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Study of SO-C101 and SO-C101 in Combination With Pembro in Adult Patients With Advanced/Metastatic Solid Tumors

Primary Purpose

Thyroid, Renal Cell Carcinoma, Non Small Cell Lung Cancer

Status

Active

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

SO-C101

pembrolizumab

About this trial

This is an interventional treatment trial for Thyroid focused on measuring thyroid cancer, Renal Cell Carcinoma, Non Small Cell Lung Cancer, Small-cell Lung Cancer, Bladder Cancer, Melanoma, Merkel Cell Carcinoma, Skin Squamous Cell Carcinoma, Microsatellite Instability High, Triple Negative Breast Cancer, Mesothelioma, Thymic Cancer, Cervical Cancer, Biliary Tract Cancer, Hepatocellular Carcinoma, Ovarian Cancer, Gastric Cancer, Head and Neck Squamous Cell Carcinoma, Anal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with selected histologically or cytologically confirmed advanced and/or metastatic solid tumors who are refractory to or intolerant of existing therapies known to provide clinical benefit for their condition.
ECOG performance score 0-1. Patients with ECOG is 2 to be discussed with the sponsor's medical monitor to be agreed for inclusion.
Estimated life expectancy of ≥3 months
Washout periods: 4 weeks for chemotherapy, 4 weeks or 5 half-lives (whichever shorter) for biologic agents including immuno-oncology therapy and 4 weeks from major surgeries, definitive radiotherapy and 2 weeks after palliative radiotherapy
At least one measurable lesion per iRECIST in a non-irradiated port. If in a previously irradiated port, must have demonstrated progression since best response to radiation therapy.
Have fully recovered from previous treatment to grade ≤1 toxicity (excluding alopecia) or have stable grade 2 neuropathy
Adequate organ system function
Negative serum pregnancy test, if woman of child-bearing potential (WOCBP; non-childbearing is defined as greater than one year postmenopausal or surgically sterilized).
Accessible tumor tissue available for fresh biopsy

Exclusion Criteria:

Key exclusion criteria (Part A and B)
- Patient with untreated CNS metastases and/or leptomeningeal carcinomatosis (see list of all exclusion criteria for details)
- Known additional malignancy that is progressing and/or requires active treatment.
- Prior exposure to drugs that are agonists of IL-2- or IL-15-like but not limited to rhIL-15 (NCI), ALT-803 (ALTOR), NKTR-214 (Nektar)
- History of and current interstitial lung disease or fibrosis and pneumonitis; patients with clinically significant or oxygen requiring COPD or any chronic inflammatory disease (sarcoidosis etc.)
- Has received a live vaccine within 30 days of planned start of study therapy (see list of all exclusion criteria for details)
- Absolute WBC count ≤ 2.0 ×109/L;
- ALC ≤0.5×109/L
- Absolute neutrophil count ≤1.0 ×109/L
- Platelet count ≤100×109/L
- Pregnant or breastfeeding women
- Any active autoimmune disease or a documented history of autoimmune disease, poorly controlled asthma, or history of syndrome that required systemic steroids (except the allowed doses) or immunosuppressive medications, except for patients with vitiligo or resolved childhood asthma/atopy (see list of all exclusion criteria for details)
- Specific co-morbidities (see list of all exclusion criteria for details)
- Is hypersensitive to any of the ingredients of pembrolizumab drug product (KeytrudaTM)
- History of solid organ transplantation or hematopoietic stem cell transplantation

Sites / Locations

Yale Cancer Center
University of Pittsburgh
MD Anderson Cancer Center
Masarykův Onkologický Ústav Brno Klinika komplexní onkologické péče
Centre Léon Bérard
Hôpitaux Universitaires de Marseille Timone
Hopital Saint Louis
Institut Gustave Roussy
Institut de Cancerologie de L'Ouest
Institut Claudius Regaud
Vall d'Hebron Institute of Oncology
University Hospital Sanchinarro

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Arm Label

Experimental: Part A (SO-C101 Monotherapy)

Experimental: Part B (SO-C101 combined with pembrolizumab)

Experimental: Part A1 (SO-C101 divided dosing, Monotherapy)

Experimental: Part B1 (SO-C101 divided dosing, combined with pembrolizumab)

Experimental: Part D (SO-C101 Monotherapy, dose expansion at the RP2D identified in Part A)

Part D1 (SO-C101 divided dosing, Monotherapy, dose expansion at RP2D identified in Part A1)

Arm Description

Drug: SO-C101

Drug: SO-C101 Drug: pembrolizumab

Drug: SO-C101, twice a day as 2 divided doses (50%:50%)

Drug: SO-C101, twice a day as 2 divided doses (50%:50%) Drug: pembrolizumab

Drug: SO-C101 Indications: Relapsed/refractory advanced/metastatic renal cell carcinoma, relapsed/refractory advanced/metastatic skin squamous-cell carcinoma, and relapsed/refractory advanced/metastatic melanoma.

Drug: SO-C101, twice a day as 2 divided doses (50%:50%) Indications: Relapsed/refractory advanced/metastatic renal cell carcinoma, relapsed/refractory advanced/metastatic skin squamous-cell carcinoma, and relapsed/refractory advanced/metastatic melanoma.

Outcomes

Primary Outcome Measures

Part A;Number of Participants With Dose-Limiting Toxicities (DLT):

DLT was defined as any of the following AEs occurring in the first cycle of treatment which were attributable to the study drug: •Grade 5 events not clearly related to disease progression or any other causes, grade 3 or higher non-hematologic toxicity regardless of duration, and Hy's law cases will be considered DLTs. .•Grade 3 AST, ALT, or bilirubinemia that lasts >5 days •Grade 4 neutropenia or thrombocytopenia lasting >7 days Febrile neutropenia Grade 3 or higher thrombocytopenia with bleeding Grade 4 immune-related AEs regardless of duration Grade 3 or grade 4 non-infectious pneumonitis regardless of duration Grade 3 immune-related AEs, excluding colitis, hepatitis, and pneumonitis, that do not downgrade to grade ≤2 within 3 days after onset of the event despite maximal supportive care including systemic corticosteroids or downgrade to grade 1 or baseline within 14 days Grade 2 pneumonitis that does not resolve to grade 1 within 3 days of care Grade 3 colitis

Part A;Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant and jeopardized the participants or required treatment to prevent other AE outcomes for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs are events which occurred between first dose of study drug and up to 90 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.

Part A;Number of Participants With Treatment Related Adverse Events (AEs) and Serious Adverse Events (SAEs

An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant and jeopardized the participants or required treatment to prevent other AE outcomes for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs are events which occurred between first dose of study drug and up to 90 days after last dose that were absent before treatment or that worsened relative to pre-treatment state

Part A;Number of Participants With Adverse Events (AEs) According to Severity of Grade 3 or Higher Severity Based on NCI CTCAE Version 5.0

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant and jeopardized the participants or required treatment to prevent other AE outcomes for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs were graded according to the Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 and coded using the Medical Dictionary for Regulatory Activities (MedDRA) as Grade 3: Severe, Grade 4: Life threatening, Grade 5: Death related to AE. Participants were counted once according to the maximum grade observed

Part A;Number of Participants With Laboratory Test Abnormalities of Grade 3 or Higher Severity Based on NCI CTCAE Version 5.0: Biochemistry and Hematology

Laboratory parameters included hematological and biochemistry includes Na, Cl, ALT, AST, bilirubin (direct, total), alkaline phosphatase, lactate dehydrogenase, creatinine, glucose (preferably fasting) for hyper- or hypoglycemia, urea or blood urea nitrogen, cholesterol, triglyceride, CRP, uric acid, amylase, and lipase, hypercalcemia, hyperkalemia, hypermagnesemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypokalemia, hypomagnesemia, hyponatremia, hypophosphatemia. Hematology parameters included anemia, hemoglobin increased, lymphocyte count increased, lymphopenia, neutrophils (absolute), platelets and white blood cells Hematology panel will include hemoglobin, glycated hemoglobin HbA1c at study entry, hematocrit, red blood cell count (for anemia), reticulocytes, WBC count (with full differentiation for leukopenia, neutropenia and etc)), ALC (lymphopenia), and platelet count assessment of for thrombocytopenia.

Part A;Number of Participants With Laboratory Test Abnormalities: Urinalysis

Urinalysis parameter includes: pH, glucose, protein, bilirubin, urobilinogen. Microscopic examination: red blood cell count, WBC, epithelial cells, bacteria. In case of proteinuria ≥100 mg/dL at screening, a 24-hour urine analysis will have to be performed (prior to the start of SO-C101 treatment) to document 24-hour proteinuria levels and a urine test will continue during the treatment period. In case of increase of proteinuria with ≥300 mg/dL (at any time), a 24-hour urine analysis will be performed. Test abnormalities was defined as deviation from normal range: Urine blood/hemoglobin abnormality was defined as presence and absence of blood/hemoglobin in urine of participants

Part A;Number of Participants With Clinically Significant Change From Screening in Vital Signs

Vital signs included blood pressure, pulse rate, respiratory rate and weight. Change from screening values which are considered to be clinically significant based on investigator's judgement

Part A; Number of Participants With Eastern Cooperative Oncology Group [ECOG] Performance Status Score

ECOG performance status was used to assess how disease affect the daily living abilities of a participant. It was measured on a scale ranging from 0 to 4, where 0=fully active (able to carry on all pre-disease activities without restriction); 1=restricted in physically strenuous activity but ambulatory (able to carry out light/sedentary work); 2=ambulatory and capable of all self-care but unable to carry out any work activities (for more than 50% of waking hours); 3=capable of limited self-care, confined to bed or chair (for >50% of waking hours); 4=completely disabled, not capable of any self-care, totally confined to bed or chair. Higher scores signified =more functional impairment of a participant.

Part B: Number of Participants With Dose-Limiting Toxicities (DLT): Dose Finding Phase

Part B: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events

Part B: Number of Participants With Treatment Related Adverse Events (AEs) and Serious Adverse Events

Part B: Number of Participants With Adverse Events (AEs) According to Severity of Grade 3 or Higher Severity Based on NCI CTCAE Version 5.0

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant and jeopardized the participants or required treatment to prevent other AE outcomes for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs were graded according to the Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 and coded using the Medical Dictionary for Regulatory Activities (MedDRA) as Grade 3: Severe, Grade 4: Life threatening, Grade 5: Death related to AE. Participants were counted once according to the maximum grade observed.

Part B: Number of Participants With Laboratory Test Abnormalities of Grade 3 or Higher Severity Based on NCI CTCAE Version 5.0: Biochemistry and Hematology

Laboratory parameters included hematological and biochemistry parameters. Biochemistry parameters includes Na, Cl, ALT, AST, bilirubin (direct, total), alkaline phosphatase, lactate dehydrogenase, creatinine, glucose (preferably fasting) for hyper- or hypoglycemia, urea or blood urea nitrogen, cholesterol, triglyceride, CRP, uric acid, amylase, and lipase, hypercalcemia, hyperkalemia, hypermagnesemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypokalemia, hypomagnesemia, hyponatremia, hypophosphatemia. Hematology parameters included anemia, hemoglobin increased, lymphocyte count increased, lymphopenia, neutrophils (absolute), platelets and white blood cells Hematology panel includes hemoglobin, glycated hemoglobin HbA1c at study entry, hematocrit, red blood cell count (for anemia), reticulocytes, WBC count (with full differentiation for leukopenia, neutropenia and etc)), ALC (lymphopenia), and platelet count assessment of for thrombocytopenia.

