reportedNot reported
Dose Expansion Phase: Cohort E2: UPS0Not reportedNot reportedNot reportedNot reported
Dose Expansion Phase: Cohort F: ATC0Not reportedNot reportedNot reportedNot reported
Treatment-Induced ADA
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Escalation Phase: Surufatinib 250 mg + Tislelizumab2Not reportedNot reportedNot reportedNot reported
Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab2Not reportedNot reportedNot reportedNot reported
Dose Expansion Phase: Cohort A: CRC5Not reportedNot reportedNot reportedNot reported
Dose Expansion Phase: Cohort B1: Thoracic NETs3Not reportedNot reportedNot reportedNot reported
Dose Expansion Phase: Cohort B2: GEP NETs5Not reportedNot reportedNot reportedNot reported
Dose Expansion Phase: Cohort C: SCLC1Not reportedNot reportedNot reportedNot reported
Dose Expansion Phase: Cohort D: GC0Not reportedNot reportedNot reportedNot reported
Dose Expansion Phase: Cohort E2: UPS5Not reportedNot reportedNot reportedNot reported
Dose Expansion Phase: Cohort F: ATC1Not reportedNot reportedNot reportedNot reported
Complete source fields
calculate Pct
false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        0
    title
    Treatment-Boosted ADA
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        5
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        5
      6. group Id
        OG005
        value
        1
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        5
      9. group Id
        OG008
        value
        1
    title
    Treatment-Induced ADA
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      5
    3. group Id
      OG002
      value
      14
    4. group Id
      OG003
      value
      8
    5. group Id
      OG004
      value
      16
    6. group Id
      OG005
      value
      13
    7. group Id
      OG006
      value
      2
    8. group Id
      OG007
      value
      9
    9. group Id
      OG008
      value
      2
    units
    Participants
description
Blood samples were collected at the specified timepoints to detect ADAs to tislelizumab. Treatment-boosted ADA was defined as ADA positive at baseline that was boosted to a 4-fold or higher-level following treatment administration. Treatment-induced ADA was defined as ADA negative at baseline and ADA positive post-baseline.
groups
  1. description
    Patients with advanced or metastatic solid tumors of any kind who had progressed on or were intolerant of standard therapies received surufatinib 250 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
    id
    OG000
    title
    Dose Escalation Phase: Surufatinib 250 mg + Tislelizumab
  2. description
    Patients with advanced or metastatic solid tumors of any kind who had progressed on or were intolerant of standard therapies received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
    id
    OG001
    title
    Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab
  3. description
    Patients with microsatellite stable, locally advanced or metastatic CRC that was previously treated with at least 3 prior lines of therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
    id
    OG002
    title
    Dose Expansion Phase: Cohort A: CRC
  4. description
    Patients with thoracic NET who had progressive, locally advanced or metastatic, low-to-intermediate grade (Grade 1 or Grade 2), well-differentiated NETs that progressed on at least 1 line of standard therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
    id
    OG003
    title
    Dose Expansion Phase: Cohort B1: Thoracic NETs
  5. description
    Patients with GEP NET who had progressive, locally advanced or metastatic, low-to-intermediate grade (Grade 1 or Grade 2), well-differentiated NETs that progressed on at least 1 line of standard therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
    id
    OG004
    title
    Dose Expansion Phase: Cohort B2: GEP NETs
  6. description
    Patients with locally advanced or metastatic SCLC that was previously progressed on first-line chemotherapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
    id
    OG005
    title
    Dose Expansion Phase: Cohort C: SCLC
  7. description
    Patients with microsatellite stable, PD-L1 ≥5%, locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction (GC) and were previously treated with at least 2 lines of standard therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
    id
    OG006
    title
    Dose Expansion Phase: Cohort D: GC
  8. description
    Patients with UPS who progressed on, or had discontinued due to intolerable toxicity to, at least 1 line of standard therapy or were unsuitable for standard frontline cytotoxic chemotherapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
    id
    OG007
    title
    Dose Expansion Phase: Cohort E2: UPS
  9. description
    Patients with locally advanced or metastatic ATC and who had a BRAFV600E mutation were previously treated with 1 line of systemic therapy (not including radiation therapy) with a BRAF-targeted therapy received surufatinib 300 mg orally QD in combination with tislelizumab 200 mg IV infusion Q3W until PD, unacceptable toxicity, withdrawal of consent, new anticancer therapy, lost to follow-up, or death.
    id
    OG008
    title
    Dose Expansion Phase: Cohort F: ATC
param Type
COUNT_OF_PARTICIPANTS
population Description
The ADA analysis set included all patients who received at least 1 dose of tislelizumab and had a baseline and at least 1 post-baseline ADA result.
reporting Status
POSTED
time Frame
From the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 9 months for dose escalation phase and approximately 33 months for dose expansion phase
title
Dose Escalation and Dose Expansion Phases: Number of Patients With Antidrug Antibodies (ADA) to Tislelizumab
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice