NCT04579757 · OUTCOME
Dose Escalation and Dose Expansion Phases: Number of Patients With Antidrug Antibodies (ADA) to Tislelizumab
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 | Source count |
|---|---|
| Dose Escalation Phase: Surufatinib 250 mg + Tislelizumab | 6 |
| Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab | 5 |
| Dose Expansion Phase: Cohort A: CRC | 14 |
| Dose Expansion Phase: Cohort B1: Thoracic NETs | 8 |
| Dose Expansion Phase: Cohort B2: GEP NETs | 16 |
| Dose Expansion Phase: Cohort C: SCLC | 13 |
| Dose Expansion Phase: Cohort D: GC | 2 |
| Dose Expansion Phase: Cohort E2: UPS | 9 |
| Dose Expansion Phase: Cohort F: ATC | 2 |
Reported measurements
Treatment-Boosted ADA
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Phase: Surufatinib 250 mg + Tislelizumab | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Phase: Cohort A: CRC | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Phase: Cohort B1: Thoracic NETs | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Phase: Cohort B2: GEP NETs | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Phase: Cohort C: SCLC | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Phase: Cohort D: GC | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Phase: Cohort E2: UPS | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Phase: Cohort F: ATC | 0 | Not reported | Not reported | Not reported | Not reported |
Treatment-Induced ADA
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Phase: Surufatinib 250 mg + Tislelizumab | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Phase: Cohort A: CRC | 5 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Phase: Cohort B1: Thoracic NETs | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Phase: Cohort B2: GEP NETs | 5 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Phase: Cohort C: SCLC | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Phase: Cohort D: GC | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Phase: Cohort E2: UPS | 5 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Phase: Cohort F: ATC | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- calculate Pct
- false
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- title
- Treatment-Boosted ADA
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 5
- group Id
- OG008
- value
- 1
- title
- Treatment-Induced ADA
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 14
- group Id
- OG003
- value
- 8
- group Id
- OG004
- value
- 16
- group Id
- OG005
- value
- 13
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
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Preserved source evidence · Not medical advice
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