Part B: Number of Participants With Laboratory Test Abnormalities: Urinalysis

Part B: Number of Participants With Clinically Significant Change From Screening in Vital Signs

Vital signs included blood pressure, pulse rate, respiratory rate and weight. Change from screening values which are considered to be clinically significant based on investigator's judgement.

Part B: Number of Participants With Eastern Cooperative Oncology Group [ECOG]

Secondary Outcome Measures

Part A PK parameters

Assess plasma concentration of SO-C101 at various timepoints

Part A Objective response rate (ORR)

based on investigator review of radiographic images according to iRECIST

Part A Best overall response (BOR)

BOR by iRECIST

Part A Duration of Response (DOR)

DOR by iRECIST

Part A Clinical benefit rate (CBR)

CBR by iRECIST

Part A Progression-Free Survival (PFS)

PFS by iRECIST

Part A Immunogenicity analysis to assess antibodies to SO-C101 in human serum

to assess antibodies to SO-C101 in human serum

Part B PK parameters of SO-C101 administered in combination with pemrolizumab

Assess plasma concentration of SO-C101 (administered in combination with pembrolizumab) at various timepoints

Part B Objective response rate (ORR)

SO-C101combined with pemrolizumab based on investigator review of radiographic images according to iRECIST

Part B Best overall response (BOR) of SO-C101

combined with pemrolizumab by iRECIST

Part B Duration of Response (DOR)

of SO-C101 combined with pembrolizumab by iRECIST

Part B Clinical benefit rate (CBR)

of SO-C101 combined with by iRECIST

Part B Progression-Free Survival (PFS)

of SO-C101combined with pemrolizumab by iRECIST

Immunogenicity analysis to assess antibodies to SO-C101

SO-C101 in human serum

Full Information

NCT ID

NCT04234113

First Posted

November 14, 2019

Last Updated

September 26, 2023

Sponsor

SOTIO Biotech AG

Collaborators

SOTIO Biotech a.s.

1. Study Identification

Unique Protocol Identification Number

NCT04234113

Brief Title

Study of SO-C101 and SO-C101 in Combination With Pembro in Adult Patients With Advanced/Metastatic Solid Tumors

Official Title

A Multicenter Open-label Phase 1/1b Study to Evaluate the Safety and Preliminary Efficacy of SO-C101 as Monotherapy and in Combination With Pembrolizumab in Patients With Selected Advanced/Metastatic Solid Tumors

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

June 13, 2019 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

SOTIO Biotech AG

Collaborators

SOTIO Biotech a.s.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

A multicenter open-label phase 1/1b study to evaluate the safety and preliminary efficacy of SO-C101 as monotherapy and in combination with pembrolizumab in patients with selected advanced/metastatic solid tumors

Detailed Description

This study will assess the safety and tolerability of SO-C101 administered as monotherapy and in combination with an anti-PD-1 antibody (pembrolizumab) in patients with selected relapsed/refractory advanced/metastatic solid tumors (renal cell carcinoma, non-small cell lung cancer, small-cell lung cancer, bladder cancer, melanoma, Merkel-cell carcinoma, skin squamous-cell carcinoma, microsatellite instability high solid tumors, triple-negative breast cancer, mesothelioma, thyroid cancer, thymic cancer, cervical cancer, biliary track cancer, hepatocellular carcinoma, ovarian cancer, gastric cancer, head and neck squamous-cell carcinoma, and anal cancer).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Thyroid, Renal Cell Carcinoma, Non Small Cell Lung Cancer, Small-cell Lung Cancer, Bladder Cancer, Melanoma, Merkel Cell Carcinoma, Skin Squamous Cell Carcinoma, Microsatellite Instability High, Triple Negative Breast Cancer, Mesothelioma, Thymic Cancer, Cervical Cancer, Biliary Tract Cancer, Hepatocellular Carcinoma, Ovarian Cancer, Gastric Cancer, Head and Neck Squamous Cell Carcinoma, Anal Cancer

