Solid TumorsPhase 1/2aCCeleR8-001NCT05101070
S-531011 as Monotherapy and in Combination With an Immune Checkpoint Inhibitor in Advanced or Metastatic Solid Tumors
A Phase 1/2 study testing S-531011, Pembrolizumab and Bevacizumab in people with Solid Tumors, run by Shionogi at 8 sites in 2 countries.
Trial summary
The primary objective of Part A is to evaluate the safety and tolerability of S-531011 and to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of S-531011 with or without pembrolizumab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- S-531011, Pembrolizumab and Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 282 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 30 May 2022to 31 May 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Presence or history of autoimmune diseases or immune-mediated diseases that require chronic use of systemic corticosteroids (> 10 milligrams of prednisone equivalent per day), immunosuppressive agents, or disease-modifying agents.
- Presence or history of interstitial lung disease and (non-infectious) pneumonitis that required corticosteroids.
- Active clinically significant bacterial, viral or fungal infection, or any major episode of infection requiring hospitalization or treatment with parenteral anti-infectives within 4 weeks before the first dose of study intervention.
- Uncontrolled or clinically significant cardiovascular disease defined as New York Heart Association classification III or IV.
- A positive test for hepatitis B surface antigen and/or hepatitis C virus (HCV) antibody (participants with positive HCV antibody are eligible if a confirmatory HCV RNA test is undetectable).
- A positive serological test for human immunodeficiency virus infection.
Show all 30Show fewer
- Known history of any other relevant congenital or acquired immunodeficiency.
- Known history of an allogeneic tissue and/or solid organ transplant.
- Known history of severe allergy, hypersensitivity, anaphylaxis, or any serious adverse reaction to any component of study intervention or formulation components and/or any other monoclonal antibodies.
- Women who are pregnant or breastfeeding (or have discontinued breastfeeding) or trying to become pregnant.
- (Parts D and E only) Serious non-healing wound, non-healing ulcer, or non healing bone fracture.
- (Parts D and E only) Presence or history of severe arterial thromboembolic events (for example, cerebral infarction, transient ischemic attacks, myocardial infarction, and angina) within 6 months prior to the first dose of study intervention, and/or ≥ Grade 3 venous thromboembolic events (for example, deep vein thrombosis) within 3 months prior to the first dose of study intervention. Participants who receive a full-dose therapeutic anticoagulation should be excluded.
- (Parts D and E only) Known coagulopathy that increases risk of bleeding, bleeding diatheses, or any other hemorrhage/bleeding event of ≥ Grade 3 within 4 weeks prior to the first dose of study intervention.
- (Parts D and E only) Presence or history of any life-threatening vascular endothelial growth factor (VEGF)-related adverse event (AE).
- (Parts D and E only) Proteinuria ≥ 2+ by urine dipstick test within 4 weeks prior to the first dose of study intervention.
- Clinical evidence of uncontrolled brain metastasis.
- Clinically uncontrollable symptomatic pleural effusion and/or ascites. (Participants who do not require fluid drainage or have no significant increase of fluid for 28 days may be eligible with approval by the sponsor.)
- Known additional malignancy that is progressing or has required active treatment within the past 3 years.
- (Part B, C, D and E CRC cohorts only): Colorectal cancer with mismatch repair deficient/microsatellite instability-high status.
- (Parts A-2, C and E only): Has received prior therapy with an anti-programmed death 1, anti-programmed death ligand 1, or anti-programmed death ligand 2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (for example, cytotoxic T-lymphocyte-associated protein 4, OX-40, CD137), and was discontinued from that treatment due to ≥ Grade 3 immune-related adverse event.
- Prior treatment with systemic anticancer drugs (including any investigational medicinal products) within 28 days or 5 half-lives (whichever is shorter) before the first dose of study intervention.
- Prior major surgery within 28 days before the first dose of study intervention.
- Prior extended field radiotherapy within 28 days before the first dose of study intervention (within 14 days for limited field radiation for palliation) or history of radiation pneumonitis.
- Participants who have not recovered from any previous treatment toxicities to ≤ Grade 1 or baseline (except alopecia and peripheral neuropathy) before the first dose of study intervention.
- Prior treatment with anti-CCR8 antibody for any indication.
- Receipt of hematopoietic growth factors (for example, granulocyte-colony stimulating factor or erythropoietin) within 14 days before the first dose of study intervention or blood transfusions within 14 days before the first dose of study intervention.
- (Parts D and E only) Presence or history of allergic reactions or hypersensitivity to bevacizumab or any of its excipients.
- (Parts D and E only) Presence or history of hypersensitivity to Chinese Hamster Ovary cell products or other recombinant human or humanized antibodies.
- Receipt of a live, attenuated vaccine within 30 days before the first dose of study intervention.
- Note: Additional protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
8 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Shionogi Clinical Trials Administrator Clinical Support Help Line contact
8 sites in 2 countries
United States5 sites, 3 recruiting
- Active, not recruiting
Henry Ford Health Center
Detroit, Michigan, 48202
- Recruiting
University of Florida Health
Gainesville, Florida, 32610
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
- Active, not recruiting
Angeles Clinic and Research Center
Los Angeles, California, 90025
- Recruiting
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Japan3 sites, 3 recruiting
- Recruiting
National Cancer Center Hospital
Chuo Ku, Tokyo
- Recruiting
National Cancer Center Hospital East
Kashiwa, Chiba
- Recruiting
The University of Osaka Hospital
Suita, Osaka
About this study
Official title: A Phase 1b/2, Multicenter, Open-label Study of S-531011 as Monotherapy and in Combination With an Immune Checkpoint Inhibitor in Participants With Locally Advanced or Metastatic Solid Tumors
The primary objective of Part A is to evaluate the safety and tolerability of S-531011 and to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of S-531011 with or without pembrolizumab.
The primary objective of Parts B and C is to evaluate the antitumor activity of S-531011 at the RP2D with or without pembrolizumab.
The primary objective of Parts D and E is to evaluate the antitumor activity of S-531011 at the RP2D in combination with bevacizumab with our without pembrolizumab.
- Conditions
- Solid Tumors
- Being tested
- S-531011, Pembrolizumab, Bevacizumab
- Keywords
- C-C motif chemokine receptor 8 (CCR8)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-531011Drug
Administered by intravenous infusion
PembrolizumabDrug
Also called KEYTRUDA
Administered by intravenous infusion
BevacizumabDrug
Also called Avastin
Administered by intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Part A-1: S-531011 Monotherapy | Experimental | Participants will receive escalating doses of S-531011 by intravenous infusion for up to approximately 12 months. Receives: Drug: S-531011 |
| Part A-2: S-531011 + Pembrolizumab | Experimental | Participants will receive escalating doses of S-531011 in combination with pembrolizumab by intravenous infusion for up to approximately 24 months. Receives: Drug: S-531011; Drug: Pembrolizumab |
| Part B: S-531011 Monotherapy | Experimental | Participants will receive S-531011 at the RP2D by intravenous infusion for up to approximately 12 months. Receives: Drug: S-531011 |
| Part C: S-531011 + Pembrolizumab | Experimental | Participants will receive S-531011 at the RP2D in combination with pembrolizumab by intravenous infusion for up to approximately 24 months. Receives: Drug: S-531011; Drug: Pembrolizumab |
| Part D: S-531011 + Bevacizumab | Experimental | Participants will receive S-531011 at the RP2D in combination with bevacizumab or bevacizumab biosimilar by intravenous infusion for up to approximately 24 months. Receives: Drug: S-531011; Drug: Bevacizumab |
| Part E: S-531011 + Bevacizumab + Pembrolizumab | Experimental | Participants will receive S-531011 at the RP2D in combination with bevacizumab or bevacizumab biosimilar and pembrolizumab by intravenous infusion for up to approximately 24 months. Receives: Drug: S-531011; Drug: Pembrolizumab; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Measured: Approximately 12 months (Part A-1); Approximately 24 months (Part A-2)
Parts B, C, D, E: Objective Response Rate
Measured: Every 6 weeks for the first 24 weeks and every 9 weeks thereafter, until disease progression (Approximately 12 months [Part B]; Approximately 24 months [Parts C, D, E])
Parts B, C, D, E: Duration of Response
Measured: Every 6 weeks for the first 24 weeks and every 9 weeks thereafter, until disease progression (Approximately 12 months [Part B]; Approximately 24 months [Parts C, D, E])
Parts B, C, D, E: Disease Control Rate
Measured: Every 6 weeks for the first 24 weeks and every 9 weeks thereafter, until disease progression (Approximately 12 months [Part B]; Approximately 24 months [Parts C, D, E])
Parts B, C, D, E: Time to Response
Measured: Every 6 weeks for the first 24 weeks and every 9 weeks thereafter, until disease progression (Approximately 12 months [Part B]; Approximately 24 months [Parts C, D, E])
Parts B, C, D, E: Progression-free Survival
Measured: Every 6 weeks for the first 24 weeks and every 9 weeks thereafter, until disease progression (Approximately 12 months [Part B]; Approximately 24 months [Parts C, D, E])
Parts B, C, D, E: Overall Survival
Measured: Every 6 weeks for the first 24 weeks and every 9 weeks thereafter, until disease progression (Approximately 12 months [Part B]; Approximately 24 months [Parts C, D, E])
Secondary outcomes (19)
Part A: Objective Response Rate
Measured: Every 6 weeks for the first 24 weeks and every 9 weeks thereafter, until disease progression (Approximately 12 months [Part A-1]; Approximately 24 months [Part A-2])
Part A: Duration of Response
Measured: Every 6 weeks for the first 24 weeks and every 9 weeks thereafter, until disease progression (Approximately 12 months [Part A-1]; Approximately 24 months [Part A-2])
Part A: Disease Control Rate
Measured: Every 6 weeks for the first 24 weeks and every 9 weeks thereafter, until disease progression (Approximately 12 months [Part A-1]; Approximately 24 months [Part A-2])
Part A: Time to Response
Measured: Every 6 weeks for the first 24 weeks and every 9 weeks thereafter, until disease progression (Approximately 12 months [Part A-1]; Approximately 24 months [Part A-2])
Part A: Progression-free Survival
Measured: Every 6 weeks for the first 24 weeks and every 9 weeks thereafter, until disease progression (Approximately 12 months [Part A-1]; Approximately 24 months [Part A-2])
All Parts: Serum concentrations of S-531011
Measured: Part A: Cycle 1, Days 8 and 15 (4 hours post infusion); Cycles 2-9, Day 1 (pre- and end-of-infusion); Safety Follow-up Visit. Parts B, C, D, E: Day 1 of Cycles 1-9 (pre- and end-of-infusion); Safety Follow-up Visit. (each cycle is 21 days)
Part A: Maximum Serum Concentration (Cmax) of S-531011
Measured: Cycle 1, Day 1: pre-infusion, end-of-infusion, and 1 and 3 hours after the end-of S-531011 infusion, and 24, 48, 72 hours after the start of S-531011 infusion (each cycle is 21 days)
Part A: Time to Maximum Serum Concentration (Tmax) of S-531011
Measured: Cycle 1, Day 1: pre-infusion, end-of-infusion, and 1 and 3 hours after the end-of S-531011 infusion, and 24, 48, 72 hours after the start of S-531011 infusion (each cycle is 21 days)
Part A: Area Under the Concentration-time Curve from Time Zero to the Time of Last Quantifiable Concentration After Dosing (AUC0-last) of S-531011
Measured: Cycle 1, Day 1: pre-infusion, end-of-infusion, and 1 and 3 hours after the end-of S-531011 infusion, and 24, 48, 72 hours after the start of S-531011 infusion (each cycle is 21 days)
Part A: Area Under the Concentration-time Curve Extrapolated from Time Zero to Infinity (AUC0-inf) of S-531011
Measured: Cycle 1, Day 1: pre-infusion, end-of-infusion, and 1 and 3 hours after the end-of S-531011 infusion, and 24, 48, 72 hours after the start of S-531011 infusion (each cycle is 21 days)
Part A: Terminal elimination rate constant (λz) of S-531011
Measured: Cycle 1, Day 1: pre-infusion, end-of-infusion, and 1 and 3 hours after the end-of S-531011 infusion, and 24, 48, 72 hours after the start of S-531011 infusion (each cycle is 21 days)
Part A: Terminal Elimination Half-life (t1/2,z) of S-531011
Measured: Cycle 1, Day 1: pre-infusion, end-of-infusion, and 1 and 3 hours after the end-of S-531011 infusion, and 24, 48, 72 hours after the start of S-531011 infusion (each cycle is 21 days)
Part A: Total Clearance (CL) of S-531011
Measured: Cycle 1, Day 1: pre-infusion, end-of-infusion, and 1 and 3 hours after the end-of S-531011 infusion, and 24, 48, 72 hours after the start of S-531011 infusion (each cycle is 21 days)
Part A: Volume of Distribution at Steady State (Vss) of S-531011
Measured: Cycle 1, Day 1: pre-infusion, end-of-infusion, and 1 and 3 hours after the end-of S-531011 infusion, and 24, 48, 72 hours after the start of S-531011 infusion (each cycle is 21 days)
Part A: Mean Residence Time (MRT) of S-531011
Measured: Cycle 1, Day 1: pre-infusion, end-of-infusion, and 1 and 3 hours after the end-of S-531011 infusion, and 24, 48, 72 hours after the start of S-531011 infusion (each cycle is 21 days)
All Parts: Anti-S-531011 Antibody (ADA) Titer Level
Measured: Day 1 of Cycles 1 to 9 (each cycle is 21 days)
All Parts: Anti-S-531011 Antibody (ADA) Titer Level
Neutralization assays will be performed only for the samples that are confirmed to have ADA.
Measured: Day 1 of Cycles 1 to 9 (each cycle is 21 days)
All Parts: Changes in serum tumor markers from pretreatment to on-treatment
Measured: Baseline and Day 1 of each treatment cycle (each cycle is 21 days)
Parts B, C, D, E: Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Measured: Approximately 12 months (Part B); Approximately 24 months (Parts C, D, E)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2021
- Study start30 May 2022
- Primary completion31 May 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- More trials run by ShionogiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 282 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shionogi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Shionogi Clinical Trials Administrator Clinical Support Help Line, Study director, Shionogi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05101070
- Sponsor's protocol ID
- 2023P2411
- Other IDs
- KEYNOTE-D85, MK-3475-D85
- Acronym
- aCCeleR8-001
- Status last verified
- Mar 2026
- First submitted
- 14 Oct 2021
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b/2, Multicenter, Open-label Study of S-531011 as Monotherapy and in Combination With an Immune Checkpoint Inhibitor in Participants With Locally Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT05101070
- Acronym / sponsor ID
- aCCeleR8-001 / 2023P2411
- Conditions
- Solid Tumors
- Keywords
- C-C motif chemokine receptor 8 (CCR8)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 282 participants (estimated)
- Lead sponsor
- ShionogiIndustry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 30 May 2022 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 1 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of Part A is to evaluate the safety and tolerability of S-531011 and to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of S-531011 with or without pembrolizumab.
The primary objective of Parts B and C is to evaluate the antitumor activity of S-531011 at the RP2D with or without pembrolizumab.
The primary objective of Parts D and E is to evaluate the antitumor activity of S-531011 at the RP2D in combination with bevacizumab with our without pembrolizumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Part A-1: S-531011 Monotherapy | Experimental | Drug: S-531011Participants will receive escalating doses of S-531011 by intravenous infusion for up to approximately 12 months. |
| Part A-2: S-531011 + Pembrolizumab | Experimental | Drug: S-531011, Drug: PembrolizumabParticipants will receive escalating doses of S-531011 in combination with pembrolizumab by intravenous infusion for up to approximately 24 months. |
| Part B: S-531011 Monotherapy | Experimental | Drug: S-531011Participants will receive S-531011 at the RP2D by intravenous infusion for up to approximately 12 months. |
| Part C: S-531011 + Pembrolizumab | Experimental | Drug: S-531011, Drug: PembrolizumabParticipants will receive S-531011 at the RP2D in combination with pembrolizumab by intravenous infusion for up to approximately 24 months. |
| Part D: S-531011 + Bevacizumab | Experimental | Drug: S-531011, Drug: BevacizumabParticipants will receive S-531011 at the RP2D in combination with bevacizumab or bevacizumab biosimilar by intravenous infusion for up to approximately 24 months. |
| Part E: S-531011 + Bevacizumab + Pembrolizumab | Experimental | Drug: S-531011, Drug: Pembrolizumab, Drug: BevacizumabParticipants will receive S-531011 at the RP2D in combination with bevacizumab or bevacizumab biosimilar and pembrolizumab by intravenous infusion for up to approximately 24 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (30 listed)
- Presence or history of autoimmune diseases or immune-mediated diseases that require chronic use of systemic corticosteroids (> 10 milligrams of prednisone equivalent per day), immunosuppressive agents, or disease-modifying agents.
- Presence or history of interstitial lung disease and (non-infectious) pneumonitis that required corticosteroids.
- Active clinically significant bacterial, viral or fungal infection, or any major episode of infection requiring hospitalization or treatment with parenteral anti-infectives within 4 weeks before the first dose of study intervention.
- Uncontrolled or clinically significant cardiovascular disease defined as New York Heart Association classification III or IV.
- A positive test for hepatitis B surface antigen and/or hepatitis C virus (HCV) antibody (participants with positive HCV antibody are eligible if a confirmatory HCV RNA test is undetectable).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S-531011Administered by intravenous infusion | Drug | Part A-1: S-531011 Monotherapy, Part A-2: S-531011 + Pembrolizumab, Part B: S-531011 Monotherapy, Part C: S-531011 + Pembrolizumab, Part D: S-531011 + Bevacizumab, Part E: S-531011 + Bevacizumab + Pembrolizumab |
| PembrolizumabAlso: KEYTRUDAAdministered by intravenous infusion | Drug | Part A-2: S-531011 + Pembrolizumab, Part C: S-531011 + Pembrolizumab, Part E: S-531011 + Bevacizumab + Pembrolizumab |
| BevacizumabAlso: AvastinAdministered by intravenous infusion | Drug | Part D: S-531011 + Bevacizumab, Part E: S-531011 + Bevacizumab + Pembrolizumab |
Primary outcome
Part A: Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: Approximately 12 months (Part A-1); Approximately 24 months (Part A-2)
Parts B, C, D, E: Objective Response Rate
Time frame: Every 6 weeks for the first 24 weeks and every 9 weeks thereafter, until disease progression (Approximately 12 months [Part B]; Approximately 24 months [Parts C, D, E])
Parts B, C, D, E: Duration of Response
Time frame: Every 6 weeks for the first 24 weeks and every 9 weeks thereafter, until disease progression (Approximately 12 months [Part B]; Approximately 24 months [Parts C, D, E])
Parts B, C, D, E: Disease Control Rate
Time frame: Every 6 weeks for the first 24 weeks and every 9 weeks thereafter, until disease progression (Approximately 12 months [Part B]; Approximately 24 months [Parts C, D, E])
Parts B, C, D, E: Time to Response
Time frame: Every 6 weeks for the first 24 weeks and every 9 weeks thereafter, until disease progression (Approximately 12 months [Part B]; Approximately 24 months [Parts C, D, E])
Parts B, C, D, E: Progression-free Survival
Time frame: Every 6 weeks for the first 24 weeks and every 9 weeks thereafter, until disease progression (Approximately 12 months [Part B]; Approximately 24 months [Parts C, D, E])
Parts B, C, D, E: Overall Survival
Time frame: Every 6 weeks for the first 24 weeks and every 9 weeks thereafter, until disease progression (Approximately 12 months [Part B]; Approximately 24 months [Parts C, D, E])
19 secondary outcomes
Part A: Objective Response Rate
Time frame: Every 6 weeks for the first 24 weeks and every 9 weeks thereafter, until disease progression (Approximately 12 months [Part A-1]; Approximately 24 months [Part A-2])
Part A: Duration of Response
Time frame: Every 6 weeks for the first 24 weeks and every 9 weeks thereafter, until disease progression (Approximately 12 months [Part A-1]; Approximately 24 months [Part A-2])
Part A: Disease Control Rate
Time frame: Every 6 weeks for the first 24 weeks and every 9 weeks thereafter, until disease progression (Approximately 12 months [Part A-1]; Approximately 24 months [Part A-2])
Part A: Time to Response
Time frame: Every 6 weeks for the first 24 weeks and every 9 weeks thereafter, until disease progression (Approximately 12 months [Part A-1]; Approximately 24 months [Part A-2])
Part A: Progression-free Survival
Time frame: Every 6 weeks for the first 24 weeks and every 9 weeks thereafter, until disease progression (Approximately 12 months [Part A-1]; Approximately 24 months [Part A-2])
All Parts: Serum concentrations of S-531011
Time frame: Part A: Cycle 1, Days 8 and 15 (4 hours post infusion); Cycles 2-9, Day 1 (pre- and end-of-infusion); Safety Follow-up Visit. Parts B, C, D, E: Day 1 of Cycles 1-9 (pre- and end-of-infusion); Safety Follow-up Visit. (each cycle is 21 days)
Part A: Maximum Serum Concentration (Cmax) of S-531011
Time frame: Cycle 1, Day 1: pre-infusion, end-of-infusion, and 1 and 3 hours after the end-of S-531011 infusion, and 24, 48, 72 hours after the start of S-531011 infusion (each cycle is 21 days)
Part A: Time to Maximum Serum Concentration (Tmax) of S-531011
Time frame: Cycle 1, Day 1: pre-infusion, end-of-infusion, and 1 and 3 hours after the end-of S-531011 infusion, and 24, 48, 72 hours after the start of S-531011 infusion (each cycle is 21 days)
Part A: Area Under the Concentration-time Curve from Time Zero to the Time of Last Quantifiable Concentration After Dosing (AUC0-last) of S-531011
Time frame: Cycle 1, Day 1: pre-infusion, end-of-infusion, and 1 and 3 hours after the end-of S-531011 infusion, and 24, 48, 72 hours after the start of S-531011 infusion (each cycle is 21 days)
Part A: Area Under the Concentration-time Curve Extrapolated from Time Zero to Infinity (AUC0-inf) of S-531011
Time frame: Cycle 1, Day 1: pre-infusion, end-of-infusion, and 1 and 3 hours after the end-of S-531011 infusion, and 24, 48, 72 hours after the start of S-531011 infusion (each cycle is 21 days)
Part A: Terminal elimination rate constant (λz) of S-531011
Time frame: Cycle 1, Day 1: pre-infusion, end-of-infusion, and 1 and 3 hours after the end-of S-531011 infusion, and 24, 48, 72 hours after the start of S-531011 infusion (each cycle is 21 days)
Part A: Terminal Elimination Half-life (t1/2,z) of S-531011
Time frame: Cycle 1, Day 1: pre-infusion, end-of-infusion, and 1 and 3 hours after the end-of S-531011 infusion, and 24, 48, 72 hours after the start of S-531011 infusion (each cycle is 21 days)
Part A: Total Clearance (CL) of S-531011
Time frame: Cycle 1, Day 1: pre-infusion, end-of-infusion, and 1 and 3 hours after the end-of S-531011 infusion, and 24, 48, 72 hours after the start of S-531011 infusion (each cycle is 21 days)
Part A: Volume of Distribution at Steady State (Vss) of S-531011
Time frame: Cycle 1, Day 1: pre-infusion, end-of-infusion, and 1 and 3 hours after the end-of S-531011 infusion, and 24, 48, 72 hours after the start of S-531011 infusion (each cycle is 21 days)
Part A: Mean Residence Time (MRT) of S-531011
Time frame: Cycle 1, Day 1: pre-infusion, end-of-infusion, and 1 and 3 hours after the end-of S-531011 infusion, and 24, 48, 72 hours after the start of S-531011 infusion (each cycle is 21 days)
All Parts: Anti-S-531011 Antibody (ADA) Titer Level
Time frame: Day 1 of Cycles 1 to 9 (each cycle is 21 days)
All Parts: Anti-S-531011 Antibody (ADA) Titer Level
Time frame: Day 1 of Cycles 1 to 9 (each cycle is 21 days)
All Parts: Changes in serum tumor markers from pretreatment to on-treatment
Time frame: Baseline and Day 1 of each treatment cycle (each cycle is 21 days)
Parts B, C, D, E: Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: Approximately 12 months (Part B); Approximately 24 months (Parts C, D, E)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: No
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Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shionogi Clinical Trials Administrator Clinical Support Help Line contact
Shionogi Clinical Trials Administrator Clinical Support Help Line study director
Shionogi
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing S-531011, Pembrolizumab and Bevacizumab in people with Solid Tumors, run by Shionogi at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shionogi Clinical Trials Administrator Clinical Support Help Line (800-849-9707, Shionogiclintrials-admin@shionogi.co.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part A: Number of Participants with Treatment-emergent Adverse Events (TEAEs) (time frame: Approximately 12 months (Part A-1); Approximately 24 months (Part A-2)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.