Description:
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
Title
- 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
Clinical Trial IDs
- ORG STUDY ID:
SC103
- NCT ID:
NCT04234113
Conditions
- 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
Interventions
Drug | Synonyms | Arms |
---|
SO-C101 | | Experimental: Part A (SO-C101 Monotherapy) |
pembrolizumab | | Experimental: Part B (SO-C101 combined with pembrolizumab) |
Purpose
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).
Trial Arms
Name | Type | Description | Interventions |
---|
Experimental: Part A (SO-C101 Monotherapy) | Experimental | Drug: SO-C101 | |
Experimental: Part B (SO-C101 combined with pembrolizumab) | Experimental | Drug: SO-C101 Drug: pembrolizumab | |
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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Part A;Number of Participants With Dose-Limiting Toxicities (DLT): |
Time Frame: | Through Cycle 1 (a cycle is 21 days] |
Safety Issue: | |
Description: | 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 |
Secondary Outcome Measures
Measure: | Part A PK parameters |
Time Frame: | assessed in average of 2 months |
Safety Issue: | |
Description: | Assess plasma concentration of SO-C101 at various timepoints |
Measure: | Part A Objective response rate (ORR) |
Time Frame: | assessed in average of 5 months |
Safety Issue: | |
Description: | based on investigator review of radiographic images according to iRECIST |
Measure: | Part A Best overall response (BOR) |
Time Frame: | assessed in average of 5 months |
Safety Issue: | |
Description: | BOR by iRECIST |
Measure: | Part A Duration of Response (DOR) |
Time Frame: | assessed in average of 5 months |
Safety Issue: | |
Description: | DOR by iRECIST |
Measure: | Part A Clinical benefit rate (CBR) |
Time Frame: | assessed in average of 5 months |
Safety Issue: | |
Description: | CBR by iRECIST |
Measure: | Part A Progression-Free Survival (PFS) |
Time Frame: | assessed in average of 5 months |
Safety Issue: | |
Description: | PFS by iRECIST |
Measure: | Part A Immunogenicity analysis to assess antibodies to SO-C101 in human serum |
Time Frame: | assessed in average of 4 months |
Safety Issue: | |
Description: | to assess antibodies to SO-C101 in human serum |
Measure: | Part B PK parameters of SO-C101 administered in combination with pemrolizumab |
Time Frame: | assessed in average of 2 months |
Safety Issue: | |
Description: | Assess plasma concentration of SO-C101 (administered in combination with pembrolizumab) at various timepoints |
Measure: | Part B Objective response rate (ORR) |
Time Frame: | assessed in average of 5 months |
Safety Issue: | |
Description: | SO-C101combined with pemrolizumab based on investigator review of radiographic images according to iRECIST |
Measure: | Part B Best overall response (BOR) of SO-C101 |
Time Frame: | assessed in average of 5 months |
Safety Issue: | |
Description: | combined with pemrolizumab by iRECIST |
Measure: | Part B Duration of Response (DOR) |
Time Frame: | assessed in average of 5 months |
Safety Issue: | |
Description: | of SO-C101 combined with pembrolizumab by iRECIST |
Measure: | Part B Clinical benefit rate (CBR) |
Time Frame: | assessed in average of 5 months |
Safety Issue: | |
Description: | of SO-C101 combined with by iRECIST |
Measure: | Part B Progression-Free Survival (PFS) |
Time Frame: | assessed in average of 5 months |
Safety Issue: | |
Description: | of SO-C101combined with pemrolizumab by iRECIST |
Measure: | Immunogenicity analysis to assess antibodies to SO-C101 |
Time Frame: | assessed in average of 4 months |
Safety Issue: | |
Description: | SO-C101 in human serum |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Sotio a.s. |
Trial 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
Last Updated
April 21, 2021