Keywords

thyroid cancer, Renal Cell Carcinoma, Non Small Cell Lung Cancer, Small-cell Lung Cancer, Bladder Cancer, Melanoma, Merkel Cell Carcinoma, Skin Squamous Cell Carcinoma, Microsatellite Instability High, Triple Negative Breast Cancer, Mesothelioma, Thymic Cancer, Cervical Cancer, Biliary Tract Cancer, Hepatocellular Carcinoma, Ovarian Cancer, Gastric Cancer, Head and Neck Squamous Cell Carcinoma, Anal Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental: Part A (SO-C101 Monotherapy)

Arm Type

Experimental

Arm Description

Drug: SO-C101

Arm Title

Experimental: Part B (SO-C101 combined with pembrolizumab)

Arm Type

Experimental

Arm Description

Drug: SO-C101 Drug: pembrolizumab

Arm Title

Experimental: Part A1 (SO-C101 divided dosing, Monotherapy)

Arm Type

Experimental

Arm Description

Drug: SO-C101, twice a day as 2 divided doses (50%:50%)

Arm Title

Experimental: Part B1 (SO-C101 divided dosing, combined with pembrolizumab)

Arm Type

Experimental

Arm Description

Drug: SO-C101, twice a day as 2 divided doses (50%:50%) Drug: pembrolizumab

Arm Title

Experimental: Part D (SO-C101 Monotherapy, dose expansion at the RP2D identified in Part A)

Arm Type

Experimental

Arm Description

Arm Title

Part D1 (SO-C101 divided dosing, Monotherapy, dose expansion at RP2D identified in Part A1)

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

SO-C101

Other Intervention Name(s)

SOT101

Intervention Description

SO-C101

Intervention Type

Drug

Intervention Name(s)

pembrolizumab

Intervention Description

pembrolizumab

Primary Outcome Measure Information:

Title

Part A;Number of Participants With Dose-Limiting Toxicities (DLT):

Description

Time Frame

Through Cycle 1 (a cycle is 21 days]

Title

Part A;Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

Description

Time Frame

Cycle 1, Day 1 (each cycle is 21 days) through study completion an average of 1 year

Title

Part A;Number of Participants With Treatment Related Adverse Events (AEs) and Serious Adverse Events (SAEs

Description

Time Frame

assessed in average of 7 months

Title

Part A;Number of Participants With Adverse Events (AEs) According to Severity of Grade 3 or Higher Severity Based on NCI CTCAE Version 5.0

Description

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant and jeopardized the participants or required treatment to prevent other AE outcomes for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs were graded according to the Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 and coded using the Medical Dictionary for Regulatory Activities (MedDRA) as Grade 3: Severe, Grade 4: Life threatening, Grade 5: Death related to AE. Participants were counted once according to the maximum grade observed

Time Frame

assessed in average of 7 months

Title

Part A;Number of Participants With Laboratory Test Abnormalities of Grade 3 or Higher Severity Based on NCI CTCAE Version 5.0: Biochemistry and Hematology

Description

Time Frame

Cycle 1 Day 1 (each cycle is 21 days) through study completion, an average of 1 year

Title

Part A;Number of Participants With Laboratory Test Abnormalities: Urinalysis

Description

Time Frame

Cycle 1 Day 1, (each cycle is 21 days) through study completion, an average of 1 year

Title

Part A;Number of Participants With Clinically Significant Change From Screening in Vital Signs

Description

Vital signs included blood pressure, pulse rate, respiratory rate and weight. Change from screening values which are considered to be clinically significant based on investigator's judgement

Time Frame

Screening, through study completion, an average of 1 year

Title

Part A; Number of Participants With Eastern Cooperative Oncology Group [ECOG] Performance Status Score

Description

Time Frame

Screening, through study completion, an average of 1 year

Title

Part B: Number of Participants With Dose-Limiting Toxicities (DLT): Dose Finding Phase

Description

Time Frame

Cycle 1 Day 1 to Cycle 2 Day 1 21 days

Title

Part B: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events

Description

Time Frame

Cycle 1 Day 1, up to 90 days after last dose of study drug (assessed in average of 7 months

Title

Part B: Number of Participants With Treatment Related Adverse Events (AEs) and Serious Adverse Events

Description

Time Frame

Cycle 1 Day 1, up to 90 days after last dose of study drug (assessed in average of 7 months

Title

Part B: Number of Participants With Adverse Events (AEs) According to Severity of Grade 3 or Higher Severity Based on NCI CTCAE Version 5.0

Description

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant and jeopardized the participants or required treatment to prevent other AE outcomes for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs were graded according to the Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 and coded using the Medical Dictionary for Regulatory Activities (MedDRA) as Grade 3: Severe, Grade 4: Life threatening, Grade 5: Death related to AE. Participants were counted once according to the maximum grade observed.

Time Frame

Cycle 1 Day 1, (each cycle is 21 days) through study completion, an average of 1 year

Title

Part B: Number of Participants With Laboratory Test Abnormalities of Grade 3 or Higher Severity Based on NCI CTCAE Version 5.0: Biochemistry and Hematology

Description

Time Frame

Cycle 1 Day 1, (each cycle is 21 days) through study completion, an average of 1 year

Title

Part B: Number of Participants With Laboratory Test Abnormalities: Urinalysis

Description

Time Frame

Screening, through study completion, an average of 1 year

Title

Part B: Number of Participants With Clinically Significant Change From Screening in Vital Signs

Description

Vital signs included blood pressure, pulse rate, respiratory rate and weight. Change from screening values which are considered to be clinically significant based on investigator's judgement.

Time Frame

Screening, through study completion, an average of 1 year

Title

Part B: Number of Participants With Eastern Cooperative Oncology Group [ECOG]

Description

Time Frame

Screening, through study completion, an average of 1 year

Secondary Outcome Measure Information:

Title

Part A PK parameters

Description

Assess plasma concentration of SO-C101 at various timepoints

Time Frame

assessed in average of 2 months

Title

Part A Objective response rate (ORR)

Description

based on investigator review of radiographic images according to iRECIST

Time Frame

assessed in average of 5 months

Title

Part A Best overall response (BOR)

Description

BOR by iRECIST

Time Frame

assessed in average of 5 months

Title

Part A Duration of Response (DOR)

Description

DOR by iRECIST

Time Frame

assessed in average of 5 months

Title

Part A Clinical benefit rate (CBR)

Description

CBR by iRECIST

Time Frame

assessed in average of 5 months

Title

Part A Progression-Free Survival (PFS)

Description

PFS by iRECIST

Time Frame

assessed in average of 5 months

Title

Part A Immunogenicity analysis to assess antibodies to SO-C101 in human serum

Description

to assess antibodies to SO-C101 in human serum

Time Frame

assessed in average of 4 months

Title

Part B PK parameters of SO-C101 administered in combination with pemrolizumab

Description

Assess plasma concentration of SO-C101 (administered in combination with pembrolizumab) at various timepoints

Time Frame

assessed in average of 2 months

Title

Part B Objective response rate (ORR)

Description

SO-C101combined with pemrolizumab based on investigator review of radiographic images according to iRECIST

Time Frame

assessed in average of 5 months

Title

Part B Best overall response (BOR) of SO-C101

Description

combined with pemrolizumab by iRECIST

Time Frame

assessed in average of 5 months

Title

Part B Duration of Response (DOR)

Description

of SO-C101 combined with pembrolizumab by iRECIST

Time Frame

assessed in average of 5 months

Title

Part B Clinical benefit rate (CBR)

Description

of SO-C101 combined with by iRECIST

Time Frame

assessed in average of 5 months

Title

Part B Progression-Free Survival (PFS)

Description

of SO-C101combined with pemrolizumab by iRECIST

Time Frame

assessed in average of 5 months

Title

Immunogenicity analysis to assess antibodies to SO-C101

Description

SO-C101 in human serum

Time Frame

assessed in average of 4 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with selected histologically or cytologically confirmed advanced and/or metastatic solid tumors who are refractory to or intolerant of existing therapies known to provide clinical benefit for their condition. ECOG performance score 0-1. Patients with ECOG is 2 to be discussed with the sponsor's medical monitor to be agreed for inclusion. Estimated life expectancy of ≥3 months Washout periods: 4 weeks for chemotherapy, 4 weeks or 5 half-lives (whichever shorter) for biologic agents including immuno-oncology therapy and 4 weeks from major surgeries, definitive radiotherapy and 2 weeks after palliative radiotherapy At least one measurable lesion per iRECIST in a non-irradiated port. If in a previously irradiated port, must have demonstrated progression since best response to radiation therapy. Have fully recovered from previous treatment to grade ≤1 toxicity (excluding alopecia) or have stable grade 2 neuropathy Adequate organ system function Negative serum pregnancy test, if woman of child-bearing potential (WOCBP; non-childbearing is defined as greater than one year postmenopausal or surgically sterilized). Accessible tumor tissue available for fresh biopsy Exclusion Criteria: Key exclusion criteria (Part A and B) Patient with untreated CNS metastases and/or leptomeningeal carcinomatosis (see list of all exclusion criteria for details) Known additional malignancy that is progressing and/or requires active treatment. Prior exposure to drugs that are agonists of IL-2- or IL-15-like but not limited to rhIL-15 (NCI), ALT-803 (ALTOR), NKTR-214 (Nektar) History of and current interstitial lung disease or fibrosis and pneumonitis; patients with clinically significant or oxygen requiring COPD or any chronic inflammatory disease (sarcoidosis etc.) Has received a live vaccine within 30 days of planned start of study therapy (see list of all exclusion criteria for details) Absolute WBC count ≤ 2.0 ×109/L; ALC ≤0.5×109/L Absolute neutrophil count ≤1.0 ×109/L Platelet count ≤100×109/L Pregnant or breastfeeding women Any active autoimmune disease or a documented history of autoimmune disease, poorly controlled asthma, or history of syndrome that required systemic steroids (except the allowed doses) or immunosuppressive medications, except for patients with vitiligo or resolved childhood asthma/atopy (see list of all exclusion criteria for details) Specific co-morbidities (see list of all exclusion criteria for details) Is hypersensitive to any of the ingredients of pembrolizumab drug product (KeytrudaTM) History of solid organ transplantation or hematopoietic stem cell transplantation

Facility Information:

Facility Name

Yale Cancer Center

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06520

Country

United States

Facility Name

University of Pittsburgh

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15216

Country

United States

Facility Name

MD Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Masarykův Onkologický Ústav Brno Klinika komplexní onkologické péče

City

Brno

ZIP/Postal Code

65653

Country

Czechia

Facility Name

Centre Léon Bérard

City

Lyon

ZIP/Postal Code

69379

Country

France

Facility Name

Hôpitaux Universitaires de Marseille Timone

City

Marseille

ZIP/Postal Code

13005

Country

France

Facility Name

Hopital Saint Louis

City

Paris

ZIP/Postal Code

75010

Country

France

Facility Name

Institut Gustave Roussy

City

Paris

ZIP/Postal Code

94805

Country

France

Facility Name

Institut de Cancerologie de L'Ouest

City

Saint Herblain

ZIP/Postal Code

44805

Country

France

Facility Name

Institut Claudius Regaud

City

Toulouse

ZIP/Postal Code

31059

Country

France

Facility Name

Vall d'Hebron Institute of Oncology

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

University Hospital Sanchinarro

City

Madrid

ZIP/Postal Code

28050

Country

Spain

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Study of SO-C101 and SO-C101 in Combination With Pembro in Adult Patients With Advanced/Metastatic Solid Tumors